Clinical Trials in Dentistry: A Cross-sectional Analysis of World Health Organization-International Clinical Trial Registry Platform.

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Sivaramakrishnan, Gowri; Sridharan, Kannan

2016-06-01

Clinical trials are the back bone for evidence-based practice (EBP) and recently EBP has been considered the best source of treatment strategies available. Clinical trial registries serve as databases of clinical trials. As regards to dentistry in specific data on the number of clinical trials and their quality is lacking. Hence, the present study was envisaged. Clinical trials registered in WHO-ICTRP (http://apps.who.int/trialsearch/AdvSearch.aspx) in dental specialties were considered. The details assessed from the collected trials include: Type of sponsors; Health condition; Recruitment status; Study design; randomization, method of randomization and allocation concealment; Single or multi-centric; Retrospective or prospective registration; and Publication status in case of completed studies. A total of 197 trials were identified. Maximum trials were from United States (n = 30) and United Kingdom (n = 38). Seventy six trials were registered in Clinical Trials.gov, 54 from International Standards of Reporting Clinical Trials, 13 each from Australia and New Zealand Trial Register and Iranian Registry of Clinical Trials, 10 from German Clinical Trial Registry, eight each from Brazilian Clinical Trial Registry and Nederland's Trial Register, seven from Japan Clinical Trial Registry, six from Clinical Trial Registry of India and two from Hong Kong Clinical Trial Registry. A total of 78.7% studies were investigator-initiated and 64% were completed while 3% were terminated. Nearly four-fifths of the registered trials (81.7%) were interventional studies of which randomized were the large majority (94.4%) with 63.2% being open label, 20.4% using single blinding technique and 16.4% were doubled blinded. The number, methodology and the characteristics of clinical trials in dentistry have been noted to be poor especially in terms of being conducted multi-centrically, employing blinding and the method for randomization and allocation concealment. More emphasis has to be

Randomized controlled trials of HIV/AIDS prevention and treatment in Africa: results from the Cochrane HIV/AIDS Specialized Register.

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Babalwa Zani

Full Text Available INTRODUCTION: To effectively address HIV/AIDS in Africa, evidence on preventing new infections and providing effective treatment is needed. Ideally, decisions on which interventions are effective should be based on evidence from randomized controlled trials (RCTs. Our previous research described African RCTs of HIV/AIDS reported between 1987 and 2003. This study updates that analysis with RCTs published between 2004 and 2008. OBJECTIVES: To describe RCTs of HIV/AIDS conducted in Africa and reported between 2004 and 2008. METHODS: We searched the Cochrane HIV/AIDS Specialized Register in September 2009. Two researchers independently evaluated studies for inclusion and extracted data using standardized forms. Details included location of trials, interventions, methodological quality, location of principal investigators and funders. RESULTS: Our search identified 834 RCTs, with 68 conducted in Africa. Forty-three assessed prevention-interventions and 25 treatment-interventions. Fifteen of the 43 prevention RCTs focused on preventing mother-to-child HIV transmission. Thirteen of the 25 treatment trials focused on opportunistic infections. Trials were conducted in 16 countries with most in South Africa (20, Zambia (12 and Zimbabwe (9. The median sample size was 628 (range 33-9645. Methods used for the generation of the allocation sequence and allocation concealment were adequate in 38 and 32 trials, respectively, and 58 reports included a CONSORT recommended flow diagram. Twenty-nine principal investigators resided in the United States of America (USA and 18 were from African countries. Trials were co-funded by different agencies with most of the funding obtained from USA governmental and non-governmental agencies. Nineteen pharmaceutical companies provided partial funding to 15 RCTs and African agencies co-funded 17 RCTs. Ethical approval was reported in 65 trials and informed consent in 61 trials. CONCLUSION: Prevention trials dominate the trial

Quality of registration for clinical trials published in emergency medicine journals.

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Jones, Christopher W; Platts-Mills, Timothy F

2012-10-01

In 2005, the International Committee of Medical Journal Editors established clinical trial registration as a requirement for articles submitted to member journals, with the goal of improving the transparency of clinical research. The objective of this study is to characterize the registration of clinical trials published in emergency medicine journals. Randomized trials involving human subjects and published between June 1, 2008, and May 31, 2011 in the 5 emergency medicine journals with the highest impact factors were included. We assessed the clarity of registered primary outcomes, timing of registration relative to patient enrollment, and consistency between registered and published outcomes. Of the 123 trials included, registry entries were identified for 57 (46%). Of the 57 registered studies, 45 (79%) were registered after the initiation of subject enrollment, 9 (16%) had registered outcomes that were unclear, and 26 (46%) had discrepancies between registered and published outcomes. Only 5 studies were registered before patient enrollment with a clear primary outcome that was consistent with the published primary outcome. Annals of Emergency Medicine was the only journal in which the majority of trials were registered. Current compliance with clinical trial registration guidelines is poor among trials published in emergency medicine journals. Copyright © 2012. Published by Mosby, Inc.

Clinical trial registration in oral health journals.

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Smaïl-Faugeron, V; Fron-Chabouis, H; Durieux, P

2015-03-01

Prospective registration of randomized controlled trials (RCTs) represents the best solution to reporting bias. The extent to which oral health journals have endorsed and complied with RCT registration is unknown. We identified journals publishing RCTs in dentistry, oral surgery, and medicine in the Journal Citation Reports. We classified journals into 3 groups: journals requiring or recommending trial registration, journals referring indirectly to registration, and journals providing no reference to registration. For the 5 journals with the highest 2012 impact factors in each group, we assessed whether RCTs with results published in 2013 had been registered. Of 78 journals examined, 32 (41%) required or recommended trial registration, 19 (24%) referred indirectly to registration, and 27 (35%) provided no reference to registration. We identified 317 RCTs with results published in the 15 selected journals in 2013. Overall, 73 (23%) were registered in a trial registry. Among those, 91% were registered retrospectively and 32% did not report trial registration in the published article. The proportion of trials registered was not significantly associated with editorial policies: 29% with results in journals that required or recommended registration, 15% in those that referred indirectly to registration, and 21% in those providing no reference to registration (P = 0.05). Less than one-quarter of RCTs with results published in a sample of oral health journals were registered with a public registry. Improvements are needed with respect to how journals inform and require their authors to register their trials. © International & American Associations for Dental Research.

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

Directory of Open Access Journals (Sweden)

Amelia Scott

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

Prospective registration, bias risk and outcome-reporting bias in randomised clinical trials of traditional Chinese medicine

DEFF Research Database (Denmark)

Liu, Jian-Ping; Han, Mei; Li, Xin-Xue

2013-01-01

Clinical trials on Traditional Chinese Medicine (TCM) should be registered in a publicly accessible international trial register and report on all outcomes. We systematically assessed and evaluated TCM trials in registries with their subsequent publications.......Clinical trials on Traditional Chinese Medicine (TCM) should be registered in a publicly accessible international trial register and report on all outcomes. We systematically assessed and evaluated TCM trials in registries with their subsequent publications....

Recent Clinical Trials in Osteoporosis: A Firm Foundation or Falling Short?

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Karen Barnard

Full Text Available The global burden of osteoporotic fractures is associated with significant morbidity, mortality, and healthcare costs. We examined the ClinicalTrials.gov database to determine whether recently registered clinical trials addressed prevention and treatment in those at high risk for fracture. A dataset of 96,346 trials registered in ClinicalTrials.gov was downloaded on September 27, 2010. At the time of the dataset download, 40,970 interventional trials had been registered since October 1, 2007. The osteoporosis subset comprised 239 interventional trials (0.6%. Those trials evaluating orthopedic procedures were excluded. The primary purpose was treatment in 67.0%, prevention in 20.1%, supportive care in 5.8%, diagnostic in 2.2%, basic science in 3.1%, health services research in 0.9%, and screening in 0.9%. The majority of studies (61.1% included drug-related interventions. Most trials (56.9% enrolled only women, 38.9% of trials were open to both men and women, and 4.2% enrolled only men. Roughly one fifth (19.7% of trials excluded research participants older than 65 years, and 33.5% of trials excluded those older than 75 years. The funding sources were industry in 51.0%, the National Institutes of Health in 6.3%, and other in 42.7%. We found that most osteoporosis-related trials registered from October 2007 through September 2010 examined the efficacy and safety of drug treatment, and fewer trials examined prevention and non-drug interventions. Trials of interventions that are not required to be registered in ClinicalTrials.gov may be underrepresented. Few trials are specifically studying osteoporosis in men and older adults. Recently registered osteoporosis trials may not sufficiently address fracture prevention.

Das sprachliche Register (Speech Registers)

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Hess-Luttich, Ernest W. B.

1974-01-01

The linguistic behavior of a given individual varies; he will on different occasions speak (or write) differently according to what may be roughly described as different social situations: he will use a number of different registers. The application of such registers both in the field of text analysis and in the preparation of teaching materials…

Tinnitus after Simultaneous and Sequential Bilateral Cochlear Implantation

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Geerte G. J. Ramakers

2017-11-01

, four patients had an additional benefit of the second CI: a total suppression of tinnitus compared with their unilateral situation.ConclusionWhile bilateral cochlear implantation can have a positive effect on preoperative tinnitus complaints, the induction of (temporary or permanent tinnitus was also reported.Clinical Trial RegistrationDutch Trial Register NTR1722.

Transparency of outcome reporting and trial registration of randomized controlled trials in top psychosomatic and behavioral health journals: A systematic review.

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Milette, Katherine; Roseman, Michelle; Thombs, Brett D

2011-03-01

The most reliable evidence for evaluating healthcare interventions comes from well-designed and conducted randomized controlled trials (RCTs). The extent to which published RCTs reflect the efficacy of interventions, however, depends on the completeness and accuracy of published results. The Consolidated Standards of Reporting Trials statement, initially developed in 1996, provides guidelines intended to improve the transparency of published RCT reports. A policy of the International Committee of Medical Journal Editors, initiated in 2005, requires clinical trials published in member journals to be registered in publicly accessible registries prior to patient enrollment. The objective of this study was to assess the clarity of outcome reporting, proportion of registered trials, and adequacy of outcome registration in RCTs published in top behavioral health journals. Eligible studies were primary or secondary reports of RCTs published in Annals of Behavioral Medicine, Health Psychology, Journal of Psychosomatic Research, and Psychosomatic Medicine from January 2008 to September 2009. Data were extracted for each study on adequacy of outcome reporting and registration. Of 63 articles reviewed, only 25 (39.7%) had adequately declared primary or secondary outcomes, whereas 38 (60.3%) had multiple primary outcomes or did not define outcomes. Only 13 studies (20.6%) were registered. Only 1 study registered sufficiently precise outcome information to compare with published outcomes, and registered and published outcomes were discrepant in that study. Greater attention to outcome reporting and trial registration by researchers, peer reviewers, and journal editors will increase the likelihood that effective behavioral health interventions are readily identified and made available to patients. Copyright © 2011 Elsevier Inc. All rights reserved.

Improving transparency and reproducibility through registration: The status of intervention trials published in clinical psychology journals.

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Cybulski, Lukasz; Mayo-Wilson, Evan; Grant, Sean

2016-09-01

Prospective registration increases the validity of randomized controlled trials (RCTs). In the United States, registration is a legal requirement for drugs and devices regulated by the Food and Drug Administration (FDA), and many biomedical journals refuse to publish trials that are not registered. Trials in clinical psychology have not been subject to these requirements; it is unknown to what extent they are registered. We searched the 25 highest-impact clinical psychology journals that published at least 1 RCT of a health-related psychological intervention in 2013. For included trials, we evaluated their registration status (prospective, retrospective, not registered) and the completeness of their outcome definitions. We identified 163 articles that reported 165 RCTs; 73 (44%) RCTs were registered, of which only 25 (15%) were registered prospectively. Of registered RCTs, only 42 (58%) indicated their registration status in the publication. Only 2 (1% of all trials) were registered prospectively and defined their primary outcomes completely. For the primary outcome(s), 72 (99%) of all registrations defined the domain, 67 (92%) the time frame, and 48 (66%) the specific measurements. Only 19 (26%) and 5 (7%) defined the specific metric and method of aggregation, respectively, for all primary outcomes. Very few reports of RCTs published in clinical psychology journals were registered prospectively and completely. Clinical psychology journals could improve transparency and reproducibility, as well as reduce bias, by requiring complete prospective trial registration for publication and by including trial registration numbers in all reports of RCTs. (PsycINFO Database Record (c) 2016 APA, all rights reserved).

Inadvertent P-hacking among trials and systematic reviews of the effect of progestogens in pregnancy? A systematic review and meta-analysis.

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Prior, M; Hibberd, R; Asemota, N; Thornton, J G

2017-06-01

Progestogens have been evaluated in numerous trials and meta-analyses, many of which concluded they were effective. However, two large trials PROMISE and OPPTIMUM have recently concluded that progesterone was ineffective. This raises the possibility that earlier studies and reviews had been biased by either selective publication or selective choice of outcomes, so called "P-hacking". To compare the findings all progestogen trials and systematic reviews with those of trials with pre-registered primary outcomes which avoided selective outcome reporting. Search of PubMed, the Cochrane Library and trial registries. Registration PROSPERO CRD42016035303. Systematic reviews of randomised trials comparing progestogen with placebo in pregnancy and the individual trials included in those reviews. The subset of trials reporting a pre-registered primary outcome were compared with the totality of trials and reviews. For reviews all outcomes were included. For individual trials all outcomes reported in the systematic reviews were included. For the comparison group we recorded the registered primary outcome from trials that were either registered before they started, or registered during the recruitment phase and also double blind. Nineteen of twenty-nine meta-analyses concluded that progestogens were effective. Twenty-two trials reported their pre-registered primary outcomes. There was no effect of progesterone on primary registered dichotomous outcome RR 1.00 (95% CI 0.94-1.07). Only one of the 22 showed a nominally statistically significant benefit. When evaluated in registered double-blind trials with analysis restricted to predefined primary outcomes, progestational agents in pregnancy are ineffective. Progestogens to prevent pregnancy loss, an example of P-hacking. © 2017 Royal College of Obstetricians and Gynaecologists.

The INCA trial (Impact of NOD2 genotype-guided antibiotic prevention on survival in patients with liver Cirrhosis and Ascites): study protocol for a randomized controlled trial.

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Casper, Markus; Mengel, Martin; Fuhrmann, Christine; Herrmann, Eva; Appenrodt, Beate; Schiedermaier, Peter; Reichert, Matthias; Bruns, Tony; Engelmann, Cornelius; Grünhage, Frank; Lammert, Frank

2015-03-08

Patients with liver cirrhosis have a highly elevated risk of developing bacterial infections that significantly decrease survival rates. One of the most relevant infections is spontaneous bacterial peritonitis (SBP). Recently, NOD2 germline variants were found to be potential predictors of the development of infectious complications and mortality in patients with cirrhosis. The aim of the INCA (Impact of NOD2 genotype-guided antibiotic prevention on survival in patients with liver Cirrhosis and Ascites) trial is to investigate whether survival of this genetically defined high-risk group of patients with cirrhosis defined by the presence of NOD2 variants is improved by primary antibiotic prophylaxis of SBP. The INCA trial is a double-blind, placebo-controlled clinical trial with two parallel treatment arms (arm 1: norfloxacin 400 mg once daily; arm 2: placebo once daily; 12-month treatment and observational period). Balanced randomization of 186 eligible patients with stratification for the protein content of the ascites (INCA trial is first in the field of hepatology aimed at rapidly transferring and validating information on individual genetic risk into clinical decision algorithms. German Clinical Trials Register DRKS00005616 . Registered 22 January 2014. EU Clinical Trials Register EudraCT 2013-001626-26 . Registered 26 January 2015.

Linking ClinicalTrials.gov and PubMed to track results of interventional human clinical trials.

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Vojtech Huser

Full Text Available OBJECTIVE: In an effort to understand how results of human clinical trials are made public, we analyze a large set of clinical trials registered at ClinicalTrials.gov, the world's largest clinical trial registry. MATERIALS AND METHODS: We considered two trial result artifacts: (1 existence of a trial result journal article that is formally linked to a registered trial or (2 the deposition of a trial's basic summary results within the registry. RESULTS: The study sample consisted of 8907 completed, interventional, phase 2-or-higher clinical trials that were completed in 2006-2009. The majority of trials (72.2% had no structured trial-article link present. A total of 2367 trials (26.6% deposited basic summary results within the registry. Of those, 969 trials (10.9% were classified as trials with extended results and 1398 trials (15.7% were classified as trials with only required basic results. The majority of the trials (54.8% had no evidence of results, based on either linked result articles or basic summary results (silent trials, while a minimal number (9.2% report results through both registry deposition and publication. DISCUSSION: Our study analyzes the body of linked knowledge around clinical trials (which we refer to as the "trialome". Our results show that most trials do not report results and, for those that do, there is minimal overlap in the types of reporting. We identify several mechanisms by which the linkages between trials and their published results can be increased. CONCLUSION: Our study shows that even when combining publications and registry results, and despite availability of several information channels, trial sponsors do not sufficiently meet the mandate to inform the public either via a linked result publication or basic results submission.

Published intimate partner violence studies often differ from their trial registration records.

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Madden, Kim; Tai, Kerry; Ali, Zak; Schneider, Patricia; Singh, Mahip; Ghert, Michelle; Bhandari, Mohit

2017-12-27

Registering study protocols in a trial registry is important for methodologic transparency and reducing selective reporting bias. The objective of this investigation was to determine whether published studies of intimate partner violence (IPV) that had been registered matched the registration record on key study design elements. We systematically searched three trial registries to identify registered IPV studies and the published literature for the associated publication. Two authors independently determined for each study whether key study elements in the registry matched those in the published paper. We included 66 studies published between 2006 and 2017. Nearly half (29/66, 44%) were registered after study completion. Many (26/66, 39%) had discrepancies regarding the primary outcome, and nearly two-thirds (42/66, 64%) had discrepancies in secondary outcomes. Discrepancies in study design were less frequent (13/66, 20%). However, large changes in sample size (26/66, 39%) and discrepancies in funding source (28/66, 42%) were frequently observed. Trial registries are important tools for research transparency and identifying and preventing outcome switching and selective outcome reporting bias. Published IPV studies often differ from their records in trial registries. Researchers should pay close attention to the accuracy of trial registry records.

Trial publication after registration in ClinicalTrials.Gov: a cross-sectional analysis.

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Joseph S Ross

2009-09-01

Full Text Available ClinicalTrials.gov is a publicly accessible, Internet-based registry of clinical trials managed by the US National Library of Medicine that has the potential to address selective trial publication. Our objectives were to examine completeness of registration within ClinicalTrials.gov and to determine the extent and correlates of selective publication.We examined reporting of registration information among a cross-section of trials that had been registered at ClinicalTrials.gov after December 31, 1999 and updated as having been completed by June 8, 2007, excluding phase I trials. We then determined publication status among a random 10% subsample by searching MEDLINE using a systematic protocol, after excluding trials completed after December 31, 2005 to allow at least 2 y for publication following completion. Among the full sample of completed trials (n = 7,515, nearly 100% reported all data elements mandated by ClinicalTrials.gov, such as intervention and sponsorship. Optional data element reporting varied, with 53% reporting trial end date, 66% reporting primary outcome, and 87% reporting trial start date. Among the 10% subsample, less than half (311 of 677, 46% of trials were published, among which 96 (31% provided a citation within ClinicalTrials.gov of a publication describing trial results. Trials primarily sponsored by industry (40%, 144 of 357 were less likely to be published when compared with nonindustry/nongovernment sponsored trials (56%, 110 of 198; p<0.001, but there was no significant difference when compared with government sponsored trials (47%, 57 of 122; p = 0.22. Among trials that reported an end date, 75 of 123 (61% completed prior to 2004, 50 of 96 (52% completed during 2004, and 62 of 149 (42% completed during 2005 were published (p = 0.006.Reporting of optional data elements varied and publication rates among completed trials registered within ClinicalTrials.gov were low. Without greater attention to reporting of all data

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

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

2016-03-22

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

An interim analysis of recruitment to the COLOFOL trial

DEFF Research Database (Denmark)

Wille-Jørgensen, Peer; Laurberg, S.; Pahlman, L.

2009-01-01

Objective To analyse the ongoing process of recruiting patients into a multicenter randomized trial on follow-up after curative surgery for colorectal cancer. The trial is registered in Clinical Trials Registration. Method Prospective registration of all operated patients as well as inclusions...

A Scandinavian Experience of Register Collaboration: The Nordic Arthroplasty Register Association (NARA)

DEFF Research Database (Denmark)

Havelin, Leif I; Robertsson, Otto; Fenstad, Anne M

2011-01-01

The Nordic (Scandinavian) countries have had working arthroplasty registers for several years. However, the small numbers of inhabitants and the conformity within each country with respect to preferred prosthesis brands and techniques have limited register research.......The Nordic (Scandinavian) countries have had working arthroplasty registers for several years. However, the small numbers of inhabitants and the conformity within each country with respect to preferred prosthesis brands and techniques have limited register research....

Josephson shift registers

International Nuclear Information System (INIS)

Przybysz, J.X.

1989-01-01

This paper gives a review of Josephson shift register circuits that were designed, fabricated, or tested, with emphasis on work in the 1980s. Operating speed is most important, since it often limits system performance. Older designs used square-wave clocks, but most modern designs use offset sine waves, with either two or three phases. Operating margins and gate bias uniformity are key concerns. The fastest measured Josephson shift register operated at 2.3 GHz, which compares well with a GaAs shift register that consumes 250 times more power. The difficulties of high-speed testing have prevented many Josephson shift registers from being operated at their highest speeds. Computer simulations suggest that 30-GHz operation is possible with current Nb/Al 2 O 3 /Nb technology. Junctions with critical current densities near 10 kA/cm 2 would make 100-GHz shift registers feasible

Practical and conceptual issues of clinical trial registration for Brazilian researchers

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Carolina Gomes Freitas

Full Text Available CONTEXT AND OBJECTIVE: Clinical trial registration is a prerequisite for publication in respected scientific journals. Recent Brazilian regulations also require registration of some clinical trials in the Brazilian Clinical Trials Registry (ReBEC but there is little information available about practical issues involved in the registration process. This article discusses the importance of clinical trial registration and the practical issues involved in this process. DESIGN AND SETTING: Descriptive study conducted by researchers within a postgraduate program at a public university in São Paulo, Brazil. METHODS: Information was obtained from clinical trial registry platforms, article reference lists and websites (last search: September 2014 on the following topics: definition of a clinical trial, history, purpose and importance of registry platforms, the information that should be registered and the registration process. RESULTS: Clinical trial registration aims to avoid publication bias and is required by Brazilian journals indexed in LILACS and SciELO and by journals affiliated to the International Committee of Medical Journal Editors (ICMJE. Recent Brazilian regulations require that all clinical trials (phases I to IV involving new drugs to be marketed in this country must be registered in ReBEC. The pros and cons of using different clinical trial registration platforms are discussed. CONCLUSIONS: Clinical trial registration is important and various mechanisms to enforce its implementation now exist. Researchers should take into account national regulations and publication requirements when choosing the platform on which they will register their trial.

Arthroplasty register for Germany

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Hagen, Anja

2009-10-01

Full Text Available Scientific background: The annual number of joint replacement operations in Germany is high. The introduction of an arthroplasty register promises an important contribution to the improvement of the quality of patient’s care. Research questions: The presented report addresses the questions on organization and functioning, benefits and cost-benefits as well as on legal, ethical and social aspects of the arthroplasty registers. Methods: A systematic literature search was conducted in September 2008 in the medical databases MEDLINE, EMBASE etc. and was complemented with a hand search. Documents describing arthroplasty registers and/or their relevance as well as papers on legal, ethical and social aspects of such registers were included in the evaluation. The most important information was extracted and analysed. Results: Data concerning 30 arthroplasty registers in 19 countries as well as one international arthroplasty register were identified. Most of the arthroplasty registers are maintained by national orthopedic societies, others by health authorities or by their cooperation. Mostly, registries are financially supported by governments and rarely by other sources.The participation of the orthopedists in the data collection process of the arthroplasty registry is voluntary in most countries. The consent of the patients is usually required. The unique patient identification is ensured in nearly all registers.Each data set consists of patient and clinic identification numbers, data on diagnosis, the performed intervention, the operation date and implanted prostheses. The use of clinical scores, patient-reported questionnaires and radiological documentation is rare. Methods for data documentation and transfer are paper form, electronic entry as well as scanning of the data using bar codes. The data are mostly being checked for their completeness and validity. Most registers offer results of the data evaluation to the treating orthopedists and

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

International Nuclear Information System (INIS)

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

2016-01-01

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

Pediatric Clinical Trials Conducted in South Korea from 2006 to 2015: An Analysis of the South Korean Clinical Research Information Service, US ClinicalTrials.gov and European Clinical Trials Registries.

Science.gov (United States)

Choi, Sheung-Nyoung; Lee, Ji-Hyun; Song, In-Kyung; Kim, Eun-Hee; Kim, Jin-Tae; Kim, Hee-Soo

2017-12-01

The status of pediatric clinical trials performed in South Korea in the last decade, including clinical trials of drugs with unapproved indications for children, has not been previously examined. The aim was to provide information regarding the current state of pediatric clinical trials and create a basis for future trials performed in South Korea by reviewing three databases of clinical trials registrations. We searched for pediatric clinical studies (participants South Korea between 2006 and 2015 registered on the Clinical Research Information Service (CRIS), ClinicalTrials.gov, and the European Clinical Trials Registry (EuCTR). Additionally, we reviewed whether unapproved indications were involved in each trial by comparing the trials with a list of authorized trials provided by the Ministry of Food and Drug Safety (MFDS). The primary and secondary outcomes were to determine the change in number of pediatric clinical trials with unapproved indications over time and to assess the status of unauthorized pediatric clinical trials from the MFDS and the publication of articles after these clinical trials, respectively. We identified 342 clinical studies registered in the CRIS (n = 81), ClinicalTrials.gov (n = 225), and EuCTR (n = 36), of which 306 were reviewed after excluding duplicate registrations. Among them, 181 studies were interventional trials dealing with drugs and biological agents, of which 129 (71.3%) involved unapproved drugs. Of these 129 trials, 107 (82.9%) were authorized by the MFDS. Pediatric clinical trials in South Korea aiming to establish the safety and efficacy of drugs in children are increasing; however, non-MFDS-authorized studies remain an issue.

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

Science.gov (United States)

Tharyan, Prathap

2009-02-01

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

Statistical analysis plan for the Pneumatic CompREssion for PreVENting Venous Thromboembolism (PREVENT) trial: a study protocol for a randomized controlled trial.

Science.gov (United States)

Arabi, Yaseen; Al-Hameed, Fahad; Burns, Karen E A; Mehta, Sangeeta; Alsolamy, Sami; Almaani, Mohammed; Mandourah, Yasser; Almekhlafi, Ghaleb A; Al Bshabshe, Ali; Finfer, Simon; Alshahrani, Mohammed; Khalid, Imran; Mehta, Yatin; Gaur, Atul; Hawa, Hassan; Buscher, Hergen; Arshad, Zia; Lababidi, Hani; Al Aithan, Abdulsalam; Jose, Jesna; Abdukahil, Sheryl Ann I; Afesh, Lara Y; Dbsawy, Maamoun; Al-Dawood, Abdulaziz

2018-03-15

The Pneumatic CompREssion for Preventing VENous Thromboembolism (PREVENT) trial evaluates the effect of adjunctive intermittent pneumatic compression (IPC) with pharmacologic thromboprophylaxis compared to pharmacologic thromboprophylaxis alone on venous thromboembolism (VTE) in critically ill adults. In this multicenter randomized trial, critically ill patients receiving pharmacologic thromboprophylaxis will be randomized to an IPC or a no IPC (control) group. The primary outcome is "incident" proximal lower-extremity deep vein thrombosis (DVT) within 28 days after randomization. Radiologists interpreting the lower-extremity ultrasonography will be blinded to intervention allocation, whereas the patients and treating team will be unblinded. The trial has 80% power to detect a 3% absolute risk reduction in the rate of proximal DVT from 7% to 4%. Consistent with international guidelines, we have developed a detailed plan to guide the analysis of the PREVENT trial. This plan specifies the statistical methods for the evaluation of primary and secondary outcomes, and defines covariates for adjusted analyses a priori. Application of this statistical analysis plan to the PREVENT trial will facilitate unbiased analyses of clinical data. ClinicalTrials.gov , ID: NCT02040103 . Registered on 3 November 2013; Current controlled trials, ID: ISRCTN44653506 . Registered on 30 October 2013.

Debug register rootkits : A study of malicious use of the IA-32 debug registers

OpenAIRE

Persson, Emil; Mattsson, Joel

2012-01-01

The debug register rootkit is a special type of rootkit that has existed for over a decade, and is told to be undetectable by any scanning tools. It exploits the debug registers in Intel’s IA-32 processor architecture. This paper investigates the debug register rootkit to find out why it is considered a threat, and which malware removal tools have implemented detection algorithms against this threat. By implementing and running a debug register rootkit against the most popular Linux tools, ne...

The Danish Adoption Register.

Science.gov (United States)

Petersen, Liselotte; Sørensen, Thorkild I A

2011-07-01

The Danish Adoption Register was established in 1963-1964 to explore the genetic and environmental contribution to familial aggregation of schizophrenia. The register encompass information on all 14,425 non-familial adoptions of Danish children legally granted in Denmark 1924-1947. It includes name and date of birth of each adoptee and his or her biological and adoptive parents, date of transfer to adoptive parents and date of formal adoption. The linkage to biological and adoptive parents is close to complete, even biological fathers are registered for 91.4% of the adoptees. Adoption registers are a unique source allowing disentangling of genetic and familial environmental influences on traits, risk of diseases, and mortality.

Prevention of abdominal wound infection (PROUD trial, DRKS00000390: study protocol for a randomized controlled trial

Directory of Open Access Journals (Sweden)

Heger Ulrike

2011-11-01

Full Text Available Abstract Background Wound infection affects a considerable portion of patients after abdominal operations, increasing health care costs and postoperative morbidity and affecting quality of life. Antibacterial coating has been suggested as an effective measure to decrease postoperative wound infections after laparotomies. The INLINE metaanalysis has recently shown the superiority of a slowly absorbable continuous suture for abdominal closure; with PDS plus® such a suture has now been made available with triclosan antibacterial coating. Methods/Design The PROUD trial is designed as a randomised, controlled, observer, surgeon and patient blinded multicenter superiority trial with two parallel groups and a primary endpoint of wound infection during 30 days after surgery. The intervention group will receive triclosan coated polydioxanone sutures, whereas the control group will receive the standard polydioxanone sutures; abdominal closure will otherwise be standardized in both groups. Statistical analysis is based on intention-to-treat population via binary logistic regression analysis, the total sample size of n = 750 is sufficient to ensure alpha = 5% and power = 80%, an interim analysis will be carried out after data of 375 patients are available. Discussion The PROUD trial will yield robust data to determine the effectiveness of antibacterial coating in one of the standard sutures for abdominal closure and potentially lead to amendment of current guidelines. The exploration of clinically objective parameters as well as quality of life holds immediate relevance for clinical management and the pragmatic trial design ensures high external validity. Trial Registration The trial protocol has been registered with the German Clinical Trials Register (DRKS00000390.

Danish registers on aspects of reproduction

DEFF Research Database (Denmark)

Blenstrup, Lene Tølbøll; Knudsen, Lisbeth B.

2011-01-01

Introduction: The establishing of three Danish population based registers, namely the Fertility Database, the Register of Legally Induced Abortions and the In Vitro Fertilisation register aimed at providing data for surveying of reproductive outcome. Content: The registers include information...... on births, abortions and assisted reproduction as well as selected characteristics of the women (and men) involved. Validity and Coverage: Both the validity and coverage of each register is considered of high quality. Conclusions: These registers provide, both individually and in combination, unique...

Identifying research priorities for effective retention strategies in clinical trials.

Science.gov (United States)

Kearney, Anna; Daykin, Anne; Shaw, Alison R G; Lane, Athene J; Blazeby, Jane M; Clarke, Mike; Williamson, Paula; Gamble, Carrol

2017-08-31

The failure to retain patients or collect primary-outcome data is a common challenge for trials and reduces the statistical power and potentially introduces bias into the analysis. Identifying strategies to minimise missing data was the second highest methodological research priority in a Delphi survey of the Directors of UK Clinical Trial Units (CTUs) and is important to minimise waste in research. Our aim was to assess the current retention practices within the UK and priorities for future research to evaluate the effectiveness of strategies to reduce attrition. Seventy-five chief investigators of NIHR Health Technology Assessment (HTA)-funded trials starting between 2009 and 2012 were surveyed to elicit their awareness about causes of missing data within their trial and recommended practices for improving retention. Forty-seven CTUs registered within the UKCRC network were surveyed separately to identify approaches and strategies being used to mitigate missing data across trials. Responses from the current practice surveys were used to inform a subsequent two-round Delphi survey with registered CTUs. A consensus list of retention research strategies was produced and ranked by priority. Fifty out of seventy-five (67%) chief investigators and 33/47 (70%) registered CTUs completed the current practice surveys. Seventy-eight percent of trialists were aware of retention challenges and implemented strategies at trial design. Patient-initiated withdrawal was the most common cause of missing data. Registered CTUs routinely used newsletters, timeline of participant visits, and telephone reminders to mitigate missing data. Whilst 36 out of 59 strategies presented had been formally or informally evaluated, some frequently used strategies, such as site initiation training, have had no research to inform practice. Thirty-five registered CTUs (74%) participated in the Delphi survey. Research into the effectiveness of site initiation training, frequency of patient contact

Introducing rapid diagnostic tests for malaria into registered drug shops in Uganda

DEFF Research Database (Denmark)

Mbonye, Anthony K; Clarke, Sîan E; Lal, Sham

2015-01-01

BACKGROUND: Malaria is a major public health problem in Uganda and the current policy recommends introduction of rapid diagnostic tests for malaria (RDTs) to facilitate effective case management. However, provision of RDTs in drug shops potentially raises a new set of issues, such as adherence...... to RDTs results, management of severe illnesses, referral of patients, and relationship with caretakers. The main objective of the study was to examine the impact of introducing RDTs in registered drug shops in Uganda and document lessons and policy implications for future scale-up of malaria control...... in the private health sector. METHODS: A cluster-randomized trial introducing RDTs into registered drug shops was implemented in central Uganda from October 2010 to July 2012. An evaluation was undertaken to assess the impact and the processes involved with the introduction of RDTs into drug shops, the lessons...

Construction of ethics in clinical research: clinical trials registration

Directory of Open Access Journals (Sweden)

C. A. Caramori

2007-01-01

Full Text Available Scientific development that has been achieved through decades finds in clinical research a great possibility of translating findings to human health application. Evidence given by clinical trials allows everyone to have access to the best health services. However, the millionaire world of pharmaceutical industries has stained clinical research with doubt and improbability. Study results (fruits of controlled clinical trials and scientific publications (selective, manipulated and with wrong conclusions led to an inappropriate clinical practice, favoring the involved economic aspect. In 2005, the International Committee of Medical Journal Editors (ICMJE, supported by the World Association of Medical Editors, started demanding as a requisite for publication that all clinical trials be registered at the database ClinicalTrials.gov. In 2006, the World Health Organization (WHO created the International Clinical Trial Registry Platform (ICTRP, which gathers several registry centers from all over the world, and required that all researchers and pharmaceutical industries register clinical trials. Such obligatory registration has progressed and will extend to all scientific journals indexed in all worldwide databases. Registration of clinical trials means another step of clinical research towards transparency, ethics and impartiality, resulting in real evidence to the forthcoming changes in clinical practice as well as in the health situation.

National Register Historic Districts

Data.gov (United States)

Iowa State University GIS Support and Research Facility — The National Register Historic District layer is a shape file showing the boundaries of Historic Districts that are listed on the National Register of Historic Places.

Differences in Investigator-Initiated Trials between Japan and Other Countries: Analyses of Clinical Trials Sponsored by Academia and Government in the ClinicalTrials.gov Registry and in the Three Japanese Registries.

Directory of Open Access Journals (Sweden)

Tatsuya Ito

Full Text Available Following the amendment of the Pharmaceutical Affairs Law in Japan in 2003 researchers were permitted to begin investigator-initiated trials (IITs. In subsequent years, however, the number of IITs remained low. In other countries in Asia as well as in Europe, North America, and South Africa, the number of IITs has increased over the past decade. The differences in the characteristics of IITs between Japan and other countries are unknown. Some studies have analyzed the characteristics of all clinical trials according to registry databases, but there has been less research focusing on IITs.The purpose of this study is to analyze the characteristics of IITs in the ClinicalTrials.gov registry and in the three Japanese registries, to identify differences in IITs between Japan and other countries.Using Thomson Reuters Pharma™, trials sponsored by academia and government as IITs in 2010 and registered in ClinicalTrials.gov were identified. IITs from 2004 to 2012 in Japan were identified in the three Japanese registries: the University Hospital Medical Information Network Clinical Trials Registry, the Japan Pharmaceutical Information Center Clinical Trials Information, and the Japan Medical Association Center for Clinical Trials, Clinical Trials Registry. Characterization was made of the trial purposes, phases, participants, masking, arms, design, controls, and other data.New and revised IITs registered in ClinicalTrials.gov during 2010 averaged about 40% of all sponsor-identified trials. IITs were nearly all early-phase studies with small numbers of participants. A total of 56 Japanese IITs were found over a period of 8 years, and these were also almost nearly all early-phase studies with small numbers of participants.There appear to be no great differences between Japan and other countries in terms of characteristics of IITs. These results should prompt a new review of the IIT environment in Japan.

Comprehensive geriatric assessment for older adults admitted to hospital: meta-analysis of randomised controlled trials

OpenAIRE

Ellis, G.; Whitehead, M.A.; Robinson, D.; O'Neill, D.; Langhorne, P.

2011-01-01

Objective - To evaluate the effectiveness of comprehensive geriatric assessment in hospital for older adults admitted as an emergency.\\ud \\ud Search strategy - We searched the EPOC Register, Cochrane’s Controlled Trials Register, the Database of Abstracts of Reviews of Effects (DARE), Medline, Embase, CINAHL, AARP Ageline, and handsearched high yield journals.\\ud \\ud Selection criteria - Randomised controlled trials of comprehensive geriatric assessment (whether by mobile teams or in designat...

Relating timed and register automata

Directory of Open Access Journals (Sweden)

Diego Figueira

2010-11-01

Full Text Available Timed automata and register automata are well-known models of computation over timed and data words respectively. The former has clocks that allow to test the lapse of time between two events, whilst the latter includes registers that can store data values for later comparison. Although these two models behave in appearance differently, several decision problems have the same (undecidability and complexity results for both models. As a prominent example, emptiness is decidable for alternating automata with one clock or register, both with non-primitive recursive complexity. This is not by chance. This work confirms that there is indeed a tight relationship between the two models. We show that a run of a timed automaton can be simulated by a register automaton, and conversely that a run of a register automaton can be simulated by a timed automaton. Our results allow to transfer complexity and decidability results back and forth between these two kinds of models. We justify the usefulness of these reductions by obtaining new results on register automata.

Proactive palliative care for patients with COPD (PROLONG): a pragmatic cluster controlled trial

NARCIS (Netherlands)

Duenk, R.G.; Verhagen, C.A.; Bronkhorst, E.M.; Mierlo, P. van; Broeders, M.E.A.C.; Collard, S.M.; Dekhuijzen, P.N.R.; Vissers, K.C.P.; Heijdra, Y.F.; Engels, Y.

2017-01-01

BACKGROUND AND AIM: Patients with advanced chronic obstructive pulmonary disease (COPD) have poor quality of life. The aim of this study was to assess the effects of proactive palliative care on the well-being of these patients. TRIAL REGISTRATION: This trial is registered with the Netherlands Trial

Optimizing Instruction Scheduling and Register Allocation for Register-File-Connected Clustered VLIW Architectures

Science.gov (United States)

Tang, Haijing; Wang, Siye; Zhang, Yanjun

2013-01-01

Clustering has become a common trend in very long instruction words (VLIW) architecture to solve the problem of area, energy consumption, and design complexity. Register-file-connected clustered (RFCC) VLIW architecture uses the mechanism of global register file to accomplish the inter-cluster data communications, thus eliminating the performance and energy consumption penalty caused by explicit inter-cluster data move operations in traditional bus-connected clustered (BCC) VLIW architecture. However, the limit number of access ports to the global register file has become an issue which must be well addressed; otherwise the performance and energy consumption would be harmed. In this paper, we presented compiler optimization techniques for an RFCC VLIW architecture called Lily, which is designed for encryption systems. These techniques aim at optimizing performance and energy consumption for Lily architecture, through appropriate manipulation of the code generation process to maintain a better management of the accesses to the global register file. All the techniques have been implemented and evaluated. The result shows that our techniques can significantly reduce the penalty of performance and energy consumption due to access port limitation of global register file. PMID:23970841

Optimizing Instruction Scheduling and Register Allocation for Register-File-Connected Clustered VLIW Architectures

Directory of Open Access Journals (Sweden)

Haijing Tang

2013-01-01

Full Text Available Clustering has become a common trend in very long instruction words (VLIW architecture to solve the problem of area, energy consumption, and design complexity. Register-file-connected clustered (RFCC VLIW architecture uses the mechanism of global register file to accomplish the inter-cluster data communications, thus eliminating the performance and energy consumption penalty caused by explicit inter-cluster data move operations in traditional bus-connected clustered (BCC VLIW architecture. However, the limit number of access ports to the global register file has become an issue which must be well addressed; otherwise the performance and energy consumption would be harmed. In this paper, we presented compiler optimization techniques for an RFCC VLIW architecture called Lily, which is designed for encryption systems. These techniques aim at optimizing performance and energy consumption for Lily architecture, through appropriate manipulation of the code generation process to maintain a better management of the accesses to the global register file. All the techniques have been implemented and evaluated. The result shows that our techniques can significantly reduce the penalty of performance and energy consumption due to access port limitation of global register file.

The Copenhagen School Health Records Register

DEFF Research Database (Denmark)

Baker, Jennifer L; Sørensen, Thorkild I A

2011-01-01

The Copenhagen School Health Records Register is an electronic register of health examination information on 372,636 children who attended school in Copenhagen, Denmark from 1936 to 2005.......The Copenhagen School Health Records Register is an electronic register of health examination information on 372,636 children who attended school in Copenhagen, Denmark from 1936 to 2005....

The Danish Adoption Register

DEFF Research Database (Denmark)

Petersen, Liselotte; Sørensen, Thorkild I A

2011-01-01

The Danish Adoption Register was established in 1963-1964 to explore the genetic and environmental contribution to familial aggregation of schizophrenia.......The Danish Adoption Register was established in 1963-1964 to explore the genetic and environmental contribution to familial aggregation of schizophrenia....

Barriers towards the publication of academic drug trials. Follow-up of trials approved by the Danish Medicines Agency

DEFF Research Database (Denmark)

Berendt, Louise; Petersen, Lene Grejs; Bach, Karin Friis

2017-01-01

OBJECTIVE: To characterize and quantify barriers towards the publication of academic drug trials. STUDY DESIGN: We identified academic drug trials approved during a 3-year period (2004-2007) by the Danish Medicines Agency. We conducted a survey among the trial sponsors to describe the rates...... of initiation, completion, and publication, and the reasons for the failure to reach each of these milestones. Information on size and methodological characteristics of the trials was extracted from the EudraCT database, a prospective register of all approved clinical drug trials submitted to European medicines...... agencies since 2004. RESULTS: A total of 181 academic drug trials were eligible for inclusion, 139 of which participated in our survey (response rate: 77%). Follow-up time ranged from 5.1 to 7.9 years. Most trials were randomized controlled trials (73%, 95% CI 65-81%). Initiation and completion rates were...

Registers of multiple sclerosis in Denmark

DEFF Research Database (Denmark)

Koch-Henriksen, N; Magyari, M; Laursen, B

2015-01-01

between a number of different environmental exposures in the past and the subsequent risk of MS. Some of these studies have been able to exonerate suspected risk factors. The other register, the nationwide Danish Multiple Sclerosis Treatment Register, is a follow-up register for all patients who have......There are two nationwide population-based registers for multiple sclerosis (MS) in Denmark. The oldest register is The Danish Multiple Sclerosis Registry (DMSR), which is an epidemiological register for estimation of prevalence and incidence of MS and survival, and for identifying exposures earlier...... received disease-modifying treatments since 1996. It has, in particular, contributed to the knowledge of the role of antibodies against the biological drugs used for the treatment of MS....

Do clinical trials conducted in India match its healthcare needs? An audit of the Clinical Trials Registry of India

Directory of Open Access Journals (Sweden)

Mansi Chaturvedi

2017-01-01

Full Text Available Background: India continues to contribute disproportionately to the global burden of disease and public health research output from India is also known to be not commensurate with her healthcare needs. We carried out the present study to assess if clinical trials were in line with the health care needs of the country by auditing the clinical trials registry of India. Materials and Methods: All the clinical studies registered in CTRI between July 20, 2007 and December 31, 2015 were searched in the “Trial Search” section. The total number of studies, their phases of development, and therapeutic areas were assessed. Trials in each therapeutic area was compared with the disease burden (DALYs in that area taken from Global Health Estimates [2014] Summary Tables of the WHO. The number of trials conducted per state in India was also compared with the population of that state [Census 2011]. Results: A total of 6474 studies were registered of which 3325 (51.4% were clinical trials. The state of Maharashtra had the highest number trials [16.4%] followed by Karnataka ( 11.6% and Tamil Nadu (10%. Populous states like Uttar Pradesh (5.3% and Bihar (1.4% had far fewer trials. The largest number of trials was in the area of cancer (16.4%, followed by diabetes (12.1% and cardiovascular diseases (10.1%. Infectious and parasitic diseases had the highest DALYs (82,681 and ranked first in disease burden but accounted for only 5% of the total trials and ranked 7th according to number of trials. Cancer ranked first in the number of trials (16.4%, but ranked 6th based on DALYs. Conclusion: Clinical trials conducted in India are not in consonance with her health care needs. Strengthening the capacity for conducting trials in the populous states and the north-eastern part of the country is necessary to allow a more equitable selection of participants. The government should introduce policies to encourage new drug development in areas where needed the most.

The Danish Pathology Register

DEFF Research Database (Denmark)

Bjerregaard, Beth; Larsen, Ole B

2011-01-01

The National Board of Health, Denmark in 1997 published guidelines for reporting of pathology data and the Danish Pathology Register (DPR) was established.......The National Board of Health, Denmark in 1997 published guidelines for reporting of pathology data and the Danish Pathology Register (DPR) was established....

IT Risk register

OpenAIRE

Kohout, Karel

2011-01-01

The theoretical part of the thesis analyzes several selected methodologies and best-practices related to information technology risks management, with focus on documents and guidance developed by ISACA. It builds a set of ideas and basic requirements for effective model of an IT risk register. Strong emphasis is placed on mapping CobiT 4.1 based Risk IT to COBIT 5. The practical part describes implementation of an exploratory web-based IT risk register in Python programming language utilizing...

Very wide register : an asymmetric register file organization for low power embedded processors.

NARCIS (Netherlands)

Raghavan, P.; Lambrechts, A.; Jayapala, M.; Catthoor, F.; Verkest, D.T.M.L.; Corporaal, H.

2007-01-01

In current embedded systems processors, multi-ported register files are one of the most power hungry parts of the processor, even when they are clustered. This paper presents a novel register file architecture, which has single ported cells and asymmetric interfaces to the memory and to the

Despite law, fewer than one in eight completed studies of drugs and biologics are reported on time on ClinicalTrials.gov.

Science.gov (United States)

Law, Michael R; Kawasumi, Yuko; Morgan, Steven G

2011-12-01

Clinical trial registries are public databases created to prospectively document the methods and measures of prescription drug studies and retrospectively collect a summary of results. In 2007 the US government began requiring that researchers register certain studies and report the results on ClinicalTrials.gov, a public database of federally and privately supported trials conducted in the United States and abroad. We found that although the mandate briefly increased trial registrations, 39 percent of trials were still registered late after the mandate's deadline, and only 12 percent of completed studies reported results within a year, as required by the mandate. This result is important because there is evidence of selective reporting even among registered trials. Furthermore, we found that trials funded by industry were more than three times as likely to report results than were trials funded by the National Institutes of Health. Thus, additional enforcement may be required to ensure disclosure of all trial results, leading to a better understanding of drug safety and efficacy. Congress should also reconsider the three-year delay in reporting results for products that have been approved by the Food and Drug Administration and are in use by patients.

Inadequate description of educational interventions in ongoing randomized controlled trials

Directory of Open Access Journals (Sweden)

Pino Cécile

2012-05-01

Full Text Available Abstract Background The registration of clinical trials has been promoted to prevent publication bias and increase research transparency. Despite general agreement about the minimum amount of information needed for trial registration, we lack clear guidance on descriptions of non-pharmacologic interventions in trial registries. We aimed to evaluate the quality of registry descriptions of non-pharmacologic interventions assessed in ongoing randomized controlled trials (RCTs of patient education. Methods On 6 May 2009, we searched for all ongoing RCTs registered in the 10 trial registries accessible through the World Health Organization International Clinical Trials Registry Platform. We included trials evaluating an educational intervention (that is, designed to teach or train patients about their own health and dedicated to participants, their family members or home caregivers. We used a standardized data extraction form to collect data related to the description of the experimental intervention, the centers, and the caregivers. Results We selected 268 of 642 potentially eligible studies and appraised a random sample of 150 records. All selected trials were registered in 4 registers, mainly ClinicalTrials.gov (61%. The median [interquartile range] target sample size was 205 [100 to 400] patients. The comparator was mainly usual care (47% or active treatment (47%. A minority of records (17%, 95% CI 11 to 23% reported an overall adequate description of the intervention (that is, description that reported the content, mode of delivery, number, frequency, duration of sessions and overall duration of the intervention. Further, for most reports (59%, important information about the content of the intervention was missing. The description of the mode of delivery of the intervention was reported for 52% of studies, the number of sessions for 74%, the frequency of sessions for 58%, the duration of each session for 45% and the overall duration for 63

Registered Nurse (Associate Degree).

Science.gov (United States)

Ohio State Univ., Columbus. Center on Education and Training for Employment.

This document, which is designed for use in developing a tech prep competency profile for the occupation of registered nurse (with an associate degree), lists technical competencies and competency builders for 19 units pertinent to the health technologies cluster in general and 5 units specific to the occupation of registered nurse. The following…

Non-commercial vs. commercial clinical trials: a retrospective study of the applications submitted to a research ethics committee.

Science.gov (United States)

Fuentes Camps, Inmaculada; Rodríguez, Alexis; Agustí, Antonia

2018-02-15

There are many difficulties in undertaking independent clinical research without support from the pharmaceutical industry. In this retrospective observational study, some design characteristics, the clinical trial public register and the publication rate of noncommercial clinical trials were compared to those of commercial clinical trials. A total of 809 applications of drug-evaluation clinical trials were submitted from May 2004 to May 2009 to the research ethics committee of a tertiary hospital, and 16.3% of trials were noncommercial. They were mainly phase IV, multicentre national, and unmasked controlled trials, compared to the commercial trials that were mainly phase II or III, multicentre international, and double-blind masked trials. The commercial trials were registered and published more often than noncommercial trials. More funding for noncommercial research is still needed. The results of the research, commercial or noncommercial, should be disseminated in order not to compromise either its scientific or its social value. © 2018 The British Pharmacological Society.

1 CFR 11.7 - Federal Register Index.

Science.gov (United States)

2010-01-01

... 1 General Provisions 1 2010-01-01 2010-01-01 false Federal Register Index. 11.7 Section 11.7... REGISTER PUBLICATIONS SUBSCRIPTIONS § 11.7 Federal Register Index. The annual subscription price for the monthly Federal Register Index, purchased separately, in paper form, is $29. The price excludes postage...

Universal Verification Methodology Based Register Test Automation Flow.

Science.gov (United States)

Woo, Jae Hun; Cho, Yong Kwan; Park, Sun Kyu

2016-05-01

In today's SoC design, the number of registers has been increased along with complexity of hardware blocks. Register validation is a time-consuming and error-pron task. Therefore, we need an efficient way to perform verification with less effort in shorter time. In this work, we suggest register test automation flow based UVM (Universal Verification Methodology). UVM provides a standard methodology, called a register model, to facilitate stimulus generation and functional checking of registers. However, it is not easy for designers to create register models for their functional blocks or integrate models in test-bench environment because it requires knowledge of SystemVerilog and UVM libraries. For the creation of register models, many commercial tools support a register model generation from register specification described in IP-XACT, but it is time-consuming to describe register specification in IP-XACT format. For easy creation of register model, we propose spreadsheet-based register template which is translated to IP-XACT description, from which register models can be easily generated using commercial tools. On the other hand, we also automate all the steps involved integrating test-bench and generating test-cases, so that designers may use register model without detailed knowledge of UVM or SystemVerilog. This automation flow involves generating and connecting test-bench components (e.g., driver, checker, bus adaptor, etc.) and writing test sequence for each type of register test-case. With the proposed flow, designers can save considerable amount of time to verify functionality of registers.

Illinois I/O Register to FASTBUS Interface

International Nuclear Information System (INIS)

Downing, R.; Lesny, D.; Whitten, W.

1983-01-01

The I/O Register to FASTBUS Interface (IORFI) is connected to a processor via two 16-bit output registers (OR1,OR2) and two 16-bit output resisters (IR1,IR2). One of the output registers (OR1) is used to specify the interface function which is to be performed when the interface is accessed via the Data-in Register (IR2) or the Data-out Register (OR2). The other input register (IR1) is used to read the direct status of the FASTBUS lines independent of OR1. The changes made to the SLAC design at the University of Illinois are described

Molecular Electronic Shift Registers

Science.gov (United States)

Beratan, David N.; Onuchic, Jose N.

1990-01-01

Molecular-scale shift registers eventually constructed as parts of high-density integrated memory circuits. In principle, variety of organic molecules makes possible large number of different configurations and modes of operation for such shift-register devices. Several classes of devices and implementations in some specific types of molecules proposed. All based on transfer of electrons or holes along chains of repeating molecular units.

Measuring clinical trial transparency: an empirical analysis of newly approved drugs and large pharmaceutical companies.

Science.gov (United States)

Miller, Jennifer E; Wilenzick, Marc; Ritcey, Nolan; Ross, Joseph S; Mello, Michelle M

2017-12-05

To define a series of clinical trial transparency measures and apply them to large pharmaceutical and biotechnology companies and their 2014 FDA-approved drugs. Cross-sectional descriptive analysis of all clinical trials supporting 2014 Food and Drugs Administration (FDA)-approved new drug applications (NDAs) for novel drugs sponsored by large companies. Data from over 45 sources, including Drugs@FDA.gov, ClinicalTrials.gov, corporate and international registries; PubMed, Google Scholar, EMBASE, corporate press releases, Securities and Exchange Commission (SEC) filings and personal communications with drug manufacturers. Trial registration, results reporting, clinical study report (CSR) synopsis sharing, biomedical journal publication, and FDA Amendments Acts (FDAAA) compliance, analysed on the drug level. The FDA approved 19 novel new drugs, sponsored by 11 large companies, involving 553 trials, in 2014. We analysed 505 relevant trials. Per drug, a median of 100% (IQR 86%-100%) of trials in patients were registered, 71% (IQR 57%-100%) reported results or shared a CSR synopsis, 80% (70%-100%) were published and 96% (80%-100%) were publicly available in some form by 13 months after FDA approval. Disclosure rates were lower at FDA approval (65%) and improved significantly by 6 months post FDA approval. Per drug, a median of 100% (IQR 75%-100%) of FDAAA-applicable trials were compliant. Half of reviewed drugs had publicly disclosed results for all trials in patients in our sample. One trial was uniquely registered in a corporate registry, and not ClinicalTrials.gov; 0 trials were uniquely registered in international registries. Among large pharmaceutical companies and new drugs, clinical trial transparency is high based on several standards, although opportunities for improvement remain. Transparency is markedly higher for trials in patients than among all trials supporting drug approval, including trials in healthy volunteers. Ongoing efforts to publicly track

Validation of a Cerebral Palsy Register

DEFF Research Database (Denmark)

Topp, Monica; Langhoff-Roos, Jens; Uldall, P.

1997-01-01

OBJECTIVES: To analyse completeness and validity of data in the Cerebral Palsy Register in Denmark, 1979-1982. METHODS: Completeness has been assessed by comparing data from The Danish National Patient Register (DNPR) with the cases included in the Cerebral Palsy Register (CPR). Agreement between......, but gestational age was subject to a systematic error, and urinary infections in pregnancy (kappa = 0.43) and placental abruption (kappa = 0.52) were seriously under-reported in the CPR. CONCLUSIONS: Completeness of the Cerebral Palsy Register in Denmark, 1979-1982, has been assessed to maximal 85%, emphasizing...

Register-based studies of healthcare costs

DEFF Research Database (Denmark)

Kruse, Marie; Christiansen, Terkel

2011-01-01

Introduction: The aim of this paper is to provide an overview and a few examples of how national registers are used in analyses of healthcare costs in Denmark. Research topics: The paper focuses on health economic analyses based on register data. For the sake of simplicity, the studies are divided...... into three main categories: economic evaluations of healthcare interventions, cost-of-illness analyses, and other analyses such as assessments of healthcare productivity. Conclusion: We examined a number of studies using register-based data on healthcare costs. Use of register-based data renders...

Register-based studies on migration, ethnicity, and health

DEFF Research Database (Denmark)

Norredam, Marie; Kastrup, Marianne; Helweg-Larsen, Karin

2011-01-01

INTRODUCTION: Researchers in Denmark have unique possibilities of register-based research in relation to migration, ethnicity, and health. This review article outlines how these opportunities have been used, so far, by presenting a series of examples. RESEARCH TOPICS: We selected six registers...... it discriminatory. Although, we do not register ethnicity in relation to use of health care in Denmark, our possibilities of linkage between population registers and registers on diseases and healthcare utilisation appear to render the same potentials....... to highlight the process of how migrant study populations have been established and studied in relation to different registers: The Danish Cancer Registry, the Danish Central Psychiatric Research Register, the Danish National Patient Register, the Danish National Health Service Register, the Danish Injury...

News from the Library: Knovel trial is approaching!

CERN Multimedia

CERN Library

2013-01-01

A trial of Knovel, a web-based application integrating technical information with analytical and search tools, started on 4 March and will finish on 5 April. Knovel is both a platform for e-books and a powerful search engine, allowing users to search the full text, and to extract and exploit numerical data available inside the e-books.  It covers several subject areas of Engineering and Materials Science.   Go to "our" Knovel trial page to learn how Knovel can support your needs, and to then use the product. Upon entering, please register as a trial participant. After registering you will receive an e-mail to activate your new profile. To help you get started, two webinar sessions will provide tips on how to navigate and search Knovel, a demonstration of the interactive tools that help you use and apply data, and a quick "how-to" on saving and organising useful information with MyKnovel. The sessions will take place on: Thursday 7 March at 11:00 ...

Cryo-thawed embryo transfer: natural versus artificial cycle. A non-inferiority trial.(ANTARCTICA trial

Directory of Open Access Journals (Sweden)

Groenewoud Eva R

2012-09-01

. Trial register Netherlands trial register (NTR: 1586

Endorsement of the CONSORT guidelines, trial registration, and the quality of reporting randomised controlled trials in leading nursing journals: A cross-sectional analysis.

Science.gov (United States)

Jull, Andrew; Aye, Phyu Sin

2015-06-01

To establish the reporting quality of trials published in leading nursing journals and investigate associations between CONSORT Statement or trial registration endorsment and reporting of design elements. The top 15 nursing journals were searched using Medline for randomised controlled trials published in 2012. Journals were categorised as CONSORT and trial registration promoting based on requirements of submitting authors or the journal's webpage as at January 2014. Data on sequence generation, allocation concealment, follow up, blinding, baseline equivalence and sample size calculation were extracted by one author and independently verified by the second author against source data. Seven journals were CONSORT promoting and three of these journals were also trial registration promoting. 114 citations were identified and 83 were randomised controlled trials. Eighteen trials (21.7%) were registered and those published in trial registration promoting journals were more likely to be registered (RR 2.64 95%CI 1.14-6.09). We assessed 68.7% of trials to be low risk of bias for sequence generation, 20.5% for allocation concealment, 38.6% for blinding, 55.4% for completeness of follow up and 79.5% for baseline equivalence. Trials published in CONSORT promoting journals were more likely to be at low risk of bias for blinding (RR 2.33, 95%CI 1.01-5.34) and completeness of follow up (RR 1.77, 95%CI 1.02-3.10), but journal endorsement of the CONSORT Statement or trial registration otherwise had no significant effect. Trials published in CONSORT and trial registration promoting journals were more likely to have high quality sample size calculations (RR 2.91, 95%CI 1.18-7.19 and RR 1.69, 95%CI 1.08-2.64, respectively). Simple endorsement of the CONSORT Statement and trials registration is insufficient action to encourage improvement of the quality of trial reporting across the most important of trial design elements. Copyright © 2014 Elsevier Ltd. All rights reserved.

In-memory interconnect protocol configuration registers

Energy Technology Data Exchange (ETDEWEB)

Cheng, Kevin Y.; Roberts, David A.

2017-09-19

Systems, apparatuses, and methods for moving the interconnect protocol configuration registers into the main memory space of a node. The region of memory used for storing the interconnect protocol configuration registers may also be made cacheable to reduce the latency of accesses to the interconnect protocol configuration registers. Interconnect protocol configuration registers which are used during a startup routine may be prefetched into the host's cache to make the startup routine more efficient. The interconnect protocol configuration registers for various interconnect protocols may include one or more of device capability tables, memory-side statistics (e.g., to support two-level memory data mapping decisions), advanced memory and interconnect features such as repair resources and routing tables, prefetching hints, error correcting code (ECC) bits, lists of device capabilities, set and store base address, capability, device ID, status, configuration, capabilities, and other settings.

In-memory interconnect protocol configuration registers

Science.gov (United States)

Cheng, Kevin Y.; Roberts, David A.

2017-09-19

Systems, apparatuses, and methods for moving the interconnect protocol configuration registers into the main memory space of a node. The region of memory used for storing the interconnect protocol configuration registers may also be made cacheable to reduce the latency of accesses to the interconnect protocol configuration registers. Interconnect protocol configuration registers which are used during a startup routine may be prefetched into the host's cache to make the startup routine more efficient. The interconnect protocol configuration registers for various interconnect protocols may include one or more of device capability tables, memory-side statistics (e.g., to support two-level memory data mapping decisions), advanced memory and interconnect features such as repair resources and routing tables, prefetching hints, error correcting code (ECC) bits, lists of device capabilities, set and store base address, capability, device ID, status, configuration, capabilities, and other settings.

Register-based research on twins

DEFF Research Database (Denmark)

Christensen, Kaare; Ohm Kyvik, Kirsten; Holm, Niels V

2011-01-01

Introduction: The Danish Twin Registry (DTR) has for more than 50 years been based on surveys and clinical investigations and over the two last decades also on register linkage. Currently these two approaches are merged within Statistics Denmark. Research topics: Here we report on three major...... groups of register-based research in the DTR that used the uniqueness of twinning. First, we focus on the ''long-term prognosis'' of being a twin compared with being a singleton and show that Danish twins have health trajectories in adulthood similar to singletons, which is a result of interest for twins...... illustrate how the co-twin control method in a register setting can be used to control for the effect of rearing environment and genetic factors in studies of the association between exposures and health. CONCLUSION: The spectrum of register-based twin studies is very wide and have changed in accordance...

Participant recruitment and retention in longitudinal preconception randomized trials: lessons learnt from the Calcium And Pre-eclampsia (CAP) trial.

Science.gov (United States)

Lawrie, Theresa A; Betrán, Ana Pilar; Singata-Madliki, Mandisa; Ciganda, Alvaro; Hofmeyr, G Justus; Belizán, José M; Purnat, Tina Dannemann; Manyame, Sarah; Parker, Catherine; Cormick, Gabriela

2017-10-26

The preconception period has the potential to influence pregnancy outcomes and randomized controlled trials (RCTs) are needed to evaluate a variety of potentially beneficial preconception interventions. However, RCTs commencing before pregnancy have significant participant recruitment and retention challenges. The Calcium And Pre-eclampsia trial (CAP trial) is a World Health Organization multi-country RCT of calcium supplementation commenced before pregnancy to prevent recurrent pre-eclampsia in which non-pregnant participants are recruited and followed up until childbirth. This sub-study explores recruitment methods and preconception retention of participants of the CAP trial to inform future trials. Recruiters at the study sites in Argentina, South Africa and Zimbabwe completed post-recruitment phase questionnaires on recruitment methods used. Qualitative data from these questionnaires and quantitative data on pre-pregnancy trial visit attendance and pregnancy rates up to September 2016 are reported in this paper. RStudio (Version 0.99.903 https://www.rstudio.org ) statistical software was used for summary statistics. Between July 2011 and 8 September 2016, 1354 women with previous pre-eclampsia were recruited. Recruitment took 2 years longer than expected and was facilitated mainly through medical record/register and maternity ward/clinic-based strategies. Recruiters highlighted difficulties associated with inadequate medical records, redundant patient contact details, and follow-up of temporarily ineligible women as some of the challenges faced. Whilst the attendance rates at pre-pregnancy visits were high (78% or more), visits often occurred later than scheduled. Forty-five percent of participants became pregnant (614/1354), 33.5% (454/1354) within 1 year of randomization. In preconception trials, both retrospective and prospective methods are useful for recruiting eligible women with certain conditions. However, these are time-consuming in low

Factors Contributing to Exacerbating Vulnerabilities in Global Clinical Trials

Science.gov (United States)

da Silva, Ricardo E.; Amato, Angélica A.; Guilhem, Dirce B.; de Carvalho, Marta R.; Lima, Elisangela da C.; Novaes, Maria Rita C. G.

2018-01-01

Background: Although policies and guidelines make use of the concept of vulnerability, few define it. The European Union's directive for clinical trials does not include explanations for or the reasoning behind the designation of certain groups as vulnerable. Emerging economies from lower middle-income countries have, in recent years, had the largest average annual growth rate, as well as increase, in number of clinical trials registered in the US government's database. Nevertheless, careful supervision of research activities has to be ensured. Objective: To describe and analyze the features of the clinical trials involving vulnerable populations in various countries classified by development status and geographic region. Methods: Retrospective study that involved analysis of data obtained from the International Clinical Trials Registry Platform (ICTRP) database between 01/2014 and 12/2014 from countries with (i) highest trial densities during 2005 to 2012, (ii) highest average growth rate in clinical trials, and (iii) greatest trial capabilities. Results: Statistical analysis of this study showed that patients incapable of giving consent personally are 11.4 times more likely to be vulnerable patients than patients who are capable, and that patients in upper-middle-income countries are 1.7 times more likely to be vulnerable patients than patients from high-income countries when participating in global clinical trials. Malaysia (21%), Egypt (20%), Turkey (19%), Israel (18%), and Brazil (17%) had the highest percentages of vulnerable populations involving children. Conclusions: Although the inability to provide consent personally was a factor associated with vulnerability, arbitrary criteria may have been considered when classifying the populations of clinical trials as vulnerable. The EU Clinical Trials Register should provide guidance regarding exactly what aspects or factors should be taken into account to frame given populations as vulnerable, because

The Danish Hip Arthroplasty Register

DEFF Research Database (Denmark)

Gundtoft, Per Hviid; Varnum, Claus; Pedersen, Alma Becic

2016-01-01

AIM OF DATABASE: The aim of the Danish Hip Arthroplasty Register (DHR) is to continuously monitor and improve the quality of treatment of primary and revision total hip arthroplasty (THA) in Denmark. STUDY POPULATION: The DHR is a Danish nationwide arthroplasty register established in January 1995...

Disproportionate Intrauterine Growth Intervention Trial At Term: DIGITAT

Directory of Open Access Journals (Sweden)

Huisjes Anjoke JM

2007-07-01

Full Text Available Abstract Background Around 80% of intrauterine growth restricted (IUGR infants are born at term. They have an increase in perinatal mortality and morbidity including behavioral problems, minor developmental delay and spastic cerebral palsy. Management is controversial, in particular the decision whether to induce labour or await spontaneous delivery with strict fetal and maternal surveillance. We propose a randomised trial to compare effectiveness, costs and maternal quality of life for induction of labour versus expectant management in women with a suspected IUGR fetus at term. Methods/design The proposed trial is a multi-centre randomised study in pregnant women who are suspected on clinical grounds of having an IUGR child at a gestational age between 36+0 and 41+0 weeks. After informed consent women will be randomly allocated to either induction of labour or expectant management with maternal and fetal monitoring. Randomisation will be web-based. The primary outcome measure will be a composite neonatal morbidity and mortality. Secondary outcomes will be severe maternal morbidity, maternal quality of life and costs. Moreover, we aim to assess neurodevelopmental and neurobehavioral outcome at two years as assessed by a postal enquiry (Child Behavioral Check List-CBCL and Ages and Stages Questionnaire-ASQ. Analysis will be by intention to treat. Quality of life analysis and a preference study will also be performed in the same study population. Health technology assessment with an economic analysis is part of this so called Digitat trial (Disproportionate Intrauterine Growth Intervention Trial At Term. The study aims to include 325 patients per arm. Discussion This trial will provide evidence for which strategy is superior in terms of neonatal and maternal morbidity and mortality, costs and maternal quality of life aspects. This will be the first randomised trial for IUGR at term. Trial registration Dutch Trial Register and ISRCTN-Register

Village registers for vital registration in rural Malawi.

Science.gov (United States)

Singogo, E; Kanike, E; van Lettow, M; Cataldo, F; Zachariah, R; Bissell, K; Harries, A D

2013-08-01

Paper-based village registers were introduced 5 years ago in Malawi as a tool to measure vital statistics of births and deaths at the population level. However, usage, completeness and accuracy of their content have never been formally evaluated. In Traditional Authority Mwambo, Zomba district, Malawi, we assessed 280 of the 325 village registers with respect to (i) characteristics of village headmen who used village registers, (ii) use and content of village registers, and (iii) whether village registers provided accurate information on births and deaths. All village headpersons used registers. There were 185 (66%) registers that were regarded as 95% completed, and according to the registers, there were 115 840 people living in the villages in the catchment area. In 2011, there were 1753 births recorded in village registers, while 6397 births were recorded in health centre registers in the same catchment area. For the same year, 199 deaths were recorded in village registers, giving crude death rates per 100 000 population of 189 for males and 153 for females. These could not be compared with death rates in health centre registers due to poor and inconsistent recording in these registers, but they were compared with death rates obtained from the 2010 Malawi Demographic Health Survey that reported 880 and 840 per 100 000 for males and females, respectively. In conclusion, this study shows that village registers are a potential source for vital statistics. However, considerable inputs are needed to improve accuracy of births and deaths, and there are no functional systems for the collation and analysis of data at the traditional authority level. Innovative ways to address these challenges are discussed, including the use of solar-powered electronic village registers and mobile phones, connected with each other and the health facilities and the District Commissioner's office through the cellular network and wireless coverage. © 2013 John Wiley & Sons Ltd.

A randomized placebo-controlled trial of the effect of coffee consumption on insulin sensitivity: Design and baseline characteristics of the Coffee for METabolic Health (COMETH study

Directory of Open Access Journals (Sweden)

Derrick Johnston Alperet

2016-12-01

Trial registration: ClinicalTrials.gov identifier: NCT01738399. Registered on 28 November 2012. Trial Sponsor: Nestlé Research Center, Lausanne, Switzerland. Trial Site: National University of Singapore.

Non-sedation versus sedation with a daily wake-up trial in critically ill patients receiving mechanical ventilation (NONSEDA Trial)

DEFF Research Database (Denmark)

Toft, Palle; Olsen, Hanne Tanghus; Jørgensen, Helene Korvenius

2014-01-01

comparing sedation with no sedation, a priori powered to have all-cause mortality as primary outcome.The objective is to assess the benefits and harms of non-sedation versus sedation with a daily wake-up trial in critically ill patients. METHODS: The non-sedation (NONSEDA) trial is an investigator......-sedation supplemented with pain management during mechanical ventilation.Control intervention is sedation with a daily wake-up trial.The primary outcome will be all cause mortality at 90 days after randomization. Secondary outcomes will be: days until death throughout the total observation period; coma- and delirium...... in mortality with a type I error risk of 5% and a type II error risk of 20% (power at 80%). DISCUSSION: The trial investigates potential benefits of non-sedation. This might have large impact on the future treatment of mechanically ventilated critically ill patients.Trial register: ClinicalTrials.gov NCT...

The European Register of Specialists in Clinical Chemistry and Laboratory Medicine: guide to the Register, version 3-2010

DEFF Research Database (Denmark)

McMurray, Janet; Zérah, Simone; Hallworth, Michael

2010-01-01

In 1997, the European Communities Confederation of Clinical Chemistry and Laboratory Medicine (EC4) set up a Register for European Specialists in Clinical Chemistry and Laboratory Medicine. The operation of the Register is undertaken by a Register Commission (EC4RC). During the last 12 years, more...... than 2200 specialists in Clinical Chemistry and Laboratory Medicine have joined the Register. In 2007, EC4 merged with the Forum of European Societies of Clinical Chemistry and Laboratory Medicine (FESCC) to form the European Federation of Clinical Chemistry and Laboratory Medicine (EFCC). Two previous...

Differential Globalization of Industry- and Non-Industry-Sponsored Clinical Trials.

Science.gov (United States)

Atal, Ignacio; Trinquart, Ludovic; Porcher, Raphaël; Ravaud, Philippe

2015-01-01

Mapping the international landscape of clinical trials may inform global health research governance, but no large-scale data are available. Industry or non-industry sponsorship may have a major influence in this mapping. We aimed to map the global landscape of industry- and non-industry-sponsored clinical trials and its evolution over time. We analyzed clinical trials initiated between 2006 and 2013 and registered in the WHO International Clinical Trials Registry Platform (ICTRP). We mapped single-country and international trials by World Bank's income groups and by sponsorship (industry- vs. non- industry), including its evolution over time from 2006 to 2012. We identified clusters of countries that collaborated significantly more than expected in industry- and non-industry-sponsored international trials. 119,679 clinical trials conducted in 177 countries were analysed. The median number of trials per million inhabitants in high-income countries was 100 times that in low-income countries (116.0 vs. 1.1). Industry sponsors were involved in three times more trials per million inhabitants than non-industry sponsors in high-income countries (75.0 vs. 24.5) and in ten times fewer trials in low- income countries (0.08 vs. 1.08). Among industry- and non-industry-sponsored trials, 30.3% and 3.2% were international, respectively. In the industry-sponsored network of collaboration, Eastern European and South American countries collaborated more than expected; in the non-industry-sponsored network, collaboration among Scandinavian countries was overrepresented. Industry-sponsored international trials became more inter-continental with time between 2006 and 2012 (from 54.8% to 67.3%) as compared with non-industry-sponsored trials (from 42.4% to 37.2%). Based on trials registered in the WHO ICTRP we documented a substantial gap between the globalization of industry- and non-industry-sponsored clinical research. Only 3% of academic trials but 30% of industry trials are

Differential Globalization of Industry- and Non-Industry–Sponsored Clinical Trials

Science.gov (United States)

Atal, Ignacio; Trinquart, Ludovic; Porcher, Raphaël; Ravaud, Philippe

2015-01-01

Background Mapping the international landscape of clinical trials may inform global health research governance, but no large-scale data are available. Industry or non-industry sponsorship may have a major influence in this mapping. We aimed to map the global landscape of industry- and non-industry–sponsored clinical trials and its evolution over time. Methods We analyzed clinical trials initiated between 2006 and 2013 and registered in the WHO International Clinical Trials Registry Platform (ICTRP). We mapped single-country and international trials by World Bank's income groups and by sponsorship (industry- vs. non- industry), including its evolution over time from 2006 to 2012. We identified clusters of countries that collaborated significantly more than expected in industry- and non-industry–sponsored international trials. Results 119,679 clinical trials conducted in 177 countries were analysed. The median number of trials per million inhabitants in high-income countries was 100 times that in low-income countries (116.0 vs. 1.1). Industry sponsors were involved in three times more trials per million inhabitants than non-industry sponsors in high-income countries (75.0 vs. 24.5) and in ten times fewer trials in low- income countries (0.08 vs. 1.08). Among industry- and non-industry–sponsored trials, 30.3% and 3.2% were international, respectively. In the industry-sponsored network of collaboration, Eastern European and South American countries collaborated more than expected; in the non-industry–sponsored network, collaboration among Scandinavian countries was overrepresented. Industry-sponsored international trials became more inter-continental with time between 2006 and 2012 (from 54.8% to 67.3%) as compared with non-industry–sponsored trials (from 42.4% to 37.2%). Conclusions Based on trials registered in the WHO ICTRP we documented a substantial gap between the globalization of industry- and non-industry–sponsored clinical research. Only 3% of

REGISTER PELAKU INDUSTRI BATIK DI KOTA PEKALONGAN: KAJIAN SOSIOLINGUISTIS

Directory of Open Access Journals (Sweden)

Afrinar Pramitasari

2014-08-01

Full Text Available Register merupakan pemakaian bahasa dalam setiap bidang kehidupan yang tiap-tiap bidang kehidupanmempunyai bahasa khusus yang tidak dimengerti oleh kelompok lain. Pekalongan dikenal sebagai kota dansebagian besar pekerjaan masyarakat di Kota Pekalongan adalah sebagai perajin batik, maka dalam tuturanmereka sehari-hari juga banyak menggunakan kosakata khas bidang industri batik. Sumber data dalampenelitian ini adalah penggalan percakapan masyarakat perajin batik di Kota Pekalongan yang di dugamengandung register. Pengumpulan data menggunakan metode simak yang dalam pelaksanaanya diwujudkanmelalui teknik dasar dan teknik lanjutan. Hasil yang diperoleh dari penelitian ini adalah ada dua bentuk registerindustri batik yang ditemukan dalam penelitian ini yaitu register berdasarkan satuan lingual bahasanya danberdasarkan jenis kata. Berdasarkan satuan lingual bahasa ditemukan dua bentuk register yaitu registerberbentuk kata tunggal dan register berbentuk kata kompleks. Register berbentuk kata kompleks mencakup 1register berbentuk frasa, 2 register berbentuk kata majemuk, 3 register bentuk reduplikasi, dan 4 registerbentuk berafiks. Register a use of language in every area of life, the life of each field specific language that is notunderstood by other groups. Pekalongan City is known as the city that have potential in the batikindustry, because most of the people work in the City Pekalongan batik is as crafters, then in theireveryday speech too much use of vocabulary typical batik industry. Data sources in the form ofpublic speech in Pekalongan batik artisans containing registers. Refer to the method of datacollection that the implementation is realized through basic techniques and advanced techniques.The results of this study was two are three forms of batik industry registers were found in thisstudy is based on the unit registers lingual languag and based on grammatical categories. Basedon unit lingual language, found two registers form the single

Performance of CASTOR {sup registered} HAW cask cold trials for loading, Transport and storage of HAW canisters

Energy Technology Data Exchange (ETDEWEB)

Wilmsmeier, Marco; Horn, Thomas; Graf, Wilhelm [GNS Gesellschaft fuer Nuklear-Service mbH (Germany)

2009-07-01

With over 30 years of experience in the design, manufacturing, assembly and loading of CASTOR {sup registered} casks, GNS is one of the worldwide leading suppliers of casks for the transport and storage of spent fuel assemblies as well as for canisters with vitrified high active wastes (meanwhile over 1.000 casks loaded and stored and more than 1.500 ordered). GNS's products are used at around 30 sites worldwide for a wide range of inventories from pressurised and boiling water reactor fuels (PWR, VVER and BWR, RBMK), thorium high-temperature reactor fuels (THTR) and research reactor fuels (MTR) to vitrified high active wastes (HAW) from reprocessing plants. GNS is responsible for all nuclear wastes resulting from German Nuclear Power Plants and assists and/or performs in the loading and dispatch of CASTOR {sup registered} casks as well as their transport to and storage at central interim storage facilities and local interim storage areas. (orig.)

46 CFR 401.510 - Operation without Registered Pilots.

Science.gov (United States)

2010-10-01

... 46 Shipping 8 2010-10-01 2010-10-01 false Operation without Registered Pilots. 401.510 Section 401... REGULATIONS Penalties; Operations Without Registered Pilots § 401.510 Operation without Registered Pilots. (a... Registered Pilot when the vessel or its cargo is in distress or jeopardy. (b) A vessel may be navigated in...

Identifying victims of violence using register-based data

DEFF Research Database (Denmark)

Kruse, Marie; Sørensen, Jan; Brønnum-Hansen, Henrik

2010-01-01

AIMS: The aim of this study was twofold. Firstly we identified victims of violence in national registers and discussed strengths and weaknesses of this approach. Secondly we assessed the magnitude of violence and the characteristics of the victims using register-based data. METHODS: We used three...... nationwide registers to identify victims of violence: The National Patient Register, the Victim Statistics, and the Causes of Death Register. We merged these data and assessed the degree of overlap between data sources. We identified a reference population by selecting all individuals in Denmark over 15....... RESULTS: In 2006, 22,000 individuals were registered as having been exposed to violence. About 70% of these victims were men. Most victims were identified from emergency room contacts and police records, and few from the Causes of Death Register. There was some overlap between the two large data sources...

Register as the Situational Variety of Language

Directory of Open Access Journals (Sweden)

Natalya B. Boyeva-Omelechko

2016-12-01

Full Text Available The problem discussed in the article is topical due to the interest of scientists to different types of language variations and especially registers or situational dialects treated by M.A.K. Halliday as use-related varieties of language or varieties used in a particular social setting. As discourse categorization is a very complex problem scholarly consensus has not been reached for the definitions of the term «register». The universal criteria for defining and discriminating registers have not been worked out either. The authors of the article give the review of scientific works devoted to the problem in question especially works by M.A.K. Halliday, R. Quirk, M. Joos, D. Hymes P. Trudgill, E.I. Belyaeva and others and analyze different definitions of the term «register», spectrums of registers and criteria for their discriminating. It enables the authors to come to the conclusion that only registers with the same field (religious, political, business etc. and mode (oral/written, dialogue/monologue can be compared. The difference lies in the sphere of tenor which depends on the degree of formality, distance of power and socio-psychological distance between speakers. The authors believe that it is also necessary to take into account the cooperative/ uncooperative character of conversation and para-verbal and non-verbal components of the speech situation. With this in mind they offer their definition of the register and describe main characteristics of registers in the sphere of oral communication.

Effectiveness of newspaper advertising for patient recruitment into a clinical trial.

Science.gov (United States)

Hapca, Adrian; Jennings, Claudine G; Wei, Li; Wilson, Adam; MacDonald, Thomas M; Mackenzie, Isla S

2014-06-01

To measure the impact of newspaper advertising across Scotland on patient interest, and subsequent recruitment into the Standard Care vs. Celecoxib Outcome Trial (SCOT), a clinical trial investigating the cardiovascular safety of non-steroidal anti-inflammatory drugs in patients with osteoarthritis or rheumatoid arthritis. Newspaper advertisements about the SCOT trial were placed sequentially in regional and national Scottish newspapers. The number of phone calls as a result of exposure to the advertisements and ongoing study recruitment rates were recorded before, during and after the advertising campaign. To enroll in SCOT individuals had to be registered with a participating GP practice. The total cost for the advertising campaign was £46 250 and 320 phone calls were received as a result of individuals responding to the newspaper advertisements. One hundred and seventy-two individuals were identified as possibly suitable to be included in the study. However only 36 were registered at participating GP practices, 17 completed a screening visit and 15 finally were randomized into the study. The average cost per respondent individual was £144 and the average cost per randomized patient was £3083. Analysis of recruitment rate trends showed that there was no impact of the newspaper advertising campaign on increasing recruitment into SCOT. Advertisements placed in local and national newspapers were not an effective recruitment strategy for the SCOT trial. The advertisements attracted relatively small numbers of respondents, many of whom did not meet study inclusion criteria or were not registered at a participating GP practice. © 2013 The British Pharmacological Society.

Effectiveness of newspaper advertising for patient recruitment into a clinical trial

Science.gov (United States)

Hapca, Adrian; Jennings, Claudine G; Wei, Li; Wilson, Adam; MacDonald, Thomas M; Mackenzie, Isla S

2014-01-01

Aims To measure the impact of newspaper advertising across Scotland on patient interest, and subsequent recruitment into the Standard Care vs. Celecoxib Outcome Trial (SCOT), a clinical trial investigating the cardiovascular safety of non-steroidal anti-inflammatory drugs in patients with osteoarthritis or rheumatoid arthritis. Methods Newspaper advertisements about the SCOT trial were placed sequentially in regional and national Scottish newspapers. The number of phone calls as a result of exposure to the advertisements and ongoing study recruitment rates were recorded before, during and after the advertising campaign. To enroll in SCOT individuals had to be registered with a participating GP practice. Results The total cost for the advertising campaign was £46 250 and 320 phone calls were received as a result of individuals responding to the newspaper advertisements. One hundred and seventy-two individuals were identified as possibly suitable to be included in the study. However only 36 were registered at participating GP practices, 17 completed a screening visit and 15 finally were randomized into the study. The average cost per respondent individual was £144 and the average cost per randomized patient was £3083. Analysis of recruitment rate trends showed that there was no impact of the newspaper advertising campaign on increasing recruitment into SCOT. Conclusions Advertisements placed in local and national newspapers were not an effective recruitment strategy for the SCOT trial. The advertisements attracted relatively small numbers of respondents, many of whom did not meet study inclusion criteria or were not registered at a participating GP practice. PMID:24283948

Global women's health: current clinical trials in low- and middle-income countries.

Science.gov (United States)

Merriel, A; Harb, H M; Williams, H; Lilford, R; Coomarasamy, A

2015-01-01

Clinical trials in low- and middle-income countries (LMICs) are necessary to develop evidence-based approaches to improve women's health. Understanding what research is currently being conducted will allow the identification of research gaps, avoidance of duplication, planning of future studies, collaboration amongst research groups, and geographical targeting for research investments. To provide an overview of active women's health trials in LMICs. The World Health Organization's International Clinical Trials Registry Platform was searched for trials registered between 1 April 2012 and 31 March 2014. Selected trials were randomised, conducted in LMICs, active, and with a women's health intervention or a significant outcome for the woman. Two reviewers extracted data. Analysis included geographical spread, speciality areas, pre-enrolment registration, study size, and funders. Of the 8966 records, 509 were eligible for inclusion. Gynaecology trials made up 57% of the research, whereas the remaining 43% of trials were in obstetrics. Research activity focused on fertility (17%), the antenatal period (15%), benign gynaecology (14%), intrapartum care (9%), and pre-invasive disease and cancers (8%). The majority of trials (84%) took place in middle-income countries (MICs). In low-income countries (LICs) 83% of research investigated obstetrics, and in MICs 60% of research investigated gynaecology. Most trials (80%) had a sample size of 500 or fewer participants. The median size of trials in LICs was 815 compared with 128 in MICs. Pre-enrolment registration occurred in 54% of trials. The majority (62%) of trials were funded locally. Many LMICs are active in women's health research. The majority of registered trials are located in MICs; however, the trials in LICs are often larger. The focus of research in MICs may be driven by local priorities and funding, with fertility being highly researched. In LICs, pregnancy is the focus, perhaps reflecting the international

Increasing Rates of Brain Tumours in the Swedish National Inpatient Register and the Causes of Death Register

Directory of Open Access Journals (Sweden)

Lennart Hardell

2015-04-01

Full Text Available Radiofrequency emissions in the frequency range 30 kHz–300 GHz were evaluated to be Group 2B, i.e., “possibly”, carcinogenic to humans by the International Agency for Research on Cancer (IARC at WHO in May 2011. The Swedish Cancer Register has not shown increasing incidence of brain tumours in recent years and has been used to dismiss epidemiological evidence on a risk. In this study we used the Swedish National Inpatient Register (IPR and Causes of Death Register (CDR to further study the incidence comparing with the Cancer Register data for the time period 1998–2013 using joinpoint regression analysis. In the IPR we found a joinpoint in 2007 with Annual Percentage Change (APC +4.25%, 95% CI +1.98, +6.57% during 2007–2013 for tumours of unknown type in the brain or CNS. In the CDR joinpoint regression found one joinpoint in 2008 with APC during 2008–2013 +22.60%, 95% CI +9.68, +37.03%. These tumour diagnoses would be based on clinical examination, mainly CT and/or MRI, but without histopathology or cytology. No statistically significant increasing incidence was found in the Swedish Cancer Register during these years. We postulate that a large part of brain tumours of unknown type are never reported to the Cancer Register. Furthermore, the frequency of diagnosis based on autopsy has declined substantially due to a general decline of autopsies in Sweden adding further to missing cases. We conclude that the Swedish Cancer Register is not reliable to be used to dismiss results in epidemiological studies on the use of wireless phones and brain tumour risk.

Registration status and outcome reporting of trials published in core headache medicine journals.

Science.gov (United States)

Rayhill, Melissa L; Sharon, Roni; Burch, Rebecca; Loder, Elizabeth

2015-11-17

To evaluate randomized controlled trial (RCT) registration and outcome reporting compliance in core headache medicine journals. We identified RCTs published in core journals (Headache, Cephalalgia, and the Journal of Headache and Pain) from 2005 through 2014. We searched articles for trial registration numbers, which were verified in the corresponding trial registry. We categorized trial funding sources as industry, academic, government, or mixed. We contacted corresponding authors to assess reasons for nonregistration. We evaluated whether primary outcomes in trial registries matched those in corresponding publications. The journals published 225 RCTs over the study period. Fifty-eight of 225 (26%) reported a trial registration number in the article that could be linked to a corresponding registry entry. Trial registration rates increased over the 9 years of the study. Forty-six of 118 (39%) of industry-funded studies were registered compared with 27% of academic and 0% of government-funded studies. Only 5% of RCTs were prospectively registered, reported primary outcomes identical to those in the trial registry, and did not report unacknowledged post hoc outcomes. The most common reason for nonregistration was lack of awareness. Only about a quarter of the articles published in the core headache medicine journals are compliant with trial registration, but compliance has increased over time. Selective reporting of outcomes remains a problem, and very few trials met all 3 reporting standards assessed in this study. Efforts to improve the quality of trial reporting in the headache literature should continue. © 2015 American Academy of Neurology.

The European Register of Specialists in Clinical Chemistry and Laboratory Medicine: guide to the Register, version 3-2010.

LENUS (Irish Health Repository)

McMurray, Janet

2010-07-01

In 1997, the European Communities Confederation of Clinical Chemistry and Laboratory Medicine (EC4) set up a Register for European Specialists in Clinical Chemistry and Laboratory Medicine. The operation of the Register is undertaken by a Register Commission (EC4RC). During the last 12 years, more than 2200 specialists in Clinical Chemistry and Laboratory Medicine have joined the Register. In 2007, EC4 merged with the Forum of European Societies of Clinical Chemistry and Laboratory Medicine (FESCC) to form the European Federation of Clinical Chemistry and Laboratory Medicine (EFCC). Two previous Guides to the Register have been published, one in 1997 and another in 2003. The third version of the Guide is presented in this article and is based on the experience gained and development of the profession since the last revision. Registration is valid for 5 years and the procedure and criteria for re-registration are presented as an Appendix at the end of the article.

Catalog of 199 register-based definitions of chronic conditions

DEFF Research Database (Denmark)

Hvidberg, Michael F; Johnsen, Søren P; Glümer, Charlotte

2016-01-01

INTRODUCTION: The aim of the current study was to present and discuss a broad range of register-based definitions of chronic conditions for use in register research, as well as the challenges and pitfalls when defining chronic conditions by the use of registers. MATERIALS AND METHODS: The definit......INTRODUCTION: The aim of the current study was to present and discuss a broad range of register-based definitions of chronic conditions for use in register research, as well as the challenges and pitfalls when defining chronic conditions by the use of registers. MATERIALS AND METHODS......: The definitions were defined based on information from nationwide Danish public healthcare registers. Medical and epidemiological specialists identified and grouped relevant diagnosis codes that covered chronic conditions, using the International Classification System version 10 (ICD-10). Where relevant...... definitions were proposed based on record linkage between multiple registers, including registers of prescribed drugs and use of general practitioners' services. CONCLUSIONS THIS STUDY PROVIDED A CATALOG OF REGISTER-BASED DEFINITIONS FOR CHRONIC CONDITIONS FOR USE IN HEALTHCARE PLANNING AND RESEARCH, WHICH IS...

Impact of improved recording of work-relatedness in primary care visits at occupational health services on sickness absences: study protocol for a randomised controlled trial.

Science.gov (United States)

Atkins, Salla; Ojajärvi, Ulla; Talola, Nina; Viljamaa, Mervi; Nevalainen, Jaakko; Uitti, Jukka

2017-07-26

Employment protects and fosters health. Occupational health services, particularly in Finland, have a central role in protecting employee health and preventing work ability problems. However, primary care within occupational health services is currently underused in informing preventive activities. This study was designed to assess whether the recording of work ability problems and improvement of follow-up of work-related primary care visits can reduce sickness absences and work disability pensions after 1 year. A pragmatic trial will be conducted using patient electronic registers and registers of the central pensions agency in Finland. Twenty-two occupational health centres will be randomised to intervention and control groups. Intervention units will receive training to improve recording of work ability illnesses in the primary care setting and improved follow-up procedures. The intervention impact will be assessed through examining rates of sickness absence across intervention and control clinics as well as before and after the intervention. The trial will develop knowledge of the intervention potential of primary care for preventing work disability pensions and sickness absence. The use of routine patient registers and pensions registers to assess the outcomes of a randomised controlled trial will bring forward trial methodology, particularly when using register-based data. If successful, the intervention will improve the quality of occupational health care primary care and contribute to reducing work disability. ISRCTN Registry reference number ISRCTN45728263 . Registered on 18 April 2016.

Registered Nurses' views on their professional role.

Science.gov (United States)

Furåker, Carina

2008-11-01

The aim is to study Registered Nurses' opinions and reflections about their work tasks, competence and organization in acute hospital care. The definition of the role of nurses has changed over time and it is often discussed whether Registered Nurses have a professional status or not. A qualitative research design was used. Data were derived from written reflections on diaries and from focus group interviews. All respondents had difficulties in identifying the essence of their work. It can be argued that being 'a spider in the web' is an important aspect of the nursing profession. Registered Nurses tend to regard their professional role as vague. Managers must be considered key persons in defining the professional role of Registered Nurses. This study contributes to an understanding of the managers' and the importance of nursing education in Registered Nurses professional development.

The association between fluoride in drinking water and dental caries in Danish children. Linking data from health registers, environmental registers and administrative registers

DEFF Research Database (Denmark)

Kirkeskov, Lilli; Kristiansen, Eva; Bøggild, Henrik

2010-01-01

Kirkeskov L, Kristiansen E, Bøggild H, von Platen-Hallermund F, Sckerl H, Carlsen A, Larsen MJ, Poulsen S. The association between fluoride in drinking water and dental caries in Danish children. Linking data from health registers, environmental registers and administrative registers. Community...... Dent Oral Epidemiol 2010. (c) 2010 John Wiley & Sons A/S Abstract - Objectives: To study the association between fluoride concentration in drinking water and dental caries in Danish children. Methods: The study linked registry data on fluoride concentration in drinking water over a 10-year period...... with data on dental caries from the Danish National Board of Health database on child dental health for 5-year-old children born in 1989 and 1999, and for 15-year-old children born in 1979 and 1989. The number of children included in the cohorts varied between 41.000 and 48.000. Logistic regression was used...

Procedure entry in the register of yachts

Directory of Open Access Journals (Sweden)

Zorana Kostović

2011-01-01

Full Text Available The procedure of ship registration is regulated in the Maritime Code of Croatia (2004. This procedure, in comparison with the recently suspended Maritime Code of Croatia (1994, includes substantial changes, especially in the domain of yacht registration. New Maritime Code has founded special yacht-register for yachts and yachts under construction. A yacht which is registered as a Croatian yacht is entitled to the benefits conffered by the Maritime Code of Croatia (right to fly a Croatian flag, etc.. There are two modes proscribed under the provisions of Maritime Code of Croatia (2004 for yacht-registration: 1 mandatory and 2 facultative. Yachts whose owners are Croatian citizens with residence i Republic Croatia or companies which are registered in the Republic of Croatia are obligated to register under the provisions of Maritime Code of Croatia (2004. On the other hand, yacht whose owners are not Croatian citizens or whose owners are Croatian citizens but without the residence in the Republic of Croatia, can be registered in the Republic of Croatia, depending on the will of the owner. Yachts under construction can be registered in special registers for such kind of vessels if they are built in Croatian shipyards (owners can be either Croatian citizens or foreigners. Jurisdiction in this matter belongs to port authorities and all procedure is carried out in accordance with the rules of administrative procedure.

Prevention of Bleeding in Orthognathic Surgery--A Systematic Review and Meta-Analysis of Randomized Controlled Trials

DEFF Research Database (Denmark)

Olsen, Jesper J; Skov, Jane; Ingerslev, Janne

2016-01-01

and operating time. This review is registered at PROSPERO (CRD42014014840). RESULTS: Eleven trials were included for review. The individual trials demonstrated the effects on IOB from hypotensive anesthetic regimens, the use of aprotinin, and the herbal medicine Yunnan Baiyao. Six studies of tranexamic acid...

Effect of Registered Partnership on Labor Earnings and Fertility for Same-Sex Couples: Evidence From Swedish Register Data.

Science.gov (United States)

Aldén, Lina; Edlund, Lena; Hammarstedt, Mats; Mueller-Smith, Michael

2015-08-01

The expansion of legal rights to same-sex couples is a foot in a number of Western countries. The effects of this rollout are not only important in their own right but can also provide a window on the institution of marriage and the rights bundled therein. In this article, using Swedish longitudinal register data covering 1994-2007, we study the impact of the extension of rights to same-sex couples on labor earnings and fertility. In 1994, registered partnership for same-sex couples was introduced, which conferred almost all rights and obligations of marriage--a notable exception being joint legal parenting, by default or election. The latter was added in the 2002 adoption act. We find registered partnership to be important to both gays and lesbians but for different reasons. For gays, resource pooling emerges as the main function of registered partnerships. For lesbians, registered partnership appears to be an important vehicle for family formation, especially after the 2002 adoption act. In contrast to heterosexual couples (included for comparison), we find no evidence of household specialization among lesbians. The lack of specialization is noteworthy given similar fertility effects of registered partnership (after 2002) and the fact that lesbian couples were less assortatively matched (on education) than heterosexual couples--children and unequal earnings power being two factors commonly believed to promote specialization.

Register-based studies of cardiovascular disease

DEFF Research Database (Denmark)

Abildstrøm, Steen Z; Torp-Pedersen, Christian; Madsen, Mette

2011-01-01

Introduction: The use of the unique personal identification number in the Nordic database systems enables the researchers to link the registers at the individual level. The registers can be used for both defining specific patient populations and to identify later events during follow-up. This rev...... the hospitalisation rate and treatment of cardiovascular disease. The risk of unmeasured factors affecting the results calls for cautious interpretation of the results.......-up. This review gives three examples within cardiovascular epidemiology to illustrate the use of the national administrative registers available to all researchers upon request. Research topics: The hospitalisation rate of acute myocardial infarction (AMI) was expected to be increased and case-fatality rate......-based treatment increased significantly over time and adherence to treatment was high. Finally, use of specific nonsteroidal antiinflammatory drugs by healthy subjects was associated with a dose-dependent increase in cardiovascular risk. CONCLUSION: The nationwide registers have proven very useful in monitoring...

Is it fair to the children? Asenapine trials for acute manic or mixed episodes in children with bipolar disorder were misrepresented

DEFF Research Database (Denmark)

Danborg, Pia Brandt; Schumann, T

% occurred in 26 (8.6%) patients on asenapine versus one on placebo, and there were 414 versus 43 non-serious AEs. During the OLE (described to assess safety), 613 serious AEs in 23 participants were registered in the trial register; self-harm was reported 192 times. Extrapyramidal symptoms events were...... was generally well tolerated”. Method: One unblinded observer extracted data on harms and quality of life from the paper and compared these to data from the trial register and the FDA clinical review. A second observer validated the data. Results: Of 404 participants, 303 were randomized to one of three...... reported 20 times and 109 experienced >7% weight gain. Non-serious AEs totaled 3437 events in 200 participants (62%) while the paper reported selected AEs. The pediatric Quality of Life Enjoyment and Satisfaction Questionnaire is a self-reported 70-point scale. Results were only reported in the trial...

Design and rationale of the Procalcitonin Antibiotic Consensus Trial (ProACT), a multicenter randomized trial of procalcitonin antibiotic guidance in lower respiratory tract infection.

Science.gov (United States)

Huang, David T; Angus, Derek C; Chang, Chung-Chou H; Doi, Yohei; Fine, Michael J; Kellum, John A; Peck-Palmer, Octavia M; Pike, Francis; Weissfeld, Lisa A; Yabes, Jonathan; Yealy, Donald M

2017-08-29

Overuse of antibiotics is a major public health problem, contributing to growing antibiotic resistance. Procalcitonin has been reported to be commonly elevated in bacterial, but not viral infection. Multiple European trials found procalcitonin-guided care reduced antibiotic use in lower respiratory tract infection, with no apparent harm. However, applicability to US practice is limited due to trial design features impractical in the US, between-country differences, and residual safety concerns. The Procalcitonin Antibiotic Consensus Trial (ProACT) is a multicenter randomized trial to determine the impact of a procalcitonin antibiotic prescribing guideline, implemented with basic reproducible strategies, in US patients with lower respiratory tract infection. We describe the trial methods using the Consolidated Standards of Reporting Trials (CONSORT) framework, and the rationale for key design decisions, including choice of eligibility criteria, choice of control arm, and approach to guideline implementation. ClinicalTrials.gov NCT02130986 . Registered May 1, 2014.

PENGGUNAAN REGISTER DALAM WACANA RESEP MASAKAN BLUE BAND

Directory of Open Access Journals (Sweden)

Asri Soraya Afsari

2018-03-01

Full Text Available AbstractOn its using, language has diverse variation. Language in formal situation will be different from the informal one. Likewise the language for advertisement is different from scientific paper. In Sociolinguistics, the application of a language variant is called as Register. The food recipe discourse is one type of the register for it has specific characteristics in particular grammar and structure. This writing tries to review the application of the register in Blue Band  food recipe discourse. The result of the research indicates that it comprises vocabularies, morphology of derivatives and phrases, and also clauses. The finding register shows ingredients, tools, processing, and, serving.Keyword: register, food recipe discourse, sociolinguistics, vocabulary, morphology

Acupuncture for treating polycystic ovary syndrome: guidance for future randomized controlled trials

OpenAIRE

Wu, Y; Robinson, N; Hardiman, PJ; Taw, MB; Zhou, J; Wang, FF; Qu, F

2016-01-01

Objective: To provide guidance for future randomized controlled trials (RCTs) based on a review concerning acupuncture for treating polycystic ovary syndrome (PCOS). Methods: A comprehensive literature search was conducted in October 2015 using MEDLINE, EMBASE, SCISEARCH, Cumulative Index to Nursing and Allied Health Literature, the Cochrane Menstrual Disorders and Subfertility Group trials register, Allied and Complementary Medicine (AMED), China National Knowledge Infrastructure (CNKI), and...

Qualitative research within trials: developing a standard operating procedure for a clinical trials unit

Science.gov (United States)

2013-01-01

Background Qualitative research methods are increasingly used within clinical trials to address broader research questions than can be addressed by quantitative methods alone. These methods enable health professionals, service users, and other stakeholders to contribute their views and experiences to evaluation of healthcare treatments, interventions, or policies, and influence the design of trials. Qualitative data often contribute information that is better able to reform policy or influence design. Methods Health services researchers, including trialists, clinicians, and qualitative researchers, worked collaboratively to develop a comprehensive portfolio of standard operating procedures (SOPs) for the West Wales Organisation for Rigorous Trials in Health (WWORTH), a clinical trials unit (CTU) at Swansea University, which has recently achieved registration with the UK Clinical Research Collaboration (UKCRC). Although the UKCRC requires a total of 25 SOPs from registered CTUs, WWORTH chose to add an additional qualitative-methods SOP (QM-SOP). Results The qualitative methods SOP (QM-SOP) defines good practice in designing and implementing qualitative components of trials, while allowing flexibility of approach and method. Its basic principles are that: qualitative researchers should be contributors from the start of trials with qualitative potential; the qualitative component should have clear aims; and the main study publication should report on the qualitative component. Conclusions We recommend that CTUs consider developing a QM-SOP to enhance the conduct of quantitative trials by adding qualitative data and analysis. We judge that this improves the value of quantitative trials, and contributes to the future development of multi-method trials. PMID:23433341

Josephson shift register design and layout

International Nuclear Information System (INIS)

Przybysz, J.X.; Buttyan, J.; Blaugher, R.D.

1989-01-01

Integrated circuit chips were designed and fabricated, based on Josephson shift register circuit that simulated operation at 25 GHz using the SPICE program. The 6.25 mm square chip featured a twelve-gate, four-stage shift register fabricated with Nb/AlO/sub x//Nb Josephson junctions with a design value of 2000 A/cm/sup 2/ critical current density. SUPERCOMPACT, a general program for the design of monolithic microwave integrated circuits, was used to model the effects of layout geometry on the uniformity and phase coherence of logic gate bias currents. Gate bias resistors were treated as resistive transmission lines. A layout geometry for the superconductive transmission lines and thin film bias resistors was developed. The original SPICE-designed circuit was modified as a result of these calculations. Modeling indicated that bias current variations could be limited to 3% for all possible logic states of the shift register, and phase coherence of the gates could be maintained to within 2 degrees of 10 Ghz. The fundamental soundness of the circuit design was demonstrated by the proper operation of fabricated shift registers

EU Transparency Register

NARCIS (Netherlands)

Mańko, R.; Thiel, M.; Bauer, E.

2014-01-01

Widespread lobbying in the EU institutions has led to criticism regarding the transparency and accountability of the EU's decision-making process. In response to these concerns, the Parliament set up its transparency register in 1995, followed by the Commission in 2008. The two institutions merged

Registered nurses' perceptions of rewarding and its significance.

Science.gov (United States)

Seitovirta, Jaana; Lehtimäki, Aku-Ville; Vehviläinen-Julkunen, Katri; Mitronen, Lasse; Kvist, Tarja

2017-11-07

To examine reward type preferences and their relationships with the significance of rewarding perceived by registered nurses in Finland. Previous studies have found relationships between nurses' rewarding and their motivation at work, job satisfaction and organisational commitment. Data were collected in a cross-sectional, descriptive, questionnaire survey from 402 registered nurses using the Registered Nurses' Perceptions of Rewarding Scale in 2015, and analysed with descriptive and multivariate statistical methods. Registered nurses assigned slightly higher values to several non-financial than to financial rewards. The non-financial reward types appreciation and feedback from work community, worktime arrangements, work content, and opportunity to develop, influence and participate were highly related to the significance of rewarding. We identified various rewards that registered nurses value, and indications that providing an appropriate array of rewards, particularly non-financial rewards, is a highly beneficial element of nursing management. It is important to understand the value of rewards for nursing management. Nurse managers should offer diverse rewards to their registered nurses to promote excellent performance and to help efforts to secure and maintain high-quality, safe patient care. The use of appropriate rewards is especially crucial to improving registered nurses' reward satisfaction and job satisfaction globally in the nursing profession. © 2017 John Wiley & Sons Ltd.

The transvaginal hybrid NOTES versus conventionally assisted laparoscopic sigmoid resection for diverticular disease (TRANSVERSAL) trial: study protocol for a randomized controlled trial.

Science.gov (United States)

Senft, Jonas D; Warschkow, Rene; Diener, Markus K; Tarantino, Ignazio; Steinemann, Daniel C; Lamm, Sebastian; Simon, Thomas; Zerz, Andreas; Müller-Stich, Beat P; Linke, Georg R

2014-11-20

current surgical standard for sigmoid resection. The trial protocol was registered in the German Clinical Trials Register ( DRKS00005995) on March 27, 2014.

Clinical trials of CAR-T cells in China.

Science.gov (United States)

Liu, Bingshan; Song, Yongping; Liu, Delong

2017-10-23

Novel immunotherapeutic agents targeting tumor-site microenvironment are revolutionizing cancer therapy. Chimeric antigen receptor (CAR)-engineered T cells are widely studied for cancer immunotherapy. CD19-specific CAR-T cells, tisagenlecleucel, have been recently approved for clinical application. Ongoing clinical trials are testing CAR designs directed at novel targets involved in hematological and solid malignancies. In addition to trials of single-target CAR-T cells, simultaneous and sequential CAR-T cells are being studied for clinical applications. Multi-target CAR-engineered T cells are also entering clinical trials. T cell receptor-engineered CAR-T and universal CAR-T cells represent new frontiers in CAR-T cell development. In this study, we analyzed the characteristics of CAR constructs and registered clinical trials of CAR-T cells in China and provided a quick glimpse of the landscape of CAR-T studies in China.

Enhancing Recruitment Using Teleconference and Commitment Contract (ERUTECC): study protocol for a randomised, stepped-wedge cluster trial within the EFFECTS trial.

Science.gov (United States)

Lundström, Erik; Isaksson, Eva; Wester, Per; Laska, Ann-Charlotte; Näsman, Per

2018-01-08

future. It might also be useful in clinical settings outside the field of stroke. The ERUTECC study was registered in the Northern Ireland Hub for Trials Methodology Research Studies Within a Trial repository ( SWAT58 ) on 30 April 2017. ClinicalTrials.gov, ID: NCT02683213 . Retrospectively registered on 2 February 2016.

Global shortage of neonatal and paediatric antibiotic trials: rapid review.

Science.gov (United States)

Thompson, Georgina; Barker, Charlotte I; Folgori, Laura; Bielicki, Julia A; Bradley, John S; Lutsar, Irja; Sharland, Mike

2017-10-13

There have been few clinical trials (CTs) on antibiotics that inform neonatal and paediatric drug labelling. The rate of unlicensed and off-label prescribing in paediatrics remains high. It is unclear whether the current neonatal and paediatric antibiotic research pipeline is adequate to inform optimal drug dosing. Using the ClinicalTrials.gov registry, this review aims to establish the current global status of antibiotic CTs in children up to 18 years of age. Studies were identified using key word searches of the ClinicalTrials.gov registry and were manually filtered using prespecified inclusion/exclusion criteria. 76 registered open CTs of antibiotics in children were identified globally; 23 (30%) were recruiting newborns (only 8 (11%) included preterm neonates), 52 (68%) infants and toddlers, 58 (76%) children and 54 (71%) adolescents. The majority of registered trials were late phase (10 (15%) phase 3 and 23 (35%) phase 4/pharmacovigilance). Two-thirds were sponsored by non-profit organisations, compared with pharmaceutical companies (50 (66%) vs 26 (34%), respectively). A greater proportion of non-profit funded trials were efficacy-based strategic trials (n=34, 68%), in comparison with industry-led trials, which were most often focused on safety or pharmacokinetic data (n=17, 65%). Only 2 of the 37 antibiotics listed on the May 2016 Pew Charitable Trusts antibiotic development pipeline, currently being studied in adults, appear to be currently recruiting in open paediatric CTs. This review highlights that very few paediatric antibiotic CTs are being conducted globally, especially in neonates. There is a striking disparity noted between antibiotic drug development programmes in adults and children. © Article author(s) (or their employer(s) unless otherwise stated in the text of the article) 2017. All rights reserved. No commercial use is permitted unless otherwise expressly granted.

Pollutant emission registers-INES and EPER toward PRTR

International Nuclear Information System (INIS)

Caricchia, A.M.; Cirillo, M.C.; Gagna, A.

2005-01-01

PRTRs (Pollutant Release and Transfer Registers) are information systems collecting and providing public access to information on pollutant releases in the environment. These registers are based on a scheduled reporting by the manufacturing facilities. Since the establishment of the TRI (Toxic Release lnventory) at the end of the '80s in the USA, international interest grew focussing on the definition of the features of national PRTRs as environmental management systems. The Protocol on PRTRs, the first international legally binding agreement, was signed in 2003 in the frame of the UNECE-Convention on Access to Information, Public Participation in Decision-making and Access to Justice in Environmental Matters (Aarhus Convention, 1999). The European register EPER (European Pollutant Emission Register), established in the Directive 96/61/EC, represents the first step at a European level towards a truly integrated pollutant emissions register, an experience which is going to improve further with the forthcoming introduction of the E-PRTR (European Pollutant Release and Transfer Register). Operating since 2003, EPER collects the information provided by 9377 facilities spread over EU15 countries plus Norway and Hungary. Concerning Italy, in accordance with European EPER, a national pollutant emission register has been established, called INES ('Inventario Nazionale delle Emissioni e loro Sorgenti'). INES can be currently browsed and queried on the following web-page: http://www.sinanet.apat.it [it

Validation of the danish national diabetes register

DEFF Research Database (Denmark)

Green, Anders; Sortsø, Camilla; Jensen, Peter Bjødstrup

2015-01-01

The Danish National Diabetes Register (NDR) was established in 2006 and builds on data from Danish health registers. We validated the content of NDR, using full information from the Danish National Patient Register and data from the literature. Our study indicates that the completeness in NDR...... is ≥95% concerning ascertainment from data sources specific for diabetes, ie, prescriptions with antidiabetic drugs and diagnoses of diabetes in the National Patient Register. Since the NDR algorithm ignores diabetes-related hospital contacts terminated before 1990, the establishment of the date...... of encounter, has been taken as the date of inclusion in NDR. We also find that some 20% of the registrations in NDR may represent false positive inclusions of persons with frequent measurements of blood glucose without having diabetes. We conclude that NDR is a novel initiative to support research...

Barriers towards the publication of academic drug trials. Follow-up of trials approved by the Danish Medicines Agency.

Science.gov (United States)

Berendt, Louise; Petersen, Lene Grejs; Bach, Karin Friis; Poulsen, Henrik Enghusen; Dalhoff, Kim

2017-01-01

To characterize and quantify barriers towards the publication of academic drug trials. We identified academic drug trials approved during a 3-year period (2004-2007) by the Danish Medicines Agency. We conducted a survey among the trial sponsors to describe the rates of initiation, completion, and publication, and the reasons for the failure to reach each of these milestones. Information on size and methodological characteristics of the trials was extracted from the EudraCT database, a prospective register of all approved clinical drug trials submitted to European medicines agencies since 2004. A total of 181 academic drug trials were eligible for inclusion, 139 of which participated in our survey (response rate: 77%). Follow-up time ranged from 5.1 to 7.9 years. Most trials were randomized controlled trials (73%, 95% CI 65-81%). Initiation and completion rates were 92% (95% CI: 88-97%) and 93% (95% CI: 89-97%) respectively. The publication rate of completed trials was 73% (95% CI: 62-79%). RCTs were published faster than non-RCTs (quartile time to publication 2.9 vs. 3.1 years, p = 0.0412). Many academic drug trials are left unpublished. Main barriers towards publication were related to the process from completion to publication. Hence, there is much to gain by facilitating the process from analysis to publication. Research institutions and funders should actively influence this process, e.g. by requiring the publication of trial results within a given time after completion.

The Danish Medical Birth Register

DEFF Research Database (Denmark)

Bliddal, Mette; Broe, Anne; Pottegård, Anton

2018-01-01

The Danish Medical Birth Register was established in 1973. It is a key component of the Danish health information system. The register enables monitoring of the health of pregnant women and their offspring, it provides data for quality assessment of the perinatal care in Denmark, and it is used...... on all births in Denmark and comprises primarily of data from the Danish National Patient Registry supplemented with forms on home deliveries and stillbirths. It contains information on maternal age provided by the Civil Registration System. Information on pre-pregnancy body mass index and smoking...

Validity of dementia diagnoses in the danish hospital registers

DEFF Research Database (Denmark)

Phung, T.K.T.; Andersen, B.B.; Phung, T.K.T.

2007-01-01

.24-0.48). Conclusion: The validity of dementia syndrome in the Danish hospital registers was high and allows for epidemiological studies about dementia. Alzheimer's disease, although underregistered, also had a good validity once the diagnosis was registered. In general, other ICD-10 dementia subtypes in the registers......Background:The validity of dementia diagnoses in the Danish nationwide hospital registers was evaluated to determine the value of these registers in epidemiological research about dementia. Methods: Two hundred patients were randomly selected from 4,682 patients registered for the first time...... with a dementia diagnosis in the last 6 months of 2003. The patients' medical journals were reviewed to evaluate if they fulfilled ICD-10 and/or DSM-IV criteria for dementia and specific dementia subtypes. The patients who were still alive in 2006 were invited to an interview. Results: One hundred and ninety...

Federal Register in XML

Data.gov (United States)

National Archives and Records Administration — The Federal Register is the official daily publication for rules, proposed rules, and notices of Federal agencies and organizations, as well as executive orders and...

7 CFR 3015.204 - Federal Register publications.

Science.gov (United States)

2010-01-01

... 7 Agriculture 15 2010-01-01 2010-01-01 false Federal Register publications. 3015.204 Section 3015.204 Agriculture Regulations of the Department of Agriculture (Continued) OFFICE OF THE CHIEF FINANCIAL... Register publications. (a) Program regulations. Most grant programs have program-specific regulations...

Published and not fully published double-blind, randomised, controlled trials with oral naratriptan in the treatment of migraine

DEFF Research Database (Denmark)

Tfelt-Hansen, Peer Carsten

2011-01-01

Naratriptan 2.5 mg is now an over-the-counter drug in Germany. This should increase the interest in drug. The GSK Trial Register was searched for published and unpublished double-blind, randomised, controlled trials (RCTs) concerning the use of naratriptan in migraine. Only 7 of 17 RCTs are publi......Naratriptan 2.5 mg is now an over-the-counter drug in Germany. This should increase the interest in drug. The GSK Trial Register was searched for published and unpublished double-blind, randomised, controlled trials (RCTs) concerning the use of naratriptan in migraine. Only 7 of 17 RCTs...... are published in full. Naratriptan 2.5 mg is superior to placebo for acute migraine treatment in 6 RCTs, but inferior to sumatriptan 100 mg and rizatriptan 10 mg in one RCT each. This dose of naratriptan has no more adverse events than placebo. Naratriptan 1 mg b.i.d. has some effect in the short...

Characteristics of clinical trials that require participants to be fluent in English.

Science.gov (United States)

Egleston, Brian L; Pedraza, Omar; Wong, Yu-Ning; Dunbrack, Roland L; Griffin, Candace L; Ross, Eric A; Beck, J Robert

2015-12-01

Diverse samples in clinical trials can make findings more generalizable. We sought to characterize the prevalence of clinical trials in the United States that required English fluency for participants to enroll in the trial. We randomly chose over 10,000 clinical trial protocols registered with ClinicalTrials.gov and examined the inclusion and exclusion criteria of the trials. We compared the relationship of clinical trial characteristics with English fluency inclusion requirements. We merged the ClinicalTrials.gov data with US Census and American Community Survey data to investigate the association of English-language restrictions with ZIP-code-level demographic characteristics of participating institutions. We used Chi-squared tests, t-tests, and logistic regression models for analyses. English fluency requirements have been increasing over time, from 1.7% of trials having such requirements before 2000 to 9.0% after 2010 (p English fluency requirements (1.8%), while behavioral trials had high rates (28.4%). Trials opening in the Northeast of the United States had the highest regional English requirement rates (10.7%), while trials opening in more than one region had the lowest (3.3%, pEnglish fluency requirements (odds ratio=0.92 for each 10% increase in proportion of Hispanics, 95% confidence interval=0.86-0.98, p=0.013). Trials opening in ZIP codes with more residents self-identifying as Black/African American (odds ratio=1.87, 95% confidence interval=1.36-2.58, pEnglish fluency requirements. ZIP codes with higher poverty rates had trials with more English-language restrictions (odds ratio=1.06 for a 10% poverty rate increase, 95% confidence interval=1.001-1.11, p=0.045). There was a statistically significant interaction between year and intervention type, such that the increase in English fluency requirements was more common for some interventions than for others. The proportion of clinical trials registered with ClinicalTrials.gov that have English fluency

The Danish multiple sclerosis treatment register

DEFF Research Database (Denmark)

Magyari, Melinda; Koch-Henriksen, Nils; Sørensen, Per Soelberg

2016-01-01

Aim of the database: The Danish Multiple Sclerosis Treatment Register (DMSTR) serves as a clinical quality register, enabling the health authorities to monitor the quality of the diseasemodifying treatment, and it is an important data source for epidemiological research. Study population: The DMSTR...... includes all patients with multiple sclerosis who had been treated with disease-modifying drugs since 1996. At present, more than 8,400 patients have been registered in this database. Data are continuously entered online into a central database from all sites in Denmark at start and at regular visits. Main...... variables: Include age, sex, onset year and year of the diagnosis, basic clinical information, and information about treatment, side effects, and relapses. Descriptive data: Notification is done at treatment start, and thereafter at every scheduled clinical visit 3 months after treatment start...

30 CFR 45.4 - Independent contractor register.

Science.gov (United States)

2010-07-01

... 30 Mineral Resources 1 2010-07-01 2010-07-01 false Independent contractor register. 45.4 Section... ADMINISTRATIVE REQUIREMENTS INDEPENDENT CONTRACTORS § 45.4 Independent contractor register. (a) Each independent contractor shall provide the production-operator in writing the following information: (1) The independent...

Clinical trials of CAR-T cells in China

Directory of Open Access Journals (Sweden)

Bingshan Liu

2017-10-01

Full Text Available Abstract Novel immunotherapeutic agents targeting tumor-site microenvironment are revolutionizing cancer therapy. Chimeric antigen receptor (CAR-engineered T cells are widely studied for cancer immunotherapy. CD19-specific CAR-T cells, tisagenlecleucel, have been recently approved for clinical application. Ongoing clinical trials are testing CAR designs directed at novel targets involved in hematological and solid malignancies. In addition to trials of single-target CAR-T cells, simultaneous and sequential CAR-T cells are being studied for clinical applications. Multi-target CAR-engineered T cells are also entering clinical trials. T cell receptor-engineered CAR-T and universal CAR-T cells represent new frontiers in CAR-T cell development. In this study, we analyzed the characteristics of CAR constructs and registered clinical trials of CAR-T cells in China and provided a quick glimpse of the landscape of CAR-T studies in China.

12 CFR 528.6 - Loan application register.

Science.gov (United States)

2010-01-01

... 12 Banks and Banking 5 2010-01-01 2010-01-01 false Loan application register. 528.6 Section 528.6 Banks and Banking OFFICE OF THRIFT SUPERVISION, DEPARTMENT OF THE TREASURY NONDISCRIMINATION... Mortgage Disclosure Act Loan Application Registers with the Office of Thrift Supervision in accordance with...

Assessment of Human Pharmaceutical Products Registered in ...

African Journals Online (AJOL)

... in order to determine the most common routes of administration and type of dosage forms that are used. Registered pharmaceutical products were categorized by route of administration and then sub-categorized by the dosage form. Oral dosage forms were the most common accounting for 73% of all registered products.

NUHOMS registered - MP197 transport cask

International Nuclear Information System (INIS)

Shih, P.; Sicard, D.; Michels, L.

2004-01-01

The NUHOMS registered -MP197 cask is an optimized transport design which can be loaded in the spent fuel pool (wet loading) or loaded the canister from the NUHOMS concrete modules at the ISFSI site. With impact limiters attached, the package can be transported within the states or world-wide. The NUHOMS registered -MP197 packaging can be used to transport either BWR or PWR canisters. The NUHOMS registered -MP197 cask is designed to the ASME B and PV Code and meets the requirements of Section III, Division 3 for Transport Packaging. The cask with impact limiters has undergone drop testing to verify the calculated g loadings during the 9m drops. The test showed good correlation with analytical results and demonstrate that the impact limiters stay in place and protect the package and fuel during the hypothetical accidents

31 CFR 537.323 - U.S. registered money transmitter.

Science.gov (United States)

2010-07-01

... 31 Money and Finance: Treasury 3 2010-07-01 2010-07-01 false U.S. registered money transmitter. 537.323 Section 537.323 Money and Finance: Treasury Regulations Relating to Money and Finance... General Definitions § 537.323 U.S. registered money transmitter. The term U.S. registered money...

31 CFR 538.319 - U.S. registered money transmitter.

Science.gov (United States)

2010-07-01

... 31 Money and Finance: Treasury 3 2010-07-01 2010-07-01 false U.S. registered money transmitter. 538.319 Section 538.319 Money and Finance: Treasury Regulations Relating to Money and Finance... General Definitions § 538.319 U.S. registered money transmitter. The term U.S. registered money...

The synchronized trial on expectant mothers with depressive symptoms by omega-3 PUFAs (SYNCHRO): Study protocol for a randomized controlled trial.

Science.gov (United States)

Nishi, Daisuke; Su, Kuan-Pin; Usuda, Kentaro; Chiang, Yi-Ju Jill; Guu, Tai-Wei; Hamazaki, Kei; Nakaya, Naoki; Sone, Toshimasa; Sano, Yo; Tachibana, Yoshiyuki; Ito, Hiroe; Isaka, Keiich; Hashimoto, Kenji; Hamazaki, Tomohito; Matsuoka, Yutaka J

2016-09-15

Maternal depression can be harmful to both mothers and their children. Omega-3 polyunsaturated fatty acid (PUFA) supplementation has been investigated as an alternative intervention for pregnant women with depressive symptoms because of the supporting evidence from clinical trials in major depression, the safety advantage, and its anti-inflammatory and neuroplasticity effects. This study examines the efficacy of omega-3 PUFA supplementation for pregnant women with depressive symptoms in Taiwan and Japan, to provide evidence available for Asia. The rationale and protocol of this trial are reported here. The Synchronized Trial on Expectant Mothers with Depressive Symptoms by Omega-3 PUFAs (SYNCHRO) is a multicenter, double-blind, parallel group, randomized controlled trial. Participants will be randomized to either the omega-3 PUFAs arm (1,200 mg eicosapentaenoic acid and 600 mg docosahexaenoic acid daily) or placebo arm. Primary outcome is total score on the Hamilton Rating Scale for Depression (HAMD) at 12 weeks after the start of the intervention. We will randomize 56 participants to have 90 % power to detect a 4.7-point difference in mean HAMD scores with omega-3 PUFAs compared with placebo. Because seafood consumption varies across countries and this may have a major effect on the efficacy of omega-3 PUFA supplementation, 56 participants will be recruited at each site in Taiwan and Japan, for a total number of 112 participants. Secondary outcomes include depressive symptoms at 1 month after childbirth, diagnosis of major depressive disorder, changes in omega-3 PUFAs concentrations and levels of biomarkers at baseline and at 12 weeks' follow-up, and standard obstetric outcomes. Data analyses will be by intention to treat. The trial was started in June 2014 and is scheduled to end in February 2018. The trial is expected to provide evidence that can contribute to promoting mental health among mothers and children in Asian populations. Clinicaltrials.gov: NCT

Linking a research register to clinical records in older adults' mental health services:a mixed-methods study

OpenAIRE

Robotham, Dan; Evans, Joanne; Watson, Andrew; Perdue, Iain; Craig, Thomas; Rose, Diana; Wykes, Til

2015-01-01

INTRODUCTION: Patients can provide consent to have their clinical records linked to a research register, a process known as consent for contact (C4C). There is evidence about how to engage people with mental illness in C4C, but nothing specific to older adults. This is a priority area for research (for example, dementia trials), although sign-up rates to C4C are lower than for younger populations. Through this study we seek to understand these disparities.METHODS: This was a two-stage cross-s...

Data register and processor for multiwire chambers

International Nuclear Information System (INIS)

Karpukhin, V.V.

1985-01-01

A data register and a processor for data receiving and processing from drift chambers of a device for investigating relativistic positroniums are described. The data are delivered to the register input in the form of the Grey 8 bit code, memorized and transformed to a position code. The register information is delivered to the KAMAK trunk and to the front panel plug. The processor selects particle tracks in a horizontal plane of the facility. ΔY maximum coordinate divergence and minimum point quantity on the track are set from the processor front panel. Processor solution time is 16 μs maximum quantity of simultaneously analyzed coordinates is 16

Quality control of portal imaging with PTW EPID QC PHANTOM registered

International Nuclear Information System (INIS)

Pesznyak, Csilla; Kiraly, Reka; Polgar, Istvan; Zarand, Pal; Mayer, Arpad; Fekete, Gabor; Mozes, Arpad; Kiss, Balazs

2009-01-01

Purpose: quality assurance (QA) and quality control (QC) of different electronic portal imaging devices (EPID) and portal images with the PTW EPID QC PHANTOM registered . Material and methods: characteristic properties of images of different file formats were measured on Siemens OptiVue500aSi registered , Siemens BeamView Plus registered , Elekta iView registered , and Varian PortalVision trademark and analyzed with the epidSoft registered 2.0 program in four radiation therapy centers. The portal images were taken with Kodak X-OMAT V registered and the Kodak Portal Localisation ReadyPack registered films and evaluated with the same program. Results: the optimal exposition both for EPIDs and portal films of different kind was determined. For double exposition, the 2+1 MU values can be recommended in the case of Siemens OptiVue500aSi registered , Elekta iView registered and Kodak Portal Localisation ReadyPack registered films, while for Siemens BeamView Plus registered , Varian PortalVision trademark and Kodak X-OMAT V registered film 7+7 MU is recommended. Conclusion: the PTW EPID QC PHANTOM registered can be used not only for amorphous silicon EPIDs but also for images taken with a video-based system or by using an ionization chamber matrix or for portal film. For analysis of QC tests, a standardized format (used at the acceptance test) should be applied, as the results are dependent on the file format used. (orig.)

Safety of intrathecal transplantation of human umbilical cord mesenchymal stem cells for treating hereditary cerebellar ataxia: study protocol for a randomized controlled trial

Directory of Open Access Journals (Sweden)

Yi-hua An

2016-01-01

Trial registration: ClinicalTrials.gov identifier: NCT01489267; registered on 30 October 2011. The study protocol has been approved by the ethics committee of the General Hospital of Chinese Armed Police Forces, China (approval No. 201117.

Sustained Aeration of Infant Lungs (SAIL) trial: study protocol for a randomized controlled trial.

Science.gov (United States)

Foglia, Elizabeth E; Owen, Louise S; Thio, Marta; Ratcliffe, Sarah J; Lista, Gianluca; Te Pas, Arjan; Hummler, Helmut; Nadkarni, Vinay; Ades, Anne; Posencheg, Michael; Keszler, Martin; Davis, Peter; Kirpalani, Haresh

2015-03-15

Extremely preterm infants require assistance recruiting the lung to establish a functional residual capacity after birth. Sustained inflation (SI) combined with positive end expiratory pressure (PEEP) may be a superior method of aerating the lung compared with intermittent positive pressure ventilation (IPPV) with PEEP in extremely preterm infants. The Sustained Aeration of Infant Lungs (SAIL) trial was designed to study this question. This multisite prospective randomized controlled unblinded trial will recruit 600 infants of 23 to 26 weeks gestational age who require respiratory support at birth. Infants in both arms will be treated with PEEP 5 to 7 cm H2O throughout the resuscitation. The study intervention consists of performing an initial SI (20 cm H20 for 15 seconds) followed by a second SI (25 cm H2O for 15 seconds), and then PEEP with or without IPPV, as needed. The control group will be treated with initial IPPV with PEEP. The primary outcome is the combined endpoint of bronchopulmonary dysplasia or death at 36 weeks post-menstrual age. www.clinicaltrials.gov , Trial identifier NCT02139800 , Registered 13 May 2014.

Socio-Economic Characteristics of Registered Cocoa Farmers in ...

African Journals Online (AJOL)

PROF HORSFALL

ABSTRACT: This study examined the socio-economic characteristics of registered cocoa farmers in Edo State; ... Key words: socio-economics, characteristics, registered cocoa farmers. ... international exchange market in two world currencies ...

7 CFR 57.690 - Person required to register.

Science.gov (United States)

2010-01-01

... business will be required to register before they start operations. [69 FR 571688, Sept. 24, 2004... hatcheries, are required to register with the Department by furnishing their name, place of business, and...

N-of-1 trials in the clinical care of patients in developing countries: a systematic review.

Science.gov (United States)

Alemayehu, Chalachew; Nikles, Jane; Mitchell, Geoffrey

2018-04-23

N-of-1 trials have a potential role in promoting patient-centered medicine in developing countries. However, there is limited academic literature regarding the use of N-of-1 trials in the clinical care of patients in resource-poor settings. To assess the extent of use, purpose and treatment outcome of N-of-1 trials in developing countries. A systematic review of clinical N-of-1 trials was conducted between 1985 and September 2015 using PubMed, Embase, CINAHL, Web of Science and the Cochrane Central Register of Controlled Trials. Grey literature databases and clinical trial registers were also searched. This review included randomized, multi-cycle, crossover within individual patient trials involving drug intervention. Quality assessment and data extraction were conducted by two independent reviewers. Out of 131 N-of-1 trials identified, only 6 (4.5%) were conducted in developing countries. The major reason that N-of-1 trials were used was to provide evidence on feasibility, effectiveness and safety of therapies. A total of 72 participants were involved in these trials. Five of the studies were conducted in China and all evaluated Chinese traditional medicine. The remaining study was conducted in Brazil. The completion rate was 93%. More than half, 46 (69%) of subjects made medication changes consistent with trial results after trial completion. A number of threats to the validity of the included evidence limited the validity of the evidence. In particular, the estimated overall effect in four of the included studies could have been affected by the "carry over" of the previous treatment effect as no adequate pharmacokinetic evidence regarding traditional medicines was presented. The prevalence and scope of N-of-1 trials in developing countries is low. A coordinated effort among government, clinicians, researchers and sponsor organizations is needed to increase their uptake and quality in developing countries. PROSPERO CRD42015026841 .

Vitamin D supplementation during pregnancy: state of the evidence from a systematic review of randomised trials.

Science.gov (United States)

Roth, Daniel E; Leung, Michael; Mesfin, Elnathan; Qamar, Huma; Watterworth, Jessica; Papp, Eszter

2017-11-29

Objectives  To estimate the effects of vitamin D supplementation during pregnancy on 11 maternal and 27 neonatal/infant outcomes; to determine frequencies at which trial outcome data were missing, unreported, or inconsistently reported; and to project the potential contributions of registered ongoing or planned trials. Design  Systematic review and meta-analysis of randomised controlled trials; systematic review of registered but unpublished trials. Data sources  Medline, Embase, PubMed, Cochrane Database of Systematic Reviews, and Cochrane Central Register of Controlled Trials from inception to September 2017; manual searches of reference lists of systematic reviews identified in the electronic search; and online trial registries for unpublished, ongoing, or planned trials. Eligibility criteria for study selection  Trials of prenatal vitamin D supplementation with randomised allocation and control groups administered placebo, no vitamin D, or vitamin D ≤600 IU/day (or its equivalent), and published in a peer reviewed journal. Results  43 trials (8406 participants) were eligible for meta-analyses. Median sample size was 133 participants. Vitamin D increased maternal/cord serum concentration of 25-hydroxyvitamin D, but the dose-response effect was weak. Maternal clinical outcomes were rarely ascertained or reported, but available data did not provide evidence of benefits. Overall, vitamin D increased mean birth weight of 58.33 g (95% confidence interval 18.88 g to 97.78 g; 37 comparisons) and reduced the risk of small for gestational age births (risk ratio 0.60, 95% confidence interval 0.40 to 0.90; seven comparisons), but findings were not robust in sensitivity and subgroup analyses. There was no effect on preterm birth (1.0, 0.77 to 1.30; 15 comparisons). There was strong evidence that prenatal vitamin D reduced the risk of offspring wheeze by age 3 years (0.81, 0.67 to 0.98; two comparisons). For most outcomes, meta-analyses included data from a minority

Perioperative antibiotic prophylaxis in the treatment of acute cholecystitis (PEANUTS II trial): study protocol for a randomized controlled trial.

Science.gov (United States)

Loozen, Charlotte S; van Santvoort, Hjalmar C; van Geloven, Antoinette A W; Nieuwenhuijzen, Grard A P; de Reuver, Philip R; Besselink, Mark H G; Vlaminckx, Bart; Kelder, Johannes C; Knibbe, Catherijne A J; Boerma, Djamila

2017-08-23

emergency cholecystectomy for acute calculous cholecystitis. Netherlands Trial Register, NTR5802 . Registered on 4 June 2016.

The HysNiche trial: hysteroscopic resection of uterine caesarean scar defect (niche) in patients with abnormal bleeding, a randomised controlled trial.

Science.gov (United States)

Vervoort, A J M W; Van der Voet, L F; Witmer, M; Thurkow, A L; Radder, C M; van Kesteren, P J M; Quartero, H W P; Kuchenbecker, W K H; Bongers, M Y; Geomini, P M A J; de Vleeschouwer, L H M; van Hooff, M H A; van Vliet, H A A M; Veersema, S; Renes, W B; van Meurs, H S; Bosmans, J; Oude Rengerink, K; Brölmann, H A M; Mol, B W J; Huirne, J A F

2015-11-12

A caesarean section (CS) can cause a defect or disruption of the myometrium at the site of the uterine scar, called a niche. In recent years, an association between a niche and postmenstrual spotting after a CS has been demonstrated. Hysteroscopic resection of these niches is thought to reduce spotting and menstrual pain. However, there are no randomised trials assessing the effectiveness of a hysteroscopic niche resection. We planned a multicentre randomised trial comparing hysteroscopic niche resection to no intervention. We study women with postmenstrual spotting after a CS and a niche with a residual myometrium of at least 3 mm during sonohysterography. After informed consent is obtained, eligible women will be randomly allocated to hysteroscopic resection of the niche or expectant management for 6 months. The primary outcome is the number of days with postmenstrual spotting during one menstrual cycle 6 months after randomisation. Secondary outcomes are menstrual characteristics, menstruation related pain and experienced discomfort due to spotting or menstrual pain, quality of life, patient satisfaction, sexual function, urological symptoms, medical consultations, medication use, complications, lost productivity and medical costs. Measurements will be performed at baseline and at 3 and 6 months after randomisation. A cost-effectiveness analysis will be performed from a societal perspective at 6 months after randomisation. This trial will provide insight in the (cost)effectiveness of hysteroscopic resection of a niche versus expectant management in women who have postmenstrual spotting and a niche with sufficient residual myometrium to perform a hysteroscopic niche resection. Dutch Trial Register NTR3269 . Registered 1 February 2012. ZonMw Grant number 80-82305-97-12030.

National Register of Historic Places - National Geospatial Data Asset (NGDA) NPS National Register Dataset

Data.gov (United States)

Federal Geographic Data Committee — A current, accurate spatial representation of all historic properties listed on the National Register of Historic Places is of interest to Federal agencies, the...

Transparency and public accessibility of clinical trial information in Croatia: how it affects patient participation in clinical trials.

Science.gov (United States)

Šolić, Ivana; Stipčić, Ana; Pavličević, Ivančica; Marušić, Ana

2017-06-15

Despite increased visibility of clinical trials through international trial registries, patients often remain uninformed of their existence, especially if they do not have access to adequate information about clinical research, including the language of the information. The aim of this study was to describe the context for transparency of clinical trials in Croatia in relation to countries in Central and Eastern Europe, and to assess how informed Croatian patients are about clinical trials and their accessibility. We assessed the transparency of clinical trials from the data available in the public domain. We also conducted an anonymous survey on a convenience sample of 257 patients visiting two family medicine offices or an oncology department in south Croatia, and members of national patients' associations. Despite legal provisions for transparency of clinical trials in Croatia, they are still not sufficiently visible in the public domain. Among countries from Central and Eastern Europe, Croatia has the fewest number of registered trials in the EU Clinical Trials Registry. 66% of the patients in the survey were aware of the existence of clinical trials but only 15% were informed about possibilities of participating in a trial. Although 58% of the respondents were willing to try new treatments, only 6% actually participated in a clinical trial. Only 2% of the respondents were aware of publicly available trial registries. Our study demonstrates that there is low transparency of clinical trials in Croatia, and that Croatian patients are not fully aware of clinical trials and the possibilities of participating in them, despite reported availability of Internet resources and good communication with their physicians. There is a need for active policy measures to increase the awareness of and access to clinical trials to patients in Croatia, particularly in their own language.

Reuma.pt - the rheumatic diseases portuguese register.

Science.gov (United States)

Canhão, H; Faustino, A; Martins, F; Fonseca, J E

2011-01-01

Since June 2008, Portuguese rheumatologists have been collecting on a routine basis, data into the nationwide Reuma.pt, the Rheumatic Diseases Portuguese Register from the Portuguese Society of Rheumatology (SPR), which includes rheumatic patients (rheumatoid arthritis - RA, ankylosing spondylitis - AS, psoriatic arthritis - PsA and juvenile idiopathic arthritis - JIA) receiving biological therapies or patients receiving synthetic disease modifying anti-rheumatic drugs (DMARDs). The aim of this publication is to describe the structure of Reuma.pt and the population registered since June 2008. Demographic and anthropometric data, life style habits, work status, co-morbidities, disease activity and functional assessment scores, previous and current therapies, adverse events codified by the Medical Dictionary for Regulatory Activities (MedDRA), reasons for discontinuation and laboratory measurements are registered at each visit. The platform is based on a structured electronic medical record linked to a SQL Server database. All Rheumatology Departments assigned to the Portuguese National Health Service (n=21), 2 Military Hospitals (Lisboa and Porto), 1 public-private Institution and 6 private centers adhered to the Register. Until now, 18 centers have entered data into Reuma.pt. By January 2011, 3438 patients and 16130 visits had been registered. 2162 (63%) were RA patients, 700 of them treated with biological agents and 1462 with synthetic DMARDs. From the 515 (15%) AS patients, 297 were medicated with biological and 218 with non-biological therapies. 293 (8%) were PsA patients, 151 treated with biological drugs and 142 with other treatment strategies. 368 (11%) had the diagnosis of JIA, 68 were under biological treatment and 300 were managed with other treatment options. The register also includes 100 (3%) patients with other rheumatic diseases, submitted to treatments that required hospital day care infusions including 18 exposed to biological therapies. Registers

Obesity research based on the Copenhagen School Health Records Register

DEFF Research Database (Denmark)

Baker, Jennifer L; Sørensen, Thorkild I A

2011-01-01

INTRODUCTION: To summarise key findings from research performed using data from the Copenhagen School Health Records Register over the last 30 years with a main focus on obesity-related research. The register contains computerised anthropometric information on 372,636 schoolchildren from the capi......INTRODUCTION: To summarise key findings from research performed using data from the Copenhagen School Health Records Register over the last 30 years with a main focus on obesity-related research. The register contains computerised anthropometric information on 372,636 schoolchildren from...... the capital city of Denmark. Additional information on the cohort members has been obtained via linkages with population studies and national registers. RESEARCH TOPICS: Studies using data from the register have made important contributions in the areas of the aetiology of obesity, the development...... of the obesity epidemic, and the long-term health consequences of birth weight as well as body size and growth in childhood. CONCLUSION: Research using this unique register is ongoing, and its contributions to the study of obesity as well as other topics will continue for years to come....

The effectiveness of delegation interventions by the registered nurse to the unlicensed assistive personnel and their impact on quality of care, patient satisfaction, and RN staff satisfaction: a systematic review.

Science.gov (United States)

Hopkins, Una; Itty, Any Sajan; Nazario, Helen; Pinon, Miriam; Slyer, Jason; Singleton, Joanne

Delegation by the registered nurse is a decision making process that includes assessment, planning, implementation, and evaluation. Due to an ever-expanding global shortage of nurses, registered nurses are increasingly dependent on unlicensed assistive personnel to assist in the provision of safe patient care. Delegation is recognised as a fundamental nursing skill that can be utilised effectively to improve quality care. To examine and synthesize the best available evidence regarding the impact of delegation interventions used by the registered nurse with the unlicensed assistive personnel and their impact on quality of care, patient satisfaction, and registered nurse staff satisfaction. Registered nurses and unlicensed assistive personnel in patient care settings where delegation occurs.This review considered studies that evaluated the effectiveness of delegation interventions by registered nurses to unlicensed assistive personnel.The outcomes examined were quality of care, patient satisfaction, and/or registered nurse staff satisfaction as measured by validated and reliable tools.The review first considered randomised controlled trials; in their absence other research designs, such as non-randomised controlled trials, or other quasi-experimental studies, observational studies and descriptive studies were considered for inclusion in the systematic review. The search strategy aimed to find both published and unpublished studies in the English language from the inception of the included databases through December 2011. The databases searched included the Central Register of Controlled Trials (CENTRAL), EMBASE, MEDLINE, CINAHL, Healthsource Nursing/Academic edition, and PsycINFO. A search of the grey literature and electronic hand searching of relevant journals was also performed. The studies selected for retrieval were critically evaluated by two independent reviewers for methodological quality using standardised critical appraisal instruments from the Joanna

Register-based statistics statistical methods for administrative data

CERN Document Server

Wallgren, Anders

2014-01-01

This book provides a comprehensive and up to date treatment of  theory and practical implementation in Register-based statistics. It begins by defining the area, before explaining how to structure such systems, as well as detailing alternative approaches. It explains how to create statistical registers, how to implement quality assurance, and the use of IT systems for register-based statistics. Further to this, clear details are given about the practicalities of implementing such statistical methods, such as protection of privacy and the coordination and coherence of such an undertaking. Thi

The electronic register patients with hypertensia in Tomsk Region

Directory of Open Access Journals (Sweden)

O. S. Kobyakova

2012-01-01

Full Text Available Within the limits of the regional program «Prevention and treatment of an arterial hypertension for the period of 2004—2008» the electronic register of the patients with hypertensia inTomskRegion has been created.The electronic register is a two-level system where interaction of two kinds of databases is carried out: the first level is the databases of separate medical organization; the second level is the central integrated database.The basic information for the electronic register are documents confirmed by the Health service Ministry of the Russian Federation, that is the coupon of the out-patient patient and a card of dynamic supervision over the patient with hypertensia.All the data about the patients, included in the register are subdivided into unchangeable and changeable ones.The electronic register is an effective control system providing local leading of health service bodies with qualitative and high-grade information in processes of preparation of decision-making and measure taken for prevention and treatment of hypertensia.The electronic register is an effective monitoring system, providing medical authority of important information for taking decisions establishment measures for prevention and treatment of hypertensia.

Single dental implant retained mandibular complete dentures – influence of the loading protocol: study protocol for a randomized controlled trial

Science.gov (United States)

2014-01-01

has been registered at Deutsches Register Klinischer Studien (German register of clinical trials) under DRKS-ID: DRKS00003730 since 23 August 2012. (http://www.germanctr.de). PMID:24884848

Validity of dementia diagnoses in the danish hospital registers

DEFF Research Database (Denmark)

Phung, T.K.T.; Andersen, B.B.; Phung, T.K.T.

2007-01-01

Background:The validity of dementia diagnoses in the Danish nationwide hospital registers was evaluated to determine the value of these registers in epidemiological research about dementia. Methods: Two hundred patients were randomly selected from 4,682 patients registered for the first time...... with a dementia diagnosis in the last 6 months of 2003. The patients' medical journals were reviewed to evaluate if they fulfilled ICD-10 and/or DSM-IV criteria for dementia and specific dementia subtypes. The patients who were still alive in 2006 were invited to an interview. Results: One hundred and ninety......-seven journals were available for review and 51 patients were interviewed. A registered diagnosis of dementia was found to be correct in 169 (85.8%) cases. Regarding dementia subtypes, the degree of agreement between the registers and the results of the validating process was low with a kappa of 0.36 (95% CI 0...

Assessing the readability of ClinicalTrials.gov.

Science.gov (United States)

Wu, Danny T Y; Hanauer, David A; Mei, Qiaozhu; Clark, Patricia M; An, Lawrence C; Proulx, Joshua; Zeng, Qing T; Vydiswaran, V G Vinod; Collins-Thompson, Kevyn; Zheng, Kai

2016-03-01

ClinicalTrials.gov serves critical functions of disseminating trial information to the public and helping the trials recruit participants. This study assessed the readability of trial descriptions at ClinicalTrials.gov using multiple quantitative measures. The analysis included all 165,988 trials registered at ClinicalTrials.gov as of April 30, 2014. To obtain benchmarks, the authors also analyzed 2 other medical corpora: (1) all 955 Health Topics articles from MedlinePlus and (2) a random sample of 100,000 clinician notes retrieved from an electronic health records system intended for conveying internal communication among medical professionals. The authors characterized each of the corpora using 4 surface metrics, and then applied 5 different scoring algorithms to assess their readability. The authors hypothesized that clinician notes would be most difficult to read, followed by trial descriptions and MedlinePlus Health Topics articles. Trial descriptions have the longest average sentence length (26.1 words) across all corpora; 65% of their words used are not covered by a basic medical English dictionary. In comparison, average sentence length of MedlinePlus Health Topics articles is 61% shorter, vocabulary size is 95% smaller, and dictionary coverage is 46% higher. All 5 scoring algorithms consistently rated CliniclTrials.gov trial descriptions the most difficult corpus to read, even harder than clinician notes. On average, it requires 18 years of education to properly understand these trial descriptions according to the results generated by the readability assessment algorithms. Trial descriptions at CliniclTrials.gov are extremely difficult to read. Significant work is warranted to improve their readability in order to achieve CliniclTrials.gov's goal of facilitating information dissemination and subject recruitment. Published by Oxford University Press on behalf of the American Medical Informatics Association 2015. This work is written by US Government

Spine device clinical trials: design and sponsorship.

Science.gov (United States)

Cher, Daniel J; Capobianco, Robyn A

2015-05-01

Multicenter prospective randomized clinical trials represent the best evidence to support the safety and effectiveness of medical devices. Industry sponsorship of multicenter clinical trials is purported to lead to bias. To determine what proportion of spine device-related trials are industry-sponsored and the effect of industry sponsorship on trial design. Analysis of data from a publicly available clinical trials database. Clinical trials of spine devices registered on ClinicalTrials.gov, a publicly accessible trial database, were evaluated in terms of design, number and location of study centers, and sample size. The relationship between trial design characteristics and study sponsorship was evaluated using logistic regression and general linear models. One thousand six hundred thrity-eight studies were retrieved from ClinicalTrials.gov using the search term "spine." Of the 367 trials that focused on spine surgery, 200 (54.5%) specifically studied devices for spine surgery and 167 (45.5%) focused on other issues related to spine surgery. Compared with nondevice trials, device trials were far more likely to be sponsored by the industry (74% vs. 22.2%, odds ratio (OR) 9.9 [95% confidence interval 6.1-16.3]). Industry-sponsored device trials were more likely multicenter (80% vs. 29%, OR 9.8 [4.8-21.1]) and had approximately four times as many participating study centers (pdevices not sponsored by the industry. Most device-related spine research is industry-sponsored. Multicenter trials are more likely to be industry-sponsored. These findings suggest that previously published studies showing larger effect sizes in industry-sponsored vs. nonindustry-sponsored studies may be biased as a result of failure to take into account the marked differences in design and purpose. Copyright © 2015 Elsevier Inc. All rights reserved.

Registered Nurses' perceptions of their work and professional development.

Science.gov (United States)

Hallin, Karin; Danielson, Ella

2008-01-01

This paper is a report of a study to elucidate Registered Nurses' perceptions of their work and professional development 6 years after graduation. Nursing education and health care has rapidly changed in the last two decades. Education and experience are important components in Registered Nurses' ability to promote a high quality of care, but a great deal depends on their work circumstances. This study emphasizes Registered Nurses' view of their work in health care, at a time in their career when they have several years of experience. Data were collected in 2003 from in-depth interviews with 15 Registered Nurses 6 years after their graduation. The interviews were semi-structured and analysed with interpretive content analysis. The findings revealed two themes and five sub-themes. The first theme, An appropriate but demanding profession, consisted of two sub-themes: 'having found one's niche' and 'growing old in nursing may be difficult'. The second theme, A profession with opportunities and obstacles, consisted of three sub-themes: 'being aware of Registered Nurses' potential', 'having knowledge that is seldom made use of' and 'attaining professional growth is no matter of course'. Keeping Registered Nurses' satisfied and avoiding their dissatisfaction is crucial for both educators and employers. It is essential that employers give priority to Registered Nurses' time with patients and to motivate and support them in professional development. Further intervention studies regarding a change of the balance between obstacles and opportunities are needed.

The Austrian Toxoplasmosis Register, 1992-2008.

Science.gov (United States)

Prusa, Andrea-Romana; Kasper, David C; Pollak, Arnold; Gleiss, Andreas; Waldhoer, Thomas; Hayde, Michael

2015-01-15

We aimed to determine the incidence of primary gestational infections with Toxoplasma gondii and congenital toxoplasmosis in Austria, a country with a nationwide prenatal serological screening program since 1974. We analyzed retrospective data from the Austrian Toxoplasmosis Register of pregnant women with Toxoplasma infection and their offspring with births between 1992 and 2008, identified by the prenatal mandatory screening program. Treatment was administered to women from diagnosis of a Toxoplasma infection until delivery. Infected infants were treated up to 1 year of life routinely. Clinical manifestations in infected infants were monitored at least for 1 year and documented in the register. The Austrian Toxoplasmosis Register included 2147 pregnant women with suspected Toxoplasma infection. Annually, 8.5 per 10 000 women acquired Toxoplasma infection during pregnancy, and 1.0 per 10 000 infants had congenital toxoplasmosis (13% mean transmission rate). Our data showed that women treated according to the Austrian scheme had a 6-fold decrease in the maternofetal transmission rate compared to women without treatment. Results from the Austrian Toxoplasmosis Register show the efficiency of the prenatal screening program. Our results are of clinical relevance for infants, healthcare systems, and policy makers to consider preventive Toxoplasma screening as a potential tool to reduce the incidence of congenital toxoplasmosis. © The Author 2014. Published by Oxford University Press on behalf of the Infectious Diseases Society of America. All rights reserved. For Permissions, please e-mail: journals.permissions@oup.com.

Selective serotonin reuptake inhibitors versus placebo in patients with major depressive disorder. A systematic review with meta-analysis and Trial Sequential Analysis

DEFF Research Database (Denmark)

Jakobsen, Janus Christian; Katakam, Kiran Kumar; Schou, Anne

2017-01-01

depressive disorder. We searched for eligible randomised clinical trials in The Cochrane Library's CENTRAL, PubMed, EMBASE, PsycLIT, PsycINFO, Science Citation Index Expanded, clinical trial registers of Europe and USA, websites of pharmaceutical companies, the U.S. Food and Drug Administration (FDA...

Register for Suicide Attempts

DEFF Research Database (Denmark)

Christiansen, Erik; Jensen, Børge Frank

2004-01-01

The Register for Suicide Attempts (RSA) is a product of the WHO research project "WHO/Euro Multicentre Study on Parasuicide", which, among other things, had the purpose of collecting data on suicide attempts from 13 European countries. Data is collected in order to calculate trends and identify...

20 CFR 325.2 - Procedure for registering for unemployment benefits.

Science.gov (United States)

2010-04-01

... 20 Employees' Benefits 1 2010-04-01 2010-04-01 false Procedure for registering for unemployment... UNEMPLOYMENT INSURANCE ACT REGISTRATION FOR RAILROAD UNEMPLOYMENT BENEFITS § 325.2 Procedure for registering for unemployment benefits. (a) Registering as unemployed. To claim unemployment benefits for any day...

Labelling and optimization of PHOTOFRIN registered with 99mTc

International Nuclear Information System (INIS)

Fakhar-e-Alam, M.; Roohi, S.; Amir, N.; Zahoor, R.; Atif, M.; Firdous, S.

2010-01-01

PHOTOFRIN registered was labelled with 99m Tc using SnCl 2 .2H 2 O as reducing agent. Instant thin layer chromatography (ITLC-SG) in 0.05 M NaOH was used for evaluation of radiochemical purity. Labelling efficiency was dependent on various factors that include the ligand/reductant ratio, pH and time of incubation. Therefore, optimum conditions of labelling were also determined. The stability of 99m Tc-PHOTOFRIN registered in serum was checked by using fresh human serum. Tissue distribution of 99m Tc-PHOTOFRIN registered was evaluated in Sprague Dawley rats. PHOTOFRIN registered was labelled with an efficiency of > 95% under optimum conditions, which were PHOTOFRIN registered : 200 μg, pH: 3-4, SnCl 2 .2H 2 O: 15 μg and 30 min incubation at room temperature. The 99m Tc-labelled PHOTOFRIN registered remained stable in human serum for 24 h. Biodistribution study in rats revealed maximum concentration of the labelled compound in liver, lungs and spleen at 0.5 h, and significant activity was also seen in the bladder and urine, indicating the mode of urinary excretion of PHOTOFRIN registered . (orig.)

Critical points based register-concurrency autotuning for GPUs

NARCIS (Netherlands)

Li, A.; Song, S.L.; Kumar, A.; Zhang, E.Z.; Chavarría-Miranda, D.; Corporaal, H.

2016-01-01

The unprecedented prevalence of GPGPU is largely attributed to its abundant on-chip register resources, which allow massively concurrent threads and extremely fast context switch. However, due to internal memory size constraints, there is a tradeoff between the per-thread register usage and the

Register of practices and teacher training: reflection, memory and authorship

Directory of Open Access Journals (Sweden)

Amanda Cristina Teagno Lopes Marques

2011-07-01

Full Text Available This article aims at analyzing the contribution of the register of practices in the process of inservice training and teacher development. It is organized in three parts: first, we elucidateconcepts of different authors about our object (FREIRE, 1996; GUARNIERI, 2001; SÁ-CHAVES, 2004, WARSCHAUER, 1993, 2001; ZABALZA, 1994, 2004, in the second part, we analyze some register of practices produced by a professor of early childhood education, seeking to highlight elements that indicate the relationship between register, reflection and training; inthe end, we indicate the need to move the register as individual attitude to the register as a collective process, as suggested by the perspective of pedagogical documentation describedin Italian literature (BALSAMO, 1998; BENZONI, 2001; BORGHI, APOSTOLI, 2001; GANDINI, GOLDHABER, 2002. The register of practices can contribute to the processes of professional and organizational development, in a reflective school (ALARCÃO, 2002, 2003 and trulypublic because it makes visible to society by documentation of the experiences that teachersand children build together (MALAGUZZI, 1999.

REGISTER PERCAKAPAN ANGGOTA KESATUAN LALU LINTAS POLRESTA PONTIANAK: KAJIAN SOSIOLINGUISTIK

Directory of Open Access Journals (Sweden)

Wahyu Damayanti

2017-10-01

Full Text Available Register adalah variasi bahasa berdasarkan penggunaannya. Variasi bahasa merupakan wujud keanekaragaman bahasa yang ditampilkan berdasarkan konteks yang menyertainya, termasuk penutur dan penggunaannya. Tujuan penelitian ini adalah mendiskripsikan bentuk register yang terdapat pada percakapan anggota kesatuan lalu lintas Polresta Pontianak. Metode yang digunakan dalam penelitian ini adalah metode kualitatif. Teknik pengumpulan data dengan cara simak dan catat. Data penelitian ini berupa kata, abreviasi, kode, istilah, dan wacana yang termasuk register dalam percakapan komunitas Satlantas Polresta Pontianak melalui jejaring sosial WhatsApp pada bulan Agustus dan September 2016. Teknik analisis data menggunakan analisis interaktif. Hasil dan pembahasaan penelitian ini menunjukkan bahwa karakteristik bentuk register dalam percakapan anggota melalui jejaring sosial WhatsApp berupa bentuk dasar, bentuk berafiks, bentuk ulang, bentuk majemuk, pemendekan atau abreviasi, pemenggalan, singkatan, akronim, kontraksi, sapaan, kode, dan istilah khusus. Dengan demikian, penelitian register dalam percakapan anggota Satlantas merupakan satu di antara bentuk register yang terjadi di masyarakat, dalam hal ini kajian sosiolinguistik.

New developments of the KOMPOFERM {sup registered} system. Lean gas management, SMARTFERM, double membrane roof; Neue Entwicklungen des KOMPOFERM {sup registered} -Systems. Schwachgasmanagement, SMARTFERM, Doppelmembrandach

Energy Technology Data Exchange (ETDEWEB)

Striewski, Sandra [KOMPOTEC Kompostierungsanlagen GmbH, Nieheim (Germany)

2012-11-01

The KOMPOFERM {sup registered} dry fermentation process is a mesophilic batch process for biogas production from solid biomass. The system is developed continuously for higher economic efficiency, emission reduction and environmental protection. The contribution describes the optimisations of the KOMPOFERM {sup registered} system and presents examples of its practical implementation, e.g. thermophilic process control, the KOMPOFERM {sup registered} double membrane roof for optimum gas utilisation and reduction of the lean gas volume, the KOMPOFERM {sup registered} plus process with a percolate fermenter below the fermenter tunnels, the automatic feeding system for the rotting and/or fermenter tunnels and SMARTFERM, the dry fermentation module for plants up to 4m000 Mg input. (org.) [German] Als mesophiles Batchverfahren hat sich das KOMPOFERM {sup registered} -Trockenvergaerungsverfahren zur Erzeugung von Biogas aus fester Biomasse am Markt etabliert. Das System wird stetig weiterentwickelt, um die Wirtschaftlichkeit wie auch den Emissions- und Umweltschutz der Anlagen zu verbessern. Die Optimierungen des KOMPOFERM {sup registered} -Systems werden in diesem Artikel erlaeutert und Beispiele fuer deren praktische Umsetzung gegeben, wie die thermophile Prozessfuehrung des Systems, das KOMPOFERM {sup registered} -Doppelmembrandach zur optimalen Gasnutzung und Reduzierung von Schwachgas, das KOMPOFERM {sup registered} plus-Verfahren mit einem Perkolatfermenter unterhalb der Fermentertunnel, das automatische Eintragungsgeraet fuer Rotte- und/oder Fermentertunnel sowie SMARTFERM, das Trockenfermentationsmodul fuer Anlagen bis 4.000 Mg Input. (org.)

The Danish heart register

DEFF Research Database (Denmark)

Abildstrøm, Steen Z; Madsen, Mette

2011-01-01

Introduction: The Danish Heart Register (DHR) is a clinical database of invasive procedures within cardiology. Content: All providers of these procedures have been obliged to report to DHR since 2000. DHR is used to monitor the activity and quality of the procedures and serves as a data source...

Homophobia in Registered Nurses: Impact on LGB Youth

Science.gov (United States)

Blackwell, Christopher W.; Kiehl, Ermalynn M.

2008-01-01

This study examined registered nurses' overall attitudes and homophobia towards gays and lesbians in the workplace. Homophobia scores, represented by the Attitudes Toward Lesbians and Gay Men (ATLG) Scale, was the dependent variable. Overall homophobia scores were assessed among a randomized stratified sample of registered nurses licensed in the…

Quality control of portal imaging with PTW EPID QC PHANTOM {sup registered}

Energy Technology Data Exchange (ETDEWEB)

Pesznyak, Csilla; Kiraly, Reka; Polgar, Istvan; Zarand, Pal; Mayer, Arpad [Inst. of Oncoradiology, Uzsoki Hospital, Budapest (Hungary); Fekete, Gabor [Dept. of Oncotherapy, Univ. of Szeged (Hungary); Mozes, Arpad [Oncology Center, Kalman Pandy County Hospital, Gyula (Hungary); Kiss, Balazs [Dept. of Radiation Oncology, Markusovszky County Hospital, Szombathely (Hungary)

2009-01-15

Purpose: quality assurance (QA) and quality control (QC) of different electronic portal imaging devices (EPID) and portal images with the PTW EPID QC PHANTOM {sup registered}. Material and methods: characteristic properties of images of different file formats were measured on Siemens OptiVue500aSi {sup registered}, Siemens BeamView Plus {sup registered}, Elekta iView {sup registered}, and Varian PortalVision trademark and analyzed with the epidSoft {sup registered} 2.0 program in four radiation therapy centers. The portal images were taken with Kodak X-OMAT V {sup registered} and the Kodak Portal Localisation ReadyPack {sup registered} films and evaluated with the same program. Results: the optimal exposition both for EPIDs and portal films of different kind was determined. For double exposition, the 2+1 MU values can be recommended in the case of Siemens OptiVue500aSi {sup registered}, Elekta iView {sup registered} and Kodak Portal Localisation ReadyPack {sup registered} films, while for Siemens BeamView Plus {sup registered}, Varian PortalVision trademark and Kodak X-OMAT V {sup registered} film 7+7 MU is recommended. Conclusion: the PTW EPID QC PHANTOM {sup registered} can be used not only for amorphous silicon EPIDs but also for images taken with a video-based system or by using an ionization chamber matrix or for portal film. For analysis of QC tests, a standardized format (used at the acceptance test) should be applied, as the results are dependent on the file format used. (orig.)

Systematic review and meta-analysis of randomized trials on probiotics for hepatic encephalopathy

DEFF Research Database (Denmark)

Holte, Kathrine; Krag, Aleksander; Gluud, Lise Lotte

2012-01-01

Aim:  The objective of this systematic review and meta-analysis was to assess the efficacy of probiotics and synbiotics in patients with hepatic encephalopathy. Methods:  Eligible trials were identified by searching electronic databases including MEDLINE, the Cochrane Library, Science Citation...... Index and Embase, abstract proceedings, reference lists and ongoing trial registers until 13 October 2010. We included randomized controlled trials comparing probiotics and synbiotics with no intervention, placebo or lactulose in patients with hepatic encephalopathy. The primary outcome measure...... was improvement in hepatic encephalopathy. Results were expressed as risk rates (RR) with confidence intervals (CI) and intertrial heterogeneity as I(2) . Results:  Seven trials with a total of 393 patients were analyzed. Compared to placebo or lactulose, treatment with probiotics or synbiotics significantly...

Register-based estimates of parents' coresidence in Sweden, 1969-2007

Directory of Open Access Journals (Sweden)

Elizabeth Thomson

2013-12-01

Full Text Available Background: Many of the dramatic changes in family formation and dissolution observed in wealthy countries over the past 60 years are tracked through vital statistics or censuses. The signature change in family behavior -- non-marital cohabitation -- is not, however, registered in most settings. Objective: We evaluate the quality of new register-based estimates of parents' union status at birth and of separation during the childrearing years. Methods: Parents of a common child are identified through the Multi-Generation Register that links each child to each parent and therefore each parent to each other. The Total Population Register identifies the property at which each parent is registered at the end of each year. We use the five-year censuses 1960-1990 as one standard of comparison because the censuses identify the dwelling unit for each parent on the census date. Results: Property-based estimates of parents' coresidence compare very well to census reports. Register-based estimates are virtually identical with those produced from the 1992 Swedish Fertility and Family Survey; differences between register estimates and those produced from the 1991 and 2000 Level of Living Survey can be explained by differences in measurement of marriage and cohabitation. Conclusions: Estimates of parents' cohabitation based on annual, property-level registration are of sufficient quality for their use in substantive analyses of union status at birth and parents' separation in Sweden. Comments: Although register-based estimates of parents' coresidence at a child's birth or afterwards can be generated only for a select group of countries, their use can be fruitful for understanding more general processes of family change. Centralized administrative registers exist in many countries but have not been made fully available for research therefore losing much of the potential value.

The Landscape of Clinical Trials Evaluating the Theranostic Role of PET Imaging in Oncology: Insights from an Analysis of ClinicalTrials.gov Database

Science.gov (United States)

Chen, Yu-Pei; Lv, Jia-Wei; Liu, Xu; Zhang, Yuan; Guo, Ying; Lin, Ai-Hua; Sun, Ying; Mao, Yan-Ping; Ma, Jun

2017-01-01

In the war on cancer marked by personalized medicine, positron emission tomography (PET)-based theranostic strategy is playing an increasingly important role. Well-designed clinical trials are of great significance for validating the PET applications and ensuring evidence-based cancer care. This study aimed to provide a comprehensive landscape of the characteristics of PET clinical trials using the substantial resource of ClinicalTrials.gov database. We identified 25,599 oncology trials registered with ClinicalTrials.gov in the last ten-year period (October 2005-September 2015). They were systematically reviewed to validate classification into 519 PET trials and 25,080 other oncology trials used for comparison. We found that PET trials were predominantly phase 1-2 studies (86.2%) and were more likely to be single-arm (78.9% vs. 57.9%, P oncology trials. Furthermore, PET trials were small in scale, generally enrolling fewer than 100 participants (20.3% vs. 25.7% for other oncology trials, P = 0.014), which might be too small to detect a significant theranostic effect. The funding support from industry or National Institutes of Health shrunk over time (both decreased by about 5%), and PET trials were more likely to be conducted in only one region lacking international collaboration (97.0% vs. 89.3% for other oncology trials, P oncology are not receiving the attention or efforts necessary to generate high-quality evidence. Advancing the clinical application of PET imaging will require a concerted effort to improve the quality of trials. PMID:28042342

Hello! Are You Registered?

Science.gov (United States)

Institute for Political/Legal Education, Sewell, NJ.

Organizational procedures and appropriate forms for high school students to conduct a community survey of non-registered voters are provided. Duties for student coordinator, field staff, and clerical staff are described and a flow chart depicts the relationship of personnel to one another and to the community. Students are instructed to notify…

Handcrafted Vacuum-Assisted Device for Skin Ulcers Treatment Versus Traditional Therapy, Randomized Controlled Trial.

Science.gov (United States)

Gonzalez, Israel Gonzalez; Angel, Medina Andrade Luis; Baez, Maria Valeria Jimenez; Ruiz Flores, Brenda; de Los Angeles Martinez Ferretiz, Maria; Woolf, Stephanny Vanestty; López, Israel; Sandoval-Jurado, Luis; Pat-Espadas, Fany Guadalupe; Cruz, Alan Alejandro Reyes; Delgado, Arsenio Torres

2017-02-01

Chronic lower limb ulcers constitute a public health problem, with important socioeconomic implications and high attention cost. This trial evaluates handcrafted vacuum-assisted therapy versus traditional treatment effectiveness for lower limbs ulcers. It was a prospective randomized clinical trial conducted over 144 patients with lower limbs ulcers. Patients were randomized into two groups of 72 patients: Experimental group were treated with debridement, cure and a handcrafted vacuum-assisted device that was changed every 72 h. Control group was treated with debridement and cure with soap every 24 h. Ulcers were evaluated every 72 h and on 10th day. The presence of systemic inflammatory response, pain, granulation tissue and viability for discharge was registered and analyzed . After exclusion of 18 patients, 126 were included, 65.1% were men with an average of 58 years. Sole region ulcer by diabetic foot was the more frequent in both groups (73%). Leukocytes count, systemic inflammatory response and pain were significantly lower in experimental group (p ulcers. This system would benefit patients favoring earlier infection control, faster granulation tissue appearance and earlier discharge. Clinical trials registered in https://www.clinicaltrials.gov/ Number NCT02512159.

Publication status of contemporary oncology randomised controlled trials worldwide.

Science.gov (United States)

Chen, Yu-Pei; Liu, Xu; Lv, Jia-Wei; Li, Wen-Fei; Zhang, Yuan; Guo, Ying; Lin, Ai-Hua; Sun, Ying; Mao, Yan-Ping; Ma, Jun

2016-10-01

Little is known about the extent of selective publication in contemporary oncology randomised controlled trials (RCTs) worldwide. This study aimed to evaluate the rates of publication and timely publication (within 24 months) for contemporary oncology RCTs from all over the world. We also investigated the trial characteristics associated with publication and timely publication. We identified all phase III oncology RCTs registered on ClinicalTrials.gov with a primary completion date between January 2008 and December 2012. We searched PubMed and EMBASE to identify publications. The final search date was 31 December 2015. Our primary outcome measure was the time to publication from the primary completion date to the date of primary publication in a peer-reviewed journal. We identified 598 completed oncology RCTs; overall, 398 (66.6%) had been published. For published trials, the median time to publication was 25 months (interquartile range, 16-37 months). Only 192 trials (32.1%) were published within 24 months. Timely publication was independently associated with trials completed late in 2012. Trials conducted in Asia and other regions were less likely to have timely publication, but trials conducted in different locations were all equally likely to be published. Industry- and NIH-funded trials were equally likely to be published timely or at any time after trial completion. Among 391 published trials with clear primary outcomes, there was a trend for timely publication of positive trials compared with negative trials. Despite the ethical obligations and societal expectations of disclosing findings promptly, oncology RCTs performed poorly. Copyright © 2016 Elsevier Ltd. All rights reserved.

Development of the CHARIOT Research Register for the Prevention of Alzheimer's Dementia and Other Late Onset Neurodegenerative Diseases.

Directory of Open Access Journals (Sweden)

Mark E Larsen

Full Text Available Identifying cognitively healthy people at high risk of developing dementia is an ever-increasing focus. These individuals are essential for inclusion in observational studies into the natural history of the prodromal and early disease stages and for interventional studies aimed at prevention or disease modification. The success of this research is dependent on having access to a well characterised, representative and sufficiently large population of individuals. Access to such a population remains challenging as clinical research has, historically, focussed on patients with dementia referred to secondary and tertiary services. The primary care system in the United Kingdom allows access to a true prodromal population prior to symptoms emerging and specialist referral. We report the development and recruitment rates of the CHARIOT register, a primary care-based recruitment register for research into the prevention of dementia. The CHARIOT register was designed specifically to support recruitment into observational natural history studies of pre-symptomatic or prodromal dementia stages, and primary or secondary prevention pharmaceutical trials or other prevention strategies for dementia and other cognitive problems associated with ageing.Participants were recruited through searches of general practice lists across the west and central London regions. Invitations were posted to individuals aged between 60 and 85 years, without a diagnosis of dementia. Upon consent, a minimum data set of demographic and contact details was extracted from the patient's electronic health record.To date, 123 surgeries participated in the register, recruiting a total of 24,509 participants-a response rate of 22.3%. The age, gender and ethnicity profiles of participants closely match that of the overall eligible population. Higher response rates tended to be associated with larger practices (r = 0.34, practices with a larger older population (r = 0.27, less

Strategies to improve retention in randomised trials

Science.gov (United States)

Brueton, Valerie C; Tierney, Jayne; Stenning, Sally; Harding, Seeromanie; Meredith, Sarah; Nazareth, Irwin; Rait, Greta

2013-01-01

Background Loss to follow-up from randomised trials can introduce bias and reduce study power, affecting the generalisability, validity and reliability of results. Many strategies are used to reduce loss to follow-up and improve retention but few have been formally evaluated. Objectives To quantify the effect of strategies to improve retention on the proportion of participants retained in randomised trials and to investigate if the effect varied by trial strategy and trial setting. Search methods We searched the Cochrane Central Register of Controlled Trials (CENTRAL), MEDLINE, PreMEDLINE, EMBASE, PsycINFO, DARE, CINAHL, Campbell Collaboration's Social, Psychological, Educational and Criminological Trials Register, and ERIC. We handsearched conference proceedings and publication reference lists for eligible retention trials. We also surveyed all UK Clinical Trials Units to identify further studies. Selection criteria We included eligible retention trials of randomised or quasi-randomised evaluations of strategies to increase retention that were embedded in 'host' randomised trials from all disease areas and healthcare settings. We excluded studies aiming to increase treatment compliance. Data collection and analysis We contacted authors to supplement or confirm data that we had extracted. For retention trials, we recorded data on the method of randomisation, type of strategy evaluated, comparator, primary outcome, planned sample size, numbers randomised and numbers retained. We used risk ratios (RR) to evaluate the effectiveness of the addition of strategies to improve retention. We assessed heterogeneity between trials using the Chi2 and I2 statistics. For main trials that hosted retention trials, we extracted data on disease area, intervention, population, healthcare setting, sequence generation and allocation concealment. Main results We identified 38 eligible retention trials. Included trials evaluated six broad types of strategies to improve retention. These

Electroacupuncture for insomnia disorder: study protocol for a randomized controlled trial.

Science.gov (United States)

Kim, Sung-Phil; Kim, Joo-Hee; Kim, Bo-Kyung; Kim, Hyeong-Jun; Jung, In Chul; Cho, Jung Hyo; Kim, Jung-Eun; Kim, Mi-Kyung; Kwon, O-Jin; Kim, Ae-Ran; Park, Hyo-Ju; Seo, Bok-Nam

2017-04-13

Insomnia is a common sleep disorder that affects many adults either transiently or chronically. The societal cost of insomnia is on the rise, while long-term use of current drug treatments can involve adverse effects. Recently, electroacupuncture (EA) has been used to treat various conditions including insomnia. The objective of this study is to provide scientific evidence for the effect and safety of using EA to treat insomnia. In this multicentre, assessor-blind, three-arm, parallel-design, randomised controlled trial, 150 participants will be assigned to the EA group, the sham EA (SEA) group, or the usual care group. The EA and SEA groups will receive the specific treatments 2-3 times a week for 4 weeks, for a total of 10 sessions, whereas the usual care group will not receive EA and will continue with usual care during the same time period. The primary outcome measure will be changes in the Insomnia Severity Index 5 weeks after randomisation. The secondary outcomes will include the Pittsburgh Sleep Quality Index, the Hospital Anxiety and Depression Scale, a sleep diary, the EuroQoL-5 dimension questionnaire, the levels of melatonin and cortisol, and the Patient Global Impression of Change. Safety will be assessed at each visit. The results of this multicentre randomised controlled trial will contribute to provide rigorous clinical evidence for the effects and safety of EA for insomnia disorder. Korean Clinical Trial Registry, CRIS, KCT0001685 . Registered on 2 November 2015 (retrospectively registered). Date of enrolment of the first participant to the trial 13 October 2015.

The First 500 Registrations to the Research Registry®: Advancing Registration of Under-registered Study Types

Directory of Open Access Journals (Sweden)

Riaz Agha

2016-09-01

Full Text Available The Declaration of Helsinki 2013 encourages the registration of all research studies involving human participants. However, emphasis has been placed on prospective clinical trials, and it is estimated that only 10% of observational studies are registered. In response, Research Registry® was launched in February 2015; a retrospectively curated registry that is free and easy to use. Research Registry® enables prospective or retrospective registration of studies, including those study types that cannot be registered on existing registries. In this study, we describe the first 500 registrations on Research Registry®.Since the launch of Research Registry® in February 2015, data of registrations have been collected, including type of studies registered, country of origin and data curation activity. Inappropriate registrations, such as duplicates, were identified by the data curation process. These were removed from the database or modified as required. A quality score was assigned for each registration, based on Bradford-Hill’s criteria on what research studies should convey. Changes in quality scores over time were assessed. 500 studies were registered on Research Registry® from February 2015 to October 2015, with a total of 1.7 million patients enrolled. The most common study types were retrospective cohort studies (37.2%, case series (14.8% and first-in-man case reports (10.4%. Registrations were received from 57 different countries; the most submissions were received from Turkey, followed by China and the United Kingdom. Retrospective data curation identified 80 studies that were initially registered as the incorrect study type, and were subsequently correct. The Kruskal-Wallis test identified a significant improvement in quality scores for registrations from February 2015 to October 2015 (p < 0.0001.Since its conception in February 2015, Research Registry® has established itself as a new registry that is free, easy to use and enables the

The First 500 Registrations to the Research Registry®: Advancing Registration of Under-Registered Study Types.

Science.gov (United States)

Agha, Riaz; Fowler, Alexander J; Limb, Christopher; Al Omran, Yasser; Sagoo, Harkiran; Koshy, Kiron; Jafree, Daniyal J; Anwar, Mohammed Omer; McCullogh, Peter; Orgill, Dennis Paul

2016-01-01

The Declaration of Helsinki 2013 encourages the registration of all research studies involving human participants. However, emphasis has been placed on prospective clinical trials, and it is estimated that only 10% of observational studies are registered. In response, Research Registry ® was launched in February 2015; a retrospectively curated registry that is free and easy to use. Research Registry ® enables prospective or retrospective registration of studies, including those study types that cannot be registered on existing registries. In this study, we describe the first 500 registrations on Research Registry ® . Since the launch of Research Registry ® in February 2015, data of registrations have been collected, including type of studies registered, country of origin, and data curation activity. Inappropriate registrations, such as duplicates, were identified by the data curation process. These were removed from the database or modified as required. A quality score was assigned for each registration, based on Sir Austin Bradford Hill's criteria on what research studies should convey. Changes in quality scores over time were assessed. A total of 500 studies were registered on Research Registry ® from February 2015 to October 2015, with a total of 1.7 million patients enrolled. The most common study types were retrospective cohort studies (37.2%), case series (14.8%), and first-in-man case reports (10.4%). Registrations were received from 57 different countries; the most submissions were received from Turkey, followed by China and the United Kingdom. Retrospective data curation identified 80 studies that were initially registered as the incorrect study type, and were subsequently correct. The Kruskal-Wallis test identified a significant improvement in quality scores for registrations from February 2015 to October 2015 ( p  < 0.0001). Since its conception in February 2015, Research Registry ® has established itself as a new registry that is free, easy to

Corrosion behavior of Haynes registered 230 registered nickel-based super-alloys for integrated coal gasification combined cycle syngas plants. A plant exposure study

International Nuclear Information System (INIS)

Lee, Sungkyu; Lee, Jieun; Kang, Suk-Hwan; Lee, Seung-Jong; Yun, Yongseung; Kim, Min Jung

2015-01-01

The corrosion behavior of commercially available Haynes registered 230 registered nickel-based alloy samples was investigated by exposure to coal-gasifying integrated coal gasification combined cycle pilot plant facilities affiliated with the Institute for Advanced Engineering (2.005 MPa and 160-300 C). The morphological and microstructural analyses of the exposed samples were conducted using scanning electron microscopy and energy-dispersive X-ray spectroscopy analysis on the external surface of the recovered corrosion test samples to obtain information of the corrosion scale. These analyses based on the pre- and post-exposure corrosion test samples combined with thermodynamic Ellingham-Pourbaix stability diagrams provided preliminary insight into the mechanism of the observed corrosion behavior prevailing in the piping materials that connected the particulate removal unit and water scrubber of the integrated coal gasification combined cycle pilot plant. Uniform material wastage was observed after 46 hours of operation, and a preliminary corrosion mechanism was suggested: the observed material waste and corrosion behavior of the Haynes registered 230 registered nickel-based alloy samples cut off from the coal syngas integrated coal gasification combined cycle plant were explained by the formation of discontinuous (complex) oxide phases and subsequent chlorine-induced active oxidation under the predominantly reducing environment encountered. This contribution continues the already published studies of the Fe-Ni-Cr-Co alloy Haynes registered 556 registered .

The Danish registers of causes of death

DEFF Research Database (Denmark)

Juel, K; Helweg-Larsen, K

1999-01-01

In 1875 registration of causes of death in Denmark was established by the National Board of Health, and annual statistics of death have since been published. Until 1970 the national statistics were based upon punched cards with data collected from the death certificates. Since then the register has...... been fully computerized and includes individual based data of all deaths occurring among all residents in Denmark dying in Denmark. Furthermore, a microfilm of all death certificates from 1943 and onward is kept in the National Board of Health. The Danish Institute for Clinical Epidemiology (DICE) has...... established a computerized register of individual records of deaths in Denmark from 1943 and onwards. No other country covers computerized individual based data of death registration for such a long period, now 54 years. This paper describes the history of the registers, the data sources and access to data...

Antibiotic prophylaxis for term or near-term premature rupture of membranes: metaanalysis of randomized trials.

Science.gov (United States)

Saccone, Gabriele; Berghella, Vincenzo

2015-05-01

The objective of the study was to evaluate the efficacy of antibiotic prophylaxis in women with term or near-term premature rupture of membranes. Searches were performed in MEDLINE, OVID, Scopus, ClinicalTrials.gov, the PROSPERO International Prospective Register of Systematic Reviews, EMBASE, ScienceDirect.com, MEDSCAPE, and the Cochrane Central Register of Controlled Trials with the use of a combination of key words and text words related to antibiotics, premature rupture of membranes, term, and trials from inception of each database to September 2014. We included all randomized trials of singleton gestations with premature rupture of membranes at 36 weeks or more, who were randomized to antibiotic prophylaxis or control (either placebo or no treatment). The primary outcomes included maternal chorioamnionitis and neonatal sepsis. A subgroup analysis on studies with latency more than 12 hours was planned. Before data extraction, the review was registered with the PROSPERO International Prospective Register of Systematic Reviews (registration number CRD42014013928). The metaanalysis was performed following the Preferred Reporting Item for Systematic Reviews and Meta-analyses statement. Women who received antibiotics had the same rate of chorioamnionitis (2.7% vs 3.7%; relative risk [RR], 0.73, 95% confidence interval [CI], 0.48-1.12), endometritis (0.4% vs 0.9%; RR, 0.44, 95% CI, 0.18-1.10), maternal infection (3.1% vs 4.6%; RR, 0.48, 95% CI, 0.19-1.21), and neonatal sepsis (1.0% vs 1.4%; RR, 0.69, 95% CI, 0.34-1.39). In the planned subgroup analysis, women with latency longer than 12 hours, who received antibiotics, had a lower rate of chorioamnionitis (2.9% vs 6.1%; RR, 0.49, 95% CI, 0.27-0.91) and endometritis (0% vs 2.2%; RR, 0.12, 95% CI, 0.02-0.62) compared with the control group. Antibiotic prophylaxis for term or near-term premature rupture of membranes is not associated with any benefits in either maternal or neonatal outcomes. In women with latency longer

A systematic review of randomised control trials of sexual health interventions delivered by mobile technologies.

Science.gov (United States)

Burns, Kara; Keating, Patrick; Free, Caroline

2016-08-12

Sexually transmitted infections (STIs) pose a serious public health problem globally. The rapid spread of mobile technology creates an opportunity to use innovative methods to reduce the burden of STIs. This systematic review identified recent randomised controlled trials that employed mobile technology to improve sexual health outcomes. The following databases were searched for randomised controlled trials of mobile technology based sexual health interventions with any outcome measures and all patient populations: MEDLINE, EMBASE, PsycINFO, Global Health, The Cochrane Library (Cochrane Database of Systematic Reviews, Cochrane Central Register of Controlled Trials, Cochrane Methodology Register, NHS Health Technology Assessment Database, and Web of Science (science and social science citation index) (Jan 1999-July 2014). Interventions designed to increase adherence to HIV medication were not included. Two authors independently extracted data on the following elements: interventions, allocation concealment, allocation sequence, blinding, completeness of follow-up, and measures of effect. Trials were assessed for methodological quality using the Cochrane risk of bias tool. We calculated effect estimates using intention to treat analysis. A total of ten randomised trials were identified with nine separate study groups. No trials had a low risk of bias. The trials targeted: 1) promotion of uptake of sexual health services, 2) reduction of risky sexual behaviours and 3) reduction of recall bias in reporting sexual activity. Interventions employed up to five behaviour change techniques. Meta-analysis was not possible due to heterogeneity in trial assessment and reporting. Two trials reported statistically significant improvements in the uptake of sexual health services using SMS reminders compared to controls. One trial increased knowledge. One trial reported promising results in increasing condom use but no trial reported statistically significant increases in condom

Patient engagement with research: European population register study.

Science.gov (United States)

McKevitt, Christopher; Fudge, Nina; Crichton, Siobhan; Bejot, Yannick; Daubail, Benoît; Di Carlo, Antonio; Fearon, Patricia; Kolominsky-Rabas, Peter; Sheldenkar, Anita; Newbound, Sophie; Wolfe, Charles D A

2015-12-01

Lay involvement in implementation of research evidence into practice may include using research findings to guide individual care, as well as involvement in research processes and policy development. Little is known about the conditions required for such involvement. To assess stroke survivors' research awareness, use of research evidence in their own care and readiness to be involved in research processes. Cross sectional survey of stroke survivors participating in population-based stroke registers in six European centres. The response rate was 74% (481/647). Reasons for participation in register research included responding to clinician request (56%) and to 'give something back' (19%); however, 20% were unaware that they were participating in a stroke register. Research awareness was generally low: 57% did not know the purpose of the register they had been recruited to; 73% reported not having received results from the register they took part in; 60% did not know about any research on stroke care. Few participants (7.6%) used research evidence during their consultations with a doctor. The 34% of participants who were interested in being involved in research were younger, more highly educated and already research aware. Across Europe, stroke survivors already participating in research appear ill informed about stroke research. Researchers, healthcare professionals and patient associations need to improve how research results are communicated to patient populations and research participants, and to raise awareness of the relationship between research evidence and increased quality of care. © 2014 John Wiley & Sons Ltd.

Register / Andri Ksenofontov

Index Scriptorium Estoniae

Ksenofontov, Andri, 1962-

2007-01-01

Näitused: Eesti Kujundusgraafikute Liidu aastanäitus "Register 2007" Kunstihoone galeriis, Signe Kivi "Võimuvaibad ja vaimukleidid" Arhitektuuri- ja Disainigaleriis, "Kehaturg / Sex market" (Dagmar Kase, Eveli Variku tööd) Tallinna Kunstihoones, Andrei Maksimjuki "Surematu klassika" Ühispanga galeriis, Katrin Veegeni "Varsti" A-galeriis, Eda Lõhmuse "Ülespoole" ja Rein Kelpmani "Grosso modo" ArtDepoo Galeriis, Jaan Elkeni "Valge valgus" Galeriis 008, Paul Rodgersi "Transplants" Hobusepea galeriis, Masayo Ave "Haptic Interface Design" Arhitektuuri- ja Disainigaleriis ja workshop Eesti Kunstiakadeemias

Registered plant list - PGDBj Registered plant list, Marker list, QTL list, Plant DB link & Genome analysis methods | LSDB Archive [Life Science Database Archive metadata

Lifescience Database Archive (English)

Full Text Available List Contact us PGDBj Registered plant list, Marker list, QTL list, Plant DB link & Genome analysis methods ...the Plant DB link list in simple search page) Genome analysis methods Presence or... absence of Genome analysis methods information in this DB (link to the Genome analysis methods information ...base Site Policy | Contact Us Registered plant list - PGDBj Registered plant list, Marker list, QTL list, Plant DB link & Genome analysis methods | LSDB Archive ...

Subdural hematoma cases identified through a Danish patient register

DEFF Research Database (Denmark)

Poulsen, Frantz Rom; Halle, Bo; Pottegård, Anton

2016-01-01

PURPOSE: This study aimed to assess the usefulness of Danish patient registers for epidemiological studies of subdural hematoma (SDH) and to describe clinical characteristics of validated cases. METHODS: Using a patient register covering a geographically defined area in Denmark, we retrieved...... use did not vary by SDH type (OR 0.9, 95%CI 0.6-1.2). CONCLUSIONS: Danish patient registers are a useful resource for SDH studies. However, choice of International Classification of Diseases code markedly influences diagnostic validity. Distinction between cSDH and aSDH is not possible based on SDH...

Validation of hospital register-based diagnosis of Parkinson's disease

DEFF Research Database (Denmark)

Wermuth, Lene; Lassen, Christina Funch; Himmerslev, Liselotte

2012-01-01

Denmark has a long-standing tradition of maintaining one of the world's largest health science specialized register data bases as the National Hospital Register (NHR). To estimate the prevalence and incidence of diseases, the correctness of the diagnoses recorded is critical. Parkinson's disease...... (PD) is a neurodegenerative disorder and only 75-80% of patients with parkinsonism will have idiopathic PD (iPD). It is necessary to follow patients in order to determine if some of them will develop other neurodegenerative diseases and a one-time-only diagnostic code for iPD reported in the register...

Price discounts significantly enhance fruit and vegetable purchases when combined with nutrition education: a randomized controlled supermarket trial.

Science.gov (United States)

Waterlander, Wilma E; de Boer, Michiel R; Schuit, Albertine J; Seidell, Jacob C; Steenhuis, Ingrid H M

2013-04-01

Reducing fruit and vegetable (F&V) prices is a frequently considered policy to improve dietary habits in the context of health promotion. However, evidence on the effectiveness of this intervention is limited. The objective was to examine the effects of a 50% price discount on F&Vs or nutrition education or a combination of both on supermarket purchases. A 6-mo randomized controlled trial within Dutch supermarkets was conducted. Regular supermarket shoppers were randomly assigned to 1 of 4 conditions: 50% price discounts on F&Vs, nutrition education, 50% price discounts plus nutrition education, or no intervention. A total of 199 participants provided baseline data; 151 (76%) were included in the final analysis. F&V purchases were measured by using supermarket register receipts at baseline, at 1 mo after the start of the intervention, at 3 mo, at 6 mo (end of the intervention period), and 3 mo after the intervention ended (9 mo). Adjusted multilevel models showed significantly higher F&V purchases (per household/2 wk) as a result of the price discount (+3.9 kg; 95% CI: 1.5, 6.3 kg) and the discount plus education intervention (+5.6 kg; 95% CI: 3.2, 7.9 kg) at 6 mo compared with control. Moreover, the percentage of participants who consumed recommended amounts of F&Vs (≥400 g/d) increased from 42.5% at baseline to 61.3% at 6 mo in both discount groups (P = 0.03). Education alone had no significant effect. Discounting F&Vs is a promising intervention strategy because it resulted in substantially higher F&V purchases, and no adverse effects were observed. Therefore, pricing strategies form an important focus for future interventions or policy. However, the long-term effects and the ultimate health outcomes require further investigation. This trial was registered at the ISRCTN Trial Register as number ISRCTN56596945 and at the Dutch Trial Register (http://www.trialregister.nl/trialreg/index.asp) as number NL22568.029.08.

Registering Researchers in Authority Files

NARCIS (Netherlands)

Altman, M.; Conlon, M.; Cristan, A.L.; Dawson, L.; Dunham, J.; Hickey, T.; Hook, D.; Horstmann, W.; MacEwan, A.; Schreur, P.; Smart, L.; Smith-Yoshimura, K.; Wacker, M.; Woutersen, S.

2014-01-01

Registering researchers in some type of authority file or identifier system has become more compelling as both institutions and researchers recognize the need to compile their scholarly output. The report presents functional requirements and recommendations for six stakeholders: researchers,

Parents' and Adolescents' Preferences for Intensified or Reduced Treatment in Randomized Lymphoblastic Leukemia Trials

DEFF Research Database (Denmark)

Tulstrup, Morten; Larsen, Hanne Bækgaard; Castor, Anders

2015-01-01

compared to younger children in trials with different toxicity profiles. PROCEDURE: Age-dependent participation rates in three consecutive, randomized childhood leukemia trials conducted by the Nordic Society of Paediatric Haematology and Oncology were evaluated. The ALL2000 dexamethasone/vincristine (Dx...... prospectively registered by the treating physicians. RESULTS: Parents of young children favored treatment intensifications (Dx/VCR: 12% refusal; 6MP: 14%; ASP: 21%), whereas parents of adolescents favored treatment reductions (Dx/VCR: 52% refusal; 6MP: 30%; ASP: 8%). Adolescents were more likely to refuse...... intensification trials than young children (adjusted ORs 6.3; P treatment (adjusted OR for median consolidation length 0.15; P = 0...

External review and validation of the Swedish national inpatient register

Directory of Open Access Journals (Sweden)

Kim Jeong-Lim

2011-06-01

Full Text Available Abstract Background The Swedish National Inpatient Register (IPR, also called the Hospital Discharge Register, is a principal source of data for numerous research projects. The IPR is part of the National Patient Register. The Swedish IPR was launched in 1964 (psychiatric diagnoses from 1973 but complete coverage did not begin until 1987. Currently, more than 99% of all somatic (including surgery and psychiatric hospital discharges are registered in the IPR. A previous validation of the IPR by the National Board of Health and Welfare showed that 85-95% of all diagnoses in the IPR are valid. The current paper describes the history, structure, coverage and quality of the Swedish IPR. Methods and results In January 2010, we searched the medical databases, Medline and HighWire, using the search algorithm "validat* (inpatient or hospital discharge Sweden". We also contacted 218 members of the Swedish Society of Epidemiology and an additional 201 medical researchers to identify papers that had validated the IPR. In total, 132 papers were reviewed. The positive predictive value (PPV was found to differ between diagnoses in the IPR, but is generally 85-95%. Conclusions In conclusion, the validity of the Swedish IPR is high for many but not all diagnoses. The long follow-up makes the register particularly suitable for large-scale population-based research, but for certain research areas the use of other health registers, such as the Swedish Cancer Register, may be more suitable.

Intervention Efficacy in Trials Targeting Cannabis Use Disorders in Patients with Comorbid Psychosis

DEFF Research Database (Denmark)

Hjorthoj, Carsten Rygaard; Baker, Amanda; Fohlmann, Allan

2014-01-01

Introduction: Cannabis use disorders are highly prevalent in patients with schizophrenia and other psychoses, and are probably associated with a range of poor outcomes. Several trials have been conducted on this population, the results of which have been summarized in several systematic reviews...... but never in meta-analyses specifically regarding cannabis use. Methods: PubMed, PsycINFO, EMBASE, and The Cochrane Central Register of Controlled Trials were searched using predefined search terms. We included randomized trials of all types of interventions targeting cannabis use disorders in patients...... with schizophrenia spectrum disorders. We extracted information on intervention types, efficacy, trial characteristics, and risk of bias. Results: There was no evidence of an effect on frequency of cannabis use, but intervention effects of motivational intervention with or without cognitive behavior therapy were...

Socio-economic characteristics of registered cocoa farmers in Edo ...

African Journals Online (AJOL)

This study examined the socio-economic characteristics of registered cocoa farmers in Edo State; Nigeria. Primary data was collected using a well structured questionnaire administered to 180 registered cocoa farmers selected using a multi-stage sampling technique. Data were analyzed using descriptive statistics and ...

Validity of a hospital-based obstetric register using medical records as reference

DEFF Research Database (Denmark)

Brixval, Carina Sjöberg; Thygesen, Lau Caspar; Johansen, Nanna Roed

2015-01-01

BACKGROUND: Data from hospital-based registers and medical records offer valuable sources of information for clinical and epidemiological research purposes. However, conducting high-quality epidemiological research requires valid and complete data sources. OBJECTIVE: To assess completeness...... and validity of a hospital-based clinical register - the Obstetric Database - using a national register and medical records as references. METHODS: We assessed completeness of a hospital-based clinical register - the Obstetric Database - by linking data from all women registered in the Obstetric Database...... Database therefore offers a valuable source for examining clinical, administrative, and research questions....

Patient-reported outcome (PRO assessment in clinical trials: a systematic review of guidance for trial protocol writers.

Directory of Open Access Journals (Sweden)

Melanie Calvert

Full Text Available Evidence suggests there are inconsistencies in patient-reported outcome (PRO assessment and reporting in clinical trials, which may limit the use of these data to inform patient care. For trials with a PRO endpoint, routine inclusion of key PRO information in the protocol may help improve trial conduct and the reporting and appraisal of PRO results; however, it is currently unclear exactly what PRO-specific information should be included. The aim of this review was to summarize the current PRO-specific guidance for clinical trial protocol developers.We searched the MEDLINE, EMBASE, CINHAL and Cochrane Library databases (inception to February 2013 for PRO-specific guidance regarding trial protocol development. Further guidance documents were identified via Google, Google scholar, requests to members of the UK Clinical Research Collaboration registered clinical trials units and international experts. Two independent investigators undertook title/abstract screening, full text review and data extraction, with a third involved in the event of disagreement. 21,175 citations were screened and 54 met the inclusion criteria. Guidance documents were difficult to access: electronic database searches identified just 8 documents, with the remaining 46 sourced elsewhere (5 from citation tracking, 27 from hand searching, 7 from the grey literature review and 7 from experts. 162 unique PRO-specific protocol recommendations were extracted from included documents. A further 10 PRO recommendations were identified relating to supporting trial documentation. Only 5/162 (3% recommendations appeared in ≥50% of guidance documents reviewed, indicating a lack of consistency.PRO-specific protocol guidelines were difficult to access, lacked consistency and may be challenging to implement in practice. There is a need to develop easily accessible consensus-driven PRO protocol guidance. Guidance should be aimed at ensuring key PRO information is routinely included in

Making Decisions about Workforce Development in Registered Training Organisations

Science.gov (United States)

Hawke, Geof

2008-01-01

The purpose of this research activity is to understand further how large and small registered training organisations (RTOs) make decisions about the allocation of resources for developing their workforces. Six registered training organisations--four technical and further education (TAFE) institutes and two private providers--were selected for…

Gestational Weight Gain: Results from the Delta Healthy Sprouts Comparative Impact Trial

Directory of Open Access Journals (Sweden)

Jessica L. Thomson

2016-01-01

Full Text Available Introduction. Delta Healthy Sprouts trial was designed to test the comparative impact of two home visiting programs on weight status, dietary intake, and health behaviors of Southern African American women and their infants. Results pertaining to the primary outcome, gestational weight gain, are reported. Methods. Participants (n=82, enrolled early in their second trimester of pregnancy, were randomly assigned to one of two treatment arms. Gestational weight gain, measured at six monthly home visits, was calculated by subtracting measured weight at each visit from self-reported prepregnancy weight. Weight gain was classified as under, within, or exceeding the Institute of Medicine recommendations based on prepregnancy body mass index. Chi-square tests and generalized linear mixed models were used to test for significant differences in percentages of participants within recommended weight gain ranges. Results. Differences in percentages of participants within the gestational weight gain guidelines were not significant between treatment arms across all visits. Conclusions. Enhancing the gestational nutrition and physical activity components of an existing home visiting program is feasible in a high risk population of primarily low income African American women. The impact of these enhancements on appropriate gestational weight gain is questionable given the more basic living needs of such women. This trial is registered with ClinicalTrials.gov NCT01746394, registered 4 December 2012.

Australian Mining's product register 1990-91

Energy Technology Data Exchange (ETDEWEB)

1990-01-01

The Australian Minings' Product Register 1990-91 contains an industry review, resource assessment, mineral industry statistics, directory of exploration and mining companies, buyers guide and directory of consultants.

The landscape of precision cancer medicine clinical trials in the United States.

Science.gov (United States)

Roper, Nitin; Stensland, Kristian D; Hendricks, Ryan; Galsky, Matthew D

2015-05-01

Advances in tumor biology and multiplex genomic analysis have ushered in the era of precision cancer medicine. Little is currently known, however, about the landscape of prospective "precision cancer medicine" clinical trials in the U.S. We identified all adult interventional cancer trials registered on ClinicalTrials.gov between September 2005 and May 2013. Trials were classified as "precision cancer medicine" if a genomic alteration in a predefined set of 88 genes was required for enrollment. Baseline characteristics were ascertained for each trial. Of the initial 18,797 trials identified, 9094 (48%) were eligible for inclusion: 684 (8%) were classified as precision cancer medicine trials and 8410 (92%) were non-precision cancer medicine trials. Compared with non-precision cancer medicine trials, precision cancer medicine trials were significantly more likely to be phase II [RR 1.19 (1.10-1.29), pPrecision medicine trials required 38 unique genomic alterations for enrollment. The proportion of precision cancer medicine trials compared to the total number of trials increased from 3% in 2006 to 16% in 2013. The proportion of adult cancer clinical trials in the U.S. requiring a genomic alteration for enrollment has increased substantially over the past several years. However, such trials still represent a small minority of studies performed within the cancer clinical trials enterprise and include a small subset of putatively "actionable" alterations. Copyright © 2015 Elsevier Ltd. All rights reserved.

Registered Replication Report

DEFF Research Database (Denmark)

Bouwmeester, S.; Verkoeijen, P. P.J.L.; Aczel, B.

2017-01-01

and colleagues. The results of studies using time pressure have been mixed, with some replication attempts observing similar patterns (e.g., Rand et al., 2014) and others observing null effects (e.g., Tinghög et al., 2013; Verkoeijen & Bouwmeester, 2014). This Registered Replication Report (RRR) assessed...... the size and variability of the effect of time pressure on cooperative decisions by combining 21 separate, preregistered replications of the critical conditions from Study 7 of the original article (Rand et al., 2012). The primary planned analysis used data from all participants who were randomly assigned...

Effects of physical exercise interventions in frail older adults: a systematic review of randomized controlled trials

OpenAIRE

de Labra, Carmen; Guimaraes-Pinheiro, Christyanne; Maseda, Ana; Lorenzo, Trinidad; Mill?n-Calenti, Jos? C.

2015-01-01

Background Low physical activity has been shown to be one of the most common components of frailty, and interventions have been considered to prevent or reverse this syndrome. The purpose of this systematic review of randomized, controlled trials is to examine the exercise interventions to manage frailty in older people. Methods The PubMed, Web of Science, and Cochrane Central Register of Controlled Trials databases were searched using specific keywords and Medical Subject Headings for random...

The Relaxation Exercise and Social Support Trial (RESST: a community-based randomized controlled trial to alleviate medically unexplained vaginal discharge symptoms

Directory of Open Access Journals (Sweden)

Kobeissi Loulou

2012-11-01

no evidence of mediation of the effect on MUVD through measures of common mental disorders. Conclusion This study confirms that MUVD is an important public health problem. While the benefits of this intervention may appear modest, the intervention offers an opportunity for women to enhance their problem-solving skills as well as use physical relaxation techniques that can help them deal with stressful in their lives. Further research is needed in a variety of contexts, for different populations and preferably involving larger randomized trials of such an intervention. Trial registration * Title of trial: The Relaxation Exercise and Social Support Trial ISRCTN assigned: ISRCTN98441241 Date of assignation: 10/09/2010 Link: http://www.controlled-trials.com/ISRCTN98441241 * Also registered at the Wellcome Trust register: http://www.controlled-trials.com/mrct/trial/469943/98441241

Comparison of trial participants and open access users of a web-based physical activity intervention regarding adherence, attrition, and repeated participation.

Science.gov (United States)

Wanner, Miriam; Martin-Diener, Eva; Bauer, Georg; Braun-Fahrländer, Charlotte; Martin, Brian W

2010-02-10

Web-based interventions are popular for promoting healthy lifestyles such as physical activity. However, little is known about user characteristics, adherence, attrition, and predictors of repeated participation on open access physical activity websites. The focus of this study was Active-online, a Web-based individually tailored physical activity intervention. The aims were (1) to assess and compare user characteristics and adherence to the website (a) in the open access context over time from 2003 to 2009, and (b) between trial participants and open access users; and (2) to analyze attrition and predictors of repeated use among participants in a randomized controlled trial compared with registered open access users. Data routinely recorded in the Active-online user database were used. Adherence was defined as: the number of pages viewed, the proportion of visits during which a tailored module was begun, the proportion of visits during which tailored feedback was received, and the time spent in the tailored modules. Adherence was analyzed according to six one-year periods (2003-2009) and according to the context (trial or open access) based on first visits and longest visits. Attrition and predictors of repeated participation were compared between trial participants and open access users. The number of recorded visits per year on Active-online decreased from 42,626 in 2003-2004 to 8343 in 2008-2009 (each of six one-year time periods ran from April 23 to April 22 of the following year). The mean age of users was between 38.4 and 43.1 years in all time periods and both contexts. The proportion of women increased from 49.5% in 2003-2004 to 61.3% in 2008-2009 (Popen access users. For open access users, adherence was similar during the first and the longest visits; for trial participants, adherence was lower during the first visits and higher during the longest visits. Of registered open access users and trial participants, 25.8% and 67.3% respectively visited Active

The Pediatric Cataract Register (PECARE)

DEFF Research Database (Denmark)

Haargaard, Birgitte; Nyström, Alf; Rosensvärd, Annika

2015-01-01

examination with a pencil light at age 5 weeks, whereas newborn red reflex examination using a handheld ophthalmoscope is routine protocol in Swedish maternity wards. Data regarding age of referral were derived from the Pediatric Cataract Register (PECARE). All children operated on before 1 year of age...

Minimally invasive versus open distal pancreatectomy (LEOPARD): study protocol for a randomized controlled trial.

Science.gov (United States)

de Rooij, Thijs; van Hilst, Jony; Vogel, Jantien A; van Santvoort, Hjalmar C; de Boer, Marieke T; Boerma, Djamila; van den Boezem, Peter B; Bonsing, Bert A; Bosscha, Koop; Coene, Peter-Paul; Daams, Freek; van Dam, Ronald M; Dijkgraaf, Marcel G; van Eijck, Casper H; Festen, Sebastiaan; Gerhards, Michael F; Groot Koerkamp, Bas; Hagendoorn, Jeroen; van der Harst, Erwin; de Hingh, Ignace H; Dejong, Cees H; Kazemier, Geert; Klaase, Joost; de Kleine, Ruben H; van Laarhoven, Cornelis J; Lips, Daan J; Luyer, Misha D; Molenaar, I Quintus; Nieuwenhuijs, Vincent B; Patijn, Gijs A; Roos, Daphne; Scheepers, Joris J; van der Schelling, George P; Steenvoorde, Pascal; Swijnenburg, Rutger-Jan; Wijsman, Jan H; Abu Hilal, Moh'd; Busch, Olivier R; Besselink, Marc G

2017-04-08

Observational cohort studies have suggested that minimally invasive distal pancreatectomy (MIDP) is associated with better short-term outcomes compared with open distal pancreatectomy (ODP), such as less intraoperative blood loss, lower morbidity, shorter length of hospital stay, and reduced total costs. Confounding by indication has probably influenced these findings, given that case-matched studies failed to confirm the superiority of MIDP. This accentuates the need for multicenter randomized controlled trials, which are currently lacking. We hypothesize that time to functional recovery is shorter after MIDP compared with ODP even in an enhanced recovery setting. LEOPARD is a randomized controlled, parallel-group, patient-blinded, multicenter, superiority trial in all 17 centers of the Dutch Pancreatic Cancer Group. A total of 102 patients with symptomatic benign, premalignant or malignant disease will be randomly allocated to undergo MIDP or ODP in an enhanced recovery setting. The primary outcome is time (days) to functional recovery, defined as all of the following: independently mobile at the preoperative level, sufficient pain control with oral medication alone, ability to maintain sufficient (i.e. >50%) daily required caloric intake, no intravenous fluid administration and no signs of infection. Secondary outcomes are operative and postoperative outcomes, including clinically relevant complications, mortality, quality of life and costs. The LEOPARD trial is designed to investigate whether MIDP reduces the time to functional recovery compared with ODP in an enhanced recovery setting. Dutch Trial Register, NTR5188 . Registered on 9 April 2015.

Registered nurses' clinical reasoning skills and reasoning process: A think-aloud study.

Science.gov (United States)

Lee, JuHee; Lee, Young Joo; Bae, JuYeon; Seo, Minjeong

2016-11-01

As complex chronic diseases are increasing, nurses' prompt and accurate clinical reasoning skills are essential. However, little is known about the reasoning skills of registered nurses. This study aimed to determine how registered nurses use their clinical reasoning skills and to identify how the reasoning process proceeds in the complex clinical situation of hospital setting. A qualitative exploratory design was used with a think-aloud method. A total of 13 registered nurses (mean years of experience=11.4) participated in the study, solving an ill-structured clinical problem based on complex chronic patients cases in a hospital setting. Data were analyzed using deductive content analysis. Findings showed that the registered nurses used a variety of clinical reasoning skills. The most commonly used skill was 'checking accuracy and reliability.' The reasoning process of registered nurses covered assessment, analysis, diagnosis, planning/implementation, and evaluation phase. It is critical that registered nurses apply appropriate clinical reasoning skills in complex clinical practice. The main focus of registered nurses' reasoning in this study was assessing a patient's health problem, and their reasoning process was cyclic, rather than linear. There is a need for educational strategy development to enhance registered nurses' competency in determining appropriate interventions in a timely and accurate fashion. Copyright © 2016 Elsevier Ltd. All rights reserved.

Corrosion behavior of Haynes {sup registered} 230 {sup registered} nickel-based super-alloys for integrated coal gasification combined cycle syngas plants. A plant exposure study

Energy Technology Data Exchange (ETDEWEB)

Lee, Sungkyu; Lee, Jieun; Kang, Suk-Hwan; Lee, Seung-Jong; Yun, Yongseung [Institute for Advanced Engineering (IAE), Gyeonggi-do (Korea, Republic of). Plant Engineering Center; Kim, Min Jung [Sungkyunkwan Univ, Gyeonggi-do (Korea, Republic of). Advanced Materials Technology Research Center

2015-07-01

The corrosion behavior of commercially available Haynes {sup registered} 230 {sup registered} nickel-based alloy samples was investigated by exposure to coal-gasifying integrated coal gasification combined cycle pilot plant facilities affiliated with the Institute for Advanced Engineering (2.005 MPa and 160-300 C). The morphological and microstructural analyses of the exposed samples were conducted using scanning electron microscopy and energy-dispersive X-ray spectroscopy analysis on the external surface of the recovered corrosion test samples to obtain information of the corrosion scale. These analyses based on the pre- and post-exposure corrosion test samples combined with thermodynamic Ellingham-Pourbaix stability diagrams provided preliminary insight into the mechanism of the observed corrosion behavior prevailing in the piping materials that connected the particulate removal unit and water scrubber of the integrated coal gasification combined cycle pilot plant. Uniform material wastage was observed after 46 hours of operation, and a preliminary corrosion mechanism was suggested: the observed material waste and corrosion behavior of the Haynes {sup registered} 230 {sup registered} nickel-based alloy samples cut off from the coal syngas integrated coal gasification combined cycle plant were explained by the formation of discontinuous (complex) oxide phases and subsequent chlorine-induced active oxidation under the predominantly reducing environment encountered. This contribution continues the already published studies of the Fe-Ni-Cr-Co alloy Haynes {sup registered} 556 {sup registered}.

Are Local Registers the Solution?

NARCIS (Netherlands)

Baldwin, R.; English, C.; Lemmen, C.H.J.; Rose, I.; Smith, A.; Solovov, A.; Sullivan, T.

2018-01-01

This paper explores the possibility of using local registers to manage and update land rights. Secure land rights are largely taken for granted in the developed world. Yet for many people in developing nations, clear and enforceable land rights are not a reality. In the developed world, land rights

Acceptability and perceived barriers and facilitators to creating a national research register to enable 'direct to patient' enrolment into research: the Scottish Health Research Register (SHARE).

Science.gov (United States)

Grant, Aileen; Ure, Jenny; Nicolson, Donald J; Hanley, Janet; Sheikh, Aziz; McKinstry, Brian; Sullivan, Frank

2013-10-18

Difficulties with recruitment pose a major, increasingly recognised challenge to the viability of research. We sought to explore whether a register of volunteers interested in research participation, with data linkage to electronic health records to identify suitable research participants, would prove acceptable to healthcare staff, patients and researchers. We undertook a qualitative study in which a maximum variation sampling approach was adopted. Focus groups and interviews were conducted with patients, general practitioners (GP), practice managers and health service researchers in two Scottish health boards. Analysis was primarily thematic to identify a range of issues and concerns for all stakeholder groups. The concept of a national research register was, in general, acceptable to all stakeholder groups and was widely regarded as beneficial for research and for society. Patients, however, highlighted a number of conditions which should be met in the design of a register to expedite confidence and facilitate recruitment. They also gave their perceptions on how a register should operate and be promoted, favouring a range of media. GPs and practice managers were primarily concerned with the security and confidentiality of patient data and the impact a register may have on their workload. Researchers were supportive of the initiative seeing advantages in more rapid access to a wider pool of patients. They did raise concerns that GPs may be able to block access to personal patient data held in general practice clinical systems and that the register may not be representative of the whole population. This work suggests that patients, healthcare staff and researchers have a favourable view of the potential benefits of a national register to identify people who are potentially eligible and willing to participate in health related research. It has highlighted a number of issues for the developers to incorporate in the design of research registers.

Investigators' viewpoint of clinical trials in India: Past, present and future

Directory of Open Access Journals (Sweden)

Mohandas K Mallath

2017-01-01

Full Text Available India's success in producing food and milk for its population (Green Revolution and White Revolution happened because of scientific research and field trials. Likewise improving the health of Indians needs clinical research and clinical trials. A Large proportion of the sick Indians are poor, illiterate with no access to good health care. They are highly vulnerable to inducement and exploitation in clinical trials. The past two decades saw the rise and fall of clinical trials in India. The rise happened when our regulators created a favorable environment, and Indian investigators were invited to participate in global clinical trials. The gap between the demand and supply resulted in inadequate protection of the trial participants. Reports of abuses of the vulnerable trial participants followed by public interest litigations led to strengthening of regulations by the regulators. The stringent new regulations made the conduct of clinical trials more laborious and increased the cost of clinical trials in India. There was a loss of interest in sponsored clinical trials resulting in the fall in global clinical trials in India. Following repeated appeals by the investigators, the Indian regulators have recently relaxed some of the stringent regulations, while continuing to ensure the adequate patient protection. Clinical trials that are relevant to our population and conducted by well-trained investigators and monitored by trained and registered Ethics Committees will increase in the future. We must remain vigilant, avoid previous mistakes, and strive hard to protect the trial participants in the future trials.

Within-trial economic evaluation of diabetes-specific cognitive behaviour therapy in patients with type 2 diabetes and subthreshold depression

Directory of Open Access Journals (Sweden)

Ohmann Christian

2010-10-01

Full Text Available Abstract Background Despite the high prevalence of subthreshold depression in patients with type 2 diabetes, evidence on cost-effectiveness of different therapy options for these patients is currently lacking. Methods/Design Within-trial economic evaluation of the diabetes-specific cognitive behaviour therapy for subthreshold depression. Patients with diabetes and subthreshold depression are randomly assigned to either 2 weeks of diabetes-specific cognitive behaviour group therapy (n = 104 or to standard diabetes education programme only (n = 104. Patients are followed for 12 months. During this period data on total health sector costs, patient costs and societal productivity costs are collected in addition to clinical data. Health related quality of life (the SF-36 and the EQ-5D is measured at baseline, immediately after the intervention, at 6 and at 12 months after the intervention. Quality adjusted life years (QALYs, and cumulative costs will be estimated for each arm of the trial. Cost-effectiveness of the diabetes-specific cognitive behaviour group therapy will be analysed from the perspective of the German statutory health insurance and from the societal perspective. To this end, incremental cost-effectiveness ratio (ICER in terms of cost per QALY gained will be calculated. Discussion Some methodological issues of the described economic evaluation are discussed. Trial registration The trial has been registered at the Clinical Trials Register (NCT01009138.

Vitamin C as an adjuvant for treating major depressive disorder and suicidal behavior, a randomized placebo-controlled clinical trial.

Science.gov (United States)

Sahraian, Ali; Ghanizadeh, Ahmad; Kazemeini, Fereshteh

2015-03-14

There are some animal studies suggesting the possible role of vitamin C for treating depression. However, the efficacy of vitamin C for treating adult patients with major depressive disorder (MDD) has never been examined. This 8-week randomized double-blind placebo-controlled clinical trial included adult patients with major depressive disorder according to DSM-IV diagnostic criteria. Twenty-one patients in the treatment group received citalopram plus vitamin C and the 22 patients in the control group received citalopram plus placebo. The Hamilton Depression Rating Scale was used to measure depressive symptoms at baseline, week 2, week 4, and week 8. We also checked for the presence of adverse effects. While depression symptoms decreased in both groups during this trial, there was no statistically significant difference between the 2 groups (P = .5). The rate of remission, partial response, and complete response was not different between the two groups. The rate of adverse effects were not different between the two groups. Adding vitamin C to citalopram did not increase the efficacy of citalopram in MDD patients. Vitamin C plus citalopram is as effective as placebo plus citalopram for treating adult patients with suicidal behavior. No serious adverse effect for this combination was identified during this trial. This trial was registered at http://www.irct.ir . The registration number of this trial was: IRCT201312263930N31 . Date registered: 5 July 2014.

Turnover of registered nurses in Israel: characteristics and predictors.

Science.gov (United States)

Toren, Orly; Zelker, Revital; Lipschuetz, Michal; Riba, Shoshana; Reicher, Sima; Nirel, Nurit

2012-05-01

In an era of global and local nursing shortages, nursing turnover has negative consequences in terms of diminished quality of care, increased costs and economic losses and decreased job satisfaction. To examine the turnover rate of registered nurses in Israel by assessing the varying degree of turnover between economic sectors, between hospital and community facilities, and/or between types of hospitals; and by examining potential predicting factors of turnover among registered nurses. A national phone survey was undertaken in Israel consisting of a random sampling of registered nurses of working age (up to age 60). The subjects comprised 10% of a national database of 32,000 registered nurses. The turnover rate among working nurses in Israel currently stands at 23%. In addition, 13% of employed nurses have taken a temporary leave of absence for a period greater than 6 months in the past 10 years, most up to 1 year. While job satisfaction rates were relatively high (72%), Professional satisfaction rates were 60% with no significant difference between hospital and community nurses. The turnover rate of registered nurses from a hospital setting to the community was significantly higher (pcommunity registered nurses to hospitals. Predicting factors of turnover were found to be: young age, part-time work, lack of advanced professional education, academic education and low satisfaction with the nursing profession. The shift of nursing workforce is mainly from hospitals to community health settings. There is a need to monitor and understand the characteristics of job and professional satisfaction among hospital nurses in order to implement crucial organizational interventions and retain hospital nursing staffs. Since young nurses, nurses working part time and nurses with no advanced professional and academic education, tend to move more than others, efforts should be targeted at these specific groups. Copyright © 2012 Elsevier Ireland Ltd. All rights reserved.

In-service education and training as experienced by registered nurses.

Science.gov (United States)

Norushe, T F; Van Rooyen, D; Strumpher, J

2004-11-01

Nursing is a dynamic profession that is subject to rapid changes in health care provision, hence the need for in-service training programmes for nurses. Newly employed registered nurses require in-service training in order to update them regarding the latest developments in nursing practice. The researcher noted that some newly appointed registered nurses were not competent in all aspects relating to their tasks. This could have been due to a knowledge deficit relating to either new developments or of the procedure relating to a specific task. In some institutions newly-appointed registered nurses on probation reported not receiving in-service training for six months or longer, yet they were still expected to perform their tasks efficiently. The objectives of the study were to, firstly, explore and describe the experiences of registered nurses regarding in-service training programmes in their institutions and, secondly, to make recommendations to Nursing Service Managers relating to the development of effective in-service training programmes in their institutions. A qualitative, exploratory, descriptive design was implemented. Data was analysed using Tesch's descriptive approach (in Creswell, 1994:155). Two main themes emerged, namely that registered nurses experienced in-service training programmes as inadequate and reacted negatively towards them. This article focuses on the experiences of registered nurses relating to in-service training programmes, as well as the formulation of guidelines to assist nursing service managers in the development of effective in-service training programmes.

Chinese Herbal Medicine for Postpartum Depression: A Systematic Review of Randomized Controlled Trials

Directory of Open Access Journals (Sweden)

Yongle Li

2016-01-01

Full Text Available Background. Postpartum depression (PPD does great harm to women following childbirth. The aim of this study was to conduct a systematic review of the literature to assess the efficacy and safety of CHM for the treatment of PPD. Methods. Published or ongoing registered trials were searched for from the inception of the various databases to December 31, 2015. Data extraction and methodology assessment were conducted independently by two researchers. RevMan 5.3 software was used to analyze the data. Results. Forty-seven registered clinical trials (RCTs were identified and reviewed. The results showed CHM alone or in combination with routine treatments could reduce HAMD score, EPDS score, incidence of adverse events, TESS, and SERS. CHM combined with routine treatment was more effective in increasing serum estradiol levels and reducing progesterone levels than routine treatment alone. Meanwhile, pooled data revealed that MRLQS combined with routine treatments or MRLQS plus MSHS combined with routine treatments were more effective than other therapeutic methods in TCM. MRLQS plus MSHS alone was found to be an effective alternative when compared to routine treatments. Conclusions. This review suggested that CHM was safe and effective in the treatment of PPD. However, this could not be proven conclusively. To ensure evidence-based clinical practice, more rigorously designed trials are warranted.

Conducting qualitative research within Clinical Trials Units: avoiding potential pitfalls.

Science.gov (United States)

Cooper, Cindy; O'Cathain, Alicia; Hind, Danny; Adamson, Joy; Lawton, Julia; Baird, Wendy

2014-07-01

The value of using qualitative research within or alongside randomised controlled trials (RCTs) is becoming more widely accepted. Qualitative research may be conducted concurrently with pilot or full RCTs to understand the feasibility and acceptability of the interventions being tested, or to improve trial conduct. Clinical Trials Units (CTUs) in the United Kingdom (UK) manage large numbers of RCTs and, increasingly, manage the qualitative research or collaborate with qualitative researchers external to the CTU. CTUs are beginning to explicitly manage the process, for example, through the use of standard operating procedures for designing and implementing qualitative research with trials. We reviewed the experiences of two UK Clinical Research Collaboration (UKCRC) registered CTUs of conducting qualitative research concurrently with RCTs. Drawing on experiences gained from 15 studies, we identify the potential for the qualitative research to undermine the successful completion or scientific integrity of RCTs. We show that potential problems can arise from feedback of interim or final qualitative findings to members of the trial team or beyond, in particular reporting qualitative findings whilst the trial is on-going. The problems include: We make recommendations for improving the management of qualitative research within CTUs. Copyright © 2014. Published by Elsevier Inc.

Validation of epilepsy diagnoses in the Danish National Hospital Register

DEFF Research Database (Denmark)

Christensen, Jakob; Vestergaard, Mogens; Olsen, Jørn

2007-01-01

PURPOSE: To validate the diagnosis of epilepsy in the Danish National Hospital Register. METHODS: We randomly selected 200 patients registered with epilepsy in the Danish National Hospital Register between 1977 and 2002 and validated the diagnosis according to the guidelines developed...... by the International League Against Epilepsy. RESULTS: We reviewed the medical records of 188 (94%) persons from 57 departments at 41 hospitals. The epilepsy diagnoses were confirmed in 153 patients, providing a positive predictive value for epilepsy of 81% (95% confidence interval (95% CI): 75-87%). Among the 35...... for syndrome classification was 60% (95% CI: 44-74%) for epilepsy with complex focal seizures and 35% (95% CI: 22-51%) for primary generalized epilepsy. CONCLUSION: The validity of the epilepsy diagnoses in the Danish National Hospital Register has a moderate to high positive predictive value for epilepsy...

THE TRANSFER OF THE COMPANY’S REGISTERED OFFICE

Directory of Open Access Journals (Sweden)

Saša Prelič

2016-01-01

Full Text Available In the light of the relevant case law of The Court of Justice of the EU it is emphasized that the cross-border transfer of company’s registered office (and its real seat must be permitted in accordance with the Treaty on the Functioning of the EU. Nevertheless, the Fourteenth Company law Directive should be adopted for the reasons of legal certainty and it should determine, whether the transfer of the registered office (without transfer of company’s real seat to another Member State is admissible or not. Furthermore, the authors discuss the cross-border restructuring of the company, which in addition to relocation of the registered office also includes a change of its legal form. The Court of Justice of the EU has not yet decided on such cross-border restructuring, nevertheless it should be allowed based of the freedom of establishment (cross-border formal transformation.

Acoustic and Perceptual Analysis of Modal and Falsetto Registers in Females with Dysphonia

Science.gov (United States)

Li, Nicole Y. K.; Yiu, Edwin M-L.

2006-01-01

Modal and falsetto registers are the basic vocal qualities used in female speaking voices. The purpose of this study was to identify the frequency at which modal register changed to falsetto register and the frequency range of each modal and falsetto register produced under three loudness levels: soft, comfortable and loud phonations in normal and…

An open-access mobile compatible electronic patient register for rheumatic heart disease (‘eRegister’) based on the World Heart Federation’s framework for patient registers

Science.gov (United States)

van Dam, Joris; Tadmor, Brigitta; Spector, Jonathan; Musuku, John; Zühlke, Liesl J; Zühlke, Liesl J; Engel, Mark E; Mayosi, Bongani M; Nestle, Nick

2015-01-01

Summary Background Rheumatic heart disease (RHD) remains a major disease burden in low-resource settings globally. Patient registers have long been recognised to be an essential instrument in RHD control and elimination programmes, yet to date rely heavily on paper-based data collection and non-networked data-management systems, which limit their functionality. Objectives To assess the feasibility and potential benefits of producing an electronic RHD patient register. Methods We developed an eRegister based on the World Heart Federation’s framework for RHD patient registers using CommCare, an open-source, cloud-based software for health programmes that supports the development of customised data capture using mobile devices. Results The resulting eRegistry application allows for simultaneous data collection and entry by field workers using mobile devices, and by providers using computer terminals in clinics and hospitals. Data are extracted from CommCare and are securely uploaded into a cloud-based database that matches the criteria established by the WHF framework. The application can easily be tailored to local needs by modifying existing variables or adding new ones. Compared with traditional paper-based data-collection systems, the eRegister reduces the risk of data error, synchronises in real-time, improves clinical operations and supports management of field team operations. Conclusions The user-friendly eRegister is a low-cost, mobile, compatible platform for RHD treatment and prevention programmes based on materials sanctioned by the World Heart Federation. Readily adaptable to local needs, this paperless RHD patient register program presents many practical benefits. PMID:26444995

Treatment of intracerebral haemorrhage with tranexamic acid – A review of current evidence and ongoing trials

DEFF Research Database (Denmark)

Law, Zhe Kang; Meretoja, Atte; Engelter, Stefan T

2017-01-01

Purpose Haematoma expansion is a devastating complication of intracerebral haemorrhage (ICH) with no established treatment. Tranexamic acid had been an effective haemostatic agent in reducing post-operative and traumatic bleeding. We review current evidence examining the efficacy of tranexamic acid...... in improving clinical outcome after ICH. Method We searched MEDLINE, EMBASE, CENTRAL and clinical trial registers for studies using search strategies incorporating the terms ‘intracerebral haemorrhage’, ‘tranexamic acid’ and ‘antifibrinolytic’. Authors of ongoing clinical trials were contacted for further...... details. Findings We screened 268 publications and retrieved 17 articles after screening. Unpublished information from three ongoing clinical trials was obtained. We found five completed studies. Of these, two randomised controlled trials (RCTs) comparing intravenous tranexamic acid to placebo (n = 54...

Bangladesh Cerebral Palsy Register (BCPR): a pilot study to develop a national cerebral palsy (CP) register with surveillance of children for CP.

Science.gov (United States)

Khandaker, Gulam; Smithers-Sheedy, Hayley; Islam, Johurul; Alam, Monzurul; Jung, Jenny; Novak, Iona; Booy, Robert; Jones, Cheryl; Badawi, Nadia; Muhit, Mohammad

2015-09-25

The causes and pathogenesis of cerebral palsy (CP) are all poorly understood, particularly in low- and middle-income countries (LMIC). There are gaps in knowledge about CP in Bangladesh, especially in the spheres of epidemiological research, intervention and service utilization. In high-income countries CP registers have made substantial contributions to our understanding of CP. In this paper, we describe a pilot study protocol to develop, implement, and evaluate a CP population register in Bangladesh (i.e., Bangladesh Cerebral Palsy Register - BCPR) to facilitate studies on prevalence, severity, aetiology, associated impairments and risk factors for CP. The BCPR will utilise a modified version of the Australian Cerebral Palsy Register (ACPR) on a secured web-based platform hosted by the Cerebral Palsy Alliance Research Institute, Australia. A standard BCPR record form (i.e., data collection form) has been developed in consultation with local and international experts. Using this form, the BPCR will capture information about maternal health, birth history and the nature of disability in all children with CP aged CP will be identified by using the community based Key Informants Method (KIM). Data from the completed BPCR record together with details of assessment by a research physician will be entered into an online data repository. Once implemented, BCPR will be, to the best of our knowledge, the first formalised CP register from a LMIC. Establishment of the BCPR will enable estimates of prevalence; facilitate clinical surveillance and promote research to improve the care of individuals with CP in Bangladesh.

National Sample Survey of Registered Nurses

Data.gov (United States)

U.S. Department of Health & Human Services — The National Sample Survey of Registered Nurses (NSSRN) Download makes data from the survey readily available to users in a one-stop download. The Survey has been...

The impact of financial incentives on participants' food purchasing patterns in a supermarket-based randomized controlled trial.

Science.gov (United States)

Olstad, Dana Lee; Crawford, David A; Abbott, Gavin; McNaughton, Sarah A; Le, Ha Nd; Ni Mhurchu, Cliona; Pollard, Christina; Ball, Kylie

2017-08-25

The impacts of supermarket-based nutrition promotion interventions might be overestimated if participants shift their proportionate food purchasing away from their usual stores. This study quantified whether participants who received price discounts on fruits and vegetables (FV) in the Supermarket Healthy Eating for Life (SHELf) randomized controlled trial (RCT) shifted their FV purchasing into study supermarkets during the intervention period. Participants were 642 females randomly assigned to a 1) skill-building (n = 160), 2) price reduction (n = 161), 3) combined skill-building and price reduction (n = 160), or 4) control (n = 161) group. Participants self-reported the proportion of FV purchased in study supermarkets at baseline, 3- and 6-months post-intervention. Fisher's exact and χ 2 tests assessed differences among groups in the proportion of FV purchased in study supermarkets at each time point. Multinomial logistic regression assessed differences among groups in the change in proportionate FV purchasing over time. Post-intervention, 49% of participants purchased ≥50% of their FV in study supermarkets. Compared to all other groups, the price reduction group was approximately twice as likely (RRR: 1.8-2.2) to have increased proportionate purchasing of FV in study supermarkets from baseline to post-intervention (psupermarkets during the intervention period. Unless food purchasing data are available for all sources, differential changes in purchasing patterns can make it difficult to discern the true impacts of nutrition interventions. The SHELf trial is registered with Current Controlled Trials Registration ISRCTN39432901, Registered 30 June 2010, Retrospectively registered ( http://www.isrctn.com/ISRCTN39432901 ).

First-in-man mesenchymal stem cells for radiation-induced xerostomia (MESRIX): study protocol for a randomized controlled trial.

Science.gov (United States)

Grønhøj, Christian; Jensen, David H; Glovinski, Peter V; Jensen, Siri Beier; Bardow, Allan; Oliveri, Roberto S; Specht, Lena; Thomsen, Carsten; Darkner, Sune; Kiss, Katalin; Fischer-Nielsen, Anne; von Buchwald, Christian

2017-03-07

Salivary gland hypofunction and xerostomia are major complications following radiotherapy for head and neck cancer and may lead to debilitating oral disorders and impaired quality of life. Currently, only symptomatic treatment is available. However, mesenchymal stem cell (MSC) therapy has shown promising results in preclinical studies. Objectives are to assess safety and efficacy in a first-in-man trial on adipose-derived MSC therapy (ASC) for radiation-induced xerostomia. This is a single-center, phase I/II, randomized, placebo-controlled, double-blinded clinical trial. A total of 30 patients are randomized in a 1:1 ratio to receive ultrasound-guided, administered ASC or placebo to the submandibular glands. The primary outcome is change in unstimulated whole salivary flow rate. The secondary outcomes are safety, efficacy, change in quality of life, qualitative and quantitative measurements of saliva, as well as submandibular gland size, vascularization, fibrosis, and secretory tissue evaluation based on contrast-induced magnetic resonance imaging (MRI) and core-needle samples. The assessments are performed at baseline (1 month prior to treatment) and 1 and 4 months following investigational intervention. The trial is the first attempt to evaluate the safety and efficacy of adipose-derived MSCs (ASCs) in patients with radiation-induced xerostomia. The results may provide evidence for the effectiveness of ASC in patients with salivary gland hypofunction and xerostomia and deliver valuable information for the design of subsequent trials. EudraCT, Identifier: 2014-004349-29. Registered on 1 April 2015. ClinicalTrials.gov, Identifier: NCT02513238 . First received on 2 July 2015. The trial is prospectively registered.

Effect of tranexamic acid on coagulation and fibrinolysis in women with postpartum haemorrhage (WOMAN-ETAC): protocol and statistical analysis plan for a randomized controlled trial.

Science.gov (United States)

Shakur, Haleema; Fawole, Bukola; Kuti, Modupe; Olayemi, Oladapo; Bello, Adenike; Ogunbode, Olayinka; Kotila, Taiwo; Aimakhu, Chris O; Huque, Sumaya; Gregg, Meghann; Roberts, Ian

2016-12-16

Background : Postpartum haemorrhage (PPH) is a leading cause of maternal death. Tranexamic acid has the potential to reduce bleeding and a large randomized controlled trial of its effect on maternal health outcomes in women with PPH (The WOMAN trial) is ongoing. We will examine the effect of tranexamic acid on fibrinolysis and coagulation in a subset of WOMAN trial participants. Methods . Adult women with clinically diagnosed primary PPH after vaginal or caesarean delivery are eligible for inclusion in the WOMAN trial. In a sub-group of trial participants, blood samples will be collected at baseline and 30 minutes after the first dose of tranexamic acid or matching placebo.  Our primary objective is to evaluate the effect of tranexamic acid on fibrinolysis. Fibrinolysis will be assessed by measuring D-dimers and by rotational thromboelastometry (ROTEM). Secondary outcomes are international normalized ratio (INR), prothrombin time (PT), activated partial thromboplastin time (APTT), fibrinogen, haemoglobin and platelets. We aim to include about 180 women from the University College Hospital, Ibadan in Nigeria. Discussion:  This sub-study of WOMAN trial participants should provide information on the mechanism of action of tranexamic acid in women with postpartum haemorrhage. We present the trial protocol and statistical analysis plan. The trial protocol was registered prior to the start of patient recruitment. The statistical analysis plan was completed before un-blinding. Trial registration: The trial was registered: ClinicalTrials.gov, Identifier NCT00872469 https://clinicaltrials.gov/ct2/show/NCT00872469; ISRCTN registry, Identifier ISRCTN76912190 http://www.isrctn.com/ISRCTN76912190 (Registration date: 22/03/2012).

Registers of pressure ulcers in an international context

Directory of Open Access Journals (Sweden)

Andrea Pokorná

2016-05-01

Full Text Available Aim: The aim of the following review was to search for existing registers of pressure ulcer (PU incidence operating and collecting data on national level. Design: Type of study - review. Methods: Articles focusing on the subject of national PU registers were searched for by means of a systematic trawl through various databases using relevant terms. The search was limited to articles in English issued between 2010 and 2015 in the electronic databases SCOPUS and Nursing OVID. Articles focused on local datasets or registry as a part of local electronic health records were not included as well as studies which do not describe the dataset or the usability of data collection. Results: In total, six papers were found fulfilling the established criteria. Conclusion: According to information available from the literature review, it was recognised that only one register of PUs currently exists at the national level - the Registry of Ulcer Treatment (RUT in Sweden. It can be assumed that registers exist in other countries, but that the information is not available on electronic databases. After a detailed inspection of the articles, it appears the information derived from the studies could provide a useful picture of the data that should be collected, and at what time during the treatment period (initial and final assessment of the patients and local symptomatology of the wound/pressure ulcer it should be collected.

Why we need easy access to all data from all clinical trials and how to accomplish it

DEFF Research Database (Denmark)

Gotzsche, Peter C

2011-01-01

ABSTRACT: International calls for registering all trials involving humans and for sharing the results, and sometimes also the raw data and the trial protocols, have increased in recent years. Such calls have come, for example, from the Organization for Economic Cooperation and Development (OECD......), the World Health Organization (WHO), the US National Institutes of Heath, the US Congress, the European Commission, the European ombudsman, journal editors, The Cochrane Collaboration, and several funders, for example the UK Medical Research Council, the Wellcome Trust, the Bill and Melinda Gates Foundation...... why it is a moral imperative to render all results from all trials involving humans, also healthy volunteers, publicly available. Respect for trial participants who often run a personal and unknown risk by participating in trials requires that they - and therefore also the society at large...

Probiotics: Prevention of Severe Pneumonia and Endotracheal Colonization Trial-PROSPECT: a pilot trial.

Science.gov (United States)

Cook, Deborah J; Johnstone, Jennie; Marshall, John C; Lauzier, Francois; Thabane, Lehana; Mehta, Sangeeta; Dodek, Peter M; McIntyre, Lauralyn; Pagliarello, Joe; Henderson, William; Taylor, Robert W; Cartin-Ceba, Rodrigo; Golan, Eyal; Herridge, Margaret; Wood, Gordon; Ovakim, Daniel; Karachi, Tim; Surette, Michael G; Bowdish, Dawn M E; Lamarche, Daphnee; Verschoor, Chris P; Duan, Erick H; Heels-Ansdell, Diane; Arabi, Yaseen; Meade, Maureen

2016-08-02

Probiotics are live microorganisms that may confer health benefits when ingested. Randomized trials suggest that probiotics significantly decrease the incidence of ventilator-associated pneumonia (VAP) and the overall incidence of infection in critically ill patients. However, these studies are small, largely single-center, and at risk of bias. The aim of the PROSPECT pilot trial was to determine the feasibility of conducting a larger trial of probiotics to prevent VAP in mechanically ventilated patients in the intensive care unit (ICU). In a randomized blinded trial, patients expected to be mechanically ventilated for ≥72 hours were allocated to receive either 1 × 10(10) colony-forming units of Lactobacillus rhamnosus GG or placebo, twice daily. Patients were excluded if they were at increased risk of L. rhamnosus GG infection or had contraindications to enteral medication. Feasibility objectives were: (1) timely recruitment; (2) maximal protocol adherence; (3) minimal contamination; and (4) estimated VAP rate ≥10 %. We also measured other infections, diarrhea, ICU and hospital length of stay, and mortality. Overall, in 14 centers in Canada and the USA, all feasibility goals were met: (1) 150 patients were randomized in 1 year; (2) protocol adherence was 97 %; (3) no patients received open-label probiotics; and (4) the VAP rate was 19 %. Other infections included: bloodstream infection (19.3 %), urinary tract infections (12.7 %), and skin and soft tissue infections (4.0 %). Diarrhea, defined as Bristol type 6 or 7 stools, occurred in 133 (88.7 %) of patients, the median length of stay in ICU was 12 days (quartile 1 to quartile 3, 7-18 days), and in hospital was 26 days (quartile 1 to quartile 3, 14-44 days); 23 patients (15.3 %) died in the ICU. The PROSPECT pilot trial supports the feasibility of a larger trial to investigate the effect of L. rhamnosus GG on VAP and other nosocomial infections in critically ill patients. Clinicaltrials

High-speed test of SFQ-shift register files using PTL wiring

International Nuclear Information System (INIS)

Fujiwara, K.; Yamashiro, Y.; Yoshikawa, N.; Hashimoto, Y.; Yorozu, S.; Terai, H.; Fujimaki, A.

2004-01-01

We have been developing an SFQ shift register memory, which is one candidate to realize high-throughput and high-density superconductive memories. We have modified our memory architecture in order to adapt it to our SFQ microprocessor, CORE1. The new version of the shift register memory is composed of shift registers with non-destructive readout operation, which have an internal feedback. We have also studied the availability of passive transmission line (PTL) wiring in the memory system at high speed. The tested circuit is a 4-byte shift register file, where four kinds of wiring circuits are used between a decoder and shift registers. We have measured the dependences of the DC bias margin on the operating frequency for all wiring methods, and obtained almost the same dependences, which shows the availability of the PTL wiring in the memory system. We have used the NEC 2.5 kA/cm 2 Nb standard process and the CONNECT cell library

RNA interference and Register Machines (extended abstract

Directory of Open Access Journals (Sweden)

Masahiro Hamano

2012-11-01

Full Text Available RNA interference (RNAi is a mechanism whereby small RNAs (siRNAs directly control gene expression without assistance from proteins. This mechanism consists of interactions between RNAs and small RNAs both of which may be single or double stranded. The target of the mechanism is mRNA to be degraded or aberrated, while the initiator is double stranded RNA (dsRNA to be cleaved into siRNAs. Observing the digital nature of RNAi, we represent RNAi as a Minsky register machine such that (i The two registers hold single and double stranded RNAs respectively, and (ii Machine's instructions are interpreted by interactions of enzyme (Dicer, siRNA (with RISC com- plex and polymerization (RdRp to the appropriate registers. Interpreting RNAi as a computational structure, we can investigate the computational meaning of RNAi, especially its complexity. Initially, the machine is configured as a Chemical Ground Form (CGF, which generates incorrect jumps. To remedy this problem, the system is remodeled as recursive RNAi, in which siRNA targets not only mRNA but also the machine instructional analogues of Dicer and RISC. Finally, probabilistic termination is investigated in the recursive RNAi system.

Impact of sending email reminders of the legal requirement for posting results on ClinicalTrials.gov: cohort embedded pragmatic randomized controlled trial.

Science.gov (United States)

Maruani, Annabel; Boutron, Isabelle; Baron, Gabriel; Ravaud, Philippe

2014-09-19

To evaluate the impact of sending an email to responsible parties of completed trials that do not comply with the Food and Drug Administration Amendments Act 801 legislation, to remind them of the legal requirement to post results. Cohort embedded pragmatic randomized controlled trial. Trials registered on ClinicalTrials.gov. 190 out of 379 trials randomly selected by computer generated randomization list to receive the intervention (personalized emails structured as a survey and sent by one of us to responsible parties of the trials, indirectly reminding them of the legal requirement and potential penalties for non-compliance). The primary outcome was the proportion of results posted on ClinicalTrials.gov at three months. The secondary outcome was the proportion posted at six months. In a second step, two assessors blinded to the intervention group collected the date of the first results being received on ClinicalTrials.gov. A post hoc sensitivity analysis excluding trials wrongly included was performed. Among 379 trials included, 190 were randomized to receive the email intervention. The rate of posting of results did not differ at three months between trials with or without the intervention: 36/190 (19%) v 24/189 (13%), respectively (relative risk 1.5, 95% confidence interval 0.9 to 2.4, P=0.096) but did at six months: 46/190 (24%) v 27/189 (14%), 1.7, 1.1 to 2.6, P=0.014. In the sensitivity analysis, which excluded 48/379 trials (13%), 26/190 (14%) and 22/189 (12%), respectively, results were significant at three months (relative risk 5.1, 1.1 to 22.9, P=0.02) and at six months (4.1, 1.3 to 10.6, P=0.001). Sending email reminders about the FDA's legal requirement to post results at ClinicalTrials.gov improved significantly the posting rate at six months but not at three months.Trial registration ClinicalTrials.gov NCT01658254. © Maruani et al 2014.

DeLLITE Depression in late life: an intervention trial of exercise. Design and recruitment of a randomised controlled trial

Directory of Open Access Journals (Sweden)

Keeling Sally

2008-05-01

Full Text Available Abstract Background Physical activity shows potential in combating the poor outcomes associated with depression in older people. Meta-analyses show gaps in the research with poor trial design compromising certainty in conclusions and few programmes showing sustained effects. Methods/design The Depression in Late Life: an Intervention Trial of Exercise (DeLLITE is a 12 month randomised controlled trial of a physical activity intervention to increase functional status in people aged 75 years and older with depressive symptoms. The intervention involves an individualised activity programme based on goal setting and progression of difficulty of activities delivered by a trained nurse during 8 home visits over 6 months. The control group received time matched home visits to discuss social contacts and networks. Baseline, 6 and 12 months measures were assessed in face to face visits with the primary outcome being functional status (SPPB, NEADL. Secondary outcomes include depressive symptoms (Geriatric Depression Scale, quality of life (SF-36, physical activity (AHS Physical Activity Questionnaire and falls (self report. Discussion Due to report in 2008 the DeLLITE study has recruited 70% of those eligible and tests the efficacy of a home based, goal setting physical activity programme in improving function, mood and quality of life in older people with depressive symptomatology. If successful in improving function and mood this trial could prove for the first time that there are long term health benefit of physical activity, independent of social activity, in this high risk group who consume excess health related costs. Trial registration Australian and New Zealand Clinical Trials Register ACTRN12605000475640

Nursing career fulfillment: statistics and statements from registered nurses.

Science.gov (United States)

Reineck, Carol; Furino, Antonio

2005-01-01

A state-level survey of registered nurses confirmed national findings and raised new issues. Findings revealed that while nurses love the intrinsic reward of nursing, they report workplace, relationship, and stress issues which contribute to frustration and exhaustion. These issues may prevent registered nurses from giving the nursing care they desire to deliver, hastening preventable retirement and costly turnover decisions.

Registered indians and tobacco taxation: a culturally-appropriate strategy?

Science.gov (United States)

Wardman, A E Dennis; Khan, Nadia A

2005-01-01

Taxation of tobacco is a widely-used strategy that prompts smoking cessation among adults and reduces cigarette consumption among continuing smokers. Registered Indian tobacco use prevalence is at least double that of the rest of Canadians and is in part due to the lower cost of tobacco products purchased on reserve by Registered Indians (RIs) as they are tax exempt. Although registered Indian communities have the ability to collect tax on tobacco products and direct the use of these revenues, this strategy is rarely utilized. Tobacco taxation could have substantial health and economic benefits to RI communities, but perhaps is not culturally-appropriate. In order to better support RI communities, governments and other organizations need to examine this policy instrument in the context of RI populations.

Assessment of Bonelike (registered) graft with a resorbable matrix using an animal model

International Nuclear Information System (INIS)

Lobato, J.V.; Hussain, N. Sooraj; Botelho, C.M.; Mauricio, A.C.; Afonso, A.; Ali, N.; Santos, J.D.

2006-01-01

Synthetic bone grafts have been developed to provide an alternative to autografts and allografts. Bonelike (registered) is a patented synthetic osteoconductive bone graft that mimics the mineral composition of natural bone. In the present preliminary animal studies a user-friendly version of synthetic bone graft Bonelike (registered) have been developed by using a resorbable matrix, Floseal (registered) , as a vehicle and raloxifene hydrochloride as a therapeutic molecule, that is known to decrease osteoclast activity and therefore enhanced bone formation. From histological and scanning electron microscopy evaluations, the use of Bonelike (registered) associated with Floseal (registered) and raloxifene hydrochloride showed that new bone was rapidly apposed on implanted granules and also that the presence of the matrix and therapeutic molecule does not alter the proven highly osteoconductivity properties of Bonelike (registered) . Therefore, this association may be one step-forward for the clinical applications of Bonelike (registered) scaffolds since it is much more easy-to-handle when compared to granular materials

The trials methodological research agenda: results from a priority setting exercise

Science.gov (United States)

2014-01-01

Background Research into the methods used in the design, conduct, analysis, and reporting of clinical trials is essential to ensure that effective methods are available and that clinical decisions made using results from trials are based on the best available evidence, which is reliable and robust. Methods An on-line Delphi survey of 48 UK Clinical Research Collaboration registered Clinical Trials Units (CTUs) was undertaken. During round one, CTU Directors were asked to identify important topics that require methodological research. During round two, their opinion about the level of importance of each topic was recorded, and during round three, they were asked to review the group’s average opinion and revise their previous opinion if appropriate. Direct reminders were sent to maximise the number of responses at each round. Results are summarised using descriptive methods. Results Forty one (85%) CTU Directors responded to at least one round of the Delphi process: 25 (52%) responded in round one, 32 (67%) responded in round two, 24 (50%) responded in round three. There were only 12 (25%) who responded to all three rounds and 18 (38%) who responded to both rounds two and three. Consensus was achieved amongst CTU Directors that the top three priorities for trials methodological research were ‘Research into methods to boost recruitment in trials’ (considered the highest priority), ‘Methods to minimise attrition’ and ‘Choosing appropriate outcomes to measure’. Fifty other topics were included in the list of priorities and consensus was reached that two topics, ‘Radiotherapy study designs’ and ‘Low carbon trials’, were not priorities. Conclusions This priority setting exercise has identified the research topics felt to be most important to the key stakeholder group of Directors of UKCRC registered CTUs. The use of robust methodology to identify these priorities will help ensure that this work informs the trials methodological research agenda, with

Fluid hydration to prevent post-ERCP pancreatitis in average- to high-risk patients receiving prophylactic rectal NSAIDs (FLUYT trial): study protocol for a randomized controlled trial.

Science.gov (United States)

Smeets, Xavier J N M; da Costa, David W; Fockens, Paul; Mulder, Chris J J; Timmer, Robin; Kievit, Wietske; Zegers, Marieke; Bruno, Marco J; Besselink, Marc G H; Vleggaar, Frank P; van der Hulst, Rene W M; Poen, Alexander C; Heine, Gerbrand D N; Venneman, Niels G; Kolkman, Jeroen J; Baak, Lubbertus C; Römkens, Tessa E H; van Dijk, Sven M; Hallensleben, Nora D L; van de Vrie, Wim; Seerden, Tom C J; Tan, Adriaan C I T L; Voorburg, Annet M C J; Poley, Jan-Werner; Witteman, Ben J; Bhalla, Abha; Hadithi, Muhammed; Thijs, Willem J; Schwartz, Matthijs P; Vrolijk, Jan Maarten; Verdonk, Robert C; van Delft, Foke; Keulemans, Yolande; van Goor, Harry; Drenth, Joost P H; van Geenen, Erwin J M

2018-04-02

Post-endoscopic retrograde cholangiopancreatography (ERCP) pancreatitis (PEP) is the most common complication of ERCP and may run a severe course. Evidence suggests that vigorous periprocedural hydration can prevent PEP, but studies to date have significant methodological drawbacks. Importantly, evidence for its added value in patients already receiving prophylactic rectal non-steroidal anti-inflammatory drugs (NSAIDs) is lacking and the cost-effectiveness of the approach has not been investigated. We hypothesize that combination therapy of rectal NSAIDs and periprocedural hydration would significantly lower the incidence of post-ERCP pancreatitis compared to rectal NSAIDs alone in moderate- to high-risk patients undergoing ERCP. The FLUYT trial is a multicenter, parallel group, open label, superiority randomized controlled trial. A total of 826 moderate- to high-risk patients undergoing ERCP that receive prophylactic rectal NSAIDs will be randomized to a control group (no fluids or normal saline with a maximum of 1.5 mL/kg/h and 3 L/24 h) or intervention group (lactated Ringer's solution with 20 mL/kg over 60 min at start of ERCP, followed by 3 mL/kg/h for 8 h thereafter). The primary endpoint is the incidence of post-ERCP pancreatitis. Secondary endpoints include PEP severity, hydration-related complications, and cost-effectiveness. The FLUYT trial design, including hydration schedule, fluid type, and sample size, maximize its power of identifying a potential difference in post-ERCP pancreatitis incidence in patients receiving prophylactic rectal NSAIDs. EudraCT: 2015-000829-37 . Registered on 18 February 2015. 13659155 . Registered on 18 May 2015.

[An Investigation of the Role Responsibilities of Clinical Research Nurses in Conducting Clinical Trials].

Science.gov (United States)

Kao, Chi-Yin; Huang, Guey-Shiun; Dai, Yu-Tzu; Pai, Ya-Ying; Hu, Wen-Yu

2015-06-01

Clinical research nurses (CRNs) play an important role in improving the quality of clinical trials. In Taiwan, the increasing number of clinical trials has increased the number of practicing CRNs. Understanding the role responsibilities of CRNs is necessary to promote professionalism in this nursing category. This study investigates the role responsibilities of CRNs in conducting clinical trials / research. A questionnaire survey was conducted in a medical center in Taipei City, Taiwan. Eighty CRNs that were registered to facilitate and conduct clinical trials at this research site completed the survey. "Subject protection" was the CRN role responsibility most recognized by participants, followed by "research coordination and management", "subject clinical care", and "advanced professional nursing". Higher recognition scores were associated with higher importance scores and lower difficulty scores. Participants with trial training had significantly higher difficulty scores for "subject clinical care" and "research coordination and management" than their peers without this training (p research coordination and management" (p clinical practice.

The relaxation exercise and social support trial-resst: study protocol for a randomized community based trial

Directory of Open Access Journals (Sweden)

Nakkash Rima

2011-08-01

Full Text Available Abstract Background Studies suggests a possible link between vaginal discharge and common mental distress, as well as highlight the implications of the subjective burden of disease and its link with mental health. Methods/Design This is a community-based intervention trial that aims to evaluate the impact of a psycho-social intervention on medically unexplained vaginal discharge (MUVD in a group of married, low-income Lebanese women, aged 18-49, and suffering from low to moderate levels of anxiety and/or depression. The intervention consisted of 12 sessions of structured social support, problem solving techniques, group discussions and trainer-supervised relaxation exercises (twice per week over six weeks. Women were recruited from Hey el Selloum, a southern disadvantaged suburb of Beirut, Lebanon, during an open recruitment campaign. The primary outcome was self-reported MUVD, upon ruling out reproductive tract infections (RTIs, through lab analysis. Anxiety and/or depression symptoms were the secondary outcomes for this trial. These were assessed using an Arabic validated version of the Hopkins Symptoms Checklist-25 (HSCL-25. Assessments were done at baseline and six months using face-to face interviews, pelvic examinations and laboratory tests. Women were randomized into either intervention or control group. Intent to treat analysis will be used. Discussion The results will indicate whether the proposed psychosocial intervention was effective in reducing MUVD (possibly mediated by common mental distress. Trial Registration The trial is registered at the Wellcome Trust Registry, ISRCTN assigned: ISRCTN: ISRCTN98441241

The Danish nationwide clinical register for patients with rheumatoid arthritis: DANBIO.

Science.gov (United States)

Ibfelt, Else Helene; Jensen, Dorte Vendelbo; Hetland, Merete Lund

2016-01-01

DANBIO is a research register and a data source for rheumatologic diseases (rheumatoid arthritis [RA], axial spondyloarthritis, and psoriatic arthritis) for monitoring clinical quality at the national, regional, and hospital levels. The register includes patients with rheumatologic diseases who are treated at a hospital or a private rheumatologic clinic. Registration is mandatory for all patients with RA regardless of treatment and also for patients with other diagnoses if treated with biological disease-modifying antirheumatic drugs. Since 2006, the registration has been done electronically, including patient-reported outcome measures registered electronically by the patients with the use of touch screens. Core variables such as diagnosis, year of diagnosis, age, and sex are registered at the beginning. Data entered at later visits included the following: patient-reported outcomes for disease activity, pain, fatigue, functional status, and physician-reported objective measures of disease activity, treatment, C-reactive protein, and, when indicated, imaging. For subgroups of patients, the variables such as quality of life, sociodemographic factors, lifestyle, and comorbidity are also registered. The DANBIO cohort comprised ∼26,000 patients with RA, 3,200 patients with axial spondyloarthritis, and 6,200 patients with psoriatic arthritis in 2015. DANBIO has high nationwide coverage and completeness on key data variables. More than 60 original papers as well as annual reports of clinical quality (since 2005) have been published. DANBIO is a powerful register for research in rheumatologic diseases and furthermore serves as a Clinical Quality Register with the aim of monitoring treatment quality in patients with RA in Denmark.

Labelling and optimization of PHOTOFRIN {sup registered} with {sup 99m}Tc

Energy Technology Data Exchange (ETDEWEB)

Fakhar-e-Alam, M. [Pakistan Institute of Engineering and Applied Sciences, Islamabad (Pakistan); Roohi, S.; Amir, N.; Zahoor, R. [Pakistan Institute of Nuclear Science and Technology, Islamabad (Pakistan). Isotope Production Div.; Atif, M.; Firdous, S. [National Institute of Laser and Optronics, Islamabad (Pakistan). Biophotonics Lab.

2010-07-01

PHOTOFRIN {sup registered} was labelled with {sup 99m}Tc using SnCl{sub 2}.2H{sub 2}O as reducing agent. Instant thin layer chromatography (ITLC-SG) in 0.05 M NaOH was used for evaluation of radiochemical purity. Labelling efficiency was dependent on various factors that include the ligand/reductant ratio, pH and time of incubation. Therefore, optimum conditions of labelling were also determined. The stability of {sup 99m}Tc-PHOTOFRIN {sup registered} in serum was checked by using fresh human serum. Tissue distribution of {sup 99m}Tc-PHOTOFRIN {sup registered} was evaluated in Sprague Dawley rats. PHOTOFRIN {sup registered} was labelled with an efficiency of > 95% under optimum conditions, which were PHOTOFRIN {sup registered}: 200 {mu}g, pH: 3-4, SnCl{sub 2}.2H{sub 2}O: 15 {mu}g and 30 min incubation at room temperature. The {sup 99m}Tc-labelled PHOTOFRIN {sup registered} remained stable in human serum for 24 h. Biodistribution study in rats revealed maximum concentration of the labelled compound in liver, lungs and spleen at 0.5 h, and significant activity was also seen in the bladder and urine, indicating the mode of urinary excretion of PHOTOFRIN {sup registered}. (orig.)

17 CFR 403.1 - Application of part to registered brokers and dealers.

Science.gov (United States)

2010-04-01

... registered brokers and dealers. 403.1 Section 403.1 Commodity and Securities Exchanges DEPARTMENT OF THE... SECURITIES AND BALANCES § 403.1 Application of part to registered brokers and dealers. With respect to their activities in government securities, compliance by registered brokers or dealers with § 240.8c-1 of this...

Statement of Agreements Registered with the Agency. Addendum

Energy Technology Data Exchange (ETDEWEB)

NONE

1961-10-24

This addendum is divided into two parts. Part I contains supplementary information on certain agreements which were registered with the Agency up to 30 June 1960; part II is a statement of all agreements so registered between July 1960 and 30 June 1961. In compliance with Article VI of the Regulations for the Registration of Agreements this document is hereby transmitted to all Members of the Agency for their information. A copy is also being sent to the Secretary-General of the United Nations.

Statement of Agreements Registered with the Agency. Addendum

International Nuclear Information System (INIS)

1961-01-01

This addendum is divided into two parts. Part I contains supplementary information on certain agreements which were registered with the Agency up to 30 June 1960; part II is a statement of all agreements so registered between July 1960 and 30 June 1961. In compliance with Article VI of the Regulations for the Registration of Agreements this document is hereby transmitted to all Members of the Agency for their information. A copy is also being sent to the Secretary-General of the United Nations

Comprehensive geriatric assessment for older adults admitted to hospital: meta-analysis of randomised controlled trials.

Science.gov (United States)

Ellis, Graham; Whitehead, Martin A; Robinson, David; O'Neill, Desmond; Langhorne, Peter

2011-10-27

To evaluate the effectiveness of comprehensive geriatric assessment in hospital for older adults admitted as an emergency. We searched the EPOC Register, Cochrane's Controlled Trials Register, the Database of Abstracts of Reviews of Effects (DARE), Medline, Embase, CINAHL, AARP Ageline, and handsearched high yield journals. Randomised controlled trials of comprehensive geriatric assessment (whether by mobile teams or in designated wards) compared with usual care. Comprehensive geriatric assessment is a multidimensional interdisciplinary diagnostic process used to determine the medical, psychological, and functional capabilities of a frail elderly person to develop a coordinated and integrated plan for treatment and long term follow-up. Three independent reviewers assessed eligibility and trial quality and extracted published data. Two additional reviewers moderated. Twenty two trials evaluating 10,315 participants in six countries were identified. For the primary outcome "living at home," patients who underwent comprehensive geriatric assessment were more likely to be alive and in their own homes at the end of scheduled follow-up (odds ratio 1.16 (95% confidence interval 1.05 to 1.28; P = 0.003; number needed to treat 33) at a median follow-up of 12 months versus 1.25 (1.11 to 1.42; P P P = 0.001) and were more likely to experience improved cognition (standardised mean difference 0.08, 0.01 to 0.15; P = 0.02) in the comprehensive geriatric assessment group. Comprehensive geriatric assessment increases patients' likelihood of being alive and in their own homes after an emergency admission to hospital. This seems to be especially true for trials of wards designated for comprehensive geriatric assessment and is associated with a potential cost reduction compared with general medical care.

A Descriptive Study of Registers Found in Spoken and Written Communication (A Semantic Analysis

Directory of Open Access Journals (Sweden)

Nurul Hidayah

2016-07-01

Full Text Available This research is descriptive study of registers found in spoken and written communication. The type of this research is Descriptive Qualitative Research. In this research, the data of the study is register in spoken and written communication that are found in a book entitled "Communicating! Theory and Practice" and from internet. The data can be in the forms of words, phrases and abbreviation. In relation with method of collection data, the writer uses the library method as her instrument. The writer relates it to the study of register in spoken and written communication. The technique of analyzing the data using descriptive method. The types of register in this term will be separated into formal register and informal register, and identify the meaning of register.

Methods for specifying the target difference in a randomised controlled trial: the Difference ELicitation in TriAls (DELTA systematic review.

Directory of Open Access Journals (Sweden)

Jenni Hislop

2014-05-01

Full Text Available Randomised controlled trials (RCTs are widely accepted as the preferred study design for evaluating healthcare interventions. When the sample size is determined, a (target difference is typically specified that the RCT is designed to detect. This provides reassurance that the study will be informative, i.e., should such a difference exist, it is likely to be detected with the required statistical precision. The aim of this review was to identify potential methods for specifying the target difference in an RCT sample size calculation.A comprehensive systematic review of medical and non-medical literature was carried out for methods that could be used to specify the target difference for an RCT sample size calculation. The databases searched were MEDLINE, MEDLINE In-Process, EMBASE, the Cochrane Central Register of Controlled Trials, the Cochrane Methodology Register, PsycINFO, Science Citation Index, EconLit, the Education Resources Information Center (ERIC, and Scopus (for in-press publications; the search period was from 1966 or the earliest date covered, to between November 2010 and January 2011. Additionally, textbooks addressing the methodology of clinical trials and International Conference on Harmonisation of Technical Requirements for Registration of Pharmaceuticals for Human Use (ICH tripartite guidelines for clinical trials were also consulted. A narrative synthesis of methods was produced. Studies that described a method that could be used for specifying an important and/or realistic difference were included. The search identified 11,485 potentially relevant articles from the databases searched. Of these, 1,434 were selected for full-text assessment, and a further nine were identified from other sources. Fifteen clinical trial textbooks and the ICH tripartite guidelines were also reviewed. In total, 777 studies were included, and within them, seven methods were identified-anchor, distribution, health economic, opinion-seeking, pilot

Methods for specifying the target difference in a randomised controlled trial: the Difference ELicitation in TriAls (DELTA) systematic review.

Science.gov (United States)

Hislop, Jenni; Adewuyi, Temitope E; Vale, Luke D; Harrild, Kirsten; Fraser, Cynthia; Gurung, Tara; Altman, Douglas G; Briggs, Andrew H; Fayers, Peter; Ramsay, Craig R; Norrie, John D; Harvey, Ian M; Buckley, Brian; Cook, Jonathan A

2014-05-01

Randomised controlled trials (RCTs) are widely accepted as the preferred study design for evaluating healthcare interventions. When the sample size is determined, a (target) difference is typically specified that the RCT is designed to detect. This provides reassurance that the study will be informative, i.e., should such a difference exist, it is likely to be detected with the required statistical precision. The aim of this review was to identify potential methods for specifying the target difference in an RCT sample size calculation. A comprehensive systematic review of medical and non-medical literature was carried out for methods that could be used to specify the target difference for an RCT sample size calculation. The databases searched were MEDLINE, MEDLINE In-Process, EMBASE, the Cochrane Central Register of Controlled Trials, the Cochrane Methodology Register, PsycINFO, Science Citation Index, EconLit, the Education Resources Information Center (ERIC), and Scopus (for in-press publications); the search period was from 1966 or the earliest date covered, to between November 2010 and January 2011. Additionally, textbooks addressing the methodology of clinical trials and International Conference on Harmonisation of Technical Requirements for Registration of Pharmaceuticals for Human Use (ICH) tripartite guidelines for clinical trials were also consulted. A narrative synthesis of methods was produced. Studies that described a method that could be used for specifying an important and/or realistic difference were included. The search identified 11,485 potentially relevant articles from the databases searched. Of these, 1,434 were selected for full-text assessment, and a further nine were identified from other sources. Fifteen clinical trial textbooks and the ICH tripartite guidelines were also reviewed. In total, 777 studies were included, and within them, seven methods were identified-anchor, distribution, health economic, opinion-seeking, pilot study, review of

The acute and sub-chronic effects of cocoa flavanols on mood, cognitive and cardiovascular health in young healthy adults: A randomized, controlled trial

Directory of Open Access Journals (Sweden)

Laura Amy Massee

2015-05-01

Full Text Available Cocoa supplementation has been associated with benefits to cardiovascular health. However, cocoa’s effects on cognition are less clear. A randomized, placebo-controlled, double-blind clinical trial (n=40, age M= 24.13 years, SD = 4.47 years was conducted to investigate the effects of both acute (same-day and sub-chronic (daily for four-weeks 250mg cocoa supplementation on mood and mental fatigue, cognitive performance and cardiovascular functioning in young, healthy adults. Assessment involved repeated 10-minute cycles of the Cognitive Demand Battery (CDB encompassing two serial subtraction tasks (Serial Threes and Sevens, a Rapid Visual Information Processing task, and a mental fatigue scale over the course of half an hour. The Swinburne University Computerised Cognitive Assessment Battery (SUCCAB was also completed to evaluate cognition. Cardiovascular function included measuring both peripheral and central blood pressure and cerebral blood flow. At the acute time point, consumption of cocoa significantly improved self-reported mental fatigue and performance on the Serial Sevens task in cycle one of the CDB. No other significant effects were found. This trial was registered with the Australian and New Zealand Clinical Trial Registry (Trial ID: ACTRN12613000626763. Accessible via http://www.anzctr.org.au/TrialSearch.aspx?searchTxt=ACTRN126130006 26763&ddlSearch=Registered

The acute and sub-chronic effects of cocoa flavanols on mood, cognitive and cardiovascular health in young healthy adults: a randomized, controlled trial.

Science.gov (United States)

Massee, Laura A; Ried, Karin; Pase, Matthew; Travica, Nikolaj; Yoganathan, Jaesshanth; Scholey, Andrew; Macpherson, Helen; Kennedy, Greg; Sali, Avni; Pipingas, Andrew

2015-01-01

Cocoa supplementation has been associated with benefits to cardiovascular health. However, cocoa's effects on cognition are less clear. A randomized, placebo-controlled, double-blind clinical trial (n = 40, age M = 24.13 years, SD = 4.47 years) was conducted to investigate the effects of both acute (same-day) and sub-chronic (daily for four-weeks) 250 mg cocoa supplementation on mood and mental fatigue, cognitive performance and cardiovascular functioning in young, healthy adults. Assessment involved repeated 10-min cycles of the Cognitive Demand Battery (CDB) encompassing two serial subtraction tasks (Serial Threes and Sevens), a Rapid Visual Information Processing task, and a mental fatigue scale over the course of half an hour. The Swinburne University Computerized Cognitive Assessment Battery (SUCCAB) was also completed to evaluate cognition. Cardiovascular function included measuring both peripheral and central blood pressure and cerebral blood flow. At the acute time point, consumption of cocoa significantly improved self-reported mental fatigue and performance on the Serial Sevens task in cycle one of the CDB. No other significant effects were found. This trial was registered with the Australian and New Zealand Clinical Trial Registry (Trial ID: ACTRN12613000626763). Accessible via http://www.anzctr.org.au/TrialSearch.aspx?searchTxt=ACTRN12613000626763&ddlSearch=Registered.

Measuring the Accuracy of Survey Responses using Administrative Register Data

DEFF Research Database (Denmark)

Kreiner, Claus Thustrup; Lassen, David Dreyer; Leth-Petersen, Søren

2015-01-01

This paper shows how Danish administrative register data can be combined with survey data at the person level and be used to validate information collected in the survey. Register data are collected by automatic third party reporting and the potential errors associated with the two data sources...

Registered nurses' use of research findings in the care of older people.

Science.gov (United States)

Boström, Anne-Marie; Kajermo, Kerstin Nilsson; Nordström, Gun; Wallin, Lars

2009-05-01

To describe registered nurses' reported use of research in the care of older people and to examine associations between research use and factors related to the elements: the communication channels, the adopter and the social system. Research use among registered nurses working in hospital settings has been reported in many studies. Few studies, however, have explored the use of research among registered nurses working in the care of older people. A cross-sectional survey. In eight municipalities, all registered nurses (n = 210) working in older people care were invited to participate (response rate 67%). The Research Utilisation Questionnaire was adopted. Questions concerning the work organisation and research-related resources were sent to the Community Chief Nurse at each municipality. Descriptive statistics and logistic regression were applied. The registered nurses reported a relatively low use of research findings in daily practice, despite reporting a positive attitude to research. The registered nurses reported lack of access to research reports at the work place and that they had little support from unit managers and colleagues. Registered nurses working in municipalities with access to research-related resources reported more use of research than registered nurses without resources. The factors 'Access to research findings at work place', 'Positive attitudes to research' and 'Nursing programme at university level' were significantly associated with research use. There is a great potential to increase registered nurses' use of research findings in the care of older people. Factors which were linked to the communication channels and the adopter were associated with research use. Strategies to enhance research use should focus on access to and adequate training in using information sources, increased knowledge on research methodology and nursing science and a supportive organisation.

Australian Mining's product register 1992-93

Energy Technology Data Exchange (ETDEWEB)

1993-01-01

This annual product register contains an assessment of resources in Australia; statistical information on mine production of principal minerals; mineral industry statistics; directory of exploration and mining companies; buyers' guide; directory of consultants; list of services and a company index.

Clinical trial regulation in Argentina: overview and analysis of regulatory framework, use of existing tools, and researchers' perspectives to identify potential barriers.

Science.gov (United States)

White, Lauren; Ortiz, Zulma; Cuervo, Luis G; Reveiz, Ludovic

2011-11-01

To review and analyze the regulatory framework of clinical trial registration, use of existing tools (publicly accessible national/international registration databases), and users' perspectives to identify possible barriers to registration compliance by sponsors and researchers in Argentina. Internationally registered trials recruiting patients in Argentina were found through clincialtrials.gov and the International Clinical Trial Registration Platform (ICTRP) and compared with publically available clinical trials registered through the National Administration of Drugs, Foods, and Medical Devices (ANMAT). A questionnaire addressing hypothesized attitudinal, knowledge-related, idiomatic, technical, economic, and regulatory barriers that could discourage or impede registration of clinical trials was developed, and semi-structured, in-depth interviews were conducted with a purposively selected sample of researchers (investigators, sponsors, and monitors) in Argentina. A response rate of 74.3% (n = 29) was achieved, and 27 interviews were ultimately used for analysis. Results suggested that the high proportion of foreign-sponsored or multinational trials (64.8% of all protocols approved by ANMAT from 1994-2006) may contribute to a communication gap between locally based investigators and foreign-based administrative officials. A lack of knowledge about available international registration tools and limited awareness of the importance of registration were also identified as limiting factors for local investigators and sponsors. To increase compliance and promote clinical trial registration in Argentina, national health authorities, sponsors, and local investigators could take the following steps: implement a grassroots educational campaign to improve clinical trial regulation, support local investigator-sponsor-initiated clinical trials, and/or encourage local and regional scientific journal compliance with standards from the International Committee of Medical Journal

17 CFR 404.1 - Application of part to registered brokers and dealers.

Science.gov (United States)

2010-04-01

... registered brokers and dealers. 404.1 Section 404.1 Commodity and Securities Exchanges DEPARTMENT OF THE... PRESERVATION OF RECORDS § 404.1 Application of part to registered brokers and dealers. Compliance by a registered broker or dealer with § 240.17a-3 of this title (pertaining to records to be made), § 240.17a-4 of...

The Healthy Heart-Mind trial: melatonin for prevention of delirium following cardiac surgery: study protocol for a randomized controlled trial.

Science.gov (United States)

Ford, Andrew H; Flicker, Leon; Passage, Jurgen; Wibrow, Bradley; Anstey, Matthew; Edwards, Mark; Almeida, Osvaldo P

2016-01-28

Delirium is a common occurrence in patients undergoing major cardiac surgery and is associated with a number of adverse consequences for the individual, their family and the health system. Current approaches to the prevention of delirium include identifying those at risk together with various non-pharmacological and pharmacological strategies, although the efficacy of these is often modest. Emerging evidence suggests that melatonin may be biologically implicated in the development of delirium and that melatonin supplementation may be beneficial in reducing the incidence of delirium in medical and surgical patients. We designed this trial to determine whether melatonin reduces the incidence of delirium following cardiac surgery compared with placebo. The Healthy Heart-Mind trial is a randomized, double-blind, placebo-controlled clinical trial of 3 mg melatonin or matching placebo administered on seven consecutive days for the prevention of delirium following cardiac surgery. We will recruit 210 adult participants, aged 50 and older, undergoing elective or semi-elective cardiac surgery with the primary outcome of interest for this study being the difference in the incidence of delirium between the groups within 7 days of surgery. Secondary outcomes of interest include the difference between groups in the severity and duration of delirious episodes, hospital length of stay and referrals to mental health services during admission. In addition, we will assess differences in depressive and anxiety symptoms, as well as cognitive performance, at discharge and 3 months after surgery. The results of this trial will clarify whether melatonin reduces the incidence of delirium following cardiac surgery. The trial is registered with the Australian Clinical Trials Registry, trial number ACTRN12615000819527 (10 August 2015).

Structured triglyceride for parenteral nutrition: meta-analysis of randomized controlled trials.

Science.gov (United States)

Zhou, Yong; Wu, Xiao-Ting; Li, Ni; Zhuang, Wen; Liu, Guanjian; Wu, Taixiang; Wei, Mao-Ling

2006-01-01

This study assessed the safety and efficacy of structured triglyceride (ST) for parenteral nutrition. A meta-analysis of all the relevant randomized controlled trials (RCTs) was performed. Clinical trials were identified from the following electronic databases: MEDLINE, EMBASE, the Cochrane Controlled Trials Register, Chinese Bio-medicine Database. The search was undertaken in March 2005. Language was restricted to Chinese and English. Literature references were checked at the same time. Only RCTs were extracted and evaluated by two reviewers independently of each other. The statistical analysis was performed by RevMan4.2 software which was provided by the Cochrane Collaboration. A P value of triglyceride (LCT), and the combined results showed that the ST had significant effect on resting energy expenditure (weighted mean difference [WMD] =1.54, 95%CI [ 1.26, 1.82], ptriglycerides (WMD = -0.10, 95%CI [-0.30, 0.10], P=0.32). Only two RCTs compared ST with the physical mixture of medium- and long-chain triglyceride (MCT/LCT), data from trials were not combined due to clinical differences between trials, and conclusions can not be drew from the present data. ST appeared to be safe and well tolerated. Further trials are required, especially compared with the MCT/LCT, with sufficient size and rigorous design.

The VICI-trial: high frequency oscillation versus conventional mechanical ventilation in newborns with congenital diaphragmatic hernia: an international multicentre randomized controlled trial.

Science.gov (United States)

van den Hout, Lieke; Tibboel, Dick; Vijfhuize, Sanne; te Beest, Harma; Hop, Wim; Reiss, Irwin

2011-11-02

Congenital diaphragmatic hernia (CDH) is a severe congenital anomaly of the diaphragm resulting in pulmonary hypoplasia and pulmonary hypertension. It is associated with a high risk of mortality and pulmonary morbidity. Previous retrospective studies have reported high frequency oscillatory ventilation (HFO) to reduce pulmonary morbidity in infants with CDH, while others indicated HFO to be associated with worse outcome. We therefore aimed to develop a randomized controlled trial to compare initial ventilatory treatment with high-frequency oscillation and conventional ventilation in infants with CDH. This trial is designed as a multicentre trial in which 400 infants (200 in each arm) will be included. Primary outcome measures are BPD, described as oxygen dependency by day 28 according to the definition of Jobe and Bancalari, and/or mortality by day 28. All liveborn infants with CDH born at a gestational age of over 34 weeks and no other severe congenital anomalies are eligible for inclusion. Parental informed consent is asked antenatally and the allocated ventilation mode starts within two hours after birth. Laboratory samples of blood, urine and tracheal aspirate are taken at the first day of life, day 3, day 7, day 14 and day 28 to evaluate laboratory markers for ventilator-induced lung injury and pulmonary hypertension. To date, randomized clinical trials are lacking in the field of CDH. The VICI-trial, as the first randomized clinical trial in the field of CDH, may provide further insight in ventilation strategies in CDH patient. This may hopefully prevent mortality and morbidity. Netherlands Trial Register (NTR): NTR1310.

SPIRIT trial: A phase III pragmatic trial of an advance care planning intervention in ESRD.

Science.gov (United States)

Song, Mi-Kyung; Unruh, Mark L; Manatunga, Amita; Plantinga, Laura C; Lea, Janice; Jhamb, Manisha; Kshirsagar, Abhijit V; Ward, Sandra E

2018-01-01

Advance care planning (ACP) is a central tenet of dialysis care, but the vast majority of dialysis patients report never engaging in ACP discussions with their care providers. Over the last decade, we have developed and iteratively tested SPIRIT (Sharing Patient's Illness Representation to Increase Trust), a theory-based, patient- and family-centered advance care planning intervention. SPIRIT is a six-step, two-session, face-to-face intervention to promote cognitive and emotional preparation for end-of-life decision making for patients with ESRD and their surrogates. In these explanatory trials, SPIRIT was delivered by trained research nurses. Findings consistently revealed that patients and surrogates in SPIRIT showed significant improvement in preparedness for end-of-life decision making, and surrogates in SPIRIT reported significantly improved post-bereavement psychological outcomes after the patient's death compared to a no treatment comparison condition. As a critical next step, we are conducting an effectiveness-implementation study. This study is a multicenter, clinic-level cluster randomized pragmatic trial to evaluate the effectiveness of SPIRIT delivered by dialysis care providers as part of routine care in free-standing outpatient dialysis clinics, compared to usual care plus delayed SPIRIT implementation. Simultaneously, we will evaluate the implementation of SPIRIT, including sustainability. We will recruit 400 dyads of patients at high risk of death in the next year and their surrogates from 30 dialysis clinics in four states. This trial of SPIRIT will generate novel, meaningful insights about improving ACP in dialysis care. ClinicalTrials.govNCT03138564, registered 05/01/2017. Copyright © 2017 Elsevier Inc. All rights reserved.

37 CFR 2.99 - Application to register as concurrent user.

Science.gov (United States)

2010-07-01

... 37 Patents, Trademarks, and Copyrights 1 2010-07-01 2010-07-01 false Application to register as concurrent user. 2.99 Section 2.99 Patents, Trademarks, and Copyrights UNITED STATES PATENT AND TRADEMARK... Proceedings § 2.99 Application to register as concurrent user. (a) An application for registration as a lawful...

Thromboprophylaxis using combined intermittent pneumatic compression and pharmacologic prophylaxis versus pharmacologic prophylaxis alone in critically ill patients: study protocol for a randomized controlled trial.

Science.gov (United States)

Arabi, Yaseen M; Alsolamy, Sami; Al-Dawood, Abdulaziz; Al-Omari, Awad; Al-Hameed, Fahad; Burns, Karen E A; Almaani, Mohammed; Lababidi, Hani; Al Bshabshe, Ali; Mehta, Sangeeta; Al-Aithan, Abdulsalam M; Mandourah, Yasser; Almekhlafi, Ghaleb; Finfer, Simon; Abdukahil, Sheryl Ann I; Afesh, Lara Y; Dbsawy, Maamoun; Sadat, Musharaf

2016-08-03

Venous thromboembolism (VTE) remains a common problem in critically ill patients. Pharmacologic prophylaxis is currently the standard of care based on high-level evidence from randomized controlled trials. However, limited evidence exists regarding the effectiveness of intermittent pneumatic compression (IPC) devices. The Pneumatic compREssion for preventing VENous Thromboembolism (PREVENT trial) aims to determine whether the adjunct use of IPC with pharmacologic prophylaxis compared to pharmacologic prophylaxis alone in critically ill patients reduces the risk of VTE. The PREVENT trial is a multicenter randomized controlled trial, which will recruit 2000 critically ill patients from over 20 hospitals in three countries. The primary outcome is the incidence of proximal lower extremity deep vein thrombosis (DVT) within 28 days after randomization. Radiologists interpreting the scans are blinded to intervention allocation, whereas the patients and caregivers are unblinded. The trial has 80 % power to detect a 3 % absolute risk reduction in proximal DVT from 7 to 4 %. The first patient was enrolled in July 2014. As of May 2015, a total of 650 patients have been enrolled from 13 centers in Saudi Arabia, Canada and Australia. The first interim analysis is anticipated in July 2016. We expect to complete recruitment by 2018. Clinicaltrials.gov: NCT02040103 (registered on 3 November 2013). Current controlled trials: ISRCTN44653506 (registered on 30 October 2013).

The VICI-trial: high frequency oscillation versus conventional mechanical ventilation in newborns with congenital diaphragmatic hernia: an international multicentre randomized controlled trial

Directory of Open Access Journals (Sweden)

van den Hout Lieke

2011-11-01

Full Text Available Abstract Background Congenital diaphragmatic hernia (CDH is a severe congenital anomaly of the diaphragm resulting in pulmonary hypoplasia and pulmonary hypertension. It is associated with a high risk of mortality and pulmonary morbidity. Previous retrospective studies have reported high frequency oscillatory ventilation (HFO to reduce pulmonary morbidity in infants with CDH, while others indicated HFO to be associated with worse outcome. We therefore aimed to develop a randomized controlled trial to compare initial ventilatory treatment with high-frequency oscillation and conventional ventilation in infants with CDH. Methods/design This trial is designed as a multicentre trial in which 400 infants (200 in each arm will be included. Primary outcome measures are BPD, described as oxygen dependency by day 28 according to the definition of Jobe and Bancalari, and/or mortality by day 28. All liveborn infants with CDH born at a gestational age of over 34 weeks and no other severe congenital anomalies are eligible for inclusion. Parental informed consent is asked antenatally and the allocated ventilation mode starts within two hours after birth. Laboratory samples of blood, urine and tracheal aspirate are taken at the first day of life, day 3, day 7, day 14 and day 28 to evaluate laboratory markers for ventilator-induced lung injury and pulmonary hypertension. Discussion To date, randomized clinical trials are lacking in the field of CDH. The VICI-trial, as the first randomized clinical trial in the field of CDH, may provide further insight in ventilation strategies in CDH patient. This may hopefully prevent mortality and morbidity. Trial registration Netherlands Trial Register (NTR: NTR1310

Building a population-based diabetes register: an Italian experience.

Science.gov (United States)

Ballotari, Paola; Chiatamone Ranieri, Sofia; Vicentini, Massimo; Caroli, Stefania; Gardini, Andrea; Rodolfi, Rossella; Crucco, Roberto; Greci, Marina; Manicardi, Valeria; Giorgi Rossi, Paolo

2014-01-01

To describe the methodology used to set up the Reggio Emilia (northern Italy) Diabetes Register. The prevalence estimates on December 31st, 2009 are also provided. The Diabetes Register covers all residents in the Reggio Emilia province. The register was created by deterministic linkage of six routinely collected data sources through a definite algorithm able to ascertain cases and to distinguish type of diabetes and model of care: Hospital Discharge, Drug Dispensation, Biochemistry Laboratory, Disease-specific Exemption, Diabetes Outpatient Clinics, and Mortality databases. Using these data, we estimated crude prevalence on December 31st, 2009 by sex, age groups, and type of diabetes. There were 25,425 ascertained prevalent cases on December 31st, 2009. Drug Dispensation and Exemption databases made the greatest contribution to prevalence. Analyzing overlapping sources, more than 80% of cases were reported by at least two sources. Crude prevalence was 4.8% and 5.9% for the whole population and for people aged 18 years and over, respectively. Males accounted for 53.6%. Type 1 diabetes accounted for 3.8% of cases, while people with Type 2 diabetes were the overriding majority (91.2%), and Diabetes Outpatient Clinics treated 75.4% of people with Type 2 diabetes. The Register is able to quantify the burden of disease, the first step in planning, implementing, and monitoring appropriate interventions. All data sources contributed to completeness and/or accuracy of the Register. Although all cases are identified by deterministic record linkage, manual revision and General Practitioner involvement are still necessary when information is insufficient or conflicting. Copyright © 2013 Elsevier Ireland Ltd. All rights reserved.

Evironmental Tax. Are Vehicle Registers in the EU Prepared?

Directory of Open Access Journals (Sweden)

Petr David

2017-01-01

Full Text Available The market system is unavailable to reflect negative externalities, caused by road motor traffic, in the realized prices. For that purpose, it would be appropriate to implement a general environmental road tax in the European Union member states. The question is whether the national registers of vehicles are prepared for such a change. Whether this is the case at present, may be found out by means of analyses of the available national registers. The next step is synthetic: the data must be subsequently completed on the basis of the knowledge of needs of currently existing systems of road motor vehicles taxation. In the end, the identified results may be supplemented with the known data published by international institutions. The results of the research show that the present systems of road motor vehicles taxation are utterly different and distortive. Only 12 countries of the European Union have registers which were clearly identified as prepared for the application of the environmental tax. Registers of the remaining countries do not contain one or more data that are necessary for the implementation of the environmental tax. For this reason we may assume that regardless of other determinants, environmental road tax shall not be introduced throughout the European Union in the foreseeable future.

Validation of sick leave measures: self-reported sick leave and sickness benefit data from a Danish national register compared to multiple workplace-registered sick leave spells in a Danish municipality.

Science.gov (United States)

Stapelfeldt, Christina Malmose; Jensen, Chris; Andersen, Niels Trolle; Fleten, Nils; Nielsen, Claus Vinther

2012-08-15

Previous validation studies of sick leave measures have focused on self-reports. Register-based sick leave data are considered to be valid; however methodological problems may be associated with such data. A Danish national register on sickness benefit (DREAM) has been widely used in sick leave research. On the basis of sick leave records from 3,554 and 2,311 eldercare workers in 14 different workplaces, the aim of this study was to: 1) validate registered sickness benefit data from DREAM against workplace-registered sick leave spells of at least 15 days; 2) validate self-reported sick leave days during one year against workplace-registered sick leave. Agreement between workplace-registered sick leave and DREAM-registered sickness benefit was reported as sensitivities, specificities and positive predictive values. A receiver-operating characteristic curve and a Bland-Altman plot were used to study the concordance with sick leave duration of the first spell. By means of an analysis of agreement between self-reported and workplace-registered sick leave sensitivity and specificity was calculated. Ninety-five percent confidence intervals (95% CI) were used. The probability that registered DREAM data on sickness benefit agrees with workplace-registered sick leave of at least 15 days was 96.7% (95% CI: 95.6-97.6). Specificity was close to 100% (95% CI: 98.3-100). The registered DREAM data on sickness benefit overestimated the duration of sick leave spells by an average of 1.4 (SD: 3.9) weeks. Separate analysis on pregnancy-related sick leave revealed a maximum sensitivity of 20% (95% CI: 4.3-48.1).The sensitivity of self-reporting at least one or at least 56 sick leave day/s was 94.5 (95% CI: 93.4 - 95.5) % and 58.5 (95% CI: 51.1 - 65.6) % respectively. The corresponding specificities were 85.3 (95% CI: 81.4 - 88.6) % and 98.9 (95% CI: 98.3 - 99.3) %. The DREAM register offered valid measures of sick leave spells of at least 15 days among eldercare employees. Pregnancy

Validation of sick leave measures: self-reported sick leave and sickness benefit data from a Danish national register compared to multiple workplace-registered sick leave spells in a Danish municipality

Directory of Open Access Journals (Sweden)

Stapelfeldt Christina Malmose

2012-08-01

Full Text Available Abstract Background Previous validation studies of sick leave measures have focused on self-reports. Register-based sick leave data are considered to be valid; however methodological problems may be associated with such data. A Danish national register on sickness benefit (DREAM has been widely used in sick leave research. On the basis of sick leave records from 3,554 and 2,311 eldercare workers in 14 different workplaces, the aim of this study was to: 1 validate registered sickness benefit data from DREAM against workplace-registered sick leave spells of at least 15 days; 2 validate self-reported sick leave days during one year against workplace-registered sick leave. Methods Agreement between workplace-registered sick leave and DREAM-registered sickness benefit was reported as sensitivities, specificities and positive predictive values. A receiver-operating characteristic curve and a Bland-Altman plot were used to study the concordance with sick leave duration of the first spell. By means of an analysis of agreement between self-reported and workplace-registered sick leave sensitivity and specificity was calculated. Ninety-five percent confidence intervals (95% CI were used. Results The probability that registered DREAM data on sickness benefit agrees with workplace-registered sick leave of at least 15 days was 96.7% (95% CI: 95.6-97.6. Specificity was close to 100% (95% CI: 98.3-100. The registered DREAM data on sickness benefit overestimated the duration of sick leave spells by an average of 1.4 (SD: 3.9 weeks. Separate analysis on pregnancy-related sick leave revealed a maximum sensitivity of 20% (95% CI: 4.3-48.1. The sensitivity of self-reporting at least one or at least 56 sick leave day/s was 94.5 (95% CI: 93.4 – 95.5 % and 58.5 (95% CI: 51.1 – 65.6 % respectively. The corresponding specificities were 85.3 (95% CI: 81.4 – 88.6 % and 98.9 (95% CI: 98.3 – 99.3 %. Conclusions The DREAM register offered valid measures of sick

Australian lobbyist registers are not serving the purposes they were designed for.

Science.gov (United States)

Robertson, Narelle; Kypri, Kypros; Stafford, Julia; Daube, Mike; Avery, Michelle; Miller, Peter

2017-07-11

There is widespread concern about the nature, extent and impacts of lobbying by industries selling unhealthy commodities, which threatens public health and undermines important democratic processes. In the last decade, all Australian jurisdictions (except the Northern Territory) have established lobbyist registers with the stated objective of increasing the capacity of government and the public to scrutinise lobbying. Our aim was to assess whether the registers are fulfilling this objective. We conducted web searches of registers in Australian jurisdictions in 2014 and 2015 to determine what type of information they collected and whether data were accessible. We supplemented searches with e-mails and phone calls to registrars to clarify policies and seek additional information. We found that the data were lacking in critical details and historical information was difficult or impossible to obtain. None of the registers required in-house lobbyists to register or to be bound by the Lobbying Codes of Conduct. None required that informal lobbying (e.g. by government relations staff within a company) be recorded, and none provided detailed information about the nature and extent of lobbying activities. The registers do not meet the stated objective of making lobbying activity transparent to the Australian public. Timely access to comprehensive information is essential to help promote the rational development of policy concerning tobacco, alcohol and gambling problems. There is an urgent need to reform lobbyist registers to ensure that they are comprehensive and transparent. [Robertson N, Kypri K, Stafford J, Daube M, Avery M, Miller P. Australian lobbyist registers are not serving the purposes they were designed for. Drug Alcohol Rev 2017;00:000-000]. © 2017 Australasian Professional Society on Alcohol and other Drugs.

The Policy Debate on Pseudonymous Health Registers in Norway

Science.gov (United States)

Andresen, Herbjørn

Patient health data has a valuable potential for secondary use, such as decision support on a national level, reimbursement settlements, and research on public health or on the effects of various treatment methods. Unfortunately, extensive secondary use of data has disproportionate negative impact on the patients' privacy. The Norwegian health data processing regulation prescribes four different ways of organizing health registers (anonymous, de-identified, pseudonymous or fully identified data subjects). Pseudonymity is the most innovative of these methods, and it has been available as a legitimate means to achieve extensive secondary use of accurate and detailed data since 2001. Up to now, two different national health registers have been organized this way. The evidence from these experiences should be encouraging: Pseudonymity works as intended. Yet, there is still discernible reluctance against extending the pseudonymity principle to encompass other national health registers as well.

SEU-hardened design for shift register in CMOS APS

International Nuclear Information System (INIS)

Meng Liya; Liu Zedong; Hu Dajiang; Wang Qingxiang

2012-01-01

The inverter-based quasi-static shift register in CMOS APS, which is used in ionizing radiation environment, is susceptible to single event upset (SEU), thus affecting the CMOS active pixel sensor (APS) working. The analysis of the SEU for inverter-based quasi-static shift register concludes that the most sensitive node to single event transient (SET) exists in the input of inverter, and the threshold voltage and capacitance of input node of inverter determine the capability of anti-SEU. A new method was proposed, which replaced the inverter with Schmitt trigger in shift register. Because there is a hysteresis on voltage transfer characteristic of Schmitt trigger, there is high flip threshold, thus better capability of anti-SEU can be achieved. Simulation results show that the anti-SEU capability of Schmitt trigger is 10 times more than that of inverter. (authors)

Knowledge and skills of cancer clinical trials nurses in Australia.

Science.gov (United States)

Scott, Kathleen; White, Kate; Johnson, Catherine; Roydhouse, Jessica K

2012-05-01

  This paper is a report of the development and testing of a questionnaire measuring knowledge and skills of cancer clinical trials nurse in Australia.   The role of cancer clinical trials nurse, widely acknowledged as an integral member of the clinical research team, has evolved in recent years. Elements of the clinical trials nurse role in cancer have previously been described. To evaluate specific cancer clinical trials nurse educational and training needs, the development of a valid and reliable tool is required.   In 2009, a study was conducted in three stages. Stage I: questionnaire development and pilot testing; stage II: focus group; stage III: national survey. Internal consistency reliability testing and multi-trait analysis of item convergent/divergent validity were employed. Regression analysis was used to identify predictors of clinical trials nurse knowledge and skills.   The national survey was a 48-item questionnaire, measuring six clinical trial knowledge and seven skills sub-scales. Of 61 respondents, 90% were women, with mean age 43 years, 19 years as a Registered Nurse and 5 years as a cancer clinical trials nurse. Self-reported knowledge and skills were satisfactory to good. Internal consistency reliability was high (Cronbach's alpha: knowledge = 0·98; skills = 0·90). Criteria for item convergent/divergent validity were met. Number of years as cancer clinical trials nurse was positively related to self-reported knowledge and skills.   Preliminary data suggest that the national survey is reliable and valid. Data have contributed to better understanding the knowledge and skills of cancer clinical trials nurse in Australia and development of a postgraduate course in clinical trials. © 2011 Blackwell Publishing Ltd.

Validation of the diagnosis 'prosthetic joint infection' in the Danish Hip Arthroplasty Register

DEFF Research Database (Denmark)

Gundtoft, P H; Pedersen, Alma Becic; Schønheyder, H C

2016-01-01

and followed them until first-time revision, death, emigration or until 31 December 2012. Revision for PJI, as registered in the DHR, was validated against a benchmark which included information from microbiology databases, prescription registers, clinical biochemistry registers and clinical records. We......AIMS: The purpose of this study was to validate the diagnosis of periprosthetic joint infection (PJI) in the Danish Hip Arthroplasty Register (DHR). PATIENTS AND METHODS: We identified a cohort of patients from the DHR who had undergone primary total hip arthroplasty (THA) since 1 January 2005...... the validity of the diagnosis of PJI and should enable future register-based studies. Cite this article: Bone Joint J 2016;98-B:320-5....

The Danish Education Registers

DEFF Research Database (Denmark)

Jensen, Vibeke Myrup; Rasmussen, Astrid Würtz

to adults continuing education and training stem from administrative education reports. Therefore, for cohorts born 1945-1990, 97 percent of the Danish population has a valid education identifier. For the immigrant population born in the same cohorts the coverage is 85-90 percent. Despite a higher level......Collection of systematic information on education is a long established practice in Denmark. Since 1910, the Danish Ministry of Education's annual reports collects information about individual-level test scores in e.g. compulsory schooling. Today, several registers from compulsory schooling...

Adjunctive minocycline treatment for major depressive disorder: A proof of concept trial.

Science.gov (United States)

Dean, Olivia M; Kanchanatawan, Buranee; Ashton, Melanie; Mohebbi, Mohammadreza; Ng, Chee Hong; Maes, Michael; Berk, Lesley; Sughondhabirom, Atapol; Tangwongchai, Sookjaroen; Singh, Ajeet B; McKenzie, Helen; Smith, Deidre J; Malhi, Gin S; Dowling, Nathan; Berk, Michael

2017-08-01

Conventional antidepressant treatments result in symptom remission in 30% of those treated for major depressive disorder, raising the need for effective adjunctive therapies. Inflammation has an established role in the pathophysiology of major depressive disorder, and minocycline has been shown to modify the immune-inflammatory processes and also reduce oxidative stress and promote neuronal growth. This double-blind, randomised, placebo-controlled trial examined adjunctive minocycline (200 mg/day, in addition to treatment as usual) for major depressive disorder. This double-blind, randomised, placebo-controlled trial investigated 200 mg/day adjunctive minocycline (in addition to treatment as usual) for major depressive disorder. A total of 71 adults with major depressive disorder ( Diagnostic and Statistical Manual of Mental Disorders-Fourth Edition) were randomised to this 12-week trial. Outcome measures included the Montgomery-Asberg Depression Rating Scale (primary outcome), Clinical Global Impression-Improvement and Clinical Global Impression-Severity, Hamilton Anxiety Rating Scale, Quality of Life Enjoyment and Satisfaction Questionnaire, Social and Occupational Functioning Scale and the Range of Impaired Functioning Tool. The study was registered on the Australian and New Zealand Clinical Trials Register: www.anzctr.org.au , #ACTRN12612000283875. Based on mixed-methods repeated measures analysis of variance at week 12, there was no significant difference in Montgomery-Asberg Depression Rating Scale scores between groups. However, there were significant differences, favouring the minocycline group at week 12 for Clinical Global Impression-Improvement score - effect size (95% confidence interval) = -0.62 [-1.8, -0.3], p = 0.02; Quality of Life Enjoyment and Satisfaction Questionnaire score - effect size (confidence interval) = -0.12 [0.0, 0.2], p minocycline may be a useful adjunct to improve global experience, functioning and quality of life in people with

17 CFR 404.5 - Securities counts by registered government securities brokers and dealers.

Science.gov (United States)

2010-04-01

... registered government securities brokers and dealers. 404.5 Section 404.5 Commodity and Securities Exchanges... AND PRESERVATION OF RECORDS § 404.5 Securities counts by registered government securities brokers and dealers. (a) Securities counts. Every registered government securities broker or dealer shall comply with...

A randomized controlled trial of Human Papillomavirus (HPV testing for cervical cancer screening: trial design and preliminary results (HPV FOCAL Trial

Directory of Open Access Journals (Sweden)

Smith Laurie W

2010-03-01

Full Text Available Abstract Background In the HPV FOCAL trial, we will establish the efficacy of hr-HPV DNA testing as a stand-alone screening test followed by liquid based cytology (LBC triage of hr-HPV-positive women compared to LBC followed by hr-HPV triage with ≥ CIN3 as the outcome. Methods/Design HPV-FOCAL is a randomized, controlled, three-armed study over a four year period conducted in British Columbia. It will recruit 33,000 women aged 25-65 through the province's population based cervical cancer screening program. Control arm: LBC at entry and two years, and combined LBC and hr-HPV at four years among those with initial negative results and hr-HPV triage of ASCUS cases; Two Year Safety Check arm: hr-HPV at entry and LBC at two years in those with initial negative results with LBC triage of hr-HPV positives; Four Year Intervention Arm: hr-HPV at entry and combined hr-HPV and LBC at four years among those with initial negative results with LBC triage of hr-HPV positive cases Discussion To date, 6150 participants have a completed sample and epidemiologic questionnaire. Of the 2019 women enrolled in the control arm, 1908 (94.5% were cytology negative. Women aged 25-29 had the highest rates of HSIL (1.4%. In the safety arm 92.2% of women were hr-HPV negative, with the highest rate of hr-HPV positivity found in 25-29 year old women (23.5%. Similar results were obtained in the intervention arm HPV FOCAL is the first randomized trial in North America to examine hr-HPV testing as the primary screen for cervical cancer within a population-based cervical cancer screening program. Trial Registration International Standard Randomised Controlled Trial Number Register, ISRCTN79347302

Creation of the uniform Chernobyl register of Russia and Belarus

International Nuclear Information System (INIS)

Sosnouskaya, Alena; Kotava, Aksana; Ivanov, Victor; Maksutov, Marat

2008-01-01

Creation of operation of uniform medical and dosimetric data banks for carrying out of collateral wide-scale radiation epidemiological researches and prediction of medical consequences of Chernobyl accident (ChA) in territory of Russia and Belarus. On the basis of medical and dosimetric data banks of the national registers of Russia and Belarus the uniform technology of collection personal of a state information of health of the population, injured from ChA . Three levels of observation are created. The first level - Bryansk area of Russia and Gomel area of Belarus, interests of research - radiation hazards of oncologic diseases of various localizations for the population living in these territories. The second level - Bryansk, Kaluga, Tula and Oryol area of Russia and Brest, Vitebsk, Gomel, Grodno, Minsk and Mogilyov area of Belarus, preferred direction of researches - thyroid cancer. The third level all territory of Russia and Belarus, area of research - medical consequences for health of the liquidators, their children and persons migrating from polluted territories. Personal uniform sub-registers are created and function on a stationary value to a basis. Is sub-registers containing information about diseases by a thyroid cancer, leukemia and breast cancer, uniform register of the liquidators and their children, uniform cancer-register of the liquidators and uniform cancer-register of the population living in territories with density of contamination on Cs 137 more than 185 kBq/m 2 . The personal information on 20440 cases of thyroid cancer, 5234 cases of a leukemia, 16679 cases of breast cancer, 252884 liquidators, 6882 cases of a cancer of various localizations among the liquidators, 35423 children of the liquidators, 11407 cases of oncologic diseases among the population living in territories with density of contamination on Cs 137 more than 185 kBq/m 2 is accumulated. (author)

The PREEMPT study - evaluating smartphone-assisted n-of-1 trials in patients with chronic pain: study protocol for a randomized controlled trial.

Science.gov (United States)

Barr, Colin; Marois, Maria; Sim, Ida; Schmid, Christopher H; Wilsey, Barth; Ward, Deborah; Duan, Naihua; Hays, Ron D; Selsky, Joshua; Servadio, Joseph; Schwartz, Marc; Dsouza, Clyde; Dhammi, Navjot; Holt, Zachary; Baquero, Victor; MacDonald, Scott; Jerant, Anthony; Sprinkle, Ron; Kravitz, Richard L

2015-02-27

Chronic pain is prevalent, costly, and clinically vexatious. Clinicians typically use a trial-and-error approach to treatment selection. Repeated crossover trials in a single patient (n-of-1 trials) may provide greater therapeutic precision. N-of-1 trials are the most direct way to estimate individual treatment effects and are useful in comparing the effectiveness and toxicity of different analgesic regimens. The goal of the PREEMPT study is to test the 'Trialist' mobile health smartphone app, which has been developed to make n-of-1 trials easier to accomplish, and to provide patients and clinicians with tools for individualizing treatments for chronic pain. A randomized controlled trial is being conducted to test the feasibility and effectiveness of the Trialist app. A total of 244 participants will be randomized to either the Trialist app intervention group (122 patients) or a usual care control group (122 patients). Patients assigned to the Trialist app will work with their clinicians to set up an n-of-1 trial comparing two pain regimens, selected from a menu of flexible options. The Trialist app provides treatment reminders and collects data entered daily by the patient on pain levels and treatment side effects. Upon completion of the n-of-1 trial, patients review results with their clinicians and develop a long-term treatment plan. The primary study outcome (comparing Trialist to usual care patients) is pain-related interference with daily functioning at 26 weeks. Trialist will allow patients and clinicians to conduct personalized n-of-1 trials. In prior studies, n-of-1 trials have been shown to encourage greater patient involvement with care, which has in turn been associated with better health outcomes. mHealth technology implemented using smartphones may offer an efficient means of facilitating n-of-1 trials so that more patients can benefit from this approach. ClinicalTrials.gov: NCT02116621 , first registered 15 April 2014.

Establishment and evolution of the Australian Inherited Retinal Disease Register and DNA Bank.

Science.gov (United States)

De Roach, John N; McLaren, Terri L; Paterson, Rachel L; O'Brien, Emily C; Hoffmann, Ling; Mackey, David A; Hewitt, Alex W; Lamey, Tina M

2013-07-01

Inherited retinal disease represents a significant cause of blindness and visual morbidity worldwide. With the development of emerging molecular technologies, accessible and well-governed repositories of data characterising inherited retinal disease patients is becoming increasingly important. This manuscript introduces such a repository. Participants were recruited from the Retina Australia membership, through the Royal Australian and New Zealand College of Ophthalmologists, and by recruitment of suitable patients attending the Sir Charles Gairdner Hospital visual electrophysiology clinic. Four thousand one hundred ninety-three participants were recruited. All participants were members of families in which the proband was diagnosed with an inherited retinal disease (excluding age-related macular degeneration). Clinical and family information was collected by interview with the participant and by examination of medical records. In 2001, we began collecting DNA from Western Australian participants. In 2009 this activity was extended Australia-wide. Genetic analysis results were stored in the register as they were obtained. The main outcome measurement was the number of DNA samples (with associated phenotypic information) collected from Australian inherited retinal disease-affected families. DNA was obtained from 2873 participants. Retinitis pigmentosa, Stargardt disease and Usher syndrome participants comprised 61.0%, 9.9% and 6.4% of the register, respectively. This resource is a valuable tool for investigating the aetiology of inherited retinal diseases. As new molecular technologies are translated into clinical applications, this well-governed repository of clinical and genetic information will become increasingly relevant for tasks such as identifying candidates for gene-specific clinical trials. © 2012 The Authors. Clinical and Experimental Ophthalmology © 2012 Royal Australian and New Zealand College of Ophthalmologists.

Functional treatment versus plaster for simple elbow dislocations (FuncSiE: a randomized trial

Directory of Open Access Journals (Sweden)

Verleisdonk Egbert JMM

2010-11-01

completion of this trial will provide evidence on the effectiveness of a functional treatment for the management of simple elbow dislocations. Trial Registration The trial is registered at the Netherlands Trial Register (NTR2025.

Characteristics of the Nafion (registered) - impregnated polycarbonate composite membranes for PEMFCs

International Nuclear Information System (INIS)

Kim, Ki-Hwan; Ahn, Sang-Yeoul; Oh, In-Hwan; Ha, Heung Yong; Hong, Seong-Ahn; Kim, Moon-Sun; Lee, Youngkwan; Lee, Yong-Chul

2004-01-01

In this work, polycarbonate composite membranes were prepared for proton exchange membrane fuel cells (PEMFCs). In the preparation of membranes, a small amount of poly(ethylene glycol) (PEG) was blended with polycarbonate (PC) solution and then cast to make membranes. PEG contained in the membrane was removed by the high solubility of supercritical CO 2 to afford porosity in the membrane. Then, porous PC membranes were soaked in Nafion (registered) solution to yield the PC/Nafion (registered) composite membranes. The PC composite membrane had lower ion conductivity but higher conductance than Nafion (registered)

Association of schizophrenia and autoimmune diseases: linkage of Danish national registers

DEFF Research Database (Denmark)

Eaton, William W.; Byrne, Majella; Ewald, Henrik

2006-01-01

the association of schizophrenia with these disorders as well as a range of other autoimmune diseases in a single large epidemiologic study. METHOD: The Danish Psychiatric Register, the National Patient Register, and a register with socioeconomic information were linked to form a data file that included all 7......,704 persons in Denmark diagnosed with schizophrenia from 1981 to 1998 and their parents along with a sample of matched comparison subjects and their parents. The data linkage required that the autoimmune disease occur before the diagnosis of schizophrenia. RESULTS: A history of any autoimmune disease...

Protocol for a multi-centre randomised controlled trial comparing arthroscopic hip surgery to physiotherapy-led care for femoroacetabular impingement (FAI): the Australian FASHIoN trial.

Science.gov (United States)

Murphy, Nicholas J; Eyles, Jillian; Bennell, Kim L; Bohensky, Megan; Burns, Alexander; Callaghan, Fraser M; Dickenson, Edward; Fary, Camdon; Grieve, Stuart M; Griffin, Damian R; Hall, Michelle; Hobson, Rachel; Kim, Young Jo; Linklater, James M; Lloyd, David G; Molnar, Robert; O'Connell, Rachel L; O'Donnell, John; O'Sullivan, Michael; Randhawa, Sunny; Reichenbach, Stephan; Saxby, David J; Singh, Parminder; Spiers, Libby; Tran, Phong; Wrigley, Tim V; Hunter, David J

2017-09-26

12 months. Secondary outcomes include patient-reported outcomes and several structural and biomechanical measures relevant to the pathogenesis of FAI and development of hip OA. Interventions will be compared by intention-to-treat analysis. The findings will help determine whether hip arthroscopy or an individualised physiotherapy program is superior for the management of FAI, including for the prevention of hip OA. Australia New Zealand Clinical Trials Registry reference: ACTRN12615001177549 . Trial registered 2/11/2015 (retrospectively registered).

Comparison of an interactive with a didactic educational intervention for improving the evidence-based practice knowledge of occupational therapists in the public health sector in South Africa: a randomised controlled trial

Science.gov (United States)

2014-01-01

similar outcomes at 12 weeks and that the interactive component had little additional effect. Trial registration Pan African Controlled Trials Register PACTR201201000346141, registered 31 January 2012. Clinical Trials NCT01512823, registered 1 February 2012. South African National Clinical Trial Register DOH2710093067, registered 27 October 2009. The first participants were randomly assigned on 16 July 2008. PMID:24916176

An analysis of characteristics of post-authorisation studies registered on the ENCePP EU PAS Register [version 2; referees: 2 approved

Directory of Open Access Journals (Sweden)

Robert Carroll

2017-11-01

Full Text Available Background: The objective of this study was to investigate the study design characteristics of Post-Authorisation Studies (PAS requested by the European Medicines Agency which were recorded on the European Union (EU PAS Register held by the European Network of Centres for Pharmacoepidemiology and Pharmacovigilance (ENCePP. Methods: We undertook a cross-sectional descriptive analysis of all studies registered on the EU PAS Register as of 18th October 2016. Results: We identified a total of 314 studies on the EU PAS Register, including 81 (26% finalised, 160 (51% ongoing and 73 (23% planned. Of those studies identified, 205 (65% included risk assessment in their scope, 133 (42% included drug utilisation and 94 (30% included effectiveness evaluation. Just over half of the studies (175; 56% used primary data capture, 135 (43% used secondary data and 4 (1% used a hybrid design combining both approaches. Risk assessment and effectiveness studies were more likely to use primary data capture (60% and 85% respectively as compared to 39% and 14% respectively for secondary. The converse was true for drug utilisation studies where 59% were secondary vs. 39% for primary. For type 2 diabetes mellitus, database studies were more commonly used (80% vs 3% chart review, 3% hybrid and 13% primary data capture study designs whereas for studies in oncology, primary data capture were more likely to be used (85% vs 4% chart review, and 11% database study designs. Conclusions: Results of this analysis show that PAS design varies according to study objectives and therapeutic area.

COgnitive behavioural therapy versus standardised medical care for adults with Dissociative non-Epileptic Seizures (CODES): statistical and economic analysis plan for a randomised controlled trial.

Science.gov (United States)

Robinson, Emily J; Goldstein, Laura H; McCrone, Paul; Perdue, Iain; Chalder, Trudie; Mellers, John D C; Richardson, Mark P; Murray, Joanna; Reuber, Markus; Medford, Nick; Stone, Jon; Carson, Alan; Landau, Sabine

2017-06-06

Dissociative seizures (DSs), also called psychogenic non-epileptic seizures, are a distressing and disabling problem for many patients in neurological settings with high and often unnecessary economic costs. The COgnitive behavioural therapy versus standardised medical care for adults with Dissociative non-Epileptic Seizures (CODES) trial is an evaluation of a specifically tailored psychological intervention with the aims of reducing seizure frequency and severity and improving psychological well-being in adults with DS. The aim of this paper is to report in detail the quantitative and economic analysis plan for the CODES trial, as agreed by the trial steering committee. The CODES trial is a multicentre, pragmatic, parallel group, randomised controlled trial performed to evaluate the clinical effectiveness and cost-effectiveness of 13 sessions of cognitive behavioural therapy (CBT) plus standardised medical care (SMC) compared with SMC alone for adult outpatients with DS. The objectives and design of the trial are summarised, and the aims and procedures of the planned analyses are illustrated. The proposed analysis plan addresses statistical considerations such as maintaining blinding, monitoring adherence with the protocol, describing aspects of treatment and dealing with missing data. The formal analysis approach for the primary and secondary outcomes is described, as are the descriptive statistics that will be reported. This paper provides transparency to the planned inferential analyses for the CODES trial prior to the extraction of outcome data. It also provides an update to the previously published trial protocol and guidance to those conducting similar trials. ISRCTN registry ISRCTN05681227 (registered on 5 March 2014); ClinicalTrials.gov NCT02325544 (registered on 15 December 2014).

Decision aids for people considering taking part in clinical trials.

Science.gov (United States)

Gillies, Katie; Cotton, Seonaidh C; Brehaut, Jamie C; Politi, Mary C; Skea, Zoe

2015-11-27

Several interventions have been developed to promote informed consent for participants in clinical trials. However, many of these interventions focus on the content and structure of information (e.g. enhanced information or changes to the presentation format) rather than the process of decision making. Patient decision aids support a decision making process about medical options. Decision aids support the decision process by providing information about available options and their associated outcomes, alongside information that enables patients to consider what value they place on particular outcomes, and provide structured guidance on steps of decision making. They have been shown to be effective for treatment and screening decisions but evidence on their effectiveness in the context of informed consent for clinical trials has not been synthesised. To assess the effectiveness of decision aids for clinical trial informed consent compared to no intervention, standard information (i.e. usual practice) or an alternative intervention on the decision making process. We searched the following databases and to March 2015: Cochrane Central Register of Controlled Trials (CENTRAL), The Cochrane Library; MEDLINE (OvidSP) (from 1950); EMBASE (OvidSP) (from 1980); PsycINFO (OvidSP) (from 1806); ASSIA (ProQuest) (from 1987); WHO International Clinical Trials Registry Platform (ICTRP) (http://apps.who.int/trialsearch/); ClinicalTrials.gov; ISRCTN Register (http://www.controlled-trials.com/isrctn/). We also searched reference lists of included studies and relevant reviews. We contacted study authors and other experts. There were no language restrictions. We included randomised and quasi-randomised controlled trials comparing decision aids in the informed consent process for clinical trials alone, or in conjunction with standard information (such as written or verbal) or alongside alternative interventions (e.g. paper-based versus web-based decision aids). Included trials involved

Registered partnerships

CERN Multimedia

Staff Association

2015-01-01

In recent decades, family patterns have changed significantly. National laws have taken these changes into account, recognizing new forms of unions, different to heterosexual marriage. Indeed, recently some countries have given the possibility to same-sex couples to enter into various forms of unions. Staff regulations of international organizations are not directly affected by national laws, but in the context of diversity policies, the lack of recognition of these new forms of unions, may appear to discriminate based on sexual orientation and to limit the freedom of choosing marital status. A study by the International Service for Remunerations and Pensions (iSRP) of the OECD in January 2015 (PROS Report (1015) 04) shows that in comparison with other international organizations, CERN offers the least favorable social conditions for its Staff with in a registered partnership. As part of the Five-year review in 2015, it is important that CERN aligns itself with the practice of these other organizations...

The Danish Education Registers

DEFF Research Database (Denmark)

Jensen, Vibeke Myrup; Würtz Rasmussen, Astrid

to adults continuing education and training stem from administrative education reports. Therefore, for cohorts born 1945-1990, 97 percent of the Danish population has a valid education identifier. For the immigrant population born in the same cohorts the coverage is 85-90 percent. Despite a higher level......Collection of systematic information on education is a long established practice in Denmark. Since 1910, the Danish Ministry of Education’s annual reports collects information about individual-level test scores in e.g. compulsory schooling. Today, several registers from compulsory schooling...

The Danish Education Registers

DEFF Research Database (Denmark)

Jensen, Vibeke Myrup; Rasmussen, Astrid Würtz

2011-01-01

Collection of systematic information on education is a long established practice in Denmark. Since 1910, the Danish Ministry of Education’s annual reports collects information about individual-level test scores in e.g. compulsory schooling. Today, several registers from compulsory schooling...... to adults continuing education and training stem from administrative education reports. Therefore, for cohorts born 1945-1990, 97 percent of the Danish population has a valid education identifier. For the immigrant population born in the same cohorts the coverage is 85-90 percent. Despite a higher level...

Constor registered full-scale prototype drop test and measuring program

International Nuclear Information System (INIS)

Koenig, S.; Diersch, R.; Quercetti, T.

2004-01-01

The CONSTOR registered steel-sandwich cask was developed as a cost-effective design by using conventional mechanical engineering technologies and commonly available materials. The CONSTOR registered consists of a cask body with an outer and an inner liner made of steel. At the upper end, the liners are welded to a ring made of forged steel. The space between the two liners is filled with heavy concrete named CONSTORIT for additional gamma and neutron shielding. The CONSTORIT consists of an iron aggregate frame and hardened cement paste. The liners of the cask and the forged head ring form the basis for the structural integrity, the CONSTORIT bears only a menial part of accident loads. The CONSTOR registered concept fulfils both the internationally valid IAEA criteria for transportation and the requirements for long-term intermediate storage in the US and various European countries. Since the beginning of the development of the CONSTOR registered design in the early nineties, two drop test series with half-scale models have already been performed. A full-scale model of a CONSTOR registered V for BWR inventory has been manufactured for the third drop test program starting in 2004, and will be presented in a first 9-meter drop test on the BAM drop test facility at Horstwalde near Berlin during the PATRAM 2004 Symposium. The transport package consists of a cask with a dummy basket, a puncture-resistant jacket and two impact limiters

High-Speed Imaging Analysis of Register Transitions in Classically and Jazz-Trained Male Voices.

Science.gov (United States)

Dippold, Sebastian; Voigt, Daniel; Richter, Bernhard; Echternach, Matthias

2015-01-01

Little data are available concerning register functions in different styles of singing such as classically or jazz-trained voices. Differences between registers seem to be much more audible in jazz singing than classical singing, and so we hypothesized that classically trained singers exhibit a smoother register transition, stemming from more regular vocal fold oscillation patterns. High-speed digital imaging (HSDI) was used for 19 male singers (10 jazz-trained singers, 9 classically trained) who performed a glissando from modal to falsetto register across the register transition. Vocal fold oscillation patterns were analyzed in terms of different parameters of regularity such as relative average perturbation (RAP), correlation dimension (D2) and shimmer. HSDI observations showed more regular vocal fold oscillation patterns during the register transition for the classically trained singers. Additionally, the RAP and D2 values were generally lower and more consistent for the classically trained singers compared to the jazz singers. However, intergroup comparisons showed no statistically significant differences. Some of our results may support the hypothesis that classically trained singers exhibit a smoother register transition from modal to falsetto register. © 2015 S. Karger AG, Basel.

Cholinesterase inhibitors in mild cognitive impairment: a systematic review of randomised trials.

Directory of Open Access Journals (Sweden)

Roberto Raschetti

2007-11-01

Full Text Available Mild cognitive impairment (MCI refers to a transitional zone between normal ageing and dementia. Despite the uncertainty regarding the definition of MCI as a clinical entity, clinical trials have been conducted in the attempt to study the role of cholinesterase inhibitors (ChEIs currently approved for symptomatic treatment of mild to moderate Alzheimer disease (AD, in preventing progression from MCI to AD. The objective of this review is to assess the effects of ChEIs (donepezil, rivastigmine, and galantamine in delaying the conversion from MCI to Alzheimer disease or dementia.The terms "donepezil", "rivastigmine", "galantamine", and "mild cognitive impairment" and their variants, synonyms, and acronyms were used as search terms in four electronic databases (MEDLINE, EMBASE, Cochrane, PsycINFO and three registers: the Cochrane Collaboration Trial Register, Current Controlled Trials, and ClinicalTrials.gov. Published and unpublished studies were included if they were randomized clinical trials published (or described in English and conducted among persons who had received a diagnosis of MCI and/or abnormal memory function documented by a neuropsychological assessment. A standardized data extraction form was used. The reporting quality was assessed using the Jadad scale. Three published and five unpublished trials met the inclusion criteria (three on donepezil, two on rivastigmine, and three on galantamine. Enrolment criteria differed among the trials, so the study populations were not homogeneous. The duration of the trials ranged from 24 wk to 3 y. No significant differences emerged in the probability of conversion from MCI to AD or dementia between the treated groups and the placebo groups. The rate of conversion ranged from 13% (over 2 y to 25% (over 3 y among treated patients, and from 18% (over 2 y to 28% (over 3 y among those in the placebo groups. Only for two studies was it possible to derive point estimates of the relative risk of

A Comparative Content Analysis of Vegetarian Food Blogs Written by Registered Dietitians and Non-Registered Dietitians.

Science.gov (United States)

Dumas, Audrée-Anne; Lemieux, Simone; Lapointe, Annie; Dugrenier, Marilyn; Desroches, Sophie

2017-06-01

This purpose of this study was to compare the nutritional content of vegetarian recipes published in food blogs written by registered dietitians (RDs) and by non-registered dietitians (non-RDs). Twelve food blogs written by RDs and 12 written by non-RDs were selected using a systematic approach. For each food blog, 2 vegetarian entrée recipes per season were selected (n = 192 recipes). Descriptive analyses were performed using Fisher's exact test. Median nutritional values per serving between RDs' and non-RDs' recipes were compared using Wilcoxon-Mann-Whitney tests. RDs' recipes were significantly lower in energy, non-heme iron, vitamin C, and sodium, contained significantly more vitamin D and had a higher protein proportion than non-RDs' recipes. Disparities were also observed across type of entrée and vegetarian dietary pattern. In conclusion, this study showed that RD and non-RD food bloggers provided vegetarian recipes with few nutritional differences. Whether expanding the comparative analysis between RDs and non-RDs' blogs targeting different nutrition-related topics would yield different results remains to be investigated.

The Danish nationwide clinical register for patients with rheumatoid arthritis: DANBIO

Directory of Open Access Journals (Sweden)

Ibfelt EH

2016-10-01

Full Text Available Else Helene Ibfelt,1 Dorte Vendelbo Jensen,2,3 Merete Lund Hetland2,4 1Registry Support Centre (East, Epidemiology and Biostatistics, Research Centre for Prevention and Health, Rigshospitalet, Glostrup University Hospital, 2DANBIO Registry and Copenhagen Center for Arthritis Research, Center for Rheumatology and Spine Diseases, Centre of Head and Orthopedics, Rigshospitalet, Glostrup, 3Department of Rheumatology, Herlev and Gentofte University Hospital, Hellerup, 4Department of Clinical Medicine, Faculty of Health and Medical Sciences, University of Copenhagen, Copenhagen, Denmark Introduction: DANBIO is a research register and a data source for rheumatologic diseases (rheumatoid arthritis [RA], axial spondyloarthritis, and psoriatic arthritis for monitoring clinical quality at the national, regional, and hospital levels. Study population: The register includes patients with rheumatologic diseases who are treated at a hospital or a private rheumatologic clinic. Registration is mandatory for all patients with RA regardless of treatment and also for patients with other diagnoses if treated with biological disease-modifying antirheumatic drugs. Since 2006, the registration has been done electronically, including patient-reported outcome measures registered electronically by the patients with the use of touch screens. Main variables: Core variables such as diagnosis, year of diagnosis, age, and sex are registered at the beginning. Data entered at later visits included the following: patient-reported outcomes for disease activity, pain, fatigue, functional status, and physician-reported objective measures of disease activity, treatment, C-reactive protein, and, when indicated, imaging. For subgroups of patients, the variables such as quality of life, sociodemographic factors, lifestyle, and comorbidity are also registered. Descriptive data: The DANBIO cohort comprised ~26,000 patients with RA, 3,200 patients with axial spondyloarthritis, and 6

Outcome measures for clinical trials in paediatric IBD: an evidence-based, expert-driven practical statement paper of the paediatric ECCO committee

NARCIS (Netherlands)

Ruemmele, Frank M.; Hyams, Jeffrey S.; Otley, Anthony; Griffiths, Anne; Kolho, Kaija-Leena; Dias, Jorge Amil; Levine, Arie; Escher, Johanna C.; Taminiau, Jan; Veres, Gabor; Colombel, Jean-Frederic; Vermeire, Séverine; Wilson, David C.; Turner, Dan

2015-01-01

Objective Although paediatric-onset IBD is becoming more common, few medications have a registered paediatric indication. There are multiple hurdles to performing clinical trials in children, emphasising the importance of choosing an appropriate outcome measure, which can facilitate enrolment, and

Influence of experimental esophageal acidification on sleep bruxism: a randomized trial.

Science.gov (United States)

Ohmure, H; Oikawa, K; Kanematsu, K; Saito, Y; Yamamoto, T; Nagahama, H; Tsubouchi, H; Miyawaki, S

2011-05-01

The aim of this cross-over, randomized, single-blinded trial was to examine whether intra-esophageal acidification induces sleep bruxism (SB). Polysomnography with electromyogram (EMG) of masseter muscle, audio-video recording, and esophageal pH monitoring were performed in a sleep laboratory. Twelve healthy adult males without SB participated. Intra-esophageal infusions of 5-mL acidic solution (0.1 N HCl) or saline were administered. The frequencies of EMG bursts, rhythmic masticatory muscle activity (RMMA) episodes, grinding noise, and the RMMA/microarousal ratio were significantly higher in the 20-minute period after acidic infusion than after saline infusion. RMMA episodes including SB were induced by esophageal acidification. This trial is registered with the UMIN Clinical Trials Registry, UMIN000002923. ASDA, American Sleep Disorders Association; EMG, electromyogram; GER, gastroesophageal reflux; LES, lower esophageal sphincter; NREM, non-rapid eye movement; REM, rapid eye movement; RMMA, rhythmic masticatory muscle activity; SB, sleep bruxism; SD, standard deviation; UES, upper esophageal sphincter.

The Danish Multiple Sclerosis Treatment Register

Directory of Open Access Journals (Sweden)

Magyari M

2016-10-01

Full Text Available Melinda Magyari,1,3 Nils Koch-Henriksen,1,2 Per Soelberg Sørensen3 1Danish Multiple Sclerosis Registry, Department of Neurology, Rigshospitalet, Copenhagen, 2Department of Clinical Epidemiology, Clinical Institute, University of Aarhus, Aarhus, 3Danish Multiple Sclerosis Center, Department of Neurology, Rigshospitalet, University of Copenhagen, Copenhagen, Denmark Aim of the database: The Danish Multiple Sclerosis Treatment Register (DMSTR serves as a clinical quality register, enabling the health authorities to monitor the quality of the disease-modifying treatment, and it is an important data source for epidemiological research. Study population: The DMSTR includes all patients with multiple sclerosis who had been treated with disease-modifying drugs since 1996. At present, more than 8,400 patients have been registered in this database. Data are continuously entered online into a central database from all sites in Denmark at start and at regular visits. Main variables: Include age, sex, onset year and year of the diagnosis, basic clinical information, and information about treatment, side effects, and relapses. Descriptive data: Notification is done at treatment start, and thereafter at every scheduled clinical visit 3 months after treatment start, and thereafter every 6 months. The longitudinally collected information about the disease activity and side effects made it possible to investigate the clinical efficacy and adverse events of different disease-modifying therapies. Conclusion: The database contributed to a certain harmonization of treatment procedures in Denmark and will continue to be a major factor in terms of quality in clinical praxis, research and monitoring of adverse events, and plays an important role in research. Keywords: multiple sclerosis, epidemiology, immunomodulatory treatment, neutralizing antibodies, observational studies, registry research, disease modifying therapy

The Fundamental Spatial Data in the Public Administration Registers

Science.gov (United States)

Čada, V.; Janečka, K.

2016-06-01

The system of basic registers was launched in the Czech Republic in 2012. The system provides a unique solution to centralize and keep actual most common and widely used information as a part of the eGovernment. The basic registers are the central information source for information systems of public authorities. In October 2014, the Czech government approved the conception of The Strategy for the Development of the Infrastructure for Spatial Information in the Czech Republic to 2020 (GeoInfoStrategy) that serves as a basis for the NSDI. The paper describes the challenges in building the National Spatial Data Infrastructure (NSDI) in the Czech Republic with focus on the fundamental spatial data and related basic registers. The GeoInfoStrategy should also contribute to increasing of the competitiveness of the economy. Therefore the paper also reflects the Directive 2014/61/EU of the European Parliament and of the Council on measures to reduce the cost of deploying high-speed electronic communication networks. The Directive states that citizens as well as the private and public sectors must have the opportunity to be part of the digital economy. A high quality digital infrastructure underpins virtually all sectors of a modern and innovative economy. To ensure a development of such infrastructure in the Czech Republic, the Register of passive infrastructure providing information on the features of passive infrastructure has to be established.

The efficacy of the Kampo medicine rikkunshito for chemotherapy-induced anorexia (RICH trial): study protocol for a randomized controlled trial.

Science.gov (United States)

Inoue, Takuya; Takagi, Hironori; Owada, Yuki; Watanabe, Yuzuru; Yamaura, Takumi; Fukuhara, Mitsuro; Muto, Satoshi; Okabe, Naoyuki; Matsumura, Yuki; Hasegawa, Takeo; Osugi, Jun; Hoshino, Mika; Higuchi, Mitsunori; Shio, Yutaka; Yokouchi, Hiroshi; Kanazawa, Kenya; Ohbuchi, Katsuya; Fukushima, Takahisa; Munakata, Mitsuru; Suzuki, Hiroyuki

2017-10-18

Cisplatin is a key drug in lung cancer therapy. However, cisplatin is also well known to induce gastrointestinal disorders, such as chemotherapy-induced nausea and vomiting, anorexia, and weight loss. These symptoms sometimes affect patients' quality of life and make continuation of chemotherapy difficult. Anorexia is a cause of concern for patients with cancer because a persistent loss of appetite progresses to cancer cachexia. Although evidence-based management for chemotherapy has recently been established, there is room for improvement. This placebo-controlled, double-blind, randomized trial will aim to determine the efficacy of the traditional Japanese Kampo medicine rikkunshito (TJ-43) for preventing anorexia caused by cisplatin-including chemotherapy in patients with lung cancer. Patients with lung cancer who plan to receive cisplatin-including chemotherapy will be recruited. Patients who provide written consent will be randomly allocated to receive either TJ-43 (arm A) or placebo (arm B) for one course of chemotherapy (21 or 28 consecutive days). Investigators and patients will be masked to the treatment assignment throughout the trial. The primary endpoint will be evaluated as the change in dietary intake from day 0 (the day before the start of chemotherapy) to day 7 of cisplatin-including chemotherapy. The two arms of the trial will comprise 30 patients each. From November 2014, a total of 60 patients will be recruited, and recruitment for the study is planned to be complete by October 2017. This trial is designed to examine the efficacy of rikkunshito (TJ-43) for reducing anorexia and maintaining food intake caused by cisplatin-including chemotherapy in patients with lung cancer. Japan Pharmaceutical Information Center Clinical Trials Information (JAPIC CTI), trial registration: JAPIC CTI-142747 . Registered on 15 December 2014; the RICH trial.

Multi-port versus single-port cholecystectomy: results of a multi-centre, randomised controlled trial (MUSIC trial).

Science.gov (United States)

Arezzo, Alberto; Passera, Roberto; Bullano, Alberto; Mintz, Yoav; Kedar, Asaf; Boni, Luigi; Cassinotti, Elisa; Rosati, Riccardo; Fumagalli Romario, Uberto; Sorrentino, Mario; Brizzolari, Marco; Di Lorenzo, Nicola; Gaspari, Achille Lucio; Andreone, Dario; De Stefani, Elena; Navarra, Giuseppe; Lazzara, Salvatore; Degiuli, Maurizio; Shishin, Kirill; Khatkov, Igor; Kazakov, Ivan; Schrittwieser, Rudolf; Carus, Thomas; Corradi, Alessio; Sitzman, Guenther; Lacy, Antonio; Uranues, Selman; Szold, Amir; Morino, Mario

2017-07-01

Single-port laparoscopic surgery as an alternative to conventional laparoscopic cholecystectomy for benign disease has not yet been accepted as a standard procedure. The aim of the multi-port versus single-port cholecystectomy trial was to compare morbidity rates after single-access (SPC) and standard laparoscopy (MPC). This non-inferiority phase 3 trial was conducted at 20 hospital surgical departments in six countries. At each centre, patients were randomly assigned to undergo either SPC or MPC. The primary outcome was overall morbidity within 60 days after surgery. Analysis was by intention to treat. The study was registered with ClinicalTrials.gov (NCT01104727). The study was conducted between April 2011 and May 2015. A total of 600 patients were randomly assigned to receive either SPC (n = 297) or MPC (n = 303) and were eligible for data analysis. Postsurgical complications within 60 days were recorded in 13 patients (4.7 %) in the SPC group and in 16 (6.1 %) in the MPC group (P = 0.468); however, single-access procedures took longer [70 min (range 25-265) vs. 55 min (range 22-185); P risk of incisional hernia following SPC do not appear to be justified. Patient satisfaction with aesthetic results was greater after SPC than after MPC.

Spiritual care perspectives of Danish Registered Nurses

DEFF Research Database (Denmark)

Christensen, Kirsten Haugaard; Turner, de Sales

2008-01-01

Spiritual care perspectives of Danish Nurses The purpose of this study was to explore how Danish registered nurses understand the phenomenon of spiritual care and how their understanding impacts on their interventions with their patients. Nurses are responsible for the provision of care which...... approach rooted in the philosophy of Gadamer was chosen as methodology. In-depth interviews were used as data collection tool, and six registered nurses who worked within hospital settings in Denmark were interviewed. The findings revealed that deep knowing of the patients were essential before nurses...... would engage in provision of spiritual care. The participants acknowledged that their understanding of spirituality influenced their provision of spiritual care, which was recognized as a challenge requiring the nurse’s initiative and courage. Spirituality was primarily understood as a patient’s private...

36 CFR 60.1 - Authorization and expansion of the National Register.

Science.gov (United States)

2010-07-01

..., DEPARTMENT OF THE INTERIOR NATIONAL REGISTER OF HISTORIC PLACES § 60.1 Authorization and expansion of the...., as amended, authorizes the Secretary of the Interior to expand and maintain a National Register of districts, sites, buildings, structures, and objects significant in American history, architecture...

Co-registered photoacoustic, thermoacoustic, and ultrasound mouse imaging

Science.gov (United States)

Reinecke, Daniel R.; Kruger, Robert A.; Lam, Richard B.; DelRio, Stephen P.

2010-02-01

We have constructed and tested a prototype test bed that allows us to form 3D photoacoustic CT images using near-infrared (NIR) irradiation (700 - 900 nm), 3D thermoacoustic CT images using microwave irradiation (434 MHz), and 3D ultrasound images from a commercial ultrasound scanner. The device utilizes a vertically oriented, curved array to capture the photoacoustic and thermoacoustic data. In addition, an 8-MHz linear array fixed in a horizontal position provides the ultrasound data. The photoacoustic and thermoacoustic data sets are co-registered exactly because they use the same detector. The ultrasound data set requires only simple corrections to co-register its images. The photoacoustic, thermoacoustic, and ultrasound images of mouse anatomy reveal complementary anatomic information as they exploit different contrast mechanisms. The thermoacoustic images differentiate between muscle, fat and bone. The photoacoustic images reveal the hemoglobin distribution, which is localized predominantly in the vascular space. The ultrasound images provide detailed information about the bony structures. Superposition of all three images onto a co-registered hybrid image shows the potential of a trimodal photoacoustic-thermoacoustic-ultrasound small-animal imaging system.

17 CFR 270.30b1-1 - Semi-annual report for registered management investment companies.

Science.gov (United States)

2010-04-01

... registered management investment companies. 270.30b1-1 Section 270.30b1-1 Commodity and Securities Exchanges....30b1-1 Semi-annual report for registered management investment companies. Every registered management... management investment company that has filed a registration statement with the Commission registering its...

Antidepressants for depressive disorder in children and adolescents: a database of randomised controlled trials.

Science.gov (United States)

Zhang, Yuqing; Zhou, Xinyu; Pu, Juncai; Zhang, Hanping; Yang, Lining; Liu, Lanxiang; Zhou, Chanjuan; Yuan, Shuai; Jiang, Xiaofeng; Xie, Peng

2018-05-31

In recent years, whether, when and how to use antidepressants to treat depressive disorder in children and adolescents has been hotly debated. Relevant evidence on this topic has increased rapidly. In this paper, we present the construction and content of a database of randomised controlled trials of antidepressants to treat depressive disorder in children and adolescents. This database can be freely accessed via our website and will be regularly updated. Major bibliographic databases (PubMed, the Cochrane Library, Web of Science, Embase, CINAHL, PsycINFO and LiLACS), international trial registers and regulatory agencies' websites were systematically searched for published and unpublished studies up to April 30, 2017. We included randomised controlled trials in which the efficacy or tolerability of any oral antidepressant was compared with that of a control group or any other treatment. In total, 7377 citations from bibliographical databases and 3289 from international trial registers and regulatory agencies' websites were identified. Of these, 53 trials were eligible for inclusion in the final database. Selected data were extracted from each study, including characteristics of the participants (the study population, setting, diagnostic criteria, type of depression, age, sex, and comorbidity), characteristics of the treatment conditions (the treatment conditions, general information, and detail of pharmacotherapy and psychotherapy) and study characteristics (the sponsor, country, number of sites, blinding method, sample size, treatment duration, depression scales, other scales, and primary outcome measure used, and side-effect monitoring method). Moreover, the risk of bias for each trial were assessed. This database provides information on nearly all randomised controlled trials of antidepressants in children and adolescents. By using this database, researchers can improve research efficiency, avoid inadvertent errors and easily focus on the targeted subgroups in

Synovial sarcoma in children and adolescents: the European Pediatric Soft Tissue Sarcoma Study Group prospective trial (EpSSG NRSTS 2005)

NARCIS (Netherlands)

Ferrari, A.; de Salvo, G. L.; Brennan, B.; van Noesel, M. M.; de Paoli, A.; Casanova, M.; Francotte, N.; Kelsey, A.; Alaggio, R.; Oberlin, O.; Carli, M.; Ben-Arush, M.; Bergeron, C.; Merks, J. H. M.; Jenney, M.; Stevens, M. C.; Bisogno, G.; Orbach, D.

2015-01-01

To report the results of the first European prospective nonrandomized trial dedicated to pediatric synovial sarcoma. From August 2005 to August 2012, 138 patients <21 years old with nonmetastatic synovial sarcoma were registered in 9 different countries (and 60 centers). Patients were treated with a

Diagnostic conversion to bipolar disorder in unipolar depressed patients participating in trials on antidepressants.

Science.gov (United States)

Holmskov, J; Licht, R W; Andersen, K; Bjerregaard Stage, T; Mørkeberg Nilsson, F; Bjerregaard Stage, K; Valentin, J B; Bech, P; Ernst Nielsen, R

2017-02-01

In unipolar depressed patients participating in trials on antidepressants, we investigated if illness characteristics at baseline could predict conversion to bipolar disorder. A long-term register-based follow-up study of 290 unipolar depressed patients with a mean age of 50.8 years (SD=11.9) participating in three randomized trials on antidepressants conducted in the period 1985-1994. The independent effects of explanatory variables were examined by applying Cox regression analyses. The overall risk of conversion was 20.7%, with a mean follow-up time of 15.2 years per patient. The risk of conversion was associated with an increasing number of previous depressive episodes at baseline, [HR 1.18, 95% CI (1.10-1.26)]. No association with gender, age, age at first depressive episode, duration of baseline episode, subtype of depression or any of the investigated HAM-D subscales included was found. The patients were followed-up through the Danish Psychiatric Central Research Register, which resulted in inherent limitations such as possible misclassification of outcome. In a sample of middle-aged hospitalized unipolar depressed patients participating in trials on antidepressants, the risk of conversion was associated with the number of previous depressive episodes. Therefore, this study emphasizes that unipolar depressed patients experiencing a relatively high number of recurrences should be followed more closely, or at least be informed about the possible increased risk of conversion. Copyright © 2016. Published by Elsevier Masson SAS.

The value of registered nurses in ambulatory care settings: a survey.

Science.gov (United States)

Mastal, Margaret; Levine, June

2012-01-01

Ambulatory care settings employ 25% of the three million registered nurses in the United States. The American Academy of Ambulatory Care Nursing (AAACN) is committed to improving the quality of health care in ambulatory settings, enhancing patient outcomes, and realizing greater health care efficiencies. A survey of ambulatory care registered nurses indicates they are well positioned to lead and facilitate health care reform activities with organizational colleagues. They are well schooled in critical thinking, triage, advocating for patients, educating patients and families, collaborating with medical staff and other professionals, and care coordination. The evolving medical home concept and other health care delivery models reinforces the critical need for registered nurses to provide chronic disease management, care coordination, health risk appraisal, care transitions, health promotion, and disease prevention services. Recommendations are offered for organizational leaders, registered nurses, and AAACN to utilize nursing knowledge and skills in the pursuit of leading change and advancing health.

Evaluating the use and limitations of the Danish National Patient Register in register-based research using an example of multiple sclerosis.

Science.gov (United States)

Mason, K; Thygesen, L C; Stenager, E; Brønnum-Hansen, H; Koch-Henriksen, N

2012-03-01

The Danish National Patient Register, Landspatientregistret (LPR), is a register of all hospital discharges and outpatient treatments in Denmark. It is increasingly used in research so it is important to understand to what extent this can be used as an accurate source of information. Virtually all patients in Denmark with multiple sclerosis (MS) are reported to the Combined MS Registry (DMSR), so this was used as the standard which the LPR was compared against. All residents of Denmark are assigned a unique Civil Register (CPR) number; this was used to compare data between registers. The LPR completeness was estimated by the proportion of cases from the DMSR that could be retrieved from the LPR. The LPR validity was estimated by the proportion of cases, listed in the LPR and DMSR, in whom the MS diagnosis could be confirmed as definite/probable/possible by the DMSR. We found that 86.9% of those who were DMSR listed with an approved MS diagnosis were also listed in the LPR with a MS diagnosis. The diagnosis was valid in 96.3% of patients listed in the LPR when compared against the DMSR. The low completeness reduces the usefulness of the LPR in epidemiological MS research, in particular incidence studies. The study also found that the completeness of the LPR could be increased to 92.8% by including LPR records from other departments in addition, but this reduced the validity of the LPR to 95.1%. However, these results cannot uncritically be applied to registration of other diseases in the LPR. © 2011 John Wiley & Sons A/S.

Customer Perception of a Supermarket Nutrition Centre Staffed by a Registered Dietitian.

Science.gov (United States)

Evans, KATE; Taper, JANETTE; Quintal, DEBORAH

2000-01-01

The purpose of this study was to examine consumers' attitudes toward a supermarket nutrition centre staffed full time by a registered dietitian. A questionnaire was administered over three consecutive days in that store and in a control store that was similar to the experimental site in every way, except for the absence of a nutrition centre. Participants were chosen randomly at timed intervals in specific areas of the store. Of 428 customers approached, 232 agreed to participate in the survey. At the experimental site, 75% of the participants were extremely satisfied with the registered dietitian's services and 69% ranked having a registered dietitian on staff in any store as extremely important, compared to 31% at the control site (p importance of 13 required and optional services offered by the supermarkets, 15% of participants at the experimental site ranked having a registered dietitian on staff in the top five, compared with 4% at the control site (p service. There may therefore be an expanded role for registered dietitians in the supermarket setting.

A randomized physiotherapy trial in patients with fecal incontinence: design of the PhysioFIT-study

Science.gov (United States)

Bols, Esther MJ; Berghmans, Bary CM; Hendriks, Erik JM; de Bie, Rob A; Melenhorst, Jarno; van Gemert, Wim G; Baeten, Cor GMI

2007-01-01

Background Fecal incontinence (FI) is defined as the recurrent involuntary excretion of feces in inappropriate places or at inappropriate times. It is a major and highly embarrassing health care problem which affects about 2 to 24% of the adult population. The prevalence increases with age in both men and women. Physiotherapy interventions are often considered a first-line approach due to its safe and non-invasive nature when dietary and pharmaceutical treatment fails or in addition to this treatment regime. Two physiotherapy interventions, rectal balloon training (RBT) and pelvic floor muscle training (PFMT) are widely used in the management of FI. However, their effectiveness remains uncertain since well-designed trials on the effectiveness of RBT and PFMT versus PFMT alone in FI have never been published. Methods/Design A two-armed randomized controlled clinical trial will be conducted. One hundred and six patients are randomized to receive either PFMT combined with RBT or PFMT alone. Physicians in the University Hospital Maastricht include eligible participants. Inclusion criteria are (1) adults (aged ≥ 18 years), (2) with fecal incontinence complaints due to different etiologies persisting for at least six months, (3) having a Vaizey incontinence score of at least 12, (4) and failure of conservative treatment (including dietary adaptations and pharmacological agents). Baseline measurements consist of the Vaizey incontinence score, medical history, physical examination, medication use, anorectal manometry, rectal capacity measurement, anorectal sensation, anal endosonography, defecography, symptom diary, Fecal Incontinence Quality of Life scale (FIQL) and the PREFAB-score. Follow-up measurements are scheduled at three, six and 12 months after inclusion. Skilled and registered physiotherapists experienced in women's health perform physiotherapy treatment. Twelve sessions are administered during three months according to a standardized protocol. Discussion This

A randomized physiotherapy trial in patients with fecal incontinence: design of the PhysioFIT-study

Directory of Open Access Journals (Sweden)

de Bie Rob A

2007-12-01

Full Text Available Abstract Background Fecal incontinence (FI is defined as the recurrent involuntary excretion of feces in inappropriate places or at inappropriate times. It is a major and highly embarrassing health care problem which affects about 2 to 24% of the adult population. The prevalence increases with age in both men and women. Physiotherapy interventions are often considered a first-line approach due to its safe and non-invasive nature when dietary and pharmaceutical treatment fails or in addition to this treatment regime. Two physiotherapy interventions, rectal balloon training (RBT and pelvic floor muscle training (PFMT are widely used in the management of FI. However, their effectiveness remains uncertain since well-designed trials on the effectiveness of RBT and PFMT versus PFMT alone in FI have never been published. Methods/Design A two-armed randomized controlled clinical trial will be conducted. One hundred and six patients are randomized to receive either PFMT combined with RBT or PFMT alone. Physicians in the University Hospital Maastricht include eligible participants. Inclusion criteria are (1 adults (aged ≥ 18 years, (2 with fecal incontinence complaints due to different etiologies persisting for at least six months, (3 having a Vaizey incontinence score of at least 12, (4 and failure of conservative treatment (including dietary adaptations and pharmacological agents. Baseline measurements consist of the Vaizey incontinence score, medical history, physical examination, medication use, anorectal manometry, rectal capacity measurement, anorectal sensation, anal endosonography, defecography, symptom diary, Fecal Incontinence Quality of Life scale (FIQL and the PREFAB-score. Follow-up measurements are scheduled at three, six and 12 months after inclusion. Skilled and registered physiotherapists experienced in women's health perform physiotherapy treatment. Twelve sessions are administered during three months according to a standardized

Job satisfaction of South African registered dietitians

African Journals Online (AJOL)

2012-01-25

Jan 25, 2012 ... career growth,5,6,9 lack of respect from healthcare professionals,39 competition from ... a reminder was posted in the ADSA monthly newsletter, six weeks ..... research and conduct open interviews with registered dietitians or.

Reporting bias in completed epilepsy intervention trials: A cross-sectional analysis.

Science.gov (United States)

Rayi, Appaji; Thompson, Stephanie; Gloss, David; Malhotra, Konark

2018-03-30

To explore the evidence of reporting bias among completed epilepsy intervention trials (EITs) and compliance of applicable EITs to Food and Drug Administration Amendments Act (FDAAA). We included consecutive EITs registered as completed on ClinicalTrials.gov from 2008 to 2015. Descriptive data was collected including study type, study phase, funding source, primary completion date, and result reporting date. Time to result reporting was analyzed using Kaplan-Meier estimates for two time periods (2008-2011 and 2012-2015). PubMed, Web of Science, and Google scholar databases were manually searched for publication details. Overall, 95/126 EITs (75%) reported, while remaining 31/126 (25%) did not report their results. Time to reporting was significantly lower for trials completed during 2012-2015 (16.5 months; 95% CI: 13.60-19.40; p = .002; Cohen's d = 0.68) as compared to the trials completed during 2008-2011 (25.9 months; 95% CI: 21.56-30.22). 72/126 trials were conducted in at least one U.S. center. 56/72 (78%) of the trials met the FDAAA criteria, while only 19/56 (34%) reported within the mandated one-year time frame. The lack of reporting of nearly one-quarter of completed epilepsy intervention trials suggests existence of reporting bias. As such, it should be considered an important criterion for determining risk of bias in epilepsy systematic reviews. Copyright © 2018 Elsevier B.V. All rights reserved.

National register of research projects

Energy Technology Data Exchange (ETDEWEB)

1985-03-01

This Register is intended to serve as a source of information on research which is being conducted in all fields (both natural and human sciences) in the Republic of South Africa. New research projects commenced during 1983 or 1984, and significantly changed research projects, as well as project that were completed or terminated during this period, on which information was received by the compilers before December 1984, are included, with the exception of confidential projects.

A consumer register: an acceptable and cost-effective alternative for accessing patient populations

Directory of Open Access Journals (Sweden)

Jamie Bryant

2016-10-01

Full Text Available Abstract Background Population-based registries are increasingly used to recruit patient samples for research, however, they have several limitations including low consent and participation rates, and potential selection bias. To improve access to samples for research, the utility of a new model of recruitment termed the ‘Consumer Register’, that allows for direct patient recruitment from hospitals, was examined. This paper reports: (i consent rates onto the register; (ii preferred methods and frequency of contact; and (iii the feasibility of establishing the register, including: (a cost per person recruited to the register; (b the differential cost and consent rates of volunteer versus paid data collectors; and (c participant completion rates. Methods A cross-sectional survey was conducted in five outpatient clinics in Australia. Patients were approached by volunteers or paid data collectors and asked to complete a touch-screen electronic survey. Consenting individuals were asked to indicate their willingness and preferences for enrolment onto a research register. Descriptive statistics were used to examine patient preferences and linear regression used to model the success of volunteer versus paid data collectors. The opportunity and financial costs of establishing the register were calculated. Results A total of 1947 patients (80.6 % consented to complete the survey, of which, 1486 (76.3 % completed the questionnaire. Of the completers, the majority (69.4 %, or 1032 participants were willing to be listed on the register and preferred to be contacted by email (50.3 %. Almost 39 % of completers were willing to be contacted three or more times in a 12 month period. The annual opportunity cost of resources consumed by the register was valued at $37,187, giving an opportunity cost per person recruited to the register of $36. After amortising fixed costs, the annual financial outlay was $23,004 or $22 per person recruited to the

Danish nationwide registers for public health and health-related research

DEFF Research Database (Denmark)

Erlangsen, Annette; Fedyszyn, Izabela

2015-01-01

AIMS: The Nordic countries have a strong tradition of using nationwide social and health registers for research purposes. The aim of the current paper is to provide an overview of the Danish population-based registers in public health and health-related research, and to discuss their strengths...... and limitations. METHODS: Danish registers on somatic and psychiatric hospital contacts as well as care provided by general practitioners were reviewed. The availability of demographic, individual-level variables of relevance for health-related research was summarized. RESULTS: Since 1968, every person living...... of prescribed medications, and a complete follow-up with respect to causes of death support public health studies surveying trends of prevalence and incidence. Historical data on psychiatric and somatic hospitalizations since 1969 and 1977, respectively, allow an in-depth assessment of the burden of disease...

Probiotics and the Microbiome in Celiac Disease: A Randomised Controlled Trial

Directory of Open Access Journals (Sweden)

Joanna Harnett

2016-01-01

Full Text Available Background. There is limited research investigating the composition of the gastrointestinal microbiota in individuals with celiac disease (CoeD reporting only partial symptom improvement despite adherence to a strict gluten-free diet (GFD. The aim of this research was to determine if the gastrointestinal microbiota could be altered by probiotic bacteria and provide a potential new therapy for this subgroup. Methods. A multicentre RCT was conducted between January and August 2011 in Australia. Participants included 45 people with CoeD reporting only partial symptom improvement despite adherence to a strict GFD for a minimum of 12 months. Participants took 5 g of VSL#™ probiotic formulation (n=23 or 5 g placebo (n=22 orally twice daily for 12 weeks. The main outcome measured was the efficacy of the probiotic formula in altering faecal microbiota counts between baseline and week 12. Safety was determined by safety blood and monitoring adverse events. Results. SPSS™ multivariate repeated measures analysis (95th confidence level revealed no statistically significant changes between the groups in the faecal microbiota counts or blood safety measures over the course of the study. Conclusion. The probiotic formula when taken orally over the 12-week period did not significantly alter the microbiota measured in this population. The trial was registered with Australian and New Zealand Clinical Trials Register ACTRN12610000630011.

EPA-Registered Repellents for Mosquitoes Transmitting Emerging Viral Disease.

Science.gov (United States)

Patel, Radha V; Shaeer, Kristy M; Patel, Pooja; Garmaza, Aleksey; Wiangkham, Kornwalee; Franks, Rachel B; Pane, Olivia; Carris, Nicholas W

2016-12-01

In many parts of the United States, mosquitoes were previously nuisance pests. However, they now represent a potential threat in the spread of viral diseases. The Aedes aegypti, Aedes albopictus, and Culex species mosquitoes are endemic to the United States and together may transmit a variety of viral diseases of growing concern, including West Nile virus, chikungunya, dengue fever, and Zika virus. The Centers for Disease Control and Prevention and the Environmental Protection Agency (EPA) recommend N,N-diethyl-meta-toluamide (DEET) as a first-line mosquito repellent, but for patients refusing to use DEET or other conventional repellents, guidance is limited to any EPA-registered product. Therefore, we conducted a systematic review of the literature to identify which EPA-registered personal mosquito repellent provides the best protection from A. aegypti, A. albopictus, and Culex spp. mosquitoes. We abstracted data from 62 published reports of EPA-registered mosquito repellents. The conventional repellent picaridin has the strongest data to support its use as a second-line agent, while IR3535 and oil of lemon eucalyptus are reasonably effective natural products. Citronella, catnip, and 2-undecanone offer limited protection or have limited data. These results can be used by pharmacists and other health care professionals to advise patients on the selection of an EPA-registered mosquito repellent. Regardless of the repellent chosen, it is vital for patients to follow all instructions/precautions in the product labeling to ensure safe and effective use. © 2016 Pharmacotherapy Publications, Inc.

a Discussion about Effective Ways of Basic Resident Register on GIS

Science.gov (United States)

Oku, Naoya; Nonaka, Yasuaki; Ito, Yutaka

2016-06-01

In Japan, each municipality keeps a database of every resident's name, address, gender and date of birth called the Basic Resident Register. If the address information in the register is converted into coordinates by geocoding, it can be plotted as point data on a map. This would enable prompt evacuation from disaster, analysis of distribution of residents, integrating statistics and so on. Further, it can be used for not only analysis of the current situation but also future planning. However, the geographic information system (GIS) incorporating the Basic Resident Register is not widely used in Japan because of the following problems: - Geocoding In order to plot address point data, it is necessary to match the Basic Resident Register and the address dictionary by using the address as a key. The information in the Basic Resident Register does not always match the actual addresses. As the register is based on applications made by residents, the information is prone to errors, such as incorrect Kanji characters. - Security policy on personal information In the register, the address of a resident is linked with his/her name and date of birth. If the information in the Basic Resident Register were to be leaked, it could be used for malicious purposes. This paper proposes solutions to the above problems. The suitable solutions for the problems depend on the purpose of use, thus it is important that the purpose should be defined and a suitable way of the application for each purpose should be chosen. In this paper, we mainly focus on the specific purpose of use: to analyse the distribution of the residents. We provide two solutions to improve the matching rate in geocoding. First, regarding errors in Kanji characters, a correction list of possible errors should be compiled in advance. Second, some sort of analyses such as distribution of residents may not require exactly correct position for the address point. Therefore we set the matching level in order: prefecture

Registered criminality and sanctioning of schizophrenia patients

DEFF Research Database (Denmark)

Munkner, Runa; Haastrup, Soeren; Joergensen, Torben

2009-01-01

BACKGROUND: Patients with schizophrenia have been shown to have an increased risk of criminality, especially violent crimes. AIMS: The aim of the current study was to describe the pattern of crimes committed by Danish patients with schizophrenia and examine the sanctions given for crimes...... in relation to the different periods in the patients' lives: not yet known to the psychiatric hospital system, known to the system but not yet diagnosed with schizophrenia, and after being diagnosed with schizophrenia. METHODS: Information from the Danish Psychiatric Central Research Register was correlated...... with data from the Danish National Crime Register. RESULTS: One of the more prominent findings was that 16% of patients diagnosed with schizophrenia receive a prison sentence or a suspended prison sentence, despite the fact that Denmark is a co-signatory of the European Prison Rules and should treat, rather...

The effect of vitamin B12 supplementation in Nepalese infants on growth and development: study protocol for a randomized controlled trial.

Science.gov (United States)

Strand, Tor A; Ulak, Manjeswori; Chandyo, Ram K; Kvestad, Ingrid; Hysing, Mari; Shrestha, Merina; Basnet, Sudha; Ranjitkar, Suman; Shrestha, Laxman; Shrestha, Prakash S

2017-04-21

Vitamin B 12 deficiency is one of the most common micronutrient deficiencies and is associated with poor cognitive development and growth. Vitamin B 12 is crucial for normal cell division and differentiation, and it is necessary for the development and myelination of the central nervous system. The aim of the present study is to measure the effect of daily supplementation of vitamin B 12 on the neurodevelopment and growth of young children in Nepal. We are conducting an individually randomized, double-blind, placebo-controlled trial with 600 marginally stunted children 6-11 months old (length for age less than -1 z-score). Children are randomized to receive a lipid-based paste containing vitamin B 12 or placebo daily for 12 months. The main outcomes are changes in growth (z-scores) and in neurodevelopment measured by the Bayley Scales of Infant and Toddler Development, Third Edition, from baseline until the end of the study. If vitamin B 12 supplementation benefits early child development and growth, this will have consequences for dietary recommendations for malnourished children worldwide. ClinicalTrials.gov Identifier: NCT02272842 . Registered on 21 October 2014. Universal Trial Number: U1111-1161-5187. Registered on 8 September 2014.

Registered nurse buddies: Educators by proxy?

Science.gov (United States)

Rebeiro, Geraldine; Evans, Alicia; Edward, Karen-Leigh; Chapman, Rose

2017-08-01

The informal clinical teaching role of the buddy nurse seems to be a uniquely Australian title, with little consistency in terminology for informal nurse educator roles internationally. Not all registered nurses are professionally developed for the informal role of facilitating the clinical learning of students in clinical settings, yet these roles are expected by nursing professional bodies. In Australia the registered nurses (RN) experience of being a buddy nurse has been reported as lacking clarity, being unsupported and structureless. Whist there is a plethora of literature published about formal RN educator roles, little is available on the informal buddy nurse role. A view of the buddy nurse role in reference to the limited but available literature in the Australian context is offered in this paper. International perspectives are also gathered describing informal clinical education RN's roles with similar responsibilities to the Australian buddy nurse. The significance of this dialogue is to ignite debate about the role, potentially informing policy for the improved support of the role within the Australian nursing landscape. Copyright © 2017 Elsevier Ltd. All rights reserved.

17 CFR 405.3 - Notification provisions for certain registered government securities brokers and dealers.

Science.gov (United States)

2010-04-01

... certain registered government securities brokers and dealers. 405.3 Section 405.3 Commodity and Securities... REPORTS AND AUDIT § 405.3 Notification provisions for certain registered government securities brokers and dealers. (a) Every registered government securities broker or dealer, other than a government securities...

Time-to-event methodology improved statistical evaluation in register-based health services research.

Science.gov (United States)

Bluhmki, Tobias; Bramlage, Peter; Volk, Michael; Kaltheuner, Matthias; Danne, Thomas; Rathmann, Wolfgang; Beyersmann, Jan

2017-02-01

Complex longitudinal sampling and the observational structure of patient registers in health services research are associated with methodological challenges regarding data management and statistical evaluation. We exemplify common pitfalls and want to stimulate discussions on the design, development, and deployment of future longitudinal patient registers and register-based studies. For illustrative purposes, we use data from the prospective, observational, German DIabetes Versorgungs-Evaluation register. One aim was to explore predictors for the initiation of a basal insulin supported therapy in patients with type 2 diabetes initially prescribed to glucose-lowering drugs alone. Major challenges are missing mortality information, time-dependent outcomes, delayed study entries, different follow-up times, and competing events. We show that time-to-event methodology is a valuable tool for improved statistical evaluation of register data and should be preferred to simple case-control approaches. Patient registers provide rich data sources for health services research. Analyses are accompanied with the trade-off between data availability, clinical plausibility, and statistical feasibility. Cox' proportional hazards model allows for the evaluation of the outcome-specific hazards, but prediction of outcome probabilities is compromised by missing mortality information. Copyright © 2016 Elsevier Inc. All rights reserved.

Swespine: the Swedish spine register : the 2012 report.

Science.gov (United States)

Strömqvist, Björn; Fritzell, Peter; Hägg, Olle; Jönsson, Bo; Sandén, Bengt

2013-04-01

Swespine, the Swedish National Spine Register, has existed for 20 years and is in general use within the country since over 10 years regarding degenerative lumbar spine disorders. Today there are protocols for registering all disorders of the entire spinal column. Patient-based pre- and postoperative questionnaires, completed before surgery and at 1, 2, 5 and 10 years postoperatively. Among patient-based data are VAS pain, ODI, SF-36 and EQ-5D. Postoperatively evaluation of leg and back pain as compared to preoperatively ("global assessment"), overall satisfaction with outcome and working conditions are registered in addition to the same parameters as preoperatively evaluation. A yearly report is produced including an analytic part of a certain topic, in this issue disc prosthesis surgery. More than 75,000 surgically treated patients are registered to date with an increasing number yearly. The present report includes 7,285 patients; 1-, 2- and 5-year follow-up data of previously operated patients are also included for lumbar disorders as well as for disc prosthesis surgery. For the degenerative lumbar spine disorders (disc herniation, spinal stenosis, spondylolisthesis and DDD) significant improvements are seen in all aspects as exemplified by pronounced improvement regarding EQ-5D and ODI. Results seem to be stable over time. Spinal stenosis is the most common indication for spine surgery. Disc prosthesis surgery yields results on a par with fusion surgery in disc degenerative pain. The utility of spine surgery is well documented by the results. Results of spine surgery as documented on a national basis can be utilized for quality assurance and quality improvement as well as for research purposes, documenting changes over time and bench marking when introducing new surgical techniques. A basis for international comparisons is also laid.

HDL cholesterol and residual risk of first cardiovascular events after treatment with potent statin therapy: an analysis from the JUPITER trial

DEFF Research Database (Denmark)

Ridker, P.M.; Genest, J.; Boekholdt, S.M.

2010-01-01

Background HDL-cholesterol concentrations are inversely associated with occurrence of cardiovascular events. We addressed, using the JUPITER trial cohort, whether this association remains when LDL-cholesterol concentrations are reduced to the very low ranges with high-dose statin treatment. Methods...... Participants in the randomised placebo-controlled JUPITER trial were adults without diabetes or previous cardiovascular disease, and had baseline concentrations of LDL cholesterol of less than 3.37 mmol/L and high-sensitivity C-reactive protein of 2 mg/L or more. Participants were randomly allocated...... these quartiles and the JUPITER primary endpoint of first non-fatal myocardial infarction or stroke, hospitalisation for unstable angina, arterial revascularisation, or cardiovascular death. This trial is registered with ClinicalTrials.gov, number NCT00239681. Findings For 17802 patients in the JUPITER trial...

State-Transition-Aware Spilling Heuristic for MLC STT-RAM-Based Registers

Directory of Open Access Journals (Sweden)

Yuanhui Ni

2017-01-01

Full Text Available Multilevel Cell Spin-Transfer Torque Random Access Memory (MLC STT-RAM is a promising nonvolatile memory technology to build registers for its natural immunity to electromagnetic radiation in rad-hard space environment. Unlike traditional SRAM-based registers, MLC STT-RAM exhibits unbalanced write state transitions due to the fact that the magnetization directions of hard and soft domains cannot be flipped independently. This feature leads to nonuniform costs of write states in terms of latency and energy. However, current SRAM-targeting register allocations do not have a clear understanding of the impact of the different write state-transition costs. As a result, those approaches heuristically select variables to be spilled without considering the spilling priority imposed by MLC STT-RAM. Aiming to address this limitation, this paper proposes a state-transition-aware spilling cost minimization (SSCM policy, to save power when MLC STT-RAM is employed in register design. Specifically, the spilling cost model is first constructed according to the linear combination of different state-transition frequencies. Directed by the proposed cost model, the compiler picks up spilling candidates to achieve lower power and higher performance. Experimental results show that the proposed SSCM technique can save energy by 19.4% and improve the lifetime by 23.2% of MLC STT-RAM-based register design.

20 CFR 655.1116 - Element VI-What notification must facilities provide to registered nurses?

Science.gov (United States)

2010-04-01

... provide to registered nurses? 655.1116 Section 655.1116 Employees' Benefits EMPLOYMENT AND TRAINING... Requirements Must a Facility Meet to Employ H-1C Nonimmigrant Workers as Registered Nurses? § 655.1116 Element VI—What notification must facilities provide to registered nurses? (a) The sixth attestation element...

Registered manufacturers of renewable energy devices

International Nuclear Information System (INIS)

Anon.

1992-01-01

Registered manufacturers of renewable energy devices in India are listed. The list is arranged under the headings : solar water heating system, solar cooker, solar still and water pumping wind mill. In all 38 manufacturers are listed. The list gives the postal address, name of the contact person and phone number of each manufacturer. (M.G.B.)

Mobile applications of photovoltaic planar antennas - SOLPLANT {sup registered}; Mobile Anwendungen von Solaren Planarantennen - SOLPLANT {sup registered}

Energy Technology Data Exchange (ETDEWEB)

Bendel, C.; Kirchhof, J. [Institut fuer Solare Energieversorgungstechnik (ISET), Kassel (Germany); Henze, N. [Kassel Univ. (Gesamthochschule) (Germany). Fachgebiet Hochfrequenztechnik

2005-07-01

This paper describes the application of photovoltaic (PV) Solar Planar Antennas in mobile applications. The radiating patch element of a planar antenna is replaced by a solar cell. Furthermore radiating slots can be built due to the cell spacing in a solar cell array. The original feature of a solar cell (DC current generation) remains, but additionally the solar cell is now able to receive and transmit electromagnetic waves. Both single solar cells as well as solar cell arrays can be used as antennas. This new approach, the ''Solar Planar Antenna - SOLPLANT {sup registered} '', avoids disadvantages of conventional applications, when solar cells and antennas are used in combination. Based on these considerations, a product development concept was originated at whose basic idea has been registered as a patent in Germany, Europe, Japan and USA. Four applications are presented: a solar cell GPS antenna for vehicular applications, a solar cell slot antenna for mobile communications (GSM), an environmental metering station with GSM function and a Worldspace Satellite Radio, equipped with a SOLPLANT {sup registered} antenna. The aim of the first two products is to integrate these antennas into vehicular glass roofs which are covered with photovoltaic solar cells in order to deliver the electric power for the indoor ventilation of the car. The GPS antenna provides circular polarisation and a main lobe in zenith direction whereas the GSM antenna is vertically polarized and has a monopole-like radiation pattern. Both antennas are built up with commonly used solar cells. The comparison of measured and simulated antenna properties shows a good agreement. At last, some applications on high altitude platforms for wireless communication services and remote sensing are depicted. (ORIG.)

Initiating change locally in bullying and aggression through the school environment (INCLUSIVE) trial: update to cluster randomised controlled trial protocol.

Science.gov (United States)

Bonell, Chris; Mathiot, Anne; Allen, Elizabeth; Bevilacqua, Leonardo; Christie, Deborah; Elbourne, Diana; Fletcher, Adam; Grieve, Richard; Legood, Rosa; Scott, Stephen; Warren, Emily; Wiggins, Meg; Viner, Russell M

2017-05-25

randomised stratified for single-sex versus mixed-sex schools, school-level deprivation and measures of school attainment. The trial involves independent research and intervention teams and is supervised by a Trial Steering Committee and a Data Monitoring Committee. Current Controlled Trials, ISRCTN10751359 . Registered on 11 March 2014.

Protocol for a scoping review of post-trial extensions of randomised controlled trials using individually linked administrative and registry data.

Science.gov (United States)

Fitzpatrick, Tiffany; Perrier, Laure; Tricco, Andrea C; Straus, Sharon E; Jüni, Peter; Zwarenstein, Merrick; Lix, Lisa M; Smith, Mark; Rosella, Laura C; Henry, David A

2017-02-17

Well-conducted randomised controlled trials (RCTs) provide the least biased estimates of intervention effects. However, RCTs are costly and time-consuming to perform and long-term follow-up of participants may be hampered by lost contacts and financial constraints. Advances in computing and population-based registries have created new possibilities for increasing the value of RCTs by post-trial extension using linkage to routinely collected administrative/registry data in order to determine long-term interventional effects. There have been recent important examples, including 20+ years follow-up studies of trials of pravastatin and mammography. Despite the potential value of post-trial extension, there has been no systematic study of this literature. This scoping review aims to characterise published post-trial extension studies, assess their value, and identify any potential challenges associated with this approach. This review will use the recommended methods for scoping reviews. We will search MEDLINE, EMBASE and the Cochrane Central Register of Controlled Trials. A draft search strategy is included in this protocol. Review of titles and abstracts, full texts of potentially eligible studies and data/information extraction will be conducted independently by pairs of investigators. Eligible studies will be RCTs that investigated healthcare interventions that were extended by individual linkage to administrative/registry/electronic medical records data after the completion of the planned follow-up period. Information concerning the original trial, characteristics of the extension study, any clinical, policy or ethical implications and methodological or practical challenges will be collected using standardised forms. As this study uses secondary data, and does not include person-level data, ethics approval is not required. We aim to disseminate these findings through journals and conferences targeting triallists and researchers involved in health data linkage. We

EVOLUTION {sup registered} BLUE. Designed for the needs of tomorrow; EVOLUTION {sup registered} BLUE. Entwickelt fuer die Anforderungen von morgen

Energy Technology Data Exchange (ETDEWEB)

Blessing, Carsten [ThyssenKrupp Aufzugswerke GmbH, Neuhausen (Germany). Product Service; Dangerfield, Nicola [ThyssenKrupp Aufzuege GmbH, Stuttgart (Germany). Sales Support/Marketing Communication

2013-11-01

The future needs innovation. The new elevator design concept EVOLUTION {sup registered} BLUE sets new standards for flexibility, shaft efficiency, energy saving and design. It uses materials of the highest quality. (orig.)

The reliability of perinatal and neonatal mortality rates: Differential under-reporting in linked professional registers vs. Dutch civil registers

NARCIS (Netherlands)

Anthony, S.; Pal-de Bruin, K.M. van der; Graafmans, W.C.; Dorrepaal, C.A.; Borkent-Polet, M.; Hemel, O.J.S. van; Jansen, F.H.M.; Lya Ouden, A. den

2001-01-01

Official Dutch perinatal mortality rates are based on birth and death certificates. These civil registration data are not detailed enough for international comparisons or extensive epidemiological research. In this study, we linked and extrapolated three national incomplete, professional registers

17 CFR 270.17f-2 - Custody of investments by registered management investment company.

Science.gov (United States)

2010-04-01

... registered management investment company. 270.17f-2 Section 270.17f-2 Commodity and Securities Exchanges....17f-2 Custody of investments by registered management investment company. (a) The securities and similar investments of a registered management investment company may be maintained in the custody of such...

Career Motivation in Newly Licensed Registered Nurses: What Makes Them Remain

Science.gov (United States)

Banks, Zarata Mann; Bailey, Jessica H.

2010-01-01

Despite vast research on newly licensed registered nurses (RNs), we don't know why some newly licensed registered nurses remain in their current jobs and others leave the nursing profession early in their career. Job satisfaction, the most significant factor emerging from the literature, plays a significant role in nurses' decisions to remain in…

The effects of an Internet based self-help course for reducing panic symptoms - Don't Panic Online: study protocol for a randomised controlled trial

Directory of Open Access Journals (Sweden)

Kramer Jeannet

2011-03-01

Full Text Available Abstract Background Internet based self-help for panic disorder (PD has proven to be effective. However, studies so far have focussed on treating a full-blown disorder. Panic symptoms that do not meet DSM-IV criteria are more prevalent than the full-blown disorder and patients with sub-clinical panic symptoms are at risk of developing PD. This study is a randomised controlled trial aimed to evaluate an Internet based self-help intervention for sub-clinical and mild PD compared to a waiting list control group. Methods Participants with mild or sub-clinical PD (N = 128 will be recruited in the general population. Severity of panic and anxiety symptoms are the primary outcome measures. Secondary outcomes include depressive symptoms, quality of life, loss of production and health care consumption. Assessments will take place on the Internet at baseline and three months after baseline. Discussion Results will indicate the effectiveness of Internet based self-help for sub-clinical and mild PD. Strengths of this design are the external validity and the fact that it is almost completely conducted online. Trial registration Netherlands Trial Register (NTR: NTR1639 The Netherlands Trial Register is part of the Dutch Cochrane Centre.

Duct-to-mucosa versus dunking techniques of pancreaticojejunostomy after pancreaticoduodenectomy: Do we need more trials? A systematic review and meta-analysis with trial sequential analysis.

Science.gov (United States)

Kilambi, Ragini; Singh, Anand Narayan

2018-03-25

Pancreaticojejunostomy (PJ is the most widely used reconstruction technique after pancreaticoduodenectomy. Despite several randomized trials, the ideal technique of pancreaticojejunostomy remains debatable. We planned a meta-analysis of randomized trials comparing the two most common techniques of PJ (duct-to-mucosa and dunking) to identify the best available evidence in the current literature. We searched the Pubmed/Medline, Web of science, Science citation index, Google scholar and Cochrane Central Register of Controlled Trials electronic databases till October 2017 for all English language randomized trials comparing the two approaches. Statistical analysis was performed using Review Manager (RevMan), Version 5.3. Copenhagen: The Nordic Cochrane Center, The Cochrane Collaboration, 2014 and results were expressed as odds ratio for dichotomous and mean difference for continuous variables. P-value ≤ 0.05 was considered significant. Trial sequential analysis was performed using TSA version 0.9.5.5 (Copenhagen: The Copenhagen Trial Unit, Center for Clinical Intervention Research, 2016). A total of 8 trials were included, with a total of 1043 patients (DTM: 518; Dunking: 525). There was no significant difference between the two groups in terms of overall as well as clinically relevant POPF rate. Similarly, both groups were comparable for the secondary outcomes. Trial sequential analysis revealed that the required information size had been crossed without achieving a clinically significant difference for overall POPF; and though the required information size had not been achieved for CR-POPF, the current data has already crossed the futility line for CR-POPF with a 10% risk difference, 80% power and 5% α error. This meta-analysis found no significant difference between the two techniques in terms of overall and CR-POPF rates. Further, the existing evidence is sufficient to conclude lack of difference and further trials are unlikely to result in any change in the

Efficient Ada multitasking on a RISC register window architecture

Science.gov (United States)

Kearns, J. P.; Quammen, D.

1987-01-01

This work addresses the problem of reducing context switch overhead on a processor which supports a large register file - a register file much like that which is part of the Berkeley RISC processors and several other emerging architectures (which are not necessarily reduced instruction set machines in the purest sense). Such a reduction in overhead is particularly desirable in a real-time embedded application, in which task-to-task context switch overhead may result in failure to meet crucial deadlines. A storage management technique by which a context switch may be implemented as cheaply as a procedure call is presented. The essence of this technique is the avoidance of the save/restore of registers on the context switch. This is achieved through analysis of the static source text of an Ada tasking program. Information gained during that analysis directs the optimized storage management strategy for that program at run time. A formal verification of the technique in terms of an operational control model and an evaluation of the technique's performance via simulations driven by synthetic Ada program traces are presented.

Registered nurses' attention to and perceptions of pressure ulcer prevention in hospital settings.

Science.gov (United States)

Sving, Eva; Gunningberg, Lena; Högman, Marieann; Mamhidir, Anna-Greta

2012-05-01

To describe how registered nurses perform, document and reflect on pressure ulcer prevention in a specific nurse-patient care situation, as well as generally, on hospital wards. Registered nurses should provide safe and qualified pressure ulcer prevention, but pressure ulcers remain a problem. Compliance with evidence-based guidelines impedes pressure ulcer formation. A descriptive design with a multimethods approach. Nine registered nurses at three wards and hospitals participated. The registered nurses were observed in a specific nurse-patient care situation with patients at risk for pressure ulcers. Interviews followed and patients' records were reviewed. Quantitative and qualitative data analysis methods were used. Pressure ulcer prevention performed by the registered nurses was dependent on the cultural care, which ranged from planned to unplanned prevention. Diversity was found in compliance with evidence-based guidelines across the wards. Although all patients involved were at risk and the nurses described pressure ulcer prevention as basic care, the nurses' attention to prevention was lacking. Few prevention activities and no structured risk assessments using risk assessment tools were observed, and few care plans were identified. The lack of attention was explained by registered nurses' trust in assistant nurses' knowledge, and prevention was seen as an assistant nurse task. Registered nurses paid little attention to pressure ulcer prevention among patients at risk. The planned and unplanned care structures affected the prevention. The nurses trusted and largely delegated their responsibility to the assistant nurses. Evidence-based pressure ulcer prevention is fundamental to patient safety. Care quality is created in situations where patients and care providers meet. How registered nurses work with pressure ulcer prevention, their role and communication, particularly with assistant nurses, should be of major concern to them as well as to healthcare

Enhancing resilience in registered aged care nurses.

Science.gov (United States)

Cameron, Fiona; Brownie, Sonya

2010-06-01

To identify the factors that impact the resilience of registered aged care nurses, that is their capacity to adapt to the physical, mental and emotional demands of working in aged care facilities. This study explored the lived experience of nine registered nurses working in residential aged care facilities on the Sunshine Coast, Queensland, who were asked to reflect on the phenomenon of resilience in the workplace. This study found that clinical expertise, a sense of purpose in a holistic care environment, a positive attitude and work-life balance are important determinants of resilience in aged care nurses. Resilience in nurses in residential aged care facilities is enhanced when they are able to maintain long-term, meaningful relationships with residents. Collegial support that provides opportunities to debrief and validate experiences as well as the use of humour to defuse stress promotes well-being and builds resilience in the workplace.

Mobile phones, cordless phones and rates of brain tumors in different age groups in the Swedish National Inpatient Register and the Swedish Cancer Register during 1998-2015.

Directory of Open Access Journals (Sweden)

Lennart Hardell

Full Text Available We used the Swedish Inpatient Register (IPR to analyze rates of brain tumors of unknown type (D43 during 1998-2015. Average Annual Percentage Change (AAPC per 100,000 increased with +2.06%, 95% confidence interval (CI +1.27, +2.86% in both genders combined. A joinpoint was found in 2007 with Annual Percentage Change (APC 1998-2007 of +0.16%, 95% CI -0.94, +1.28%, and 2007-2015 of +4.24%, 95% CI +2.87, +5.63%. Highest AAPC was found in the age group 20-39 years. In the Swedish Cancer Register the age-standardized incidence rate per 100,000 increased for brain tumors, ICD-code 193.0, during 1998-2015 with AAPC in men +0.49%, 95% CI +0.05, +0.94%, and in women +0.33%, 95% CI -0.29, +0.45%. The cases with brain tumor of unknown type lack morphological examination. Brain tumor diagnosis was based on cytology/histopathology in 83% for men and in 87% for women in 1980. This frequency increased to 90% in men and 88% in women in 2015. During the same time period CT and MRI imaging techniques were introduced and morphology is not always necessary for diagnosis. If all brain tumors based on clinical diagnosis with CT or MRI had been reported to the Cancer Register the frequency of diagnoses based on cytology/histology would have decreased in the register. The results indicate underreporting of brain tumor cases to the Cancer Register. The real incidence would be higher. Thus, incidence trends based on the Cancer Register should be used with caution. Use of wireless phones should be considered in relation to the change of incidence rates.

Pressure ulcers: effectiveness of risk-assessment tools. A randomised controlled trial (the ULCER trial).

Science.gov (United States)

Webster, Joan; Coleman, Kerrie; Mudge, Alison; Marquart, Louise; Gardner, Glenn; Stankiewicz, Monica; Kirby, Julie; Vellacott, Catherine; Horton-Breshears, Margaret; McClymont, Alice

2011-04-01

To evaluate the effectiveness of two pressure-ulcer screening tools against clinical judgement in preventing pressure ulcers. A single blind randomised controlled trial. A large metropolitan tertiary hospital. 1231 patients admitted to internal medicine or oncology wards. Patients were excluded if their hospital stay was expected to be 2 days or less. Participants allocated to either a Waterlow (n=410) or Ramstadius (n=411) screening tool group or to a clinical judgement group (n=410) where no formal risk screening instrument was used. Incidence of hospital acquired pressure ulcers ascertained by regular direct observation. Use of any devices for the prevention of pressure ulcers, documentation of a pressure plan and any dietetic or specialist skin integrity review were recorded. On admission, 71 (5.8%) patients had an existing pressure ulcer. The incidence of hospital-acquired pressure ulcers was similar between groups (clinical judgement 28/410 (6.8%); Waterlow 31/411 (7.5%); Ramstadius 22/410 (5.4%), p=0.44). Significant associations with pressure injury in regression modelling included requiring a dietetic referral, being admitted from a location other than home and age over 65 years. The authors found no evidence to show that two common pressure-ulcer risk-assessment tools are superior to clinical judgement to prevent pressure injury. Resources associated with use of these tools might be better spent on careful daily skin inspection and improving management targetted at specific risks. The trial was registered with the Australian and New Zealand Clinicat Trials Registry (ACTRN 12608000541303).

The Austrian breast implant register: recent trends in implant-based breast surgery.

Science.gov (United States)

Wurzer, Paul; Rappl, Thomas; Friedl, Herwig; Kamolz, Lars-Peter; Spendel, Stephan; Hoflehner, Helmut; Parvizi, Daryousch

2014-12-01

Due to the fact that the number of breast implant surgeries for cosmetic and medical purposes is rising yearly, a discussion about the quality of service for both patients and physicians is more important than ever. To this end, we reviewed the Austrian Breast Implant Register with one specific question in mind: What are the trends? In the statistical analysis of the Austrian Breast Implant Register, we were able to identify 13,112 registered breast implants between 2004 and 2012. The whole dataset was then divided into medical and cosmetic groups. We focused on device size, surface characteristics, filling material, device placement and incision site. All factors were considered for all examined years. In summary, the most used device had a textured surface (97 %) and silicone gel as the filling material (93 %). The mean size of implants for the cosmetic group was 240 cc, placement was submuscular (58 %) and the incision site was inframammary (67 %). In the medical group, the mean size was 250 cc. Yearly registrations had their peak in 2008 (1,898 registered devices); from this year on, registrations decreased annually. A slight trend away from subglandular placement in the cosmetic group was noted. Also, the usage of implants with polyurethane surface characteristics has increased since 2008. The smooth surface implants had a peak usage in 2006 and their usage decreased steadily from then on whereas the textured surface was steady over the years. Keeping the problems related to the quality of breast implants in mind, we could recommend an obligatory national register. Organisations of surgeons and governments should develop and establish these registers. Furthermore, an all-encompassing international register should be established by the European Union and the American FDA (Food and Drug Administration); this might be useful in comparing the individual country registers and also would help in delivering "evidence based" medicine in cosmetic and medical procedures

Effect of tranexamic acid on coagulation and fibrinolysis in women with postpartum haemorrhage (WOMAN-ETAC: protocol and statistical analysis plan for a randomized controlled trial [version 1; referees: 2 approved

Directory of Open Access Journals (Sweden)

Haleema Shakur

2016-12-01

Full Text Available Background: Postpartum haemorrhage (PPH is a leading cause of maternal death. Tranexamic acid has the potential to reduce bleeding and a large randomized controlled trial of its effect on maternal health outcomes in women with PPH (The WOMAN trial is ongoing. We will examine the effect of tranexamic acid on fibrinolysis and coagulation in a subset of WOMAN trial participants.   Methods. Adult women with clinically diagnosed primary PPH after vaginal or caesarean delivery are eligible for inclusion in the WOMAN trial. In a sub-group of trial participants, blood samples will be collected at baseline and 30 minutes after the first dose of tranexamic acid or matching placebo.  Our primary objective is to evaluate the effect of tranexamic acid on fibrinolysis. Fibrinolysis will be assessed by measuring D-dimers and by rotational thromboelastometry (ROTEM. Secondary outcomes are international normalized ratio (INR, prothrombin time (PT, activated partial thromboplastin time (APTT, fibrinogen, haemoglobin and platelets. We aim to include about 180 women from the University College Hospital, Ibadan in Nigeria.   Discussion:  This sub-study of WOMAN trial participants should provide information on the mechanism of action of tranexamic acid in women with postpartum haemorrhage. We present the trial protocol and statistical analysis plan. The trial protocol was registered prior to the start of patient recruitment. The statistical analysis plan was completed before un-blinding.     Trial registration: The trial was registered: ClinicalTrials.gov, Identifier NCT00872469 https://clinicaltrials.gov/ct2/show/NCT00872469; ISRCTN registry, Identifier   ISRCTN76912190 http://www.isrctn.com/ISRCTN76912190 (Registration date: 22/03/2012.

Intensive home treatment for patients in acute psychiatric crisis situations: a multicentre randomized controlled trial.

Science.gov (United States)

Cornelis, Jurgen; Barakat, Ansam; Dekker, Jack; Schut, Tessy; Berk, Sandra; Nusselder, Hans; Ruhl, Nikander; Zoeteman, Jeroen; Van, Rien; Beekman, Aartjan; Blankers, Matthijs

2018-02-27

internationally. The trial is registered in the Netherlands Trial Register as # NTR-6151 . Registered 23 November 2016.

VISUALIZATION OF REGISTERED SUBSURFACE ANATOMY

DEFF Research Database (Denmark)

2010-01-01

A system and method for visualization of subsurface anatomy includes obtaining a first image from a first camera and a second image from a second camera or a second channel of the first camera, where the first and second images contain shared anatomical structures. The second camera and the secon....... A visual interface displays the registered visualization of the first and second images. The system and method are particularly useful for imaging during minimally invasive surgery, such as robotic surgery....

Surgical-site infections and postoperative complications: agreement between the Danish Gynecological Cancer Database and a randomized clinical trial

DEFF Research Database (Denmark)

Antonsen, Sofie L; Meyhoff, Christian Sylvest; Lundvall, Lene

2011-01-01

between November 2006 and October 2008 and data from the DGCD. METHODS: Outcomes within 30 days from the trial and the database were compared and levels of agreements were calculated with kappa-statistics. MAIN OUTCOME MEASURES: Primary outcome was surgical-site infection. Other outcomes included re-operation...... registered in the PROXI trial, but not in the DGCD. Agreements between secondary outcomes were very varying (kappa-value 0.77 for re-operation, 0.37 for urinary tract infections, 0.19 for sepsis and 0.18 for pneumonia). CONCLUSIONS: The randomized trial reported significantly more surgical-site infections......OBJECTIVE: Surgical-site infections are serious complications and thorough follow-up is important for accurate surveillance. We aimed to compare the frequency of complications recorded in a clinical quality database with those noted in a randomized clinical trial with follow-up visits. DESIGN...

A nested mechanistic sub-study into the effect of tranexamic acid versus placebo on intracranial haemorrhage and cerebral ischaemia in isolated traumatic brain injury: study protocol for a randomised controlled trial (CRASH-3 Trial Intracranial Bleeding Mechanistic Sub-Study [CRASH-3 IBMS]).

Science.gov (United States)

Mahmood, Abda; Roberts, Ian; Shakur, Haleema

2017-07-17

volume. Bleeding volumes and new ischaemic lesions will be compared across treatment groups using relative risks and 95% confidence intervals. The CRASH-3 IBMS will provide an insight into the mechanism of action of tranexamic acid in traumatic brain injury, as well as information about the risks and benefits. Evidence from this trial could inform the management of patients with traumatic brain injury. The CRASH-3 trial was prospectively registered and the CRASH-3 IBMS is an addition to the original protocol registered at the International Standard Randomised Controlled Trials registry ( ISRCTN15088122 ) 19 July 2011, and ClinicalTrials.gov on 25 July 2011 (NCT01402882).

Nurses On-Line: Career Mobility for Registered Nurses.

Science.gov (United States)

O'Brien, Barbara S.; Renner, Alice

2000-01-01

Describes how adult learning theory was used to restructure registered nurse courses for online instruction. Hardware/software needs, technical support, instructional model, teaching-learning considerations, and evaluation are discussed. (SK)

PROBLEMS OF THE BURIAL REGISTERS IN TURKEY: A QUALITATIVE STUDY ON MATERNAL MORTALITY

OpenAIRE

ERGÖÇMEN, Banu Akadlı; YÜKSEL, İlknur

2006-01-01

In this article deficiencies of the burial registers in Turkey are discussed with specificemphasis on maternal mortality. The analysis is based on the qualitative data of “Turkey NationalMaternal Mortality Study, 2005”. This article aims to understand the reasons behind thedeficiencies in reporting and registering of the maternal deaths through interviews conducted withthe officers in charge of the burial registers in urban and rural settlements as well as the personsresponsible in recording ...

Danish Register of chronic obstructive pulmonary disease

DEFF Research Database (Denmark)

Lange, Peter; Tøttenborg, Sandra Søgaard; Sorknæs, Anne Dichmann

2016-01-01

AIM OF DATABASE: The Danish Register of Chronic Obstructive Pulmonary Disease (DrCOPD) is a nationwide database aiming to describe the quality of treatment of all patients with chronic obstructive pulmonary disease (COPD) in Denmark. STUDY POPULATION: DrCOPD comprises data on all patients...

Register-based studies of cancer screening effects

DEFF Research Database (Denmark)

Von Euler-Chelpin, My; Lynge, Elsebeth; Rebolj, Matejka

2011-01-01

INTRODUCTION: There are two organised cancer screening programmes in Denmark, against cervical and breast cancers. The aim with this study was to give an overview of the available register-based research regarding these two programmes, to demonstrate the usefulness of data from the national regis...

Machine Directional Register System Modeling for Shaft-Less Drive Gravure Printing Machines

Directory of Open Access Journals (Sweden)

Shanhui Liu

2013-01-01

Full Text Available In the latest type of gravure printing machines referred to as the shaft-less drive system, each gravure printing roller is driven by an individual servo motor, and all motors are electrically synchronized. The register error is regulated by a speed difference between the adjacent printing rollers. In order to improve the control accuracy of register system, an accurate mathematical model of the register system should be investigated for the latest machines. Therefore, the mathematical model of the machine directional register (MDR system is studied for the multicolor gravure printing machines in this paper. According to the definition of the MDR error, the model is derived, and then it is validated by the numerical simulation and experiments carried out in the experimental setup of the four-color gravure printing machines. The results show that the established MDR system model is accurate and reliable.

From challenges to advanced practice registered nursing role development: Qualitative interview study.

Science.gov (United States)

Jokiniemi, Krista; Haatainen, Kaisa; Pietilä, Anna-Maija

2015-12-01

The aim of this study is to describe the factors hindering and facilitating the implementation of the advanced practice registered nurses role at Finnish university hospitals, and to examine the implications for its future development. A descriptive qualitative approach, using thematic individual interviews, was conducted in 2011 with a sample of 11 advanced practice registered nurses. The data were analysed using qualitative content analysis. The advanced practice registered nurses role barriers had an impact on the role development needs. In turn, the facilitating factors helped encounter the challenges of the role, therefore having an impact on both the current role achievement, as well as contributing to the future role development. The factors hindering and facilitating the advanced practice registered nurses role need to be acknowledged to support the role implementation and planning of the future of the role. © 2014 Wiley Publishing Asia Pty Ltd.

The Felix-trial. Double-blind randomization of interspinous implant or bony decompression for treatment of spinal stenosis related intermittent neurogenic claudication

Directory of Open Access Journals (Sweden)

Brand Ronald

2010-05-01

Full Text Available Abstract Background Decompressive laminotomy is the standard surgical procedure in the treatment of patients with canal stenosis related intermittent neurogenic claudication. New techniques, such as interspinous process implants, claim a shorter hospital stay, less post-operative pain and equal long-term functional outcome. A comparative (cost- effectiveness study has not been performed yet. This protocol describes the design of a randomized controlled trial (RCT on (cost- effectiveness of the use of interspinous process implants versus conventional decompression surgery in patients with lumbar spinal stenosis. Methods/Design Patients (age 40-85 presenting with intermittent neurogenic claudication due to lumbar spinal stenosis lasting more than 3 months refractory to conservative treatment, are included. Randomization into interspinous implant surgery versus bony decompression surgery will take place in the operating room after induction of anesthesia. The primary outcome measure is the functional assessment of the patient measured by the Zurich Claudication Questionnaire (ZCQ, at 8 weeks and 1 year after surgery. Other outcome parameters include perceived recovery, leg and back pain, incidence of re-operations, complications, quality of life, medical consumption, absenteeism and costs. The study is a randomized multi-institutional trial, in which two surgical techniques are compared in a parallel group design. Patients and research nurses are kept blinded of the allocated treatment during the follow-up period of 1 year. Discussion Currently decompressive laminotomy is the golden standard in the surgical treatment of lumbar spinal stenosis. Whether surgery with interspinous implants is a reasonable alternative can be determined by this trial. Trial register Dutch Trial register number: NTR1307

Safety and efficacy of device closure for patent foramen ovale for secondary prevention of neurological events: Comprehensive systematic review and meta-analysis of randomized controlled trials

International Nuclear Information System (INIS)

Hakeem, Abdul; Marmagkiolis, Konstantinos; Hacioglu, Yalcin; Uretsky, Barry F.; Gundogdu, Betul; Leesar, Massoud; Bailey, Steven R.; Cilingiroglu, Mehmet

2013-01-01

Background: Controversy persists regarding the management of patients with cryptogenic stroke and patent foramen ovale (PFO). We performed a meta-analysis of randomized controlled trials comparing PFO closure with medical therapy. Methods and Results: A prospective protocol was developed and registered using the following data sources: PubMed, Cochrane Register of Controlled Trials, conference proceedings, and Internet-based resources of clinical trials. Primary analyses were performed using the intention-to-treat method. Three randomized trials comparing percutaneous PFO closure vs. medical therapy for secondary prevention of embolic neurological events formed the data set. Baseline characteristics were similar. During long-term follow-up, the pooled incidence of the primary endpoint (composite of stroke, death, or fatal stroke) was 3.4% in the PFO closure arm and 4.8% in the medical therapy group [risk-reduction (RR) 0.7 (0.48–1.06); p = 0.09]. The incidence of recurrent neurological events (secondary endpoint) was 1.7% for PFO closure and 2.7% for medical therapy [RR 0.66 (0.35–1.24), p = 0.19]. There was no difference in terms of death or adverse events between the two groups. Conclusions: While this meta-analysis of randomized clinical trials demonstrated no statistical significance in comparison to medical therapy, there was a trend towards overall improvement in outcomes in the PFO closure group

Safety and efficacy of device closure for patent foramen ovale for secondary prevention of neurological events: Comprehensive systematic review and meta-analysis of randomized controlled trials

Energy Technology Data Exchange (ETDEWEB)

Hakeem, Abdul [University of Arkansas for Medical Sciences, Little Rock, AR (United States); Marmagkiolis, Konstantinos [Citizens Memorial Hospital Heart and Vascular Institute, Bolivar, MO (United States); Hacioglu, Yalcin; Uretsky, Barry F.; Gundogdu, Betul [University of Arkansas for Medical Sciences, Little Rock, AR (United States); Leesar, Massoud [University of Alabama at Birmingham, Birmingham, AL (United States); Bailey, Steven R. [University of Texas Health Sciences Center at San Antonio, San Antonio, TX (United States); Cilingiroglu, Mehmet, E-mail: mcilingiroglu@yahoo.com [Arkansas Heart Hospital, Little Rock, AR (United States)

2013-11-15

Background: Controversy persists regarding the management of patients with cryptogenic stroke and patent foramen ovale (PFO). We performed a meta-analysis of randomized controlled trials comparing PFO closure with medical therapy. Methods and Results: A prospective protocol was developed and registered using the following data sources: PubMed, Cochrane Register of Controlled Trials, conference proceedings, and Internet-based resources of clinical trials. Primary analyses were performed using the intention-to-treat method. Three randomized trials comparing percutaneous PFO closure vs. medical therapy for secondary prevention of embolic neurological events formed the data set. Baseline characteristics were similar. During long-term follow-up, the pooled incidence of the primary endpoint (composite of stroke, death, or fatal stroke) was 3.4% in the PFO closure arm and 4.8% in the medical therapy group [risk-reduction (RR) 0.7 (0.48–1.06); p = 0.09]. The incidence of recurrent neurological events (secondary endpoint) was 1.7% for PFO closure and 2.7% for medical therapy [RR 0.66 (0.35–1.24), p = 0.19]. There was no difference in terms of death or adverse events between the two groups. Conclusions: While this meta-analysis of randomized clinical trials demonstrated no statistical significance in comparison to medical therapy, there was a trend towards overall improvement in outcomes in the PFO closure group.

Systemic hydrocortisone to prevent bronchopulmonary dysplasia in preterm infants (the SToP-BPD study; a multicenter randomized placebo controlled trial

Directory of Open Access Journals (Sweden)

Onland Wes

2011-11-01

Full Text Available Abstract Background Randomized controlled trials have shown that treatment of chronically ventilated preterm infants after the first week of life with dexamethasone reduces the incidence of the combined outcome death or bronchopulmonary dysplasia (BPD. However, there are concerns that dexamethasone may increase the risk of adverse neurodevelopmental outcome. Hydrocortisone has been suggested as an alternative therapy. So far no randomized controlled trial has investigated its efficacy when administered after the first week of life to ventilated preterm infants. Methods/Design The SToP-BPD trial is a randomized double blind placebo controlled multicenter study including 400 very low birth weight infants (gestational age Discussion This trial will determine the efficacy and safety of postnatal hydrocortisone administration at a moderately early postnatal onset compared to placebo for the reduction of the combined outcome mortality and BPD at 36 weeks postmenstrual age in ventilator dependent preterm infants. Trial registration number Netherlands Trial Register (NTR: NTR2768

Pulsed laser deposition of antimicrobial silver coating on Ormocer (registered) microneedles

Energy Technology Data Exchange (ETDEWEB)

Gittard, S D; Narayan, R J; Jin, C; Monteiro-Riviere, N A [Joint Department of Biomedical Engineering, North Carolina State University, Raleigh, NC 27695 (United States); Ovsianikov, A; Chichkov, B N [Laser Zentrum Hannover, Hollerithallee 8, 30419 Hannover (Germany); Stafslien, S; Chisholm, B, E-mail: roger_narayan@msn.co [Center for Nanoscale Science and Engineering, North Dakota State University, 1805 Research Park Drive, Fargo, ND 58102 (United States)

2009-12-15

One promising option for transdermal delivery of protein- and nucleic acid-based pharmacologic agents involves the use of microneedles. However, microneedle-generated pores may allow microorganisms to penetrate the stratum corneum layer of the epidermis and cause local or systemic infection. In this study, microneedles with antimicrobial functionality were fabricated using two-photon polymerization-micromolding and pulsed laser deposition. The antibacterial activity of the silver-coated organically modified ceramic (Ormocer (registered) ) microneedles was demonstrated using an agar diffusion assay. Human epidermal keratinocyte viability on the Ormocer (registered) surfaces coated with silver was similar to that on uncoated Ormocer (registered) surfaces. This study indicates that coating microneedles with silver thin films using pulsed laser deposition is a useful and novel approach for creating microneedles with antimicrobial functionality. (communication)

Pulsed laser deposition of antimicrobial silver coating on Ormocer (registered) microneedles

International Nuclear Information System (INIS)

Gittard, S D; Narayan, R J; Jin, C; Monteiro-Riviere, N A; Ovsianikov, A; Chichkov, B N; Stafslien, S; Chisholm, B

2009-01-01

One promising option for transdermal delivery of protein- and nucleic acid-based pharmacologic agents involves the use of microneedles. However, microneedle-generated pores may allow microorganisms to penetrate the stratum corneum layer of the epidermis and cause local or systemic infection. In this study, microneedles with antimicrobial functionality were fabricated using two-photon polymerization-micromolding and pulsed laser deposition. The antibacterial activity of the silver-coated organically modified ceramic (Ormocer (registered) ) microneedles was demonstrated using an agar diffusion assay. Human epidermal keratinocyte viability on the Ormocer (registered) surfaces coated with silver was similar to that on uncoated Ormocer (registered) surfaces. This study indicates that coating microneedles with silver thin films using pulsed laser deposition is a useful and novel approach for creating microneedles with antimicrobial functionality. (communication)

Decoherence in large NMR quantum registers

International Nuclear Information System (INIS)

Krojanski, Hans Georg; Suter, Dieter

2006-01-01

Decoherence causes the decay of the quantum information that is stored in highly correlated states during quantum computation. It is thus a limiting factor for all implementations of a quantum computer. Because a scalable quantum computer with hundreds or thousands of qubits is not available yet, experimental data about decoherence rates was restricted to small quantum registers. With solid state nuclear magnetic resonance we create highly correlated multiqubit states that serve as a model quantum register and measure their decay. By measuring the decay as a function of the system size, we determined the scaling of the decoherence rate with the number of qubits. Using the same system, we also used decoupling techniques to reduce the coupling between system and environment and thereby the decoherence rate by more than an order of magnitude, independent of the system size. For the free decay as well as for the decoupled case, we found a relatively weak scaling with system size, which could be fitted to a power law ∝K p with an exponent p≅1/2. This raises the prospect for large-scale quantum computation

Assessment of Veterinary Pharmaceutical Products Registered in ...

African Journals Online (AJOL)

Topical, intramammary, intrauterine and ophthalmic routes accounted for 4.7%, 3.3%, 1.0% and 0.1% of the registered products respectively. ... Dosage forms for oral administration included solids (53.4%) namely powders, tablets, boluses, freeze dried products, granules; liquids (46.3%) namely suspensions, solutions, ...

Systematic Review of Randomized Clinical Trials of Acupressure Therapy for Primary Dysmenorrhea

Directory of Open Access Journals (Sweden)

Hui-ru Jiang

2013-01-01

Full Text Available The evidence of acupressure is limited in the management of dysmenorrhea. To evaluate the efficacy of acupressure in the treatment of primary dysmenorrhea based on randomized controlled trials (RCTs, we searched MEDLINE, the Chinese Biomedical Database (CBM, and the Cochrane Central Register of Controlled Trials (CENTRAL databases from inception until March 2012. Two reviewers independently selected articles and extracted data. Statistical analysis was performed with RevMan 5.1 software. Eight RCTs were identified from the retrieved 224 relevant records. Acupressure improved pain measured with VAS (−1.41 cm 95% CI [−1.61, −1.21], SF-MPQ at the 3-month followup (WMD −2.33, 95% CI [−4.11, −0.54] and 6-month followup (WMD −4.67, 95% CI [−7.30, −2.04], and MDQ at the 3-month followup (WMD −2.31, 95% CI [−3.74, −0.87] and 6-month followup (WMD −4.67, 95% CI [−7.30, −2.04]. All trials did not report adverse events. These results were limited by the methodological flaws of trials.

Impact of hydroxyurea on clinical events in the BABY HUG trial

Science.gov (United States)

Files, Beatrice A.; Luo, Zhaoyu; Miller, Scott T.; Kalpatthi, Ram; Iyer, Rathi; Seaman, Phillip; Lebensburger, Jeffrey; Alvarez, Ofelia; Thompson, Bruce; Ware, Russell E.; Wang, Winfred C.

2012-01-01

The Pediatric Hydroxyurea Phase 3 Clinical Trial (BABY HUG) was a phase 3 multicenter, randomized, double-blind, placebo-controlled clinical trial of hydroxyurea in infants (beginning at 9-18 months of age) with sickle cell anemia. An important secondary objective of this study was to compare clinical events between the hydroxyurea and placebo groups. One hundred and ninety-three subjects were randomized to hydroxyurea (20 mg/kg/d) or placebo; there were 374 patient-years of on-study observation. Hydroxyurea was associated with statistically significantly lower rates of initial and recurrent episodes of pain, dactylitis, acute chest syndrome, and hospitalization; even infants who were asymptomatic at enrollment had less dactylitis as well as fewer hospitalizations and transfusions if treated with hydroxyurea. Despite expected mild myelosuppression, hydroxyurea was not associated with an increased risk of bacteremia or serious infection. These data provide important safety and efficacy information for clinicians considering hydroxyurea therapy for very young children with sickle cell anemia. This clinical trial is registered with the National Institutes of Health (NCT00006400, www.clinicaltrials.gov). PMID:22915643

The patient's safety and access to experimental drugs after the termination of clinical trials: regulations and trends.

Science.gov (United States)

da Silva, Ricardo Eccard; Amato, Angélica Amorim; Sousa, Thiago do Rego; de Carvalho, Marta Rodrigues; Novaes, Maria Rita Carvalho Garbi

2018-05-12

Participants' rights and safety must be guaranteed not only while a clinical trial is being conducted but also when a clinical trial finishes. The criteria for post-trial access to experimental drugs, however, are unclear in various countries. The objectives of this study were (i) to ascertain if there were regulations or guidelines related to patients' access to drugs after the end of clinical trials in the countries selected in the study and (ii) to analyze trends in post-trial access in countries classified by their level of economic development. This study is a retrospective review. The data are from the records of clinical trials from 2014 registered in the World Health Organization's International Clinical Trials Registry Platform (ICTRP) database. Among the countries selected, provision of drugs post-trial is mandatory only in Argentina, Brazil, Chile, Finland, and Peru. The plans for post-trial access tend to be more present in low- and middle-income and upper middle-income countries, in comparison with high-income countries. Studies involving vulnerable populations are 2.53 times more likely to have plans for post-trial access than studies which do not. The guaranteeing of post-trial access remains mandatory in few countries. Considering that individuals seen as vulnerable have been included in clinical trials without plans for post-trial access, stakeholders must discuss the need to develop regulations mandating the guaranteeing of post-trial access in specified situations.

Implementing conventional logic unconventionally: photochromic molecular populations as registers and logic gates.

Science.gov (United States)

Chaplin, J C; Russell, N A; Krasnogor, N

2012-07-01

In this paper we detail experimental methods to implement registers, logic gates and logic circuits using populations of photochromic molecules exposed to sequences of light pulses. Photochromic molecules are molecules with two or more stable states that can be switched reversibly between states by illuminating with appropriate wavelengths of radiation. Registers are implemented by using the concentration of molecules in each state in a given sample to represent an integer value. The register's value can then be read using the intensity of a fluorescence signal from the sample. Logic gates have been implemented using a register with inputs in the form of light pulses to implement 1-input/1-output and 2-input/1-output logic gates. A proof of concept logic circuit is also demonstrated; coupled with the software workflow describe the transition from a circuit design to the corresponding sequence of light pulses. Copyright © 2012 Elsevier Ireland Ltd. All rights reserved.

17 CFR 210.3-18 - Special provisions as to registered management investment companies and companies required to be...

Science.gov (United States)

2010-04-01

... registered management investment companies and companies required to be registered as management investment... Financial Statements § 210.3-18 Special provisions as to registered management investment companies and companies required to be registered as management investment companies. (a) For filings by registered...

Register Variation in Electronic Business Correspondence

Directory of Open Access Journals (Sweden)

Rosa Giménez Moreno

2011-06-01

Full Text Available Electronic correspondence is a highly dynamic genre within the business world in which Register Variation (RV is frequently used as a tool to improve communication but it often can lead to misunderstanding. In order to shed some light on this still unexplored area, the present study firstly offers a practical approach to classify and analyse RV within professional communication. After this, it reviews previous studies on email writing to apply their findings to this approach and, in the third part of the study, a corpus of recent business emails in English is analysed to examine how the key parameters of RV are currently used within this genre. The results will show that, not only the context, but also the roles and intentions of the senders influence an email’s register, often causing internal oscillations between different registers within the same text.La correspondencia electrónica es un género comunicativo de especial dinamismo dentro del mundo empresarial en el que la variación de registros se utiliza como herramienta para mejorar la interacción y las relaciones entre los interlocutores, pero que a menudo también genera confusión y malentendidos. Para aportar luz a esta área, el presente trabajo ofrece una aproximación práctica para la clasificación y el análisis de los registros lingüísticos dentro de la comunicación profesional. A continuación, revisa los estudios previos sobre este género con el fin de adaptar sus resultados a la teoría propuesta. Finalmente, se analiza un corpus de mensajes escritos en inglés para examinar el funcionamiento de los registros dentro de este género. Los resultados mostrarán que, no solo el contexto situacional, sino sobre todo los roles e intenciones de los emisores determinan el registro de un mensaje, provocando a menudo oscilación interna entre varios registros dentro del mismo texto.

The Norwegian National Reporting System and Register of Severe Allergic Reactions to Food

Directory of Open Access Journals (Sweden)

Martinus Løvik

2009-10-01

Full Text Available The Norwegian National Reporting System and Register of Severe Allergic Reactions to Food, or the Food Allergy Register, is a nation-wide, government-funded permanent reporting and registration system for severe allergic reactions to food. The Food Allergy Register collects information based on a one-page reporting form, serum samples for specific IgE analysis, and food samples for food allergen analysis. Reporting physicians receive in return an extensive commentary on the reported case and the relevant allergies, and results of the specific IgE analysis and food allergen analysis.The Food Allergy Register has, after being active for a little more than four years, given valuable information about several important aspects of food allergy in Norway. The Food Allergy Register has revealed food safety problems in relation to allergy that probably could be discovered only with the help of a systematic, nation-wide registration of cases. The reactions of peanut allergic individuals to lupine flour in bakery products is an example of how the Food Allergy Register is able to reveal potentially serious problems that would otherwise probably have gone unnoticed and certainly unexplained. The amount and the value of the information from the Food Allergy Register are increasing as new reports of more cases are added. The typical Norwegian patient with a severe allergic reaction to food appears to be a young adult, female rather than male. The offending meal is consumed at a restaurant or fast-food stand or in a private party away from home, and peanuts, nuts and shellfish are among the most common offending foods, while fish allergy appears to be rather rare.

REVIEW: Towards a risk register for natural capital.

Science.gov (United States)

Mace, Georgina M; Hails, Rosemary S; Cryle, Philip; Harlow, Julian; Clarke, Stewart J

2015-06-01

Natural capital is essential for goods and services on which people depend. Yet pressures on the environment mean that natural capital assets are continuing to decline and degrade, putting such benefits at risk. Systematic monitoring of natural assets is a major challenge that could be both unaffordable and unmanageable without a way to focus efforts. Here we introduce a simple approach, based on the commonly used management tool of a risk register, to highlight natural assets whose condition places benefits at risk.We undertake a preliminary assessment using a risk register for natural capital assets in the UK based solely on existing information. The status and trends of natural capital assets are assessed using asset-benefit relationships for ten kinds of benefits (food, fibre (timber), energy, aesthetics, freshwater (quality), recreation, clean air, wildlife, hazard protection and equable climate) across eight broad habitat types in the UK based on three dimensions of natural capital within each of the habitat types (quality, quantity and spatial configuration). We estimate the status and trends of benefits relative to societal targets using existing regulatory limits and policy commitments, and allocate scores of high, medium or low risk to asset-benefit relationships that are both subject to management and of concern.The risk register approach reveals substantial gaps in knowledge about asset-benefit relationships which limit the scope and rigour of the assessment (especially for marine and urban habitats). Nevertheless, we find strong indications that certain assets (in freshwater, mountain, moors and heathland habitats) are at high risk in relation to their ability to sustain certain benefits (especially freshwater, wildlife and climate regulation). Synthesis and applications . With directed data gathering, especially to monitor trends, improve metrics related to asset-benefit relationships, and improve understanding of nonlinearities and thresholds, the

Effects of improved sanitation on diarrheal reduction for children under five in Idiofa, DR Congo: a cluster randomized trial.

Science.gov (United States)

Cha, Seungman; Lee, JaeEun; Seo, DongSik; Park, Byoung Mann; Mansiangi, Paul; Bernard, Kabore; Mulakub-Yazho, Guy Jerome Nkay; Famasulu, Honore Minka

2017-09-19

The lack of safe water and sanitation contributes to the rampancy of diarrhea in many developing countries. This study describes the design of a cluster-randomized trial in Idiofa, the Democratic Republic of the Congo, seeking evidence of the impact of improved sanitation on diarrhea for children under four. Of the 276 quartiers, 18 quartiers were randomly allocated to the intervention or control arm. Seven hundred and-twenty households were sampled and the youngest under-four child in each household was registered for this study. The primary endpoint of the study is diarrheal incidence, prevalence and duration in children under five. Material subsidies will be provided only to the households who complete pit digging plus superstructure and roof construction, regardless of their income level. This study employs a Sanitation Calendar so that the mother of each household can record the diarrheal episodes of her under-four child on a daily basis. The diary enables examination of the effect of the sanitation intervention on diarrhea duration and also resolves the limitation of the small number of clusters in the trial. In addition, the project will be monitored through the 'Sanitation Map', on which all households in the study area, including both the control and intervention arms, are registered. To avoid information bias or courtesy bias, photos will be taken of the latrine during the household visit, and a supervisor will determine well-equipped latrine uptake based on the photos. This reduces the possibility of recall bias and under- or over-estimation of diarrhea, which was the main limitation of previous studies. The study was approved by the Institutional Review Board of the School of Public Health, Kinshasa University (ESP/CE/040/15; April 13, 2015) and registered as an International Standard Randomized Controlled Trial (ISRCTN: 10,419,317) on March 13, 2015.

The use of feasibility studies for stepped-wedge cluster randomised trials: protocol for a review of impact and scope.

Science.gov (United States)

Kristunas, Caroline A; Hemming, Karla; Eborall, Helen C; Gray, Laura J

2017-08-01

The stepped-wedge cluster randomised trial (SW-CRT) is a complex design, for which many decisions about key design parameters must be made during the planning. These include the number of steps and the duration of time needed to embed the intervention. Feasibility studies are likely to be useful for informing these decisions and increasing the likelihood of the main trial's success. However, the number of feasibility studies being conducted for SW-CRTs is currently unknown. This review aims to establish the number of feasibility studies being conducted for SW-CRTs and determine which feasibility issues are commonly investigated. Fully published feasibility studies for SW-CRTs will be identified, according to predefined inclusion criteria, from searches conducted in Ovid MEDLINE, Scopus, Embase and PsycINFO. To also identify and gain information on unpublished feasibility studies the following will be contacted: authors of published SW-CRTs (identified from the most recent systematic reviews); contacts for registered SW-CRTs (identified from clinical trials registries); lead statisticians of UK registered clinical trials units and researchers known to work in the area of SW-CRTs.Data extraction will be conducted independently by two reviewers. For the fully published feasibility studies, data will be extracted on the study characteristics, the rationale for the study, the process for determining progression to a main trial, how the study informed the main trial and whether the main trial went ahead. The researchers involved in the unpublished feasibility studies will be contacted to elicit the same information.A narrative synthesis will be conducted and provided alongside a descriptive analysis of the study characteristics. This review does not require ethical approval, as no individual patient data will be used. The results of this review will be published in an open-access peer-reviewed journal. © Article author(s) (or their employer(s) unless otherwise stated in

The Prosody of Topic Transition in Interaction: Pitch Register Variations.

Science.gov (United States)

Riou, Marine

2017-12-01

In conversation, speakers can mobilize a variety of prosodic cues to signal a switch in topics. This paper uses a mixed-methods approach combining Conversation Analysis and Instrumental Prosody to investigate the prosody of topic transition in American English, and analyzes the ways in which speakers can play on register level and on register span. A cluster of three prosodic parameters was found to be predictive of transitions: a higher maximum fundamental frequency (F0), a higher median F0 (key), and an expanded register span. Relative to speakers' habitual profiles, the mobilization of such prosodic cues corresponds to a marked upgraded prosodic design. This finding is consistent with the general assumption that continuation constitutes the norm in conversation, and that departing from it, as in the case of a topic transition, requires a marked action and marked linguistic design. The disjunctive action of opening a new topic corresponds to the use of a marked prosodic cue.

Registering Names and Addresses for Information Technology.

Science.gov (United States)

Knapp, Arthur A.

The identification of administrative authorities and the development of associated procedures for registering and accessing names and addresses of communications data systems are considered in this paper. It is noted that, for data communications systems using standards based on the Open Systems Interconnection (OSI) Reference Model specified by…

Single memory with multiple shift register functionality

NARCIS (Netherlands)

2010-01-01

The present invention relates to a memory device comprising a memory (EM) having at least two predetermined register memory sections addressable by respective address ranges AS1-ASz) and at least one access port (P1-PZ) for providing access to said memory (EM). Furthermore, access control means (A)

78 FR 69539 - Removal of Attestation Process for Facilities Using H-1A Registered Nurses

Science.gov (United States)

2013-11-20

... of Attestation Process for Facilities Using H-1A Registered Nurses AGENCY: Employment and Training... registered nurses under the H-1A visa program. These subparts became obsolete after the authorizing statute... nonimmigrant classification exclusively for the temporary admission and employment of registered nurses, which...

Immediate versus delayed loading of strategic mini dental implants for the stabilization of partial removable dental prostheses: a patient cluster randomized, parallel-group 3-year trial.

Science.gov (United States)

Mundt, Torsten; Al Jaghsi, Ahmad; Schwahn, Bernd; Hilgert, Janina; Lucas, Christian; Biffar, Reiner; Schwahn, Christian; Heinemann, Friedhelm

2016-07-30

Acceptable short-term survival rates (>90 %) of mini-implants (diameter implants as strategic abutments for a better retention of partial removable dental prosthesis (PRDP) are not available. The purpose of this study is to test the hypothesis that immediately loaded mini-implants show more bone loss and less success than strategic mini-implants with delayed loading. In this four-center (one university hospital, three dental practices in Germany), parallel-group, controlled clinical trial, which is cluster randomized on patient level, a total of 80 partially edentulous patients with unfavourable number and distribution of remaining abutment teeth in at least one jaw will receive supplementary min-implants to stabilize their PRDP. The mini-implant are either immediately loaded after implant placement (test group) or delayed after four months (control group). Follow-up of the patients will be performed for 36 months. The primary outcome is the radiographic bone level changes at implants. The secondary outcome is the implant success as a composite variable. Tertiary outcomes include clinical, subjective (quality of life, satisfaction, chewing ability) and dental or technical complications. Strategic implants under an existing PRDP are only documented for standard-diameter implants. Mini-implants could be a minimal invasive and low cost solution for this treatment modality. The trial is registered at Deutsches Register Klinischer Studien (German register of clinical trials) under DRKS-ID: DRKS00007589 ( www.germanctr.de ) on January 13(th), 2015.

Effect of spontaneous pushing versus Valsalva pushing in the second stage of labour on mother and fetus: a systematic review of randomised trials

NARCIS (Netherlands)

Prins, M. [=Marianne; Boxem, J.; Lucas, C.; Hutton, E.

2011-01-01

To critically evaluate any benefit or harm for the mother and her baby of Valsalva pushing versus spontaneous pushing in the second stage of labour. Electronic databases from MEDLINE, EMBASE, CINAHL, and the Cochrane Central Register of Controlled Trials were systematically searched (last search May

Comparison of an interactive with a didactic educational intervention for improving the evidence-based practice knowledge of occupational therapists in the public health sector in South Africa: a randomised controlled trial.

Science.gov (United States)

Buchanan, Helen; Siegfried, Nandi; Jelsma, Jennifer; Lombard, Carl

2014-06-10

interactive component had little additional effect. Pan African Controlled Trials Register PACTR201201000346141, registered 31 January 2012. Clinical Trials NCT01512823, registered 1 February 2012. South African National Clinical Trial Register DOH2710093067, registered 27 October 2009. The first participants were randomly assigned on 16 July 2008.

The effect of exercise in clinically depressed adults: systematic review and meta-analysis of randomized controlled trials

DEFF Research Database (Denmark)

Krogh, Jesper; Nordentoft, Merete; Sterne, Jonathan A C

2011-01-01

SH) and text word terms depression, depressive disorder and exercise, aerobic, non-aerobic, physical activity, physical fitness, walk*, jog*, run*, bicycling, swim*, strength, and resistance. STUDY SELECTION: Randomized trials including adults with clinical depression according to any diagnostic system were......OBJECTIVE: To assess the effectiveness of exercise in adults with clinical depression. DATA SOURCES: The databases CINAHL, Embase, Cochrane Database of Systematic reviews, Cochrane Controlled Trials Register, MEDLINE, and PsycINFO were searched (1806-2008) using medical subject headings (Me...... with depression (P = .002). No other characteristics were related to between-study heterogeneity. Pooled analysis of 5 trials with long-term follow-up (ie, that examined outcomes beyond the end of the intervention) suggested no long-term benefit (SMD, -0.01; 95% CI, -0.28 to 0.26), with no strong evidence...

Identifying patients with myasthenia for epidemiological research by linkage of automated registers

DEFF Research Database (Denmark)

Pedersen, Emil Greve; Hallas, Jesper; Hansen, Klaus

2011-01-01

We validated a new method of identifying patients with incident myasthenia in automated Danish registers for the purpose of conducting epidemiological studies of the disorder.......We validated a new method of identifying patients with incident myasthenia in automated Danish registers for the purpose of conducting epidemiological studies of the disorder....

Individual Placement and Support supplemented with cognitive remediation and work-related social skills training in Denmark: study protocol for a randomized controlled trial.

Science.gov (United States)

Christensen, Thomas Nordahl; Nielsen, Iben Gammelgaard; Stenager, Elsebeth; Morthorst, Britt Reuter; Lindschou, Jane; Nordentoft, Merete; Eplov, Lene Falgaard

2015-06-21

Individual Placement and Support (IPS) appears to be an effective vocational intervention for obtaining competitive employment for people with severe mental illness. However, no IPS studies or trials have been conducted in Denmark, a country characterized by a specialized labor market with a higher minimum wage and fewer entry-level jobs in comparison with other countries such as the US. Furthermore, long-term job retention and economic self-sufficiency have not been clearly demonstrated. Integrating methods such as cognitive remediation and work-related social skills training may be ways to address these issues. The trial design is an investigator-initiated, randomized, assessor-blinded, multi-center trial. A total of 750 patients with severe mental illness will be randomly assigned into three groups: (1) IPS, (2) IPS enhanced with cognitive remediation and work-related social skills training, and (3) service as usual. The primary outcome is number of hours in competitive employment or education at 18-month follow-up. Secondary and exploratory outcomes are money earned, days to first employment, symptoms, functional level, self-esteem, and self-efficacy at 18-month follow-up. Thirty- and 60-month follow-ups will be register-based. This will be one of the largest randomized trials investigating IPS to date. The trial will be conducted with high methodological quality in order to reduce the risk of bias. If the results of this trial show that IPS, or IPS enhanced with cognitive remediation and work-related social skills training, is superior to service as usual, this will support preliminary evidence. Furthermore, it will show that the method is generalizable to a variety of labor markets and welfare systems and provide important knowledge about the effect of adding cognitive remediation and social skills training to the IPS intervention. ClinicalTrials registration number: NCT01722344 (registered 2 Nov. 2012).

Use of an online portal to facilitate clinical trial recruitment: a preliminary analysis of Fox Trial Finder.

Science.gov (United States)

Rocker, Charlotte; Cappelletti, Lily; Marshall, Claudia; Meunier, Claire C; Brooks, Deborah W; Sherer, Todd; Chowdhury, Sohini

2015-01-01

As in other therapeutic areas, clinical studies in Parkinson's disease (PD) face significant recruitment challenges. However, qualitative surveys suggest that individuals with PD are willing to participate in clinical research. The Michael J. Fox Foundation therefore established Fox Trial Finder in 2011 to facilitate connection between PD research teams and volunteers. Characterize the research volunteers (with and without PD) registered on Fox Trial Finder as of June 2014, and the published, recruiting studies to identify trends and highlight gaps between research requirements and available volunteers. Profiles of volunteers with and without PD were analyzed to explore trends in geography, demographics, family history and, for those volunteers with PD, disease progression and treatment history. Clinical study profiles were analyzed to determine study type, phase, sponsor, focus, location and eligibility criteria. The analysis focused on volunteers and studies based in the United States. The database contained 26,261 US-based volunteers, including 19,243 volunteers (73%) with PD and 7,018 (27%) controls without PD. The average time since diagnosis for PD volunteers was 5.7 years and the average age at diagnosis was 58 years. Control volunteers were more likely than volunteers with PD to be female (67% vs. 35%) and to have a family history of PD (49% vs. 12%). Fox Trial Finder's registration history to date demonstrates the high level of willingness among individuals affected by PD to participate in clinical research and provide a significant amount of personal health information to facilitate that participation.

Configurable multi-step linear feedback shift register

NARCIS (Netherlands)

2010-01-01

The state transition of a linear feedback shift register (LFSR) controlled by a clock (310) with length N and step size W, W being at least two, is accomplished via a next-state function (320). The next-state function deploys a state transition matrix (350). The state vector (330), which represents

Protocol for the SEED-trial: Supported Employment and preventing Early Disability

Directory of Open Access Journals (Sweden)

Vigdis Sveinsdottir

2016-07-01

Full Text Available Abstract Background Early withdrawal or exclusion from the labor market leads to significant personal and societal costs. In Norway, the increasing numbers of young adults receiving disability pension is a growing problem. While a large body of research demonstrates positive effects of Supported Employment (SE in patients with severe mental illness, no studies have yet investigated the effectiveness of SE in young adults with a range of social and health conditions who are receiving benefits. Methods/design The SEED-trial is a randomized controlled trial (RCT comparing traditional vocational rehabilitation (TVR to SE in 124 unemployed individuals between the ages of 18-29 who are receiving benefits due to various social- or health-related problems. The primary outcome is labor market participation during the first year after enrollment. Secondary outcomes include physical and mental health, health behaviors, and well-being, collected at baseline, 6, and 12 months. A cost-benefit analysis will also be conducted. Discussion The SEED-trial is the first RCT to compare SE to TVR in this important and vulnerable group, at risk of being excluded from working life at an early age. Trial registration Clinicaltrials.gov, registration number NCT02375074 . Registered on December 3rd 2014

Balanced Bipartite Graph Based Register Allocation for Network Processors in Mobile and Wireless Networks

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Feilong Tang

2010-01-01

Full Text Available Mobile and wireless networks are the integrant infrastructure of mobile and pervasive computing that aims at providing transparent and preferred information and services for people anytime anywhere. In such environments, end-to-end network bandwidth is crucial to improve user's transparent experience when providing on-demand services such as mobile video playing. As a result, powerful computing power is required for networked nodes, especially for routers. General-purpose processors cannot meet such requirements due to their limited processing ability, and poor programmability and scalability. Intel's network processor IXP is specially designed for fast packet processing to achieve a broad bandwidth. IXP provides a large number of registers to reduce the number of memory accesses. Registers in an IXP are physically partitioned as two banks so that two source operands in an instruction have to come from the two banks respectively, which makes the IXP register allocation tricky and different from conventional ones. In this paper, we investigate an approach for efficiently generating balanced bipartite graph and register allocation algorithms for the dual-bank register allocation in IXPs. The paper presents a graph uniform 2-way partition algorithm (FPT, which provides an optimal solution to the graph partition, and a heuristic algorithm for generating balanced bipartite graph. Finally, we design a framework for IXP register allocation. Experimental results demonstrate the framework and the algorithms are efficient in register allocation for IXP network processors.

Optimal timing of an invasive strategy in patients with non-ST-elevation acute coronary syndrome: a meta-analysis of randomised trials.

Science.gov (United States)

Jobs, Alexander; Mehta, Shamir R; Montalescot, Gilles; Vicaut, Eric; Van't Hof, Arnoud W J; Badings, Erik A; Neumann, Franz-Josef; Kastrati, Adnan; Sciahbasi, Alessandro; Reuter, Paul-Georges; Lapostolle, Frédéric; Milosevic, Aleksandra; Stankovic, Goran; Milasinovic, Dejan; Vonthein, Reinhard; Desch, Steffen; Thiele, Holger

2017-08-19

A routine invasive strategy is recommended for patients with non-ST-elevation acute coronary syndromes (NSTE-ACS). However, optimal timing of invasive strategy is less clearly defined. Individual clinical trials were underpowered to detect a mortality benefit; we therefore did a meta-analysis to assess the effect of timing on mortality. We identified randomised controlled trials comparing an early versus a delayed invasive strategy in patients presenting with NSTE-ACS by searching MEDLINE, Cochrane Central Register of Controlled Trials, and Embase. We included trials that reported all-cause mortality at least 30 days after in-hospital randomisation and for which the trial investigators agreed to collaborate (ie, providing individual patient data or standardised tabulated data). We pooled hazard ratios (HRs) using random-effects models. This meta-analysis is registered at PROSPERO (CRD42015018988). We included eight trials (n=5324 patients) with a median follow-up of 180 days (IQR 180-360). Overall, there was no significant mortality reduction in the early invasive group compared with the delayed invasive group HR 0·81, 95% CI 0·64-1·03; p=0·0879). In pre-specified analyses of high-risk patients, we found lower mortality with an early invasive strategy in patients with elevated cardiac biomarkers at baseline (HR 0·761, 95% CI 0·581-0·996), diabetes (0·67, 0·45-0·99), a GRACE risk score more than 140 (0·70, 0·52-0·95), and aged 75 years older (0·65, 0·46-0·93), although tests for interaction were inconclusive. An early invasive strategy does not reduce mortality compared with a delayed invasive strategy in all patients with NSTE-ACS. However, an early invasive strategy might reduce mortality in high-risk patients. None. Copyright © 2017 Elsevier Ltd. All rights reserved.

Cost-effectiveness of cryotherapy versus salicylic acid for the treatment of plantar warts: economic evaluation alongside a randomised controlled trial (EVerT trial

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Stamuli Eugena

2012-02-01

Full Text Available Abstract Background Plantar warts (verrucae are extremely common. Although many will spontaneously disappear without treatment, treatment may be sought for a variety of reasons such as discomfort. There are a number of different treatments for cutaneous warts, with salicylic acid and cryotherapy using liquid nitrogen being two of the most common forms of treatment. To date, no full economic evaluation of either salicylic acid or cryotherapy has been conducted based on the use of primary data in a pragmatic setting. This paper describes the cost-effectiveness analysis which was conducted alongside a pragmatic multicentre, randomised trial evaluating the clinical effectiveness of cryotherapy versus 50% salicylic acid of the treatment of plantar warts. Methods A cost-effectiveness analysis was undertaken alongside a pragmatic multicentre, randomised controlled trial assessing the clinical effectiveness of 50% salicylic acid and cryotherapy using liquid nitrogen at 12 weeks after randomisation of patients. Cost-effectiveness outcomes were expressed as the additional cost required to completely cure the plantar warts of one additional patient. A NHS perspective was taken for the analysis. Results Cryotherapy costs on average £101.17 (bias corrected and accelerated (BCA 95% CI: 85.09-117.26 more per participant over the 12 week time-frame, while there is no additional benefit, in terms of proportion of patients healed compared with salicylic acid. Conclusions Cryotherapy is more costly and no more effective than salicylic acid. Trial registration Current Controlled Trials ISRCTN18994246 [controlled-trials.com] and National Research Register N0484189151.

Cost-effectiveness of cryotherapy versus salicylic acid for the treatment of plantar warts: economic evaluation alongside a randomised controlled trial (EVerT trial)

Science.gov (United States)

2012-01-01

Abstract Background Plantar warts (verrucae) are extremely common. Although many will spontaneously disappear without treatment, treatment may be sought for a variety of reasons such as discomfort. There are a number of different treatments for cutaneous warts, with salicylic acid and cryotherapy using liquid nitrogen being two of the most common forms of treatment. To date, no full economic evaluation of either salicylic acid or cryotherapy has been conducted based on the use of primary data in a pragmatic setting. This paper describes the cost-effectiveness analysis which was conducted alongside a pragmatic multicentre, randomised trial evaluating the clinical effectiveness of cryotherapy versus 50% salicylic acid of the treatment of plantar warts. Methods A cost-effectiveness analysis was undertaken alongside a pragmatic multicentre, randomised controlled trial assessing the clinical effectiveness of 50% salicylic acid and cryotherapy using liquid nitrogen at 12 weeks after randomisation of patients. Cost-effectiveness outcomes were expressed as the additional cost required to completely cure the plantar warts of one additional patient. A NHS perspective was taken for the analysis. Results Cryotherapy costs on average £101.17 (bias corrected and accelerated (BCA) 95% CI: 85.09-117.26) more per participant over the 12 week time-frame, while there is no additional benefit, in terms of proportion of patients healed compared with salicylic acid. Conclusions Cryotherapy is more costly and no more effective than salicylic acid. Trial registration Current Controlled Trials ISRCTN18994246 [controlled-trials.com] and National Research Register N0484189151. PMID:22369511

The Apathy in Dementia Methylphenidate Trial 2 (ADMET 2): study protocol for a randomized controlled trial.

Science.gov (United States)

Scherer, Roberta W; Drye, Lea; Mintzer, Jacobo; Lanctôt, Krista; Rosenberg, Paul; Herrmann, Nathan; Padala, Prasad; Brawman-Mintzer, Olga; Burke, William; Craft, Suzanne; Lerner, Alan J; Levey, Allan; Porsteinsson, Anton; van Dyck, Christopher H

2018-01-18

treatment for apathy in AD. With a larger sample size and longer follow up, ADMET 2 is poised to confirm or refute the original ADMET findings. ClinicalTrials.gov, NCT02346201 . Registered on 26 January 2015.

Perceptions of the clinical competence of newly registered nurses in the North West province

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M.R. Moeti

2004-09-01

Full Text Available The clinical competence of newly registered nurses relating to the care of individual Clients, depends on their ability to correlate theoretical knowledge learned in the classroom with practice and the development of clinical skills. Its foundation lies in the ability to identify and solve problems that emanate from critical thinking, analytical reasoning and reflective practice. It is clear that the quality of clinical exposure plays a leading role in the development of nursing professionals. Nursing skills alone cannot ensure quality care of clients without the application of theory. Facilitation of this theory to practice therefore remains an essential component of nursing education. This study was aimed at identifying areas of incompetence of newly registered nurses (1998- 2001 in the clinical area by determining the newly registered nurses1 and professional nurses1 perceptions of the competence of the newly registered nurses. A quantitative, non-experimental, descriptive survey was used to collect the data regarding the clinical competence of newly registered nurses (1998-2001.

Ca teos report in register N 13377

International Nuclear Information System (INIS)

Pena, S; Arrighetti, R.

2011-01-01

This work is about a report about ca teos carried out in register N 13377 in the department of Canelones to know the depth of the field. The drilling done allowed to identify granite and clay. This granite outcrops are developed in the east of the middle course of the stream Pando

The Danish nationwide clinical register for patients with rheumatoid arthritis

DEFF Research Database (Denmark)

Ibfelt, Else Helene; Jensen, Dorte Vendelbo; Hetland, Merete Lund

2016-01-01

the following: patient-reported outcomes for disease activity, pain, fatigue, functional status, and physician-reported objective measures of disease activity, treatment, C-reactive protein, and, when indicated, imaging. For subgroups of patients, the variables such as quality of life, sociodemographic factors...... original papers as well as annual reports of clinical quality (since 2005) have been published. Conclusion: DANBIO is a powerful register for research in rheumatologic diseases and furthermore serves as a Clinical Quality Register with the aim of monitoring treatment quality in patients with RA in Denmark....

Effect of joint mobilization techniques for primary total knee arthroplasty: Study protocol for a randomized controlled trial.

Science.gov (United States)

Xu, Jiao; Zhang, Juan; Wang, Xue-Qiang; Wang, Xuan-Lin; Wu, Ya; Chen, Chan-Cheng; Zhang, Han-Yu; Zhang, Zhi-Wan; Fan, Kai-Yi; Zhu, Qiang; Deng, Zhi-Wei

2017-12-01

Total knee arthroplasty (TKA) has become the most preferred procedure by patients for the relief of pain caused by knee osteoarthritis. TKA patients aim a speedy recovery after the surgery. Joint mobilization techniques for rehabilitation have been widely used to relieve pain and improve joint mobility. However, relevant randomized controlled trials showing the curative effect of these techniques remain lacking to date. Accordingly, this study aims to investigate whether joint mobilization techniques are valid for primary TKA. We will manage a single-blind, prospective, randomized, controlled trial of 120 patients with unilateral TKA. Patients will be randomized into an intervention group, a physical modality therapy group, and a usual care group. The intervention group will undergo joint mobilization manipulation treatment once a day and regular training twice a day for a month. The physical modality therapy group will undergo physical therapy once a day and regular training twice a day for a month. The usual care group will perform regular training twice a day for a month. Primary outcome measures will be based on the visual analog scale, the knee joint Hospital for Special Surgery score, range of motion, surrounded degree, and adverse effect. Secondary indicators will include manual muscle testing, 36-Item Short Form Health Survey, Berg Balance Scale function evaluation, Pittsburgh Sleep Quality Index, proprioception, and muscle morphology. We will direct intention-to-treat analysis if a subject withdraws from the trial. The important features of this trial for joint mobilization techniques in primary TKA are randomization procedures, single-blind, large sample size, and standardized protocol. This study aims to investigate whether joint mobilization techniques are effective for early TKA patients. The result of this study may serve as a guide for TKA patients, medical personnel, and healthcare decision makers. It has been registered at http

A randomized controlled trial of Human Papillomavirus (HPV) testing for cervical cancer screening: trial design and preliminary results (HPV FOCAL Trial)

International Nuclear Information System (INIS)

Ogilvie, Gina S; Cook, Darrel A; Mei, Wendy; Stuart, Gavin CE; Franco, Eduardo L; Coldman, Andrew J; Niekerk, Dirk J van; Krajden, Mel; Martin, Ruth E; Ehlen, Thomas G; Ceballos, Kathy; Peacock, Stuart J; Smith, Laurie W; Kan, Lisa

2010-01-01

In the HPV FOCAL trial, we will establish the efficacy of hr-HPV DNA testing as a stand-alone screening test followed by liquid based cytology (LBC) triage of hr-HPV-positive women compared to LBC followed by hr-HPV triage with ≥ CIN3 as the outcome. HPV-FOCAL is a randomized, controlled, three-armed study over a four year period conducted in British Columbia. It will recruit 33,000 women aged 25-65 through the province's population based cervical cancer screening program. Control arm: LBC at entry and two years, and combined LBC and hr-HPV at four years among those with initial negative results and hr-HPV triage of ASCUS cases; Two Year Safety Check arm: hr-HPV at entry and LBC at two years in those with initial negative results with LBC triage of hr-HPV positives; Four Year Intervention Arm: hr-HPV at entry and combined hr-HPV and LBC at four years among those with initial negative results with LBC triage of hr-HPV positive cases To date, 6150 participants have a completed sample and epidemiologic questionnaire. Of the 2019 women enrolled in the control arm, 1908 (94.5%) were cytology negative. Women aged 25-29 had the highest rates of HSIL (1.4%). In the safety arm 92.2% of women were hr-HPV negative, with the highest rate of hr-HPV positivity found in 25-29 year old women (23.5%). Similar results were obtained in the intervention arm HPV FOCAL is the first randomized trial in North America to examine hr-HPV testing as the primary screen for cervical cancer within a population-based cervical cancer screening program. International Standard Randomised Controlled Trial Number Register, ISRCTN79347302

Effect of candesartan on progression and regression of retinopathy in type 2 diabetes (DIRECT-Protect 2): a randomised placebo-controlled trial

DEFF Research Database (Denmark)

Sjolie, A.K.; Klein, R.; Porta, M.

2008-01-01

-group, placebo-controlled trial in 309 centres worldwide. We recruited normoalbuminuric, normotensive, or treated hypertensive people with type 2 diabetes with mild to moderately severe retinopathy and assigned them to candesartan 16 mg once a day or placebo. After a month, the dose was doubled to 32 mg once per...... day. Investigators and patients were unaware of the treatment allocation status. Progression of retinopathy was the primary endpoint, and regression was a secondary endpoint. Analysis was by intention to treat. The trial is registered with ClinicalTrials.gov, number NCT00252694. FINDINGS: 1905...... or changes in blood pressure during the trial. An overall change towards less severe retinopathy by the end of the trial was observed in the candesartan group (odds 1.17, 95% CI 1.05-1.30, p=0.003). Adverse events did not differ between the treatment groups. INTERPRETATION: Treatment with candesartan in type...

Schizophrenia trials conducted in African countries: a drop of evidence in the ocean of morbidity?

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Purgato Marianna

2012-07-01

Full Text Available Abstract Objective To quantify schizophrenia trialling activity in African countries and to describe the main features of these trials. Methods We searched the Cochrane Schizophrenia Group Register, which contains 16,000 citations to 13,000 studies relating only to people with schizophrenia or schizophrenia-like illness, to identify schizophrenia trials conducted in Africa without time limitation. Results A total of 38 trials met the inclusion criteria and were included in our analysis. Of the 54 countries of Africa, only 8 produced at least one trial: South Africa produced the majority of trials (20 out of 38 trials, 53%, followed by Nigeria (7 out of 38 trials, 18% and Egypt (4 out of 38 trials, 11%. The majority of studies investigated the efficacy of pharmacological interventions, were short in duration, and employed a double-blind design. The quality of reporting was generally poor. We found six trials comparing antipsychotics from the WHO Essential List of Medicine versus new generation antipsychotics. In terms of efficacy and acceptability, these studies failed to show any advantage of newer antipsychotics over first-generation agents. Conclusions We observed an impressive mismatch between the number of individuals with schizophrenia living in African countries, estimated to be around 10 million, and the overall number of patients included in African trials, which is less than 2,000. These few trials were of low quality and appeared not to reflect the real needs of the population. We argue that the concept of pragmatism should be introduced into the design of randomized trials in African countries. Pragmatic trials should investigate whether treatments, given in real-world circumstances, really have clinically meaningful effects.

The geographical distribution of leadership in globalized clinical trials.

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Jarno Hoekman

Full Text Available BACKGROUND: Pharmaceutical trials are mainly initiated by sponsors and investigators in the United States, Western Europe and Japan. However, more and more patients are enrolled in Central and Eastern Europe, Latin America and Asia. The involvement of patients in new geographical settings raises questions about scientific and ethical integrity, especially when experience with those settings is lacking at the level of trial management. We therefore studied to what extent the geographical shift in patient enrolment is anticipated in the composition of trial management teams using the author nationalities on the primary outcome publication as an indicator of leadership. METHODS AND FINDINGS: We conducted a cohort-study among 1,445 registered trials in www.clinicaltrials.gov that could be matched with a primary outcome publication using clinical trial registry numbers listed in publications. The name of the sponsor and the enrolment countries were extracted from all registrations. The author-addresses of all authors were extracted from the publications. We searched the author-address of all publications to determine whether enrolment countries and sponsors listed on registrations also appeared on a matched publication. Of all sponsors, 80.1% were listed with an author-address on the publication. Of all enrolment countries, 50.3% appeared with an author-address on the publication. The listing of enrolment countries was especially low for industry-funded trials (39.9% as compared to government (90.4% and not-for-profit funding (93.7%. We found that listing of enrolment countries in industry-funded trials was higher for traditional research locations such as the United States (98.2% and Japan (72.0% as compared to nontraditional research locations such as Poland (27.3% and Mexico (14.1%. CONCLUSIONS: Despite patient enrolment efforts, the involvement of researchers from nontraditional locations in trial management as measured by their contribution to

The geographical distribution of leadership in globalized clinical trials.

Science.gov (United States)

Hoekman, Jarno; Frenken, Koen; de Zeeuw, Dick; Heerspink, Hiddo Lambers

2012-01-01

Pharmaceutical trials are mainly initiated by sponsors and investigators in the United States, Western Europe and Japan. However, more and more patients are enrolled in Central and Eastern Europe, Latin America and Asia. The involvement of patients in new geographical settings raises questions about scientific and ethical integrity, especially when experience with those settings is lacking at the level of trial management. We therefore studied to what extent the geographical shift in patient enrolment is anticipated in the composition of trial management teams using the author nationalities on the primary outcome publication as an indicator of leadership. We conducted a cohort-study among 1,445 registered trials in www.clinicaltrials.gov that could be matched with a primary outcome publication using clinical trial registry numbers listed in publications. The name of the sponsor and the enrolment countries were extracted from all registrations. The author-addresses of all authors were extracted from the publications. We searched the author-address of all publications to determine whether enrolment countries and sponsors listed on registrations also appeared on a matched publication. Of all sponsors, 80.1% were listed with an author-address on the publication. Of all enrolment countries, 50.3% appeared with an author-address on the publication. The listing of enrolment countries was especially low for industry-funded trials (39.9%) as compared to government (90.4%) and not-for-profit funding (93.7%). We found that listing of enrolment countries in industry-funded trials was higher for traditional research locations such as the United States (98.2%) and Japan (72.0%) as compared to nontraditional research locations such as Poland (27.3%) and Mexico (14.1%). Despite patient enrolment efforts, the involvement of researchers from nontraditional locations in trial management as measured by their contribution to manuscript writing is modest. This division of labor has

Predictive value of stroke discharge diagnoses in the Danish National Patient Register.

Science.gov (United States)

Lühdorf, Pernille; Overvad, Kim; Schmidt, Erik B; Johnsen, Søren P; Bach, Flemming W

2017-08-01

To determine the positive predictive values for stroke discharge diagnoses, including subarachnoidal haemorrhage, intracerebral haemorrhage and cerebral infarction in the Danish National Patient Register. Participants in the Danish cohort study Diet, Cancer and Health with a stroke discharge diagnosis in the National Patient Register between 1993 and 2009 were identified and their medical records were retrieved for validation of the diagnoses. A total of 3326 records of possible cases of stroke were reviewed. The overall positive predictive value for stroke was 69.3% (95% confidence interval (CI) 67.8-70.9%). The predictive values differed according to hospital characteristics, with the highest predictive value of 87.8% (95% CI 85.5-90.1%) found in departments of neurology and the lowest predictive value of 43.0% (95% CI 37.6-48.5%) found in outpatient clinics. The overall stroke diagnosis in the Danish National Patient Register had a limited predictive value. We therefore recommend the critical use of non-validated register data for research on stroke. The possibility of optimising the predictive values based on more advanced algorithms should be considered.

Shine on: achieving career satisfaction as a registered nurse.

Science.gov (United States)

Perry, Beth

2008-01-01

This phenomenological study focuses on the experience of career satisfaction among registered nurses. Potential participants were asked, "Do you love your work as a nurse?" A random sample of eight nurses who answered yes to this question was questioned further during semistructured conversations. Conversations were recorded and transcribed. Data collected were in the form of descriptions of times during the participants' careers when they felt most professionally fulfilled. Through narrative and poetic analysis, themes of "upholding the vulnerable," "going the extra mile," and "attending to the essential ordinary" were identified. Nurse educators play an important role facilitating career satisfaction for registered nurses. Practical implications for continuing education for educators and practicing nurses are addressed.

Workplace violence experienced by registered nurses: a concept analysis.

Science.gov (United States)

Ventura-Madangeng, Judee; Wilson, Denise

2009-11-01

Workplace violence toward nurses has increased during the last decade with serious consequences that may extend beyond individual nurses to an entire health care organisation. The variety of definitions of workplace violence experienced by registered nurses contribute to a lack of clarity about what it constitutes, which in turn jeopardizes the reporting of incidences by nurses. Drawing on the relevant literature from 1990 to 2005, a concept analysis using Walker and Avant's framework was undertaken to develop an operational definition of this phenomenon as experienced by registered nurses (excluding mental health nurses). Having a clear understanding of workplace violence assists with the creation of strategies aimed at preventing and/or resolving this problem.

Measuring Certified Registered Nurse Anesthetist Organizational Climate: Instrument Adaptation.

Science.gov (United States)

Boyd, Donald; Poghosyan, Lusine

2017-08-01

No tool exists measuring certified registered nurse anesthetist (CRNA) organizational climate. The study's purpose is to adapt a validated tool to measure CRNA organizational climate. Content validity of the Certified Registered Nurse Anesthetist Organizational Climate Questionnaire (CRNA-OCQ) was established. Pilot testing was conducted to determine internal reliability consistency of the subscales. Experts rated the tool as content valid. The subscales had high internal consistency reliability (with respective Cronbach's alphas): CRNA-Anesthesiologist Relations (.753), CRNA-Physician Relations (.833), CRNA-Administration Relations (.895), Independent Practice (.830), Support for CRNA Practice (.683), and Professional Visibility (.772). Further refinement of the CRNA-OCQ is necessary. Measurement and assessment of CRNA organizational climate may produce evidence needed to improve provider and patient outcomes.

Hand-assisted retroperitoneoscopic versus standard laparoscopic donor nephrectomy: HARP-trial

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Alwayn Ian PJ

2010-03-01

Full Text Available Abstract Background Transplantation is the only treatment offering long-term benefit to patients with chronic kidney failure. Live donor nephrectomy is performed on healthy individuals who do not receive direct therapeutic benefit of the procedure themselves. In order to guarantee the donor's safety, it is important to optimise the surgical approach. Recently we demonstrated the benefit of laparoscopic nephrectomy experienced by the donor. However, this method is characterised by higher in hospital costs, longer operating times and it requires a well-trained surgeon. The hand-assisted retroperitoneoscopic technique may be an alternative to a complete laparoscopic, transperitoneal approach. The peritoneum remains intact and the risk of visceral injuries is reduced. Hand-assistance results in a faster procedure and a significantly reduced operating time. The feasibility of this method has been demonstrated recently, but as to date there are no data available advocating the use of one technique above the other. Methods/design The HARP-trial is a multi-centre randomised controlled, single-blind trial. The study compares the hand-assisted retroperitoneoscopic approach with standard laparoscopic donor nephrectomy. The objective is to determine the best approach for live donor nephrectomy to optimise donor's safety and comfort while reducing donation related costs. Discussion This study will contribute to the evidence on any benefits of hand-assisted retroperitoneoscopic versus standard laparoscopic donor nephrectomy. Trial Registration Dutch Trial Register NTR1433

Employing open/hidden administration in psychotherapy research: A randomized-controlled trial of expressive writing

Science.gov (United States)

Tondorf, Theresa; Kaufmann, Lisa-Katrin; Degel, Alexander; Locher, Cosima; Birkhäuer, Johanna; Gerger, Heike; Ehlert, Ulrike

2017-01-01

Psychotherapy has been shown to be effective, but efforts to prove specific effects by placebo-controlled trials have been practically and conceptually hampered. We propose that adopting open/hidden designs from placebo research would offer a possible way to establish specificity in psychotherapy. Therefore, we tested the effects of providing opposing treatment rationales in an online expressive writing intervention on affect in healthy subjects. Results indicate that it was possible to conduct the expressive writing intervention both covertly and openly, but that participants in the hidden administration condition did not fully benefit from the otherwise effective expressive writing intervention in the long-run. Effect sizes between open and hidden administration groups were comparable to pre-post effect sizes of the intervention. While this finding is important for the understanding of psychotherapy's effects per se, it also proves that alternative research approaches to establish specificity are feasible and informative in psychotherapy research. Trial registration: German Clinical Trials Register DRKS00009428 PMID:29176768

Inositol treatment of anovulation in women with polycystic ovary syndrome: a meta-analysis of randomised trials.

Science.gov (United States)

Pundir, J; Psaroudakis, D; Savnur, P; Bhide, P; Sabatini, L; Teede, H; Coomarasamy, A; Thangaratinam, S

2018-02-01

Polycystic ovary syndrome is a common cause of anovulation and infertility, and a risk factor for development of metabolic syndrome and endometrial cancer. Systematic review and meta-analysis of randomised controlled trials (RCT) that evaluated the effects of inositol as an ovulation induction agent. We searched MEDLINE, EMBASE, Cochrane and ISI conference proceedings, Register and Meta-register for RCT and WHO trials' search portal. We included studies that compared inositol with placebo or other ovulation induction agents. Quality of studies was assessed for risk of bias. Results were pooled using random effects meta-analysis and findings were reported as relative risk or standardised mean differences. We included ten randomised trials. A total of 362 women were on inositol (257 on myo-inositol; 105 on di-chiro-inositol), 179 were on placebo and 60 were on metformin. Inositol was associated with significantly improved ovulation rate (RR 2.3; 95% CI 1.1-4.7; I 2 = 75%) and increased frequency of menstrual cycles (RR 6.8; 95% CI 2.8-16.6; I 2 = 0%) compared with placebo. One study reported on clinical pregnancy rate with inositol compared with placebo (RR 3.3; 95% CI 0.4-27.1), and one study compared with metformin (RR 1.5; 95% CI 0.7-3.1). No studies evaluated live birth and miscarriage rates. Inositol appears to regulate menstrual cycles, improve ovulation and induce metabolic changes in polycystic ovary syndrome; however, evidence is lacking for pregnancy, miscarriage or live birth. A further, well-designed multicentre trial to address this issue to provide robust evidence of benefit is warranted. Inositols improve menstrual cycles, ovulation and metabolic changes in polycystic ovary syndrome. © 2017 Royal College of Obstetricians and Gynaecologists.

A community-based cluster randomised trial of safe storage to reduce pesticide self-poisoning in rural Sri Lanka

DEFF Research Database (Denmark)

Pearson, Melissa; Konradsen, Flemming; Gunnell, David

2011-01-01

. One approach to reducing access to pesticides is for households to store pesticides in lockable "safe-storage" containers. However, before this approach can be promoted, evidence is required on its effectiveness and safety. Methods/Design A community-based cluster randomised controlled trial has been...... at the 5% significance level. Secondary outcomes will include the incidence of all pesticide poisoning and total self-harm. Discussion This paper describes a large effectiveness study of a community intervention to reduce the burden of intentional poisoning in rural Sri Lanka. The study builds on a strong...... partnership between provincial health services, local and international researchers, and local communities. We discuss issues in relation to randomisation and contamination, engaging control villages, the intervention, and strategies to improve adherence. Trial Registritation The trial is registered...

17 CFR 270.30b1-2 - Semi-annual report for totally-owned registered management investment company subsidiary of...

Science.gov (United States)

2010-04-01

...-owned registered management investment company subsidiary of registered management investment company...-owned registered management investment company subsidiary of registered management investment company... subsidiary of a registered management investment company need not file a semi-annual report on Form N-SAR if...

The central dose register for the nuclear industry in Sweden

International Nuclear Information System (INIS)

Widell, C.-O.

1978-06-01

The central dose register for the nuclear industry in Sweden has been in operation since 1974. The system contains today about 18 000 persons in the register. The dose information is stored on discs on a CDC Cyber 172 computer and all information to and from the system is handled by terminals at the different nuclear sites. The terminals are connected to the computer by normal telephone lines. Most doses are recorded on TLD. The data from the TLD readers is automatically transferred to the computer via punched tape and the local computer terminal. The dose results are stored under the person's unique social security number. It is also possible to use social security number systems of other countries. The dose register system also supervises the condition of the readers and their calibration by circulation dosimeters which have been given a reference dose. The information from the system can be obtained on many different types of lists, for example, annual, quarterly, monthly, departementally, personal history, job number. (author)

20 years TraumaRegister DGU(®): development, aims and structure.

Science.gov (United States)

2014-10-01

The TraumaRegister DGU(®) organisational and technical development has undergone an evolution process, which started 20 years ago. Currently, the management of the registry is under the management of the "AUC - Academy for Trauma Surgery" (infrastructure) and the "Sektion NIS" (scientific responsibility). The aim of the registry was to establish an inter-hospital quality assessment tool with the option to use the increasing database for scientific evaluations of acute care. Year after year and most recently with the obligatory participation of certified hospitals the number of participating hospitals has grown as well as the registered cases per annum. Recently, even hospitals from other countries joined the registry too. Starting with six German hospitals and 260 cases in 1993, 20 years later more than 600 hospitals from eleven countries deliver over 30,000 trauma cases per year resulting in over 150,000 reported cases until 2013. In this article a historical perspective is presented of the evolution and current status of the TraumaRegister DGU(®). Copyright © 2014 Elsevier Ltd. All rights reserved.

The extended Infant Feeding, Activity and Nutrition Trial (InFANT Extend Program: a cluster-randomized controlled trial of an early intervention to prevent childhood obesity

Directory of Open Access Journals (Sweden)

Karen J. Campbell

2016-02-01

Full Text Available Abstract Background Understanding how we can prevent childhood obesity in scalable and sustainable ways is imperative. Early RCT interventions focused on the first two years of life have shown promise however, differences in Body Mass Index between intervention and control groups diminish once the interventions cease. Innovative and cost-effective strategies seeking to continue to support parents to engender appropriate energy balance behaviours in young children need to be explored. Methods/Design The Infant Feeding Activity and Nutrition Trial (InFANT Extend Program builds on the early outcomes of the Melbourne InFANT Program. This cluster randomized controlled trial will test the efficacy of an extended (33 versus 15 month and enhanced (use of web-based materials, and Facebook® engagement, version of the original Melbourne InFANT Program intervention in a new cohort. Outcomes at 36 months of age will be compared against the control group. Discussion This trial will provide important information regarding capacity and opportunities to maximize early childhood intervention effectiveness over the first three years of life. This study continues to build the evidence base regarding the design of cost-effective, scalable interventions to promote protective energy balance behaviors in early childhood, and in turn, promote improved child weight and health across the life course. Trial registration ACTRN12611000386932 . Registered 13 April 2011.

Effects of acupuncture treatment on depression insomnia: a study protocol of a multicenter randomized controlled trial

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Chen Yuan-Fang

2013-01-01

Full Text Available Abstract Background More than 70% of patients with depression who see their doctors experience insomnia. Insomnia treatment is a very important link for depression treatment. Furthermore, antidepression treatment is also important for depression insomnia. In acupuncture, LU-7 (Lie Que and KID-6 (Zhao Hai, which are two of the eight confluence points in meridian theory, are used as main points. An embedded needle technique is used, alternately, at two groups of points to consolidate the treatment effect. These two groups of points are BL-15 (Xin Shu with BL-23 (Shen Shu and BL-19 (Dan Shu with N-HN-54 (An Mian. The effectiveness of these optimized acupuncture formulas is well proven in the practice by our senior acupuncturists in Guangdong Provincial Hospital of TCM. This study has been designed to examine whether this set of optimized clinical formulas is able to increase the clinical efficacy of depression insomnia treatment. Methods/design In this randomized controlled multicenter trial, all the eligible participants are diagnosed with depression insomnia. All participants are randomly assigned to one of two groups in a ratio of 1:1 and receive either conventional acupuncture treatment or optimized acupuncture treatment. Patients are evaluated using the Pittsburgh Sleep Quality Index(PSQIand the Hamilton rating scale(HAMD for depression. The use of antidepression and hypnotics drugs is also considered. Results are obtained at the start of treatment, 1 and 2 months after treatment has begun, and at the end of treatment. The entire duration of the study will be approximately 36 months. Discussion A high quality of trial methodologies is utilized in the study, and the results may provide better evidence for the effectiveness of acupuncture as a treatment for depression insomnia. The optimized acupuncture formula has potential benefits in increasing the efficacy of treating depression insomnia. Trial registration The trial was registered in

Early rehabilitation in sepsis: a prospective randomised controlled trial investigating functional and physiological outcomes The i-PERFORM Trial (Protocol Article

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Kayambu Geetha

2011-10-01

Full Text Available Abstract Background Patients with sepsis syndromes in comparison to general intensive care patients can have worse outcomes for physical function, quality of life and survival. Early intensive care rehabilitation can improve the outcome in general Intensive Care Unit (ICU patients, however no investigations have specifically looked at patients with sepsis syndromes. The 'i-PERFORM Trial' will investigate if early targeted rehabilitation is both safe and effective in patients with sepsis syndromes admitted to ICU. Methods/Design A single-centred blinded randomized controlled trial will be conducted in Brisbane, Australia. Participants (n = 252 will include those ≥ 18 years, mechanically ventilated for ≥ 48 hours and diagnosed with a sepsis syndrome. Participants will be randomised to an intervention arm which will undergo an early targeted rehabilitation program according to the level of arousal, strength and cardiovascular stability and a control group which will receive normal care. The primary outcome measures will be physical function tests on discharge from ICU (The Acute Care Index of Function and The Physical Function ICU Test. Health-related quality of life will be measured using the Short Form-36 and the psychological component will be tested using The Hospital Anxiety and Depression Scale. Secondary measures will include inflammatory biomarkers; Interleukin-6, Interleukin-10 and Tumour Necrosis Factor-α, peripheral blood mitochondrial DNA content and lactate, fat free muscle mass, tissue oxygenation and microcirculatory flow. Discussion The 'i-PERFORM Trial' will determine whether early rehabilitation for patients with sepsis is effective at improving patient outcomes with functional and physiological parameters reflecting long and short-term effects of early exercise and the safety in its application in critical illness. Trial Registration Australia and New Zealand Clinical Trials Register (ANZCTR: ACTRN12610000808044

Forty-five years of schizophrenia trials in Italy: a survey

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Purgato Marianna

2012-04-01

Full Text Available Abstract Background Well-designed and properly executed randomized controlled trials (RCTs provide the best evidence on the efficacy of healthcare interventions. Mental health has a strong tradition of using trial to evaluate treatments, but the translation of research to clinical practice is not always easy. Even well-conducted trials do not necessarily address the needs of every day care and trials can reflect local needs and the specific culture in which they are undertaken. Generalizing results to other contexts can become problematic but these trials may, nevertheless, be very helpful within their own context. Moreover, pathways for drug approval can be different depending on local regulatory agencies. Local trials are helpful for decision-making in the region from which they come, but should not be viewed in isolation. National quantity and quality of trials may vary across nations. The aim of this study is to quantify trialing activity in Italy from 1948 until 2009 and to describe characteristics of these trials. In addition, we evaluated change over time in three keys aspects: sample size, follow-up duration, and number of outcomes. Methods We used the Cochrane Schizophrenia Group's register that contains 16,000 citations to 13,000 studies relating only to people with schizophrenia or schizophrenia-like illness. Randomized controlled trials and controlled clinical trials undertaken in Italy and involving pharmacological interventions were included. Results The original search identified 155 records of potentially eligible studies, 74 of which were excluded because do not meet inclusion criteria. A total of 81 studies were included in the analysis. The majority of trials were conducted in north Italy, and published in international journals between 1981 and 1995. The majority of studies (52 out of 81 used standardized diagnostic criteria for schizophrenia disorder. They were defined as randomized and used blind methods to administer