Prospective registration trends, reasons for retrospective registration and mechanisms to increase prospective registration compliance: descriptive analysis and survey

PubMed Central

Seidler, Anna Lene; Askie, Lisa M

2018-01-01

Objectives To analyse prospective versus retrospective trial registration trends on the Australian New Zealand Clinical Trials Registry (ANZCTR) and to evaluate the reasons for non-compliance with prospective registration. Design Part 1: Descriptive analysis of trial registration trends from 2006 to 2015. Part 2: Online registrant survey. Participants Part 1: All interventional trials registered on ANZCTR from 2006 to 2015. Part 2: Random sample of those who had retrospectively registered a trial on ANZCTR between 2010 and 2015. Main outcome measures Part 1: Proportion of prospective versus retrospective clinical trial registrations (ie, registration before versus after enrolment of the first participant) on the ANZCTR overall and by various key metrics, such as sponsor, funder, recruitment country and sample size. Part 2: Reasons for non-compliance with prospective registration and perceived usefulness of various proposed mechanisms to improve prospective registration compliance. Results Part 1: Analysis of the complete dataset of 9450 trials revealed that compliance with prospective registration increased from 48% (216 out of 446 trials) in 2006 to 63% (723/1148) in 2012 and has since plateaued at around 64%. Patterns of compliance were relatively consistent across sponsor and funder types (industry vs non-industry), type of intervention (drug vs non-drug) and size of trial (n<100, 100–500, >500). However, primary sponsors from Australia/New Zealand were almost twice as likely to register prospectively (62%; 4613/7452) compared with sponsors from other countries with a WHO Network Registry (35%; 377/1084) or sponsors from countries without a WHO Registry (29%; 230/781). Part 2: The majority (56%; 84/149) of survey respondents cited lack of awareness as a reason for not registering their study prospectively. Seventy-four per cent (111/149) stated that linking registration to ethics approval would facilitate prospective registration. Conclusions Despite some

Review of the registration of clinical trials in UMIN-CTR from 2 June 2005 to 1 June 2010 - focus on Japan domestic, academic clinical trials

PubMed Central

2013-01-01

Background Established on 1 June 2005, the University Hospital Medical Information Network Clinical Trials Registry (UMIN-CTR) is the largest clinical trial registry in Japan, and joined the World Health Organization (WHO) registry network in October 2008. Our aim was to understand the registration trend and overall characteristics of Japan domestic, academic (non-industry-funded) clinical trials, which constitute the main body of registrations in UMIN-CTR. In addition, we aimed to investigate the accessibility of clinical trials in UMIN-CTR to people worldwide, as well as the accessibility of clinical trials conducted in Japan but registered abroad to Japanese people in the Japanese language. Methods We obtained the data for registrations in UMIN-CTR from the UMIN Center, and extracted Japan domestic, academic clinical trials to analyze their registration trend and overall characteristics. We also investigated how many of the trials registered in UMIN-CTR could be accessed from the International Clinical Trials Registry Platform (ICTRP). Finally, we searched ClinicalTrials.gov for all clinical trials conducted in Japan and investigated how many of them were also registered in Japanese registries. All of the above analyses included clinical trials registered from 2 June 2005 to 1 June 2010. Results During the period examined, the registration trend showed an obvious peak around September 2005 and rapid growth from April 2009. Of the registered trials, 46.4% adopted a single-arm design, 34.5% used an active control, only 10.9% were disclosed before trial commencement, and 90.0% did not publish any results. Overall, 3,063 of 3,064 clinical trials registered in UMIN-CTR could be accessed from ICTRP. Only 8.7% of all clinical trials conducted in Japan and registered in ClinicalTrials.gov were also registered in Japanese registries. Conclusions The International Committee of Medical Journal Editors (ICMJE) announcements about clinical trial registration and the Ethical

Registration status and methodological reporting of randomized controlled trials in obesity research: A review.

PubMed

Byrne, Jillian L S; Yee, Tamara; O'Connor, Kathleen; Dyson, Michele P; Ball, Geoff D C

2017-04-01

To assess registration and reporting details of randomized controlled trials (RCTs) published from 2011 to 2016 across four obesity journals. All issues from four leading obesity journals were searched systematically for RCTs from January 2011 to June 2016. Data on registration status were extracted from manuscripts, online trial registries, and a trial database; corresponding authors were contacted for registration details, when necessary. The methodological reporting of RCTs was assessed on specific criteria from the Consolidated Standards of Reporting Trials. A total of 223 RCTs were reviewed. Three-quarters (n = 170) were registered publicly; 94 (55.3%) reported registration details in the manuscript, and 82 (48.2%) were registered prospectively. Newer RCTs were more likely to be registered prospectively than older RCTs (2014-2016: 57.3% vs. 2011-2013: 39.2%; c 2  = 5.5, P = 0.02). Assessment on the Consolidated Standards of Reporting Trials demonstrated that less than half of all studies reported data collection dates (n = 108; 48.4%) or included "randomized trial" in the title (n = 89; 39.9%). The methodological reporting of RCTs published in obesity journals is suboptimal, despite current guidelines and policies. To complement existing standards, editorial boards should incorporate mandatory fields within the online manuscript submission process to enhance the quality, transparency, and comprehensiveness of reporting RCTs in obesity journals. © 2017 The Obesity Society.

Clinical trial transparency: a reassessment of industry compliance with clinical trial registration and reporting requirements in the United States

PubMed Central

Lassman, Scott M; Shopshear, Olivia M; Jazic, Ina; Ulrich, Jocelyn; Francer, Jeffrey

2017-01-01

Objective To evaluate the accuracy of a 2015 cross-sectional analysis published in the BMJ Open which reported that pharmaceutical industry compliance with clinical trial registration and results reporting requirements under US law was suboptimal and varied widely among companies. Design We performed a reassessment of the data reported in Miller et al to evaluate whether statutory compliance analyses and conclusions were valid. Data sources Information from the Dryad Digital Repository, ClinicalTrials.gov, Drugs@FDA and direct communications with sponsors. Main outcome measures Compliance with the clinical trial registration and results reporting requirements under the Food and Drug Administration Amendments Act (FDAAA). Results Industry compliance with FDAAA disclosure requirements was notably higher than reported by Miller et al. Among trials subject to FDAAA, Miller et al reported that, per drug, a median of 67% (middle 50% range: 0%–100%) of trials fully complied with registration and results reporting requirements. On reanalysis of the data, we found that a median of 100% (middle 50% range: 93%–100%) of clinical trials for a particular drug fully complied with the law. When looking at overall compliance at the trial level, our reassessment yields 94% timely registration and 90% timely results reporting among the 49 eligible trials, and an overall FDAAA compliance rate of 86%. Conclusions The claim by Miller et al that industry compliance is below legal standards is based on an analysis that relies on an incomplete dataset and an interpretation of FDAAA that requires disclosure of study results for drugs that have not yet been approved for any indication. On reanalysis using a different interpretation of FDAAA that focuses on whether results were disclosed within 30 days of drug approval, we found that industry compliance with US statutory disclosure requirements for the 15 reviewed drugs was consistently high. PMID:28942418

Association of the FDA Amendment Act with trial registration, publication, and outcome reporting.

PubMed

Phillips, Adam T; Desai, Nihar R; Krumholz, Harlan M; Zou, Constance X; Miller, Jennifer E; Ross, Joseph S

2017-07-18

Selective clinical trial publication and outcome reporting has the potential to bias the medical literature. The 2007 Food and Drug Administration (FDA) Amendment Act (FDAAA) mandated clinical trial registration and outcome reporting on ClinicalTrials.gov, a publicly accessible trial registry. Using publicly available data from ClinicalTrials.gov, FDA documents, and PubMed, we determined registration, publication, and reporting of findings for all efficacy trials supporting FDA approval of new drugs for cardiovascular disease and diabetes between 2005 and 2014, before and after the FDAAA. For published trials, we compared the published interpretation of the findings (positive, equivocal, or negative) with the FDA reviewer's interpretation. Between 2005 and 2014, the FDA approved 30 drugs for 32 indications of cardiovascular disease (n = 17) and diabetes (n = 15) on the basis of 183 trials (median per indication 5.7 (IQR, 3-8)). Compared with pre FDAAA, post-FDAAA studies were more likely to be registered (78 of 78 (100%) vs 73 of 105 (70%); p < 0.001), to be published (76 of 78 (97%) vs 93 of 105 (89%); p = 0.03), and to present findings concordant with the FDA reviewer's interpretation (74 of 76 (97%) vs 78 of 93 (84%); p = 0.004). Pre FDAAA, the FDA reviewer interpreted 80 (76%) trials as positive and 91 (98%) were published as positive. Post FDAAA, the FDA reviewer interpreted 71 (91%) trials as positive and 71 (93%) were published as positive. FDAAA was associated with increased registration, publication, and FDA-concordant outcome reporting for trials supporting FDA approval of new drugs for cardiovascular disease and diabetes.

[Registration of observational studies: it is time to comply with the Declaration of Helsinki requirement].

PubMed

Dal-Ré, Rafael; Delgado, Miguel; Bolumar, Francisco

2015-01-01

Publication bias is a serious deficiency in the current system of disseminating the results of human research studies. Clinical investigators know that, from an ethical standpoint, they should prospectively register clinical trials in a public registry before starting them. In addition, it is believed that this approach will help to reduce publication bias. However, most studies conducted in humans are observational rather than experimental. It is estimated that less than 2% out of 2 million concluded or ongoing observational studies have been registered. The 2013 revision of the Declaration of Helsinki requires registration of any type of research study involving humans or identifiable samples or data. It is proposed that funding agencies, such as the Fondo de Investigaciones Sanitarias, as well as private companies, require preregistration of observational studies before providing funding. It is also proposed that Research Ethics Committees which, following Spanish regulation, have been using the Declaration as the framework for assessing the ethics of clinical trials with medicines since 1990, should follow the same provisions for the assessment of health-related observational studies: therefore, they should require prospective registration of studies before granting their final approval. This would allow observational study investigators to be educated in complying with an ethical requirement recently introduced in the most important ethical code for research involving humans. Copyright © 2014 SESPAS. Published by Elsevier Espana. All rights reserved.

Unreported links between trial registrations and published articles were identified using document similarity measures in a cross-sectional analysis of ClinicalTrials.gov.

PubMed

Dunn, Adam G; Coiera, Enrico; Bourgeois, Florence T

2018-03-01

Trial registries can be used to measure reporting biases and support systematic reviews, but 45% of registrations do not provide a link to the article reporting on the trial. We evaluated the use of document similarity methods to identify unreported links between ClinicalTrials.gov and PubMed. We extracted terms and concepts from a data set of 72,469 ClinicalTrials.gov registrations and 276,307 PubMed articles and tested methods for ranking articles across 16,005 reported links and 90 manually identified unreported links. Performance was measured by the median rank of matching articles and the proportion of unreported links that could be found by screening ranked candidate articles in order. The best-performing concept-based representation produced a median rank of 3 (interquartile range [IQR] 1-21) for reported links and 3 (IQR 1-19) for the manually identified unreported links, and term-based representations produced a median rank of 2 (1-20) for reported links and 2 (IQR 1-12) in unreported links. The matching article was ranked first for 40% of registrations, and screening 50 candidate articles per registration identified 86% of the unreported links. Leveraging the growth in the corpus of reported links between ClinicalTrials.gov and PubMed, we found that document similarity methods can assist in the identification of unreported links between trial registrations and corresponding articles. Copyright © 2017 Elsevier Inc. All rights reserved.

Impact of registration on clinical trials on infection risk in pediatric acute myeloid leukemia.

PubMed

Dix, David; Aplenc, Richard; Bowes, Lynette; Cellot, Sonia; Ethier, Marie-Chantal; Feusner, Jim; Gillmeister, Biljana; Johnston, Donna L; Lewis, Victor; Michon, Bruno; Mitchell, David; Portwine, Carol; Price, Victoria; Silva, Mariana; Stobart, Kent; Yanofsky, Rochelle; Zelcer, Shayna; Beyene, Joseph; Sung, Lillian

2016-04-01

Little is known about the impact of enrollment on therapeutic clinical trials on adverse event rates. Primary objective was to describe the impact of clinical trial registration on sterile site microbiologically documented infection for children with newly diagnosed acute myeloid leukemia (AML). We conducted a multicenter cohort study that included children aged ≤18 years with de novo AML. Primary outcome was microbiologically documented sterile site infection. Infection rates were compared between those registered and not registered on clinical trials. Five hundred seventy-four children with AML were included of which 198 (34.5%) were registered on a therapeutic clinical trial. Overall, 400 (69.7%) had at least one sterile site microbiologically documented infection. In multiple regression, registration on clinical trials was independently associated with a higher risk of microbiologically documented sterile site infection [adjusted odds ratio (OR) 1.24, 95% confidence interval (CI) 1.01-1.53; p = 0.040] and viridans group streptococcal infection (OR 1.46, 95% CI 1.08-1.98; p = 0.015). Registration on trials was not associated with Gram-negative or invasive fungal infections. Children with newly diagnosed AML enrolled on clinical trials have a higher risk of microbiologically documented sterile site infection. This information may impact on supportive care practices in pediatric AML. © 2015 UICC.

Gender differences in clinical registration trials: is there a real problem?

PubMed Central

Labots, Geert; Jones, Aubrey; de Visser, Saco J.; Burggraaf, Jacobus

2018-01-01

Aims Several studies have reported the under‐representation of women in clinical trials, thereby challenging the external validity of the benefit/risk assessments of launched drugs. Our aim was to determine the extent to which women have been included in clinical trials used for drug registration and to analyse the fraction of women participating in phases I, II and III. Methods We conducted cross‐sectional, structured research into publicly available registration dossiers of Food and Drug Administration (FDA)‐approved drugs that are prescribed frequently. Furthermore, we analysed compounds with high hepatic clearance and a known gender‐related difference in drug response. In a sensitivity analysis, we compared figures with US disease prevalence data. Results For 38 of the initial 137 drugs (28%), sufficient data were reported and publicly available. For these drugs, 185 479 trial participants were included, of whom 47% were female and 44% were male; gender was not reported for 9% of participants. However, the number of female participants varied with the phase of the trial, with 22% females in phase I trials vs. 48% and 49%, respectively, in phase II and III trials. When compared with US disease prevalence data, 10 drugs (26%) had a greater than 20% difference between the proportion of females affected with the disease compared with representation in clinical trials. Conclusions From these publicly available data, there was no evidence of any systematic under‐representation of women in clinical trials. PMID:29293280

Changes to registration elements and results in a cohort of Clinicaltrials.gov trials were not reflected in published articles.

PubMed

Pranić, Shelly; Marušić, Ana

2016-02-01

To assess effectiveness of legislative initiatives to stimulate public registration of trial results, we assessed adherence to protocol and results reporting, changes to registry, and publication data for randomized controlled trials (RCTs) after introduction of Food and Drug Administration Amendment Act (FDAAA). Observational study of a cohort of ClinicalTrials.gov registered FDAAA-covered RCTs found through ClinicalTrials.gov between 2009 and 2012 and data from corresponding publications. WHO Minimum Data Set items were abstracted by one author and verified by the other author. Among 81 eligible trials, most were industry-funded, with a drug intervention in parallel assignment. Secondary outcomes at the initial and last registration were omitted for 17% and 19.7% of RCTs, respectively. RCT registration changes mostly involved scientific title (18.8%). Inclusion criteria omission was most common (88%) in publications. Inferential statistical methods for primary and secondary outcomes matched between registry and publication for 53.4% and 28.6% of RCTs, respectively. Serious and other adverse events (AEs) that were absent for 23.8% and 4.8% of RCTs, respectively, were published as nonoccurring. Discrepancies remain relatively high between registered and published outcomes, particularly regarding registered omissions in publications and concomitant reporting, nature of statistical method used, and reporting of AEs. This seriously undermines transparency of clinical trials and needs immediate attention of all stakeholders in health research. Copyright © 2016 Elsevier Inc. All rights reserved.

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

PubMed

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.

ClinicalTrials.gov registration can supplement information in abstracts for systematic reviews: a comparison study.

PubMed

Scherer, Roberta W; Huynh, Lynn; Ervin, Ann-Margret; Taylor, Jakeisha; Dickersin, Kay

2013-06-18

The inclusion of randomized controlled trials (RCTs) reported in conference abstracts in systematic reviews is controversial, partly because study design information and risk of bias is often not fully reported in the abstract. The Association for Research in Vision and Ophthalmology (ARVO) requires trial registration of abstracts submitted for their annual conference as of 2007. Our goal was to assess the feasibility of obtaining study design information critical to systematic reviews, but not typically included in conference abstracts, from the trial registration record. We reviewed all conference abstracts presented at the ARVO meetings from 2007 through 2009, and identified 496 RCTs; 154 had a single matching registration record in ClinicalTrials.gov. Two individuals independently extracted information from the abstract and the ClinicalTrials.gov record, including study design, sample size, inclusion criteria, masking, interventions, outcomes, funder, and investigator name and contact information. Discrepancies were resolved by consensus. We assessed the frequencies of reporting variables appearing in the abstract and the trial register and assessed agreement of information reported in both sources. We found a substantial amount of study design information in the ClinicalTrials.gov record that was unavailable in the corresponding conference abstract, including eligibility criteria associated with gender (83%; 128/154); masking or blinding of study participants (53%, 82/154), persons administering treatment (30%, 46/154), and persons measuring the outcomes (40%, 61/154)); and number of study centers (58%; 90/154). Only 34% (52/154) of abstracts explicitly described a primary outcome, but a primary outcome was included in the "Primary Outcome" field in the ClinicalTrials.gov record for 82% (126/154) of studies. One or more study interventions were reported in each abstract, but agreed exactly with those reported in ClinicalTrials.gov only slightly more than half

ClinicalTrials.gov registration can supplement information in abstracts for systematic reviews: a comparison study

PubMed Central

2013-01-01

Background The inclusion of randomized controlled trials (RCTs) reported in conference abstracts in systematic reviews is controversial, partly because study design information and risk of bias is often not fully reported in the abstract. The Association for Research in Vision and Ophthalmology (ARVO) requires trial registration of abstracts submitted for their annual conference as of 2007. Our goal was to assess the feasibility of obtaining study design information critical to systematic reviews, but not typically included in conference abstracts, from the trial registration record. Methods We reviewed all conference abstracts presented at the ARVO meetings from 2007 through 2009, and identified 496 RCTs; 154 had a single matching registration record in ClinicalTrials.gov. Two individuals independently extracted information from the abstract and the ClinicalTrials.gov record, including study design, sample size, inclusion criteria, masking, interventions, outcomes, funder, and investigator name and contact information. Discrepancies were resolved by consensus. We assessed the frequencies of reporting variables appearing in the abstract and the trial register and assessed agreement of information reported in both sources. Results We found a substantial amount of study design information in the ClinicalTrials.gov record that was unavailable in the corresponding conference abstract, including eligibility criteria associated with gender (83%; 128/154); masking or blinding of study participants (53%, 82/154), persons administering treatment (30%, 46/154), and persons measuring the outcomes (40%, 61/154)); and number of study centers (58%; 90/154). Only 34% (52/154) of abstracts explicitly described a primary outcome, but a primary outcome was included in the “Primary Outcome” field in the ClinicalTrials.gov record for 82% (126/154) of studies. One or more study interventions were reported in each abstract, but agreed exactly with those reported in ClinicalTrials

Do emergency medicine journals promote trial registration and adherence to reporting guidelines? A survey of "Instructions for Authors".

PubMed

Sims, Matthew T; Henning, Nolan M; Wayant, C Cole; Vassar, Matt

2016-11-24

The aim of this study was to evaluate the current state of two publication practices, reporting guidelines requirements and clinical trial registration requirements, by analyzing the "Instructions for Authors" of emergency medicine journals. We performed a web-based data abstraction from the "Instructions for Authors" of the 27 Emergency Medicine journals catalogued in the Expanded Science Citation Index of the 2014 Journal Citation Reports and Google Scholar Metrics h5-index to identify whether each journal required, recommended, or made no mention of the following reporting guidelines: EQUATOR Network, ICMJE, ARRIVE, CARE, CONSORT, STARD, TRIPOD, CHEERS, MOOSE, STROBE, COREQ, SRQR, SQUIRE, PRISMA-P, SPIRIT, PRISMA, and QUOROM. We also extracted whether journals required or recommended trial registration. Authors were blinded to one another's ratings until completion of the data validation. Cross-tabulations and descriptive statistics were calculated using IBM SPSS 22. Of the 27 emergency medicine journals, 11 (11/27, 40.7%) did not mention a single guideline within their "Instructions for Authors," while the remaining 16 (16/27, 59.3%) mentioned one or more guidelines. The QUOROM statement and SRQR were not mentioned by any journals whereas the ICMJE guidelines (18/27, 66.7%) and CONSORT statement (15/27, 55.6%) were mentioned most often. Of the 27 emergency medicine journals, 15 (15/27, 55.6%) did not mention trial or review registration, while the remaining 12 (12/27, 44.4%) at least mentioned one of the two. Trial registration through ClinicalTrials.gov was mentioned by seven (7/27, 25.9%) journals while the WHO registry was mentioned by four (4/27, 14.8%). Twelve (12/27, 44.4%) journals mentioned trial registration through any registry platform. The aim of this study was to evaluate the current state of two publication practices, reporting guidelines requirements and clinical trial registration requirements, by analyzing the "Instructions for Authors" of

Serious adverse events and compensation in registration trials: a review of data from a Japanese university hospital

PubMed Central

2014-01-01

Background Clinical trials leading to regulatory approval, or registration trials, play a central role in the development of drugs and medical devices. The contribution of support staff, such as the clinical research coordinator (CRC) and administrative officers, in registration trials is now widely recognized. Attending to serious adverse events is an important duty of the CRC and investigators alike, and managing these complications and compensation constitutes a key responsibility. We retrospectively examined the frequency of serious adverse events and compensation events reported from 2007 through 2011 at Tokushima University Hospital, an academic hospital in rural Japan. We present herein the results of our analysis. Results Over the five-year period, 284 subjects participating in 106 registration trials experienced a total of 43 serious adverse events, and eight compensation events were documented. Among the serious adverse events, 35 (81.4%) were considered not related to the investigational drug, and 17 (39.5%) resulted in withdrawal of the study drug. Patients with malignant diseases experienced serious adverse events significantly more frequently compared to those with non-malignant diseases (28.3% versus 8.2%, respectively; P < 0.01). Conclusions The CRC should be vigilant for serious adverse events in oncology clinical trials due to the generally higher frequency of these complications in subjects with malignancy. However, on an individual basis, the CRC may be seldom involved in the process for compensating serious adverse events. Therefore, the CRC’s ability to share such experiences may serve as an opportunity for educating clinical trial support staff at the study site as well as those at other sites. However, further study is warranted to determine the role of the clinical trial support staff in optimizing methods for managing adverse events requiring compensation in registration trials. PMID:24742228

Compliance with prospective trial registration guidance remained low in high-impact journals and has implications for primary end point reporting.

PubMed

Dal-Ré, Rafael; Ross, Joseph S; Marušić, Ana

2016-07-01

To examine compliance with International Committee of Medical Journal Editors' (ICMJE) policy on prospective trial registration along with predictors of compliance. Cross-sectional analysis of all articles reporting trial results published in the six highest-impact general medicine journals in January-June 2014 that were registered in a public trial registry. The main outcome measure was compliance with ICMJE policy. The time frame for trial primary end point ascertainment was used to assess whether retrospective registration could have allowed changing of primary end points following an interim analysis. Forty of 144 (28%) articles did not comply with the ICMJE policy. Trials of non-FDA-regulated interventions were less compliant than trials of FDA-regulated interventions (i.e., medicines, medical devices) (42% vs. 21%; P = 0.016). Twenty-nine of these 40 (72%; 20% overall) were registered before any interim analysis of primary end points could have been conducted; 11 (28%; 8% overall) were registered after primary end point ascertainment, such that investigators could have had the opportunity to conduct an interim analysis before trial registration. Twenty-eight percent of trials published in high-impact journals were retrospectively registered including nearly 10% that were registered after primary end point ascertainment could have had taken place. Prospective registration should be prompted and enforced to ensure transparency and accountability in clinical research. Copyright © 2016 Elsevier Inc. All rights reserved.

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

PubMed

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.

Participant Recruitment and Engagement in Automated eHealth Trial Registration: Challenges and Opportunities for Recruiting Women Who Experience Violence.

PubMed

Koziol-McLain, Jane; McLean, Christine; Rohan, Maheswaran; Sisk, Rose; Dobbs, Terry; Nada-Raja, Shyamala; Wilson, Denise; Vandal, Alain C

2016-10-25

Automated eHealth Web-based research trials offer people an accessible, confidential opportunity to engage in research that matters to them. eHealth trials may be particularly useful for sensitive issues when seeking health care may be accompanied by shame and mistrust. Yet little is known about people's early engagement with eHealth trials, from recruitment to preintervention autoregistration processes. A recent randomized controlled trial that tested the effectiveness of an eHealth safety decision aid for New Zealand women in the general population who experienced intimate partner violence (isafe) provided the opportunity to examine recruitment and preintervention participant engagement with a fully automated Web-based registration process. The trial aimed to recruit 340 women within 24 months. The objective of our study was to examine participant preintervention engagement and recruitment efficiency for the isafe trial, and to analyze dropout through the registration pathway, from recruitment to eligibility screening and consent, to completion of baseline measures. In this case study, data collection sources included the trial recruitment log, Google Analytics reports, registration and program metadata, and costs. Analysis included a qualitative narrative of the recruitment experience and descriptive statistics of preintervention participant engagement and dropout rates. A Koyck model investigated the relationship between Web-based online marketing website advertisements (ads) and participant accrual. The isafe trial was launched on September 17, 2012. Placement of ads in an online classified advertising platform increased the average number of recruited participants per month from 2 to 25. Over the 23-month recruitment period, the registration website recorded 4176 unique visitors. Among 1003 women meeting eligibility criteria, 51.55% (517) consented to participate; among the 501 women who enrolled (consented, validated, and randomized), 412 (82.2%) were

The assessment of field trials in GMO research around the world and their possible integration in field trials for variety registration.

PubMed

Slot, M M; van de Wiel, C C M; Kleter, G A; Visser, R G F; Kok, E J

2018-05-04

Most regulations worldwide stipulate that a new genetically modified (GM) crop event has to be compared to its closest non-GM counterpart as a corner stone of the pre-market risk assessment. To this end the GM crop and its comparator should be grown in field trials for a phenotypic comparison as well as for subsequent detailed analysis of the composition of the two crop varieties. A more in-depth globally harmonised approach for the conduct of these field trials is lacking. Only a few countries have formulated detailed protocols for the set-up of GM field trials. In some countries, commercial non-GM reference varieties need to be included in a field study to compile reliable data that indicate the range of natural variation for the compounds tested at the specific location. Detailed analysis of pre-market assessment reports have so far not shown the added value of including these reference varieties in the field trials. In all cases where specific values were found to be outside of the range of the reference varieties, it proved possible to draw conclusions on the part of the pre-market risk assessment that relates to the compositional analysis, on the basis of already available compositional data. With the increasing quality of several databases on compositional data of a growing number of crop species, it seems unlikely that reference varieties will become more important on future occasions. It was furthermore investigated whether this part of the risk assessment can be related to field trial requirements for variety registration with the explicit intention of reducing the data burden on producers of new GM plant varieties. Field trials for variety registration so far include an assessment of phenotypic characteristics that do not cover safety aspects, with the exception of establishment of the glycoalkaloid content in potatoes in the Netherlands and Sweden. It may, however, under certain conditions be relatively easy to exchange data from compositional

Participant Recruitment and Engagement in Automated eHealth Trial Registration: Challenges and Opportunities for Recruiting Women Who Experience Violence

PubMed Central

McLean, Christine; Rohan, Maheswaran; Sisk, Rose; Dobbs, Terry; Nada-Raja, Shyamala; Wilson, Denise; Vandal, Alain C

2016-01-01

Background Automated eHealth Web-based research trials offer people an accessible, confidential opportunity to engage in research that matters to them. eHealth trials may be particularly useful for sensitive issues when seeking health care may be accompanied by shame and mistrust. Yet little is known about people’s early engagement with eHealth trials, from recruitment to preintervention autoregistration processes. A recent randomized controlled trial that tested the effectiveness of an eHealth safety decision aid for New Zealand women in the general population who experienced intimate partner violence (isafe) provided the opportunity to examine recruitment and preintervention participant engagement with a fully automated Web-based registration process. The trial aimed to recruit 340 women within 24 months. Objective The objective of our study was to examine participant preintervention engagement and recruitment efficiency for the isafe trial, and to analyze dropout through the registration pathway, from recruitment to eligibility screening and consent, to completion of baseline measures. Methods In this case study, data collection sources included the trial recruitment log, Google Analytics reports, registration and program metadata, and costs. Analysis included a qualitative narrative of the recruitment experience and descriptive statistics of preintervention participant engagement and dropout rates. A Koyck model investigated the relationship between Web-based online marketing website advertisements (ads) and participant accrual. Results The isafe trial was launched on September 17, 2012. Placement of ads in an online classified advertising platform increased the average number of recruited participants per month from 2 to 25. Over the 23-month recruitment period, the registration website recorded 4176 unique visitors. Among 1003 women meeting eligibility criteria, 51.55% (517) consented to participate; among the 501 women who enrolled (consented, validated

Exclusion of patients with concomitant chronic conditions in ongoing randomised controlled trials targeting 10 common chronic conditions and registered at ClinicalTrials.gov: a systematic review of registration details.

PubMed

Buffel du Vaure, Céline; Dechartres, Agnès; Battin, Constance; Ravaud, Philippe; Boutron, Isabelle

2016-09-27

To systematically assess registration details of ongoing randomised controlled trials (RCTs) targeting 10 common chronic conditions and registered at ClinicalTrials.gov and to determine the prevalence of (1) trial records excluding patients with concomitant chronic condition(s) and (2) those specifically targeting patients with concomitant chronic conditions. Systematic review of trial registration records. ClinicalTrials.gov register. All ongoing RCTs registered from 1 January 2014 to 31 January 2015 that assessed an intervention targeting adults with coronary heart disease (CHD), hypertension, heart failure, stroke/transient ischaemic attack, atrial fibrillation, type 2 diabetes, chronic obstructive pulmonary disease, painful condition, depression and dementia with a target sample size ≥100. From the trial registration records, 2 researchers independently recorded the trial characteristics and the number of exclusion criteria and determined whether patients with concomitant chronic conditions were excluded or specifically targeted. Among 319 ongoing RCTs, despite the high prevalence of the concomitant chronic conditions, patients with these conditions were excluded in 251 trials (79%). For example, although 91% of patients with CHD had a concomitant chronic condition, 69% of trials targeting such patients excluded patients with concomitant chronic condition(s). When considering the co-occurrence of 2 chronic conditions, 31% of patients with chronic pain also had depression, but 58% of the trials targeting patients with chronic pain excluded patients with depression. Only 37 trials (12%) assessed interventions specifically targeting patients with concomitant chronic conditions; 31 (84%) excluded patients with concomitant chronic condition(s). Despite widespread multimorbidity, more than three-quarters of ongoing trials assessing interventions for patients with chronic conditions excluded patients with concomitant chronic conditions. Published by the BMJ

Pharmacy Students' Knowledge and Attitude toward Registration Trials and Clinical Research: A Survey in a Japanese University Hospital.

PubMed

Ise, Natsuko; Takechi, Kenshi; Miyamoto, Toshiko; Ishizawa, Keisuke; Yanagawa, Hiroaki

2017-12-11

Clinical research plays a fundamental role in establishing new treatments. Clinical research coordinators are considered essential in clinical research, and medical professionals such as pharmacists often take on this role. Pharmacy students can be considered future candidates for this task. We used questionnaires to survey the knowledge of and attitudes toward registration trials and clinical research of pharmacy students at Tokushima University Hospital. All pharmacy students (103) to whom questionnaires were sent responded. Almost all respondents were aware of registration trials and clinical research. More than 90% were aware of the existence of clinical research coordinators, and about half (48.6%) understood their role. In clinical research terminology, most respondents were aware of informed consent and related issues, but fewer than 20% were aware of more practical things. In total, 29.1% and 40.8% of the respondents were willing to carry out and coordinate research. These findings suggest that pharmacy students have basic knowledge of clinical research and that many students are willing to carry out and coordinate clinical research. More practical exposure to clinical research may help to strengthen their future contribution. Further studies may help to determine how to provide education on registration trials and clinical research to pharmacy students.

Assessment of Registration Information on Methodological Design of Acupuncture RCTs: A Review of 453 Registration Records Retrieved from WHO International Clinical Trials Registry Platform

PubMed Central

Gu, Jing; Wang, Qi; Wang, Xiaogang; Li, Hailong; Gu, Mei; Ming, Haixia; Dong, Xiaoli; Yang, Kehu; Wu, Hongyan

2014-01-01

Background. This review provides the first methodological information assessment of protocol of acupuncture RCTs registered in WHO International Clinical Trials Registry Platform (ICTRP). Methods. All records of acupuncture RCTs registered in the ICTRP have been collected. The methodological design assessment involved whether the randomization methods, allocation concealment, and blinding were adequate or not based on the information of registration records (protocols of acupuncture RCTs). Results. A total of 453 records, found in 11 registries, were examined. Methodological details were insufficient in registration records; there were 76.4%, 89.0%, and 21.4% records that did not provide information on randomization methods, allocation concealment, and blinding respectively. The proportions of adequate randomization methods, allocation concealment, and blinding were only 107 (23.6%), 48 (10.6%), and 210 (46.4%), respectively. The methodological design improved year by year, especially after 2007. Additionally, methodology of RCTs with ethics approval was clearly superior to those without ethics approval and different among registries. Conclusions. The overall methodological design based on registration records of acupuncture RCTs is not very well but improved year by year. The insufficient information on randomization methods, allocation concealment, and blinding maybe due to the relevant description is not taken seriously in acupuncture RCTs' registration. PMID:24688591

Assessment of Registration Information on Methodological Design of Acupuncture RCTs: A Review of 453 Registration Records Retrieved from WHO International Clinical Trials Registry Platform.

PubMed

Gu, Jing; Wang, Qi; Wang, Xiaogang; Li, Hailong; Gu, Mei; Ming, Haixia; Dong, Xiaoli; Yang, Kehu; Wu, Hongyan

2014-01-01

Background. This review provides the first methodological information assessment of protocol of acupuncture RCTs registered in WHO International Clinical Trials Registry Platform (ICTRP). Methods. All records of acupuncture RCTs registered in the ICTRP have been collected. The methodological design assessment involved whether the randomization methods, allocation concealment, and blinding were adequate or not based on the information of registration records (protocols of acupuncture RCTs). Results. A total of 453 records, found in 11 registries, were examined. Methodological details were insufficient in registration records; there were 76.4%, 89.0%, and 21.4% records that did not provide information on randomization methods, allocation concealment, and blinding respectively. The proportions of adequate randomization methods, allocation concealment, and blinding were only 107 (23.6%), 48 (10.6%), and 210 (46.4%), respectively. The methodological design improved year by year, especially after 2007. Additionally, methodology of RCTs with ethics approval was clearly superior to those without ethics approval and different among registries. Conclusions. The overall methodological design based on registration records of acupuncture RCTs is not very well but improved year by year. The insufficient information on randomization methods, allocation concealment, and blinding maybe due to the relevant description is not taken seriously in acupuncture RCTs' registration.

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

PubMed

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

Promoting deceased organ and tissue donation registration in family physician waiting rooms (RegisterNow-1 trial): study protocol for a pragmatic, stepped-wedge, cluster randomized controlled registry.

PubMed

Li, Alvin H; Garg, Amit X; Prakash, Versha; Grimshaw, Jeremy M; Taljaard, Monica; Mitchell, Joanna; Matti, Danny; Linklater, Stefanie; Naylor, Kyla L; Dixon, Stephanie; Faulds, Cathy; Bevan, Rachel; Getchell, Leah; Knoll, Greg; Kim, S Joseph; Sontrop, Jessica; Bjerre, Lise M; Tong, Allison; Presseau, Justin

2017-12-21

There is a worldwide shortage of organs available for transplant, leading to preventable mortality associated with end-stage organ disease. While most citizens in many countries with an intent-to-donate "opt-in" system support organ donation, registration rates remain low. In Canada, most Canadians support organ donation but less than 25% in most provinces have registered their desire to donate their organs when they die. The family physician office is a promising yet underused setting in which to promote organ donor registration and address known barriers and enablers to registering for deceased organ and tissue donation. We developed a protocol to evaluate an intervention to promote registration for organ and tissue donation in family physician waiting rooms. This protocol describes a planned, stepped-wedge, cluster randomized registry trial in six family physician offices in Ontario, Canada to evaluate the effectiveness of reception staff providing patients with a pamphlet that addresses barriers and enablers to registration including a description of how to register for organ donation. An Internet-enabled tablet will also be provided in waiting rooms so that interested patients can register while waiting for their appointments. Family physicians and reception staff will be provided with training and/or materials to support any conversations about organ donation with their patients. Following a 2-week control period, the six offices will cross sequentially into the intervention arm in randomized sequence at 2-week intervals until all offices deliver the intervention. The primary outcome will be the proportion of patients visiting the office who are registered organ donors 7 days following their office visit. We will evaluate this outcome using routinely collected registry data from provincial administrative databases. A post-trial qualitative evaluation process will assess the experiences of reception staff and family physicians with the intervention and the

Accurate CT-MR image registration for deep brain stimulation: a multi-observer evaluation study

NASA Astrophysics Data System (ADS)

Rühaak, Jan; Derksen, Alexander; Heldmann, Stefan; Hallmann, Marc; Meine, Hans

2015-03-01

Since the first clinical interventions in the late 1980s, Deep Brain Stimulation (DBS) of the subthalamic nucleus has evolved into a very effective treatment option for patients with severe Parkinson's disease. DBS entails the implantation of an electrode that performs high frequency stimulations to a target area deep inside the brain. A very accurate placement of the electrode is a prerequisite for positive therapy outcome. The assessment of the intervention result is of central importance in DBS treatment and involves the registration of pre- and postinterventional scans. In this paper, we present an image processing pipeline for highly accurate registration of postoperative CT to preoperative MR. Our method consists of two steps: a fully automatic pre-alignment using a detection of the skull tip in the CT based on fuzzy connectedness, and an intensity-based rigid registration. The registration uses the Normalized Gradient Fields distance measure in a multilevel Gauss-Newton optimization framework and focuses on a region around the subthalamic nucleus in the MR. The accuracy of our method was extensively evaluated on 20 DBS datasets from clinical routine and compared with manual expert registrations. For each dataset, three independent registrations were available, thus allowing to relate algorithmic with expert performance. Our method achieved an average registration error of 0.95mm in the target region around the subthalamic nucleus as compared to an inter-observer variability of 1.12 mm. Together with the short registration time of about five seconds on average, our method forms a very attractive package that can be considered ready for clinical use.

Beating-heart registration for organ-mounted robots.

PubMed

Wood, Nathan A; Schwartzman, David; Passineau, Michael J; Moraca, Robert J; Zenati, Marco A; Riviere, Cameron N

2018-03-06

Organ-mounted robots address the problem of beating-heart surgery by adhering to the heart, passively providing a platform that approaches zero relative motion. Because of the quasi-periodic deformation of the heart due to heartbeat and respiration, registration must address not only spatial registration but also temporal registration. Motion data were collected in the porcine model in vivo (N = 6). Fourier series models of heart motion were developed. By comparing registrations generated using an iterative closest-point approach at different phases of respiration, the phase corresponding to minimum registration distance is identified. The spatiotemporal registration technique presented here reduces registration error by an average of 4.2 mm over the 6 trials, in comparison with a more simplistic static registration that merely averages out the physiological motion. An empirical metric for spatiotemporal registration of organ-mounted robots is defined and demonstrated using data from animal models in vivo. Copyright © 2018 John Wiley & Sons, Ltd.

Optimizing image registration and infarct definition in stroke research.

PubMed

Harston, George W J; Minks, David; Sheerin, Fintan; Payne, Stephen J; Chappell, Michael; Jezzard, Peter; Jenkinson, Mark; Kennedy, James

2017-03-01

Accurate representation of final infarct volume is essential for assessing the efficacy of stroke interventions in imaging-based studies. This study defines the impact of image registration methods used at different timepoints following stroke, and the implications for infarct definition in stroke research. Patients presenting with acute ischemic stroke were imaged serially using magnetic resonance imaging. Infarct volume was defined manually using four metrics: 24-h b1000 imaging; 1-week and 1-month T2-weighted FLAIR; and automatically using predefined thresholds of ADC at 24 h. Infarct overlap statistics and volumes were compared across timepoints following both rigid body and nonlinear image registration to the presenting MRI. The effect of nonlinear registration on a hypothetical trial sample size was calculated. Thirty-seven patients were included. Nonlinear registration improved infarct overlap statistics and consistency of total infarct volumes across timepoints, and reduced infarct volumes by 4.0 mL (13.1%) and 7.1 mL (18.2%) at 24 h and 1 week, respectively, compared to rigid body registration. Infarct volume at 24 h, defined using a predetermined ADC threshold, was less sensitive to infarction than b1000 imaging. 1-week T2-weighted FLAIR imaging was the most accurate representation of final infarct volume. Nonlinear registration reduced hypothetical trial sample size, independent of infarct volume, by an average of 13%. Nonlinear image registration may offer the opportunity of improving the accuracy of infarct definition in serial imaging studies compared to rigid body registration, helping to overcome the challenges of anatomical distortions at subacute timepoints, and reducing sample size for imaging-based clinical trials.

Automatic segmentation of male pelvic anatomy on computed tomography images: a comparison with multiple observers in the context of a multicentre clinical trial.

PubMed

Geraghty, John P; Grogan, Garry; Ebert, Martin A

2013-04-30

algorithms based on image-registration as in iPlan, it is apparent that agreement between observer and automatic segmentation will be a function of patient-specific image characteristics, particularly for anatomy with poor contrast definition. For this reason, it is suggested that automatic registration based on transformation of a single reference dataset adds a significant systematic bias to the resulting volumes and their use in the context of a multicentre trial should be carefully considered.

A pivotal registration phase III, multicenter, randomized tuberculosis controlled trial: design issues and lessons learnt from the Gatifloxacin for TB (OFLOTUB) project.

PubMed

Merle, Corinne S C; Sismanidis, Charalambos; Sow, Oumou Bah; Gninafon, Martin; Horton, John; Lapujade, Olivier; Lo, Mame Bocar; Mitchinson, Denis A; Perronne, Christian; Portaels, Francoise; Odhiambo, Joseph; Olliaro, Piero; Rustomjee, Roxana; Lienhardt, Christian; Fielding, Katherine

2012-05-18

There have been no major advances in tuberculosis (TB) drug development since the first East African/British Medical Research Council short course chemotherapy trial 35 years ago. Since then, the landscape for conducting TB clinical trials has profoundly changed with the emergence of HIV infection, the spread of resistant TB bacilli strains, recent advances in mycobacteriological capacity, and drug discovery. As a consequence questions have arisen on the most appropriate approach to design and conduct current TB trials. To highlight key issues discussed: Is a superiority, equivalence, or non-inferiority design most appropriate? What should be the primary efficacy outcome? How to consider re-infections in the definition of the outcome? What is the optimal length of patient follow-up? Is blinding appropriate when treatment duration in test arm is shorter? What are the appropriate assumptions for sample size calculation? Various drugs are currently in the development pipeline. We are presenting in this paper the design of the most recently completed phase III TB trial, the OFLOTUB project, which is the pivotal trial of a registration portfolio for a gatifloxacin-containing TB regimen. It is a randomized, open-label, multicenter, controlled trial aiming to evaluate the efficacy and safety of a gatifloxacin-containing 4-month regimen (trial registration: ClinicalTrial.gov database: NCT00216385). In the light of the recent scientific and regulatory discussions, we discuss some of the design issues in TB clinical trials and more specifically the reasons that guided our choices, in order to best answer the trial objectives, while at the same time satisfying regulatory authority requirements. When shortening TB treatment, we are advocating for a non-inferiority, non-blinded design, with a composite unfavorable endpoint assessed 12 months post treatment completion, and added trial procedures specifically aiming to: (1) minimize endpoint unavailability; and (2) distinguish

Development and evaluation of an articulated registration algorithm for human skeleton registration

NASA Astrophysics Data System (ADS)

Yip, Stephen; Perk, Timothy; Jeraj, Robert

2014-03-01

Accurate registration over multiple scans is necessary to assess treatment response of bone diseases (e.g. metastatic bone lesions). This study aimed to develop and evaluate an articulated registration algorithm for the whole-body skeleton registration in human patients. In articulated registration, whole-body skeletons are registered by auto-segmenting into individual bones using atlas-based segmentation, and then rigidly aligning them. Sixteen patients (weight = 80-117 kg, height = 168-191 cm) with advanced prostate cancer underwent the pre- and mid-treatment PET/CT scans over a course of cancer therapy. Skeletons were extracted from the CT images by thresholding (HU>150). Skeletons were registered using the articulated, rigid, and deformable registration algorithms to account for position and postural variability between scans. The inter-observers agreement in the atlas creation, the agreement between the manually and atlas-based segmented bones, and the registration performances of all three registration algorithms were all assessed using the Dice similarity index—DSIobserved, DSIatlas, and DSIregister. Hausdorff distance (dHausdorff) of the registered skeletons was also used for registration evaluation. Nearly negligible inter-observers variability was found in the bone atlases creation as the DSIobserver was 96 ± 2%. Atlas-based and manual segmented bones were in excellent agreement with DSIatlas of 90 ± 3%. Articulated (DSIregsiter = 75 ± 2%, dHausdorff = 0.37 ± 0.08 cm) and deformable registration algorithms (DSIregister = 77 ± 3%, dHausdorff = 0.34 ± 0.08 cm) considerably outperformed the rigid registration algorithm (DSIregsiter = 59 ± 9%, dHausdorff = 0.69 ± 0.20 cm) in the skeleton registration as the rigid registration algorithm failed to capture the skeleton flexibility in the joints. Despite superior skeleton registration performance, deformable registration algorithm failed to preserve the local rigidity of bones as over 60% of the

Public availability of results of observational studies evaluating an intervention registered at ClinicalTrials.gov.

PubMed

Baudart, Marie; Ravaud, Philippe; Baron, Gabriel; Dechartres, Agnes; Haneef, Romana; Boutron, Isabelle

2016-01-28

(s) registered at ClinicalTrials.gov had their results published at least 30 months after study completion. The registration of these observational studies allowed searching other sources (results posted at ClinicalTrials.gov and sponsor website) and obtaining results for half of unpublished studies and 93% of the total target number of participants.

[Clinical trials registry].

PubMed

Ryder, Elena

2004-12-01

Authors and journals are more enthusiastic about the publication of trials with positive results than those negative or inconclusive trials. The International Committee of Medical Journal Editors proposed comprehensive trials registration as a solution to the problem of selective awareness and announces that the ICMJE member journals will adopt a trial-registration policy to promote this goal. They establish as a condition of consideration for publication, registration in a public trials registry. They recommend registries that meet certain criteria as www.clinicaltrials.com. Among those criteria is that the registry must be supported by a non-profit organization. On the other hand, people from Current Controlled Trials Ltd. being a commercial company, but meeting all the other criteria established by the ICMJE, feel that is being put aside. We wonder if clinical trials in our country are being registered in some of these International Registries. If not, would it be time to do so?

Clinical trial registration, reporting, publication and FDAAA compliance: a cross-sectional analysis and ranking of new drugs approved by the FDA in 2012

PubMed Central

Miller, Jennifer E; Korn, David; Ross, Joseph S

2015-01-01

Objective To evaluate clinical trial registration, reporting and publication rates for new drugs by: (1) legal requirements and (2) the ethical standard that all human subjects research should be publicly accessible to contribute to generalisable knowledge. Design Cross-sectional analysis of all clinical trials submitted to the Food and Drug Administration (FDA) for drugs approved in 2012, sponsored by large biopharmaceutical companies. Data sources Information from Drugs@FDA, ClinicalTrials.gov, MEDLINE-indexed journals and drug company communications. Main outcome measures Clinical trial registration and results reporting in ClinicalTrials.gov, publication in the medical literature, and compliance with the 2007 FDA Amendments Acts (FDAAA), analysed on the drug level. Results The FDA approved 15 drugs sponsored by 10 large companies in 2012. We identified 318 relevant trials involving 99 599 research participants. Per drug, a median of 57% (IQR 32–83%) of trials were registered, 20% (IQR 12–28%) reported results in ClinicalTrials.gov, 56% (IQR 41–83%) were published, and 65% (IQR 41–83%) were either published or reported results. Almost half of all reviewed drugs had at least one undisclosed phase II or III trial. Per drug, a median of 17% (IQR 8–20%) of trials supporting FDA approvals were subject to FDAAA mandated public disclosure; of these, a median of 67% (IQR 0–100%) were FDAAA-compliant. 68% of research participants (67 629 of 99 599) participated in FDAAA-subject trials, with 51% (33 405 of 67 629) enrolled in non-compliant trials. Transparency varied widely among companies. Conclusions Trial disclosures for new drugs remain below legal and ethics standards, with wide variation in practices among drugs and their sponsors. Best practices are emerging. 2 of our 10 reviewed companies disclosed all trials and complied with legal disclosure requirements for their 2012 approved drugs. Ranking new drugs on transparency criteria may improve

A pivotal registration phase III, multicenter, randomized tuberculosis controlled trial: design issues and lessons learnt from the Gatifloxacin for TB (OFLOTUB) project

PubMed Central

2012-01-01

Background There have been no major advances in tuberculosis (TB) drug development since the first East African/British Medical Research Council short course chemotherapy trial 35 years ago. Since then, the landscape for conducting TB clinical trials has profoundly changed with the emergence of HIV infection, the spread of resistant TB bacilli strains, recent advances in mycobacteriological capacity, and drug discovery. As a consequence questions have arisen on the most appropriate approach to design and conduct current TB trials. To highlight key issues discussed: Is a superiority, equivalence, or non-inferiority design most appropriate? What should be the primary efficacy outcome? How to consider re-infections in the definition of the outcome? What is the optimal length of patient follow-up? Is blinding appropriate when treatment duration in test arm is shorter? What are the appropriate assumptions for sample size calculation? Methods Various drugs are currently in the development pipeline. We are presenting in this paper the design of the most recently completed phase III TB trial, the OFLOTUB project, which is the pivotal trial of a registration portfolio for a gatifloxacin-containing TB regimen. It is a randomized, open-label, multicenter, controlled trial aiming to evaluate the efficacy and safety of a gatifloxacin-containing 4-month regimen (trial registration: ClinicalTrial.gov database: NCT00216385). Results In the light of the recent scientific and regulatory discussions, we discuss some of the design issues in TB clinical trials and more specifically the reasons that guided our choices, in order to best answer the trial objectives, while at the same time satisfying regulatory authority requirements. Conclusion When shortening TB treatment, we are advocating for a non-inferiority, non-blinded design, with a composite unfavorable endpoint assessed 12 months post treatment completion, and added trial procedures specifically aiming to: (1) minimize

The Effects of Industry Sponsorship on Comparator Selection in Trial Registrations for Neuropsychiatric Conditions in Children

PubMed Central

Dunn, Adam G.; Mandl, Kenneth D.; Coiera, Enrico; Bourgeois, Florence T.

2013-01-01

Pediatric populations continue to be understudied in clinical drug trials despite the increasing use of pharmacotherapy in children, particularly with psychotropic drugs. Most pertinent to the clinical selection of drug interventions are trials directly comparing drugs against other drugs. The aim was to measure the prevalence of active drug comparators in neuropsychiatric drug trials in children and identify the effects of funding source on comparator selection. We analyzed the selection of drugs and drug comparisons in clinical trials registered between January 2006 and May 2012. Completed and ongoing interventional trials examining treatments for six neuropsychiatric conditions in children were included. Networks of drug comparisons for each condition were constructed using information about the trial study arms. Of 421 eligible trial registrations, 228 (63,699 participants) were drug trials addressing ADHD (106 trials), autism spectrum disorders (47), unipolar depression (16), seizure disorders (38), migraines and other headaches (15), or schizophrenia (11). Active drug comparators were used in only 11.0% of drug trials while 44.7% used a placebo control and 44.3% no drug or placebo comparator. Even among conditions with well-established pharmacotherapeutic options, almost all drug interventions were compared to a placebo. Active comparisons were more common among trials without industry funding (17% vs. 8%, p=0.04). Trials with industry funding differed from non-industry trials in terms of the drugs studied and the comparators selected. For 73% (61/84) of drugs and 90% (19/21) of unique comparisons, trials were funded exclusively by either industry or non-industry. We found that industry and non-industry differed when choosing comparators and active drug comparators were rare for both groups. This gap in pediatric research activity limits the evidence available to clinicians treating children and suggests a need to reassess the design and funding of pediatric

The effects of industry sponsorship on comparator selection in trial registrations for neuropsychiatric conditions in children.

PubMed

Dunn, Adam G; Mandl, Kenneth D; Coiera, Enrico; Bourgeois, Florence T

2013-01-01

Pediatric populations continue to be understudied in clinical drug trials despite the increasing use of pharmacotherapy in children, particularly with psychotropic drugs. Most pertinent to the clinical selection of drug interventions are trials directly comparing drugs against other drugs. The aim was to measure the prevalence of active drug comparators in neuropsychiatric drug trials in children and identify the effects of funding source on comparator selection. We analyzed the selection of drugs and drug comparisons in clinical trials registered between January 2006 and May 2012. Completed and ongoing interventional trials examining treatments for six neuropsychiatric conditions in children were included. Networks of drug comparisons for each condition were constructed using information about the trial study arms. Of 421 eligible trial registrations, 228 (63,699 participants) were drug trials addressing ADHD (106 trials), autism spectrum disorders (47), unipolar depression (16), seizure disorders (38), migraines and other headaches (15), or schizophrenia (11). Active drug comparators were used in only 11.0% of drug trials while 44.7% used a placebo control and 44.3% no drug or placebo comparator. Even among conditions with well-established pharmacotherapeutic options, almost all drug interventions were compared to a placebo. Active comparisons were more common among trials without industry funding (17% vs. 8%, p=0.04). Trials with industry funding differed from non-industry trials in terms of the drugs studied and the comparators selected. For 73% (61/84) of drugs and 90% (19/21) of unique comparisons, trials were funded exclusively by either industry or non-industry. We found that industry and non-industry differed when choosing comparators and active drug comparators were rare for both groups. This gap in pediatric research activity limits the evidence available to clinicians treating children and suggests a need to reassess the design and funding of pediatric

Multidimensional Treatment Foster Care for Adolescents in English care: randomised trial and observational cohort evaluation.

PubMed

Green, J M; Biehal, N; Roberts, C; Dixon, J; Kay, C; Parry, E; Rothwell, J; Roby, A; Kapadia, D; Scott, S; Sinclair, I

2014-03-01

Children in care often have poor outcomes. There is a lack of evaluative research into intervention options. To examine the efficacy of Multidimensional Treatment Foster Care for Adolescents (MTFC-A) compared with usual care for young people at risk in foster care in England. A two-arm single (assessor) blinded randomised controlled trial (RCT) embedded within an observational quasi-experimental case-control study involving 219 young people aged 11-16 years (trial registration: ISRCTN 68038570). The primary outcome was the Child Global Assessment Scale (CGAS). Secondary outcomes were ratings of educational attendance, achievement and rate of offending. The MTFC-A group showed a non-significant improvement in CGAS outcome in both the randomised cohort (n = 34, adjusted mean difference 1.3, 95% CI -7.1 to 9.7, P = 0.75) and in the trimmed observational cohort (n = 185, adjusted mean difference 0.95, 95% CI -2.38 to 4.29, P = 0.57). No significant effects were seen in secondary outcomes. There was a possible differential effect of the intervention according to antisocial behaviour. There was no evidence that the use of MTFC-A resulted in better outcomes than usual care. The intervention may be more beneficial for young people with antisocial behaviour but less beneficial than usual treatment for those without.

The evolution in registration of clinical trials: a chronicle of the historical calls and current initiatives promoting transparency.

PubMed

Pansieri, Claudia; Pandolfini, Chiara; Bonati, Maurizio

2015-10-01

Quality of care is strongly influenced by evidence-based medicine, a large part of which is based on results obtained from clinical trials. If trials are conducted in secret, patient safety is at risk. Several mandates-legal, editorial, financial, and ethical-have tried to influence the disclosure of clinical trials, first by encouraging registration in publicly accessible registers and, second, by calling for the publication of results. Not all these initiatives have reached high rates of compliance, but the succession of national and international events over a few years gave an important boost to information disclosure. This article provides a chronicle of the succession of the events, from the historical calls to the recent EMA policy and WHO statement, and public consultations requested by the NIH, and the HHS, which will inevitably change the international panorama. The path of these new policies is moving towards more supervised clinical research. Individual scientific institutions can also contribute, at the local level, to such an ethical endeavor as is improving research transparency, by disclosing information on the trials coordinated by their own researchers. The way is long and complex, but, if everyone contributes there could be a prompt, worldwide diffusion of the findings of clinical trials, and therefore a more possible evidenced-based medicine.

Three controlled trials of interventions to increase recruitment to a randomized controlled trial of mobile phone based smoking cessation support.

PubMed

Free, Caroline; Hoile, Elizabeth; Robertson, Steven; Knight, Rosemary

2010-06-01

Recruitment is a major challenge for trials but there is little evidence regarding interventions to increase trial recruitment. We report three controlled trials of interventions to increase recruitment to the Txt2stop trial. To evaluate: Trial 1. The impact on registrations of a text message regarding an online registration facility; Trial 2. The impact on randomizations of sending pound5 with a covering letter to those eligible to join the trial; Trial 3. The impact on randomizations of text messages containing quotes from existing participants. Single blind controlled trials with allocation concealment. Trial 1: A text message regarding our new online registration facility; Trial 2: A letter with pound5 enclosed; Trial 3: A series of four text messages containing quotes from participants. The control group in each trial received standard Txt2stop procedures. Trial 1: 3.6% (17/470) of the intervention group and 1.1% (5/467) of the control group registered for the trial, risk difference 2.5% (95% CI 0.6-4.5). 0% (0/ 470) of the intervention group and 0.2% (1/467) of the control group registered successfully online, risk difference -0.2 (95% CI -0.6-0.2); Trial 2: 4.5% (11/246) of the intervention group and 0.4% (1/245) of the control group were randomized into the Txt2stop trial, risk difference 4.0% (95% CI 1.4-6.7); Trial 3: 3.5% (14/405) of the intervention group and 0% (0/406) of the control group were randomized into the Txt2stop trial, risk difference 3.5 (95% CI 1.7-5.2). There were no baseline data available for trial 1. Allocation of participant IDs in trials 2 and 3 were systematic. Sending a text message about an online registration facility increased registrations to Txt2stop, but did not increase online registrations. Sending a pound5 reimbursement for participants' time and sending text messages containing quotes from existing participants increased randomizations into the Txt2stop trial. Clinical Trials 2010; 7: 265-273. http://ctj.sagepub.com.

76 FR 4940 - Algirdas J. Krisciunas, M.D.; Revocation of Registration

Federal Register 2010, 2011, 2012, 2013, 2014

2011-01-27

... substances and the visit. Id. at 5-6. On January 7, 2010, a Federal Grand Jury indicted Registrant. United..., 2010, a Federal Grand Jury issued a superseding indictment. United States v. Algirdas Krisciunas and... went to trial. On July 6, 2010, a jury found Registrant guilty on all six counts. U.S. v. Algirdas...

A highly efficacious pediculicide based on dimeticone: Randomized observer blinded comparative trial

PubMed Central

Heukelbach, Jorg; Pilger, Daniel; Oliveira, Fabíola A; Khakban, Adak; Ariza, Liana; Feldmeier, Hermann

2008-01-01

Background Infestation with the human head louse (Pediculus humanus capitis) occurs worldwide. Existing treatment options are limited, and reports of resistance to commonly used pediculicides have been increasing. In this trial we assessed the efficacy of a product containing a high (92%) concentration of the silicone oil dimeticone (identical in composition to NYDA®), as compared to a 1% permethrin lotion. Methods Randomized, controlled, observer blinded clinical trial. Participants were recruited from a poor urban neighbourhood in Brazil where pediculosis capitis was highly prevalent. To minimize reinfestation during the trial, participants (145 children aged 5–15 years with head lice infestations) were transferred to a holiday resort outside the endemic area for a period of 9 days. Two applications of dimeticone or 1% permethrin were done, seven days apart. Outcome measures were defined as cure (absence of vital head lice) after first application and before and after second applications, degree of itching, cosmetic acceptability, and clinical pathology. Results Overall cure rates were: day 2 – dimeticone 94.5% (95% CI: 86.6% – 98.5%) and permethrin 66.7% (95% CI: 54.6% – 77.3%; p < 0.0001); day 7 – dimeticone 64.4% (95% CI: 53.3% – 75.3%) and permethrin 59.7% (95% CI: 47.5% – 71.1%; p = 0.5); day 9 – dimeticone 97.2% (95% CI: 90.3% – 99.7%) and permethrin 67.6% (95% CI: 55.4%-78.2%); p < 0.0001). Itching was reduced similarly in both groups. Cosmetic acceptability was significantly better in the dimeticone group as compared to the permethrin group (p = 0.01). Two mild product-related incidents occurred in the dimeticone group. Conclusion The dimeticone product is a safe and highly efficacious pediculicide. Due to its physical mode of action (interruption of the lice's oxygen supply of the central nervous system), development of resistance is unlikely. Trial registration Current Controlled Trials ISRCTN15117709. PMID:18783606

[Developing a harmonised system for the recognition of clinical trials for veterinary product registration].

PubMed

Maliandi, F S

2008-12-01

The increase of commerce between developing countries requires a harmonised system for accepting the results of clinical trials (CT) of veterinary products, similar to those that exist in developed countries. The objective of this paper is to propose a basis for the creation of a system that harmonises CTs for approving veterinary products (VP) for registration. Such a system would be a step towards unifying the CTs of different countries, while maintaining country-specific variations that are compatible with the scientific method, international standards, and the principles of objectivity, transparency and confidentiality. Basic requirements to be fulfilled by both private institutions and public offices are described, as are professional responsibilities and possible administrative procedures that could be adapted in each country. The conclusion reached is that a harmonised system is feasible, as has been demonstrated in numerous countries throughout the world. A harmonised system will result in a more efficient product approval process, a reduction in costs, greater transparency in controls, an improvement in the reliability of the health system, and a reduction in the time the process takes. It will also contribute to animal welfare by avoiding the need to repeat trials. The author acknowledges that there are cultural, technological and economic limitations and that these problems, and others, have yet to be overcome.

From randomized controlled trials to observational studies.

PubMed

Silverman, Stuart L

2009-02-01

Randomized controlled trials are considered the gold standard in the hierarchy of research designs for evaluating the efficacy and safety of a treatment intervention. However, their results can have limited applicability to patients in clinical settings. Observational studies using large health care databases can complement findings from randomized controlled trials by assessing treatment effectiveness in patients encountered in day-to-day clinical practice. Results from these designs can expand upon outcomes of randomized controlled trials because of the use of larger and more diverse patient populations with common comorbidities and longer follow-up periods. Furthermore, well-designed observational studies can identify clinically important differences among therapeutic options and provide data on long-term drug effectiveness and safety.

Consistency-based rectification of nonrigid registrations

PubMed Central

Gass, Tobias; Székely, Gábor; Goksel, Orcun

2015-01-01

Abstract. We present a technique to rectify nonrigid registrations by improving their group-wise consistency, which is a widely used unsupervised measure to assess pair-wise registration quality. While pair-wise registration methods cannot guarantee any group-wise consistency, group-wise approaches typically enforce perfect consistency by registering all images to a common reference. However, errors in individual registrations to the reference then propagate, distorting the mean and accumulating in the pair-wise registrations inferred via the reference. Furthermore, the assumption that perfect correspondences exist is not always true, e.g., for interpatient registration. The proposed consistency-based registration rectification (CBRR) method addresses these issues by minimizing the group-wise inconsistency of all pair-wise registrations using a regularized least-squares algorithm. The regularization controls the adherence to the original registration, which is additionally weighted by the local postregistration similarity. This allows CBRR to adaptively improve consistency while locally preserving accurate pair-wise registrations. We show that the resulting registrations are not only more consistent, but also have lower average transformation error when compared to known transformations in simulated data. On clinical data, we show improvements of up to 50% target registration error in breathing motion estimation from four-dimensional MRI and improvements in atlas-based segmentation quality of up to 65% in terms of mean surface distance in three-dimensional (3-D) CT. Such improvement was observed consistently using different registration algorithms, dimensionality (two-dimensional/3-D), and modalities (MRI/CT). PMID:26158083

Improvement of registration accuracy in accelerated partial breast irradiation using the point-based rigid-body registration algorithm for patients with implanted fiducial markers

DOE Office of Scientific and Technical Information (OSTI.GOV)

Inoue, Minoru; Yoshimura, Michio, E-mail: myossy@kuhp.kyoto-u.ac.jp; Sato, Sayaka

2015-04-15

Purpose: To investigate image-registration errors when using fiducial markers with a manual method and the point-based rigid-body registration (PRBR) algorithm in accelerated partial breast irradiation (APBI) patients, with accompanying fiducial deviations. Methods: Twenty-two consecutive patients were enrolled in a prospective trial examining 10-fraction APBI. Titanium clips were implanted intraoperatively around the seroma in all patients. For image-registration, the positions of the clips in daily kV x-ray images were matched to those in the planning digitally reconstructed radiographs. Fiducial and gravity registration errors (FREs and GREs, respectively), representing resulting misalignments of the edge and center of the target, respectively, were comparedmore » between the manual and algorithm-based methods. Results: In total, 218 fractions were evaluated. Although the mean FRE/GRE values for the manual and algorithm-based methods were within 3 mm (2.3/1.7 and 1.3/0.4 mm, respectively), the percentages of fractions where FRE/GRE exceeded 3 mm using the manual and algorithm-based methods were 18.8%/7.3% and 0%/0%, respectively. Manual registration resulted in 18.6% of patients with fractions of FRE/GRE exceeding 5 mm. The patients with larger clip deviation had significantly more fractions showing large FRE/GRE using manual registration. Conclusions: For image-registration using fiducial markers in APBI, the manual registration results in more fractions with considerable registration error due to loss of fiducial objectivity resulting from their deviation. The authors recommend the PRBR algorithm as a safe and effective strategy for accurate, image-guided registration and PTV margin reduction.« less

Adding value to clinical trial registries: insights from Australian Cancer Trials Online, a website for consumers.

PubMed

Dear, Rachel; Barratt, Alexandra; Askie, Lisa; McGeechan, Kevin; Arora, Sheena; Crossing, Sally; Currow, David; Tattersall, Martin

2011-02-01

Clinical trials registries are now operating in the USA, Europe, Australia, China, and India and more are planned. Trial registries could be an excellent source of information about clinical trials for patients and others affected by cancer as well as health care professionals, but may be difficult for patients to navigate and use. An opportunity arose in Australia to develop a consumer friendly cancer clinical trials website (Australian Cancer Trials Online (ACTO), www.australiancancertrials.gov.au) using an automated data feed from two large clinical trial registries. In this article, we describe aspects of this new website, and explore ways in which such a website may add value to clinical trial data which are already collected and held by trial registries. The development of ACTO was completed by a Web company working in close association with staff at the Australian New Zealand Clinical Trials Registry (ANZCTR), and with consumer representatives. Data for the website were sourced directly and only from clinical trial registries, thus avoiding the creation of an additional trials database. It receives an automated, daily data feed of newly registered cancer clinical trials from both the ANZCTR and Clinical Trials.gov. The development of ACTO exemplifies the advantage of a local clinical trial registry working with consumers to provide accessible information about cancer clinical trials to meet consumers' information needs. We found that the inclusion of a lay summary added substantial value for consumers, and recommend that consideration be given to adding a lay summary to the mandatory data items collected by all trial registries. Furthermore, improved navigation, decision support tools, and consistency in data collection between clinical trial registries will also enable consumer websites to provide additional value for users. Clinical trial registration is not compulsory in Australia. If the additional cancer items (including a lay summary) are not provided

Time to publication for publicly funded clinical trials in Australia: an observational study.

PubMed

Strand, Linn Beate; Clarke, Philip; Graves, Nicholas; Barnett, Adrian G

2017-03-22

To examine the length of time between receiving funding and publishing the protocol and main paper for randomised controlled trials. An observational study using survival analysis. Publicly funded health and medical research in Australia. Randomised controlled trials funded by the National Health and Medical Research Council of Australia between 2008 and 2010. Time from funding to the protocol paper and main results paper. Multiple variable survival models examining whether study characteristics predicted publication times. We found 77 studies with a total funding of $A59 million. The median time to publication of the protocol paper was 6.4 years after funding (95% CI 4.1 to 8.1). The proportion with a published protocol paper 8 years after funding was 0.61 (95% CI 0.48 to 0.74). The median time to publication of the main results paper was 7.1 years after funding (95% CI 6.3 to 7.6). The proportion with a published main results paper 8 years after funding was 0.72 (95% CI 0.56 to 0.87). The HRs for how study characteristics might influence timing were generally close to one with narrow CIs, the notable exception was that a longer study length lengthened the time to the main paper (HR=0.62 per extra study year, 95% CI 0.43 to 0.89). Despite the widespread registration of clinical trials, there remain serious concerns of trial results not being published or being published with a long delay. We have found that these same concerns apply to protocol papers, which should be publishable soon after funding. Funding agencies could set a target of publishing the protocol paper within 18 months of funding. Published by the BMJ Publishing Group Limited. For permission to use (where not already granted under a licence) please go to http://www.bmj.com/company/products-services/rights-and-licensing/.

ACCORDION MIND: results of the observational extension of the ACCORD MIND randomised trial.

PubMed

Murray, Anne M; Hsu, Fang-Chi; Williamson, Jeff D; Bryan, R Nick; Gerstein, Hertzel C; Sullivan, Mark D; Miller, Michael E; Leng, Iris; Lovato, Laura L; Launer, Lenore J

2017-01-01

The Memory in Diabetes (MIND) substudy of the Action to Control Cardiovascular Risk in Diabetes (ACCORD) study, a double 2x2 factorial parallel-group randomised clinical trial, tested whether intensive compared with standard management of hyperglycaemia, BP or lipid levels reduced cognitive decline and brain atrophy in 2977 people with type 2 diabetes. We describe the results of the observational extension study, ACCORDION MIND (ClinicalTrials.gov registration no. NCT00182910), which aimed to measure the long-term effects of the three ACCORD interventions on cognitive and brain structure outcomes approximately 4 years after the trial ended. Participants (mean diabetes duration 10 years; mean age 62 years at baseline) received a fourth cognitive assessment and a third brain MRI, targeted at 80 months post-randomisation. Primary outcomes were performance on the Digit Symbol Substitution Test (DSST) and total brain volume (TBV). The contrast of primary interest compared glycaemic intervention groups at the ACCORDION visit; secondary contrasts were the BP and lipid interventions. Of the surviving ACCORD participants eligible for ACCORDION MIND, 1328 (68%) were re-examined at the ACCORDION follow-up visit, approximately 47 months after the intensive glycaemia intervention was stopped. The significant differences in therapeutic targets for each of the three interventions (glycaemic, BP and lipid) were not sustained. We found no significant difference in 80 month mean change from baseline in DSST scores or in TBV between the glycaemic intervention groups, or the BP and lipid interventions. Sensitivity analyses of the sites with ≥70% participation at 80 months revealed consistent results. The ACCORD interventions did not result in long-term beneficial or adverse effects on cognitive or brain MRI outcomes at approximately 80 months follow-up. Loss of separation in therapeutic targets between treatment arms and loss to follow-up may have contributed to the lack of

Onboard Image Registration from Invariant Features

NASA Technical Reports Server (NTRS)

Wang, Yi; Ng, Justin; Garay, Michael J.; Burl, Michael C

2008-01-01

This paper describes a feature-based image registration technique that is potentially well-suited for onboard deployment. The overall goal is to provide a fast, robust method for dynamically combining observations from multiple platforms into sensors webs that respond quickly to short-lived events and provide rich observations of objects that evolve in space and time. The approach, which has enjoyed considerable success in mainstream computer vision applications, uses invariant SIFT descriptors extracted at image interest points together with the RANSAC algorithm to robustly estimate transformation parameters that relate one image to another. Experimental results for two satellite image registration tasks are presented: (1) automatic registration of images from the MODIS instrument on Terra to the MODIS instrument on Aqua and (2) automatic stabilization of a multi-day sequence of GOES-West images collected during the October 2007 Southern California wildfires.

Methodological issues in negative symptom trials.

PubMed

Marder, Stephen R; Daniel, David G; Alphs, Larry; Awad, A George; Keefe, Richard S E

2011-03-01

Individuals from academia, the pharmaceutical industry, and the US Food and Drug Administration used a workshop format to discuss important methodological issues in the design of trials of pharmacological agents for improving negative symptoms in schizophrenia. The issues addressed included the need for a coprimary functional measure for registration trials; the characteristics of individuals who should enter negative symptom trials; the optimal duration for a proof-of-concept or registration trial; the optimal design of a study of a broad-spectrum agent that treats both positive and negative symptoms or a co-medication that is added to an antipsychotic; the relative strengths and weaknesses of available instruments for measuring negative symptoms; the definition of clinically meaningful improvement for these trials; and whether drugs can be approved for a subdomain of negative symptoms.

Methodological Issues in Negative Symptom Trials

PubMed Central

Marder, Stephen R.; Daniel, David G.; Alphs, Larry; Awad, A. George; Keefe, Richard S. E.

2011-01-01

Individuals from academia, the pharmaceutical industry, and the US Food and Drug Administration used a workshop format to discuss important methodological issues in the design of trials of pharmacological agents for improving negative symptoms in schizophrenia. The issues addressed included the need for a coprimary functional measure for registration trials; the characteristics of individuals who should enter negative symptom trials; the optimal duration for a proof-of-concept or registration trial; the optimal design of a study of a broad-spectrum agent that treats both positive and negative symptoms or a co-medication that is added to an antipsychotic; the relative strengths and weaknesses of available instruments for measuring negative symptoms; the definition of clinically meaningful improvement for these trials; and whether drugs can be approved for a subdomain of negative symptoms. PMID:21270473

37 CFR 7.41 - Renewal of international registration and extension of protection.

Code of Federal Regulations, 2013 CFR

2013-07-01

... registration may be issued to 2.171 Not domiciled in U.S. 3.61 Right to take action when assignment is recorded... Trial and Appeal Board 2.145(d) Waiver of right to proceed by civil action in ex parte case 2.145(c)(2... Trial and Appeal Board) Ex parte matter disclosed but not tried in inter partes case 2.131 Express...

Clinical trials for drug registrations in Asian-Pacific countries: proposal for a new paradigm from a statistical perspective.

PubMed

Shih, W J

2001-08-01

The world has become more interdependent in the movement of free trade and global markets. The regulations for approval of new drugs in the Asian markets have always been an important issue in the free trade negotiation between the U.S.- and E.U.-based international manufacturers and the Asian-Pacific countries, since pharmaceuticals are of large trade value for them. In 1998 the University of Hong Kong and the Singapore National Medical Research Council jointly hosted the first Asian Clinical Trials Conference. The Society for Clinical Trials was invited as a collaborator for the event, which signified a milestone for interaction between the East and West in the discussion of clinical trials. Many have participated in the discussion of drug approval and registration issues for the Asian region based on the drug development experience in the United States. However, there are many interesting differences between the two regions, which lead to different approval processes for new drugs developed by the U.S.- and E.U.-based international manufacturers. This article highlights some regulatory dilemmas and some key statistical concepts pertinent to these differences. The purpose of this paper is to resolve the regional regulatory and scientific dilemma. A new paradigm of sample size design and data analysis for drug approval for countries in the Asian-Pacific region is proposed. The central premise is that substantial information from multicenter studies has already shown efficacy in the United States or the European Union when a drug manufacturer seeks marketing approval in an Asian country. This leads to the idea of a "consistency trial" using the method of Bayesian most plausible prediction. The method is illustrated with an example.

75 FR 1813 - Manufacturer of Controlled Substances; Notice of Registration

Federal Register 2010, 2011, 2012, 2013, 2014

2010-01-13

... Parkinson's Disease and for manufacture in bulk for investigational new drug (IND) submission and clinical trials. No comments or objections have been received. DEA has considered the factors in 21 U.S.C. 823(a... to ensure that the company's registration is consistent with the public interest. The investigation...

[Establishing the acupuncture-moxibustion clinical trial registry and improving the transparence of clinical trials of acupuncture and moxibustion].

PubMed

Liu, Yali; He, Liyun; Liu, Jia; Yang, Xingyue; Yan, Dongning; Wang, Xin; Luo, Lin; Li, Hongjiao; Yan, Shiyan; Wen, Tiancai; Bai, Wenjing; Wu, Taixiang; Liu, Baoyan

2017-07-12

As a kind of intervention measures of traditional Chinese medicine, acupuncture-moxibustion is highly adopted on global clinical practice. Even though the global clinical trial registration system was established more than 10 years ago, the proportion of acupuncture-moxibustion clinical trial registration is still very low; and it is very problematic on the methodological quality and report quality in the published acupuncture-moxibustion clinical trials. In order to manage particularly the acupuncture-moxibustion clinical trials, China Academy of Chinese Medical Sciences, collaborated with China Association of Acupuncture and Moxibustion and World Federation of Acupuncture Societies, established the Acupuncture-Moxibustion Clinical Trail Registry (AMCTR). AMCTR is a secondary registry platform affiliated to the Chinese Clinical Trial Registry (ChiCTR) and WHO International Clinical Trials Registry Platform (ICTRP), specifically for the acceptance and management of clinical trials in the field of acupuncture and moxibustion. It is a nonprofit academic organization, located in China Academy of Chinese Medical Sciences.

Challenges in translating endpoints from trials to observational cohort studies in oncology

PubMed Central

Ording, Anne Gulbech; Cronin-Fenton, Deirdre; Ehrenstein, Vera; Lash, Timothy L; Acquavella, John; Rørth, Mikael; Sørensen, Henrik Toft

2016-01-01

Clinical trials are considered the gold standard for examining drug efficacy and for approval of new drugs. Medical databases and population surveillance registries are valuable resources for post-approval observational research, which are increasingly used in studies of benefits and risk of new cancer drugs. Here, we address the challenges in translating endpoints from oncology trials to observational studies. Registry-based cohort studies can investigate real-world safety issues – including previously unrecognized concerns – by examining rare endpoints or multiple endpoints at once. In contrast to clinical trials, observational cohort studies typically do not exclude real-world patients from clinical practice, such as old and frail patients with comorbidity. The observational cohort study complements the clinical trial by examining the effectiveness of interventions applied in clinical practice and by providing evidence on long-term clinical outcomes, which are often not feasible to study in a clinical trial. Various endpoints can be included in clinical trials, such as hard endpoints, soft endpoints, surrogate endpoints, and patient-reported endpoints. Each endpoint has it strengths and limitations for use in research studies. Endpoints used in oncology trials are often not applicable in observational cohort studies which are limited by the setting of standard clinical practice and by non-standardized endpoint determination. Observational studies can be more helpful moving research forward if they restrict focus to appropriate and valid endpoints. PMID:27354827

Making a decision about trial participation: the feasibility of measuring deliberation during the informed consent process for clinical trials.

PubMed

Gillies, Katie; Elwyn, Glyn; Cook, Jonathan

2014-07-30

Informed consent of trial participants is both an ethical and a legal requirement. When facing a decision about trial participation, potential participants are provided with information about the trial and have the opportunity to have any questions answered before their degree of 'informed-ness' is assessed, usually subjectively, and before they are asked to sign a consent form. Currently, standardised methods for assessing informed consent have tended to be focused on aspects of understanding and associated outcomes, rather than on the process of consent and the steps associated with decision-making. Potential trial participants who were approached regarding participation in one of three randomised controlled trials were asked to complete a short questionnaire to measure their deliberation about trial participation. A total of 136 participants completed the 10-item questionnaire (DelibeRATE) before they made an explicit decision about trial participation (defined as signing the clinical trial consent form). Overall DelibeRATE scores were compared and investigated for differences between trial consenters and refusers. No differences in overall DelibeRATE scores were identified. In addition, there was no significant difference between overall score and the decision to participate, or not, in the parent trial. To our knowledge, this is the first study to prospectively measure the deliberation stage of the informed consent decision-making process of potential trial participants across different conditions and clinical areas. Although there were no differences detected in overall scores or scores of trial consenters and refusers, we did identify some interesting findings. These findings should be taken into consideration by those designing trials and others interested in developing and implementing measures of potential trial participants decision making during the informed consent process for research. International Standard Randomised Controlled Trial Number (ISRCTN

Efficient Method for Scalable Registration of Remote Sensing Images

NASA Astrophysics Data System (ADS)

Prouty, R.; LeMoigne, J.; Halem, M.

2017-12-01

The goal of this project is to build a prototype of a resource-efficient pipeline that will provide registration within subpixel accuracy of multitemporal Earth science data. Accurate registration of Earth-science data is imperative to proper data integration and seamless mosaicing of data from multiple times, sensors, and/or observation geometries. Modern registration methods make use of many arithmetic operations and sometimes require complete knowledge of the image domain. As such, while sensors become more advanced and are able to provide higher-resolution data, the memory resources required to properly register these data become prohibitive. The proposed pipeline employs a region of interest extraction algorithm in order to extract image subsets with high local feature density. These image subsets are then used to generate local solutions to the global registration problem. The local solutions are then 'globalized' to determine the deformation model that best solves the registration problem. The region of interest extraction and globalization routines are tested for robustness among the variety of scene-types and spectral locations provided by Earth-observing instruments such as Landsat, MODIS, or ASTER.

21 CFR 1301.35 - Certificate of registration; denial of registration.

Code of Federal Regulations, 2011 CFR

2011-04-01

... registration. (a) The Administrator shall issue a Certificate of Registration (DEA Form 223) to an applicant if... Federal Register. (c) The Certificate of Registration (DEA Form 223) shall contain the name, address, and...

21 CFR 1301.35 - Certificate of registration; denial of registration.

Code of Federal Regulations, 2010 CFR

2010-04-01

... registration. (a) The Administrator shall issue a Certificate of Registration (DEA Form 223) to an applicant if... Federal Register. (c) The Certificate of Registration (DEA Form 223) shall contain the name, address, and...

21 CFR 1309.42 - Certificate of registration; denial of registration.

Code of Federal Regulations, 2010 CFR

2010-04-01

...; denial of registration. (a) The Administrator shall issue a Certificate of Registration (DEA Form 511) to..., shall hold a hearing on the application pursuant to § 1309.51. (b) The Certificate of Registration (DEA...

21 CFR 1309.42 - Certificate of registration; denial of registration.

Code of Federal Regulations, 2011 CFR

2011-04-01

...; denial of registration. (a) The Administrator shall issue a Certificate of Registration (DEA Form 511) to..., shall hold a hearing on the application pursuant to § 1309.51. (b) The Certificate of Registration (DEA...

A Randomized Trial Comparing the Efficacy and Safety of Intravitreal Triamcinolone With Observation to Treat Vision Loss Associated With Macular Edema Secondary to Central Retinal Vein Occlusion

PubMed Central

Ip, Michael S.; Scott, Ingrid U.; VanVeldhuisen, Paul C.; Oden, Neal L.; Blodi, Barbara A.; Fisher, Marian; Singerman, Lawrence J.; Tolentino, Michael; Chan, Clement K.; Gonzalez, Victor H.

2009-01-01

Objective: To compare the efficacy and safety of 1-mg and 4-mg doses of preservative-free intravitreal triamcinolone with observation for eyes with vision loss associated with macular edema secondary to perfused central retinal vein occlusion (CRVO). Methods: Multicenter, randomized, clinical trial of 271 participants. Main Outcome Measure: Gain in visual acuity letter score of 15 or more from baseline to month 12. Results: Seven percent, 27%, and 26% of participants achieved the primary outcome in the observation, 1-mg, and 4-mg groups, respectively. The odds of achieving the primary outcome were 5.0 times greater in the 1-mg group than the observation group (odds ratio [OR],5.0; 95% confidence interval [CI], 1.8-14.1; P=.001) and 5.0 times greater in 4-mg group than the observation group (OR,5.0; 95% CI, 1.8-14.4; P=.001); there was no difference identified between the 1-mg and 4-mg groups (OR, 1.0; 95% CI, 0.5-2.1; P=.97). The rates of elevated intraocular pressure and cataract were similar for the observation and 1-mg groups, but higher in the 4-mg group. Conclusions: Intravitreal triamcinolone is superior to observation for treating vision loss associated with macular edema secondary to CRVO in patients who have characteristics similar to those in the SCORE-CRVO trial. The 1-mg dose has a safety profile superior to that of the 4-mg dose. Application to Clinical Practice: Intravitreal triamcinolone in a 1-mg dose, following the retreatment criteria applied in the SCORE Study, should be considered for up to 1 year, and possibly 2 years, for patients with characteristics similar to those in the SCORE-CRVO trial. Trial Registration: clinicaltrials.gov Identifier: NCT00105027 PMID:19752419

Registration and fusion quantification of augmented reality based nasal endoscopic surgery.

PubMed

Chu, Yakui; Yang, Jian; Ma, Shaodong; Ai, Danni; Li, Wenjie; Song, Hong; Li, Liang; Chen, Duanduan; Chen, Lei; Wang, Yongtian

2017-12-01

This paper quantifies the registration and fusion display errors of augmented reality-based nasal endoscopic surgery (ARNES). We comparatively investigated the spatial calibration process for front-end endoscopy and redefined the accuracy level of a calibrated endoscope by using a calibration tool with improved structural reliability. We also studied how registration accuracy was combined with the number and distribution of the deployed fiducial points (FPs) for positioning and the measured registration time. A physically integrated ARNES prototype was customarily configured for performance evaluation in skull base tumor resection surgery with an innovative approach of dynamic endoscopic vision expansion. As advised by surgical experts in otolaryngology, we proposed a hierarchical rendering scheme to properly adapt the fused images with the required visual sensation. By constraining the rendered sight in a known depth and radius, the visual focus of the surgeon can be induced only on the anticipated critical anatomies and vessel structures to avoid misguidance. Furthermore, error analysis was conducted to examine the feasibility of hybrid optical tracking based on point cloud, which was proposed in our previous work as an in-surgery registration solution. Measured results indicated that the error of target registration for ARNES can be reduced to 0.77 ± 0.07 mm. For initial registration, our results suggest that a trade-off for a new minimal time of registration can be reached when the distribution of five FPs is considered. For in-surgery registration, our findings reveal that the intrinsic registration error is a major cause of performance loss. Rigid model and cadaver experiments confirmed that the scenic integration and display fluency of ARNES are smooth, as demonstrated by three clinical trials that surpassed practicality. Copyright © 2017 Elsevier B.V. All rights reserved.

Registration and Marking Requirements for UAS. Unmanned Aircraft System (UAS) Registration

NASA Technical Reports Server (NTRS)

2005-01-01

The registration of an aircraft is a prerequisite for issuance of a U.S. certificate of airworthiness by the FAA. The procedures and requirements for aircraft registration, and the subsequent issuance of registration numbers, are contained in FAR Part 47. However, the process/method(s) for applying the requirements of Parts 45 & 47 to Unmanned Aircraft Systems (UAS) has not been defined. This task resolved the application of 14 CFR Parts 45 and 47 to UAS. Key Findings: UAS are aircraft systems and as such the recommended approach to registration is to follow the same process for registration as manned aircraft. This will require manufacturers to comply with the requirements for 14 CFR 47, Aircraft Registration and 14 CFR 45, Identification and Registration Marking. In addition, only the UA should be identified with the N number registration markings. There should also be a documentation link showing the applicability of the control station and communication link to the UA. The documentation link can be in the form of a Type Certificate Data Sheet (TCDS) entry or a UAS logbook entry. The recommended process for the registration of UAS is similar to the manned aircraft process and is outlined in a 6-step process in the paper.

Randomized clinical trials and observational studies in the assessment of drug safety.

PubMed

Sawchik, J; Hamdani, J; Vanhaeverbeek, M

2018-05-01

Randomized clinical trials are considered as the preferred design to assess the potential causal relationships between drugs or other medical interventions and intended effects. For this reason, randomized clinical trials are generally the basis of development programs in the life cycle of drugs and the cornerstone of evidence-based medicine. Instead, randomized clinical trials are not the design of choice for the detection and assessment of rare, delayed and/or unexpected effects related to drug safety. Moreover, the highly homogeneous populations resulting from restrictive eligibility criteria make randomized clinical trials inappropriate to describe comprehensively the safety profile of drugs. In that context, observational studies have a key added value when evaluating the benefit-risk balance of the drugs. However, observational studies are more prone to bias than randomized clinical trials and they have to be designed, conducted and reported judiciously. In this article, we discuss the strengths and limitations of randomized clinical trials and of observational studies, more particularly regarding their contribution to the knowledge of medicines' safety profile. In addition, we present general recommendations for the sensible use of observational data. Copyright © 2018 Elsevier Masson SAS. All rights reserved.

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

PubMed

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

21 CFR 710.6 - Notification of registrant; cosmetic product establishment registration number.

Code of Federal Regulations, 2013 CFR

2013-04-01

... 21 Food and Drugs 7 2013-04-01 2013-04-01 false Notification of registrant; cosmetic product... OF HEALTH AND HUMAN SERVICES (CONTINUED) COSMETICS VOLUNTARY REGISTRATION OF COSMETIC PRODUCT ESTABLISHMENTS § 710.6 Notification of registrant; cosmetic product establishment registration number. The...

21 CFR 710.6 - Notification of registrant; cosmetic product establishment registration number.

Code of Federal Regulations, 2012 CFR

2012-04-01

... 21 Food and Drugs 7 2012-04-01 2012-04-01 false Notification of registrant; cosmetic product... OF HEALTH AND HUMAN SERVICES (CONTINUED) COSMETICS VOLUNTARY REGISTRATION OF COSMETIC PRODUCT ESTABLISHMENTS § 710.6 Notification of registrant; cosmetic product establishment registration number. The...

21 CFR 710.6 - Notification of registrant; cosmetic product establishment registration number.

Code of Federal Regulations, 2010 CFR

2010-04-01

... 21 Food and Drugs 7 2010-04-01 2010-04-01 false Notification of registrant; cosmetic product... OF HEALTH AND HUMAN SERVICES (CONTINUED) COSMETICS VOLUNTARY REGISTRATION OF COSMETIC PRODUCT ESTABLISHMENTS § 710.6 Notification of registrant; cosmetic product establishment registration number. The...

21 CFR 710.6 - Notification of registrant; cosmetic product establishment registration number.

Code of Federal Regulations, 2011 CFR

2011-04-01

... 21 Food and Drugs 7 2011-04-01 2010-04-01 true Notification of registrant; cosmetic product... OF HEALTH AND HUMAN SERVICES (CONTINUED) COSMETICS VOLUNTARY REGISTRATION OF COSMETIC PRODUCT ESTABLISHMENTS § 710.6 Notification of registrant; cosmetic product establishment registration number. The...

21 CFR 710.6 - Notification of registrant; cosmetic product establishment registration number.

Code of Federal Regulations, 2014 CFR

2014-04-01

... 21 Food and Drugs 7 2014-04-01 2014-04-01 false Notification of registrant; cosmetic product... OF HEALTH AND HUMAN SERVICES (CONTINUED) COSMETICS VOLUNTARY REGISTRATION OF COSMETIC PRODUCT ESTABLISHMENTS § 710.6 Notification of registrant; cosmetic product establishment registration number. The...

Healthcare benefits linked with Below Poverty Line registration in India: Observations from Maharashtra Anaemia Study (MAS).

PubMed

Ahankari, Anand; Fogarty, Andrew; Tata, Laila; Myles, Puja

2017-01-01

A 2015 Lancet paper by Patel et al. on healthcare access in India comprehensively discussed national health programmes where some benefits are linked with the country's Below Poverty Line (BPL) registration scheme. BPL registration aims to support poor families by providing free/subsidised healthcare. Technical issues in obtaining BPL registration by poor families have been previously reported in the Indian literature; however there are no data on family assets of BPL registrants. Here, we provide evidence of family-level assets among BPL registration holders (and non-BPL households) using original research data from the Maharashtra Anaemia Study (MAS). Social and health data from 287 pregnant women and 891 adolescent girls (representing 1178 family households) across 34 villages in Maharashtra state, India, were analysed. Several assets were shown to be similarly distributed between BPL and non-BPL households; a large proportion of families who would probably be eligible were not registered, whereas BPL-registered families often had significant assets that should not make them eligible. This is likely to be the first published evidence where asset distribution such as agricultural land, housing structures and livestock are compared between BPL and non-BPL households in a rural population. These findings may help planning BPL administration to allocate health benefits equitably, which is an integral part of national health programmes.

21 CFR 710.8 - Misbranding by reference to registration or to registration number.

Code of Federal Regulations, 2012 CFR

2012-04-01

... HUMAN SERVICES (CONTINUED) COSMETICS VOLUNTARY REGISTRATION OF COSMETIC PRODUCT ESTABLISHMENTS § 710.8 Misbranding by reference to registration or to registration number. Registration of a cosmetic product...

21 CFR 710.8 - Misbranding by reference to registration or to registration number.

Code of Federal Regulations, 2011 CFR

2011-04-01

... HUMAN SERVICES (CONTINUED) COSMETICS VOLUNTARY REGISTRATION OF COSMETIC PRODUCT ESTABLISHMENTS § 710.8 Misbranding by reference to registration or to registration number. Registration of a cosmetic product...

21 CFR 710.8 - Misbranding by reference to registration or to registration number.

Code of Federal Regulations, 2014 CFR

2014-04-01

... HUMAN SERVICES (CONTINUED) COSMETICS VOLUNTARY REGISTRATION OF COSMETIC PRODUCT ESTABLISHMENTS § 710.8 Misbranding by reference to registration or to registration number. Registration of a cosmetic product...

21 CFR 710.8 - Misbranding by reference to registration or to registration number.

Code of Federal Regulations, 2013 CFR

2013-04-01

... HUMAN SERVICES (CONTINUED) COSMETICS VOLUNTARY REGISTRATION OF COSMETIC PRODUCT ESTABLISHMENTS § 710.8 Misbranding by reference to registration or to registration number. Registration of a cosmetic product...

21 CFR 710.8 - Misbranding by reference to registration or to registration number.

Code of Federal Regulations, 2010 CFR

2010-04-01

... HUMAN SERVICES (CONTINUED) COSMETICS VOLUNTARY REGISTRATION OF COSMETIC PRODUCT ESTABLISHMENTS § 710.8 Misbranding by reference to registration or to registration number. Registration of a cosmetic product...

75 FR 41968 - Re-Registration and Renewal of Aircraft Registration

Federal Register 2010, 2011, 2012, 2013, 2014

2010-07-20

... the use of the second or ``Pink Copy'' of the application for registration for a reasonable period of... under ``Pink Copy'' temporary authority at any time if an application for registration is made. Due to... reference to the ``pink copy'' of the Aircraft Registration Application. V. Miscellaneous Comments A. Re...

Comparison of the performance of tracer kinetic model-driven registration for dynamic contrast enhanced MRI using different models of contrast enhancement.

PubMed

Buonaccorsi, Giovanni A; Roberts, Caleb; Cheung, Sue; Watson, Yvonne; O'Connor, James P B; Davies, Karen; Jackson, Alan; Jayson, Gordon C; Parker, Geoff J M

2006-09-01

The quantitative analysis of dynamic contrast-enhanced (DCE) magnetic resonance imaging (MRI) data is subject to model fitting errors caused by motion during the time-series data acquisition. However, the time-varying features that occur as a result of contrast enhancement can confound motion correction techniques based on conventional registration similarity measures. We have therefore developed a heuristic, locally controlled tracer kinetic model-driven registration procedure, in which the model accounts for contrast enhancement, and applied it to the registration of abdominal DCE-MRI data at high temporal resolution. Using severely motion-corrupted data sets that had been excluded from analysis in a clinical trial of an antiangiogenic agent, we compared the results obtained when using different models to drive the tracer kinetic model-driven registration with those obtained when using a conventional registration against the time series mean image volume. Using tracer kinetic model-driven registration, it was possible to improve model fitting by reducing the sum of squared errors but the improvement was only realized when using a model that adequately described the features of the time series data. The registration against the time series mean significantly distorted the time series data, as did tracer kinetic model-driven registration using a simpler model of contrast enhancement. When an appropriate model is used, tracer kinetic model-driven registration influences motion-corrupted model fit parameter estimates and provides significant improvements in localization in three-dimensional parameter maps. This has positive implications for the use of quantitative DCE-MRI for example in clinical trials of antiangiogenic or antivascular agents.

Undergraduate Cross Registration.

ERIC Educational Resources Information Center

Grupe, Fritz H.

This report discusses various aspects of undergraduate cross-registration procedures, including the dimensions, values, roles and functions, basic assumptions, and facilitating and encouragment of cross-registration. Dimensions of cross-registration encompass financial exchange, eligibility, program limitations, type of grade and credit; extent of…

The heart of the matter: Outcome reporting bias and registration status in cardio-thoracic surgery.

PubMed

Wiebe, Jordan; Detten, Grant; Scheckel, Caleb; Gearhart, David; Wheeler, Denna; Sanders, Donald; Vassar, Matt

2017-01-15

Our objective is to compare registered outcomes to published reports; to evaluate for discrepancies favoring statistically significant outcomes; to examine funding source and likelihood of outcome reporting bias; and to evaluate for any temporal trends in outcome reporting bias. PubMed was searched for randomized controlled trials published between 2008 and 2015 from 4 high impact cardio-thoracic journals: European Journal of Cardio-thoracic Surgery (EJCS), The Journal of Cardiothoracic Surgery (JCS), The Journal of Thoracic and Cardiovascular Surgery (JTCS), and Annals of Cardiothoracic Surgery (ACS). Data was collected using a standardized extraction form. We reviewed 287 articles, of which 214 (74.6%) did not meet registration criteria. Of those 214, 94 (43.9%) were published in the EJCS, 34 (15.9%) in JCS, 86 (40.2%) in JTCS, and 0 (0%) in the ACS. Of the remaining 73 articles, 34 (46.6%) had a discrepancy between the primary outcome registered and the published outcome, and 11 of the 34 reported p-values favoring the change. We also found that 12 of the 73 registrations had updated primary outcomes from the initial report to the final report. The timing of registration was an incidental finding showing 14 (19.1%) articles retrospectively registered, 29 (39.7%) registered during patient enrollment, and 30 (41.1%) registered prospectively. The results indicated that selective outcome reporting is prevalent in cardio-thoracic surgery journals. The more concerning issue, however, is the lack of registration or provision of registration number for randomized controlled trials within these journals. Copyright © 2016 Elsevier Ireland Ltd. All rights reserved.

Reporting of Positive Results in Randomized Controlled Trials of Mindfulness-Based Mental Health Interventions.

PubMed

Coronado-Montoya, Stephanie; Levis, Alexander W; Kwakkenbos, Linda; Steele, Russell J; Turner, Erick H; Thombs, Brett D

2016-01-01

A large proportion of mindfulness-based therapy trials report statistically significant results, even in the context of very low statistical power. The objective of the present study was to characterize the reporting of "positive" results in randomized controlled trials of mindfulness-based therapy. We also assessed mindfulness-based therapy trial registrations for indications of possible reporting bias and reviewed recent systematic reviews and meta-analyses to determine whether reporting biases were identified. CINAHL, Cochrane CENTRAL, EMBASE, ISI, MEDLINE, PsycInfo, and SCOPUS databases were searched for randomized controlled trials of mindfulness-based therapy. The number of positive trials was described and compared to the number that might be expected if mindfulness-based therapy were similarly effective compared to individual therapy for depression. Trial registries were searched for mindfulness-based therapy registrations. CINAHL, Cochrane CENTRAL, EMBASE, ISI, MEDLINE, PsycInfo, and SCOPUS were also searched for mindfulness-based therapy systematic reviews and meta-analyses. 108 (87%) of 124 published trials reported ≥1 positive outcome in the abstract, and 109 (88%) concluded that mindfulness-based therapy was effective, 1.6 times greater than the expected number of positive trials based on effect size d = 0.55 (expected number positive trials = 65.7). Of 21 trial registrations, 13 (62%) remained unpublished 30 months post-trial completion. No trial registrations adequately specified a single primary outcome measure with time of assessment. None of 36 systematic reviews and meta-analyses concluded that effect estimates were overestimated due to reporting biases. The proportion of mindfulness-based therapy trials with statistically significant results may overstate what would occur in practice.

Registration of Space Objects

NASA Astrophysics Data System (ADS)

Schmidt-Tedd, Bernhard

2017-07-01

Space objects are subject to registration in order to allocate "jurisdiction and control" over those objects in the sovereign-free environment of outer space. This approach is similar to the registration of ships in view of the high sea and for aircrafts with respect to the international airspace. Registration is one of the basic principles of space law, starting with UN General Assembly Resolution 1721 B (XVI) of December 20, 1961, followed by Resolution 1962 (XVIII) of December 13, 1963, then formulated in Article VIII of the Outer Space Treaty of 1967 and as specified in the Registration Convention of 1975. Registration of space objects can be seen today as a principle of customary international law, relevant for each spacefaring state. Registration is divided into a national and an international level. The State Party establishes a national registry for its space objects, and those registrations have to be communicated via diplomatic channel to the UN Register of space objects. This UN Register is handled by the UN Office for Outer Space Affairs (UNOOSA) and is an open source of information for space objects worldwide. Registration is linked to the so-called launching state of the relevant space object. There might be more than one launching state for the specific launch event, but only one state actor can register a specific space object. The state of registry gains "jurisdiction and control" over the space object and therefore no double registration is permissible. Based on the established UN Space Law, registration practice was subject to some adaptions due to technical developments and legal challenges. After the privatization of the major international satellite organizations, a number of non-registrations had to be faced. The state actors reacted with the UN Registration Practice Resolution of 2007 as elaborated in the Legal Subcommittee of UNCOPUOS, the Committee for the Peaceful Use of Outer Space. In this context an UNOOSA Registration Information

Clinical trials in dentistry in India: Analysis from trial registry.

PubMed

Gowri, S; Kannan, Sridharan

2017-01-01

Evidence-based practice requires clinical trials to be performed. In India, if any clinical trial has to be performed, it has to be registered with clinical trial registry of India. Studies have shown that the report of clinical trials is poor in dentistry. Hence, the present study has been conducted to assess the type and trends of clinical trials being undertaken in dentistry in India over a span of 6 years. All the clinical trials which were registered with the Central Trial Registry of India (CTRI) (www.ctri.nic.in) from January 1, 2007 to March 3, 2014 were evaluated using the keyword "dental." Following information were collected for each of the clinical trials obtained from the search; number of centres (single center/multicentric), type of the institution undertaking the research (government/private/combined), study (observational/interventional), study design (randomized/single blinded/double-blinded), type of health condition, type of participants (healthy/patients), sponsors (academia/commercial), phase of clinical trial (Phase 1/2/3/4), publication details (published/not published), whether it was a postgraduate thesis or not and prospective or retrospective registration of clinical trials, methodological quality (method of randomization, allocation concealment). Descriptive statistics was used for analysis of various categories. Trend analysis was done to assess the changes over a period of time. The search yielded a total of 84 trials of which majority of them were single centered. Considering the study design more than half of the registered clinical trials were double-blinded (47/84 [56%]). With regard to the place of conducting a trial, most of the trials were planned to be performed in private hospitals (56/84 [66.7%]). Most (79/84, 94.1%) of the clinical trials were interventional while only 5/84 (5.9%) were observational. Majority (65/84, 77.4%) of the registered clinical trials were recruiting patients while the rest were being done in healthy

16 CFR 1130.8 - Requirements for Web site registration or alternative e-mail registration.

Code of Federal Regulations, 2012 CFR

2012-01-01

... 16 Commercial Practices 2 2012-01-01 2012-01-01 false Requirements for Web site registration or... PRODUCTS § 1130.8 Requirements for Web site registration or alternative e-mail registration. (a) Link to registration page. The manufacturer's Web site, or other Web site established for the purpose of registration...

16 CFR 1130.8 - Requirements for Web site registration or alternative e-mail registration.

Code of Federal Regulations, 2011 CFR

2011-01-01

... 16 Commercial Practices 2 2011-01-01 2011-01-01 false Requirements for Web site registration or... PRODUCTS § 1130.8 Requirements for Web site registration or alternative e-mail registration. (a) Link to registration page. The manufacturer's Web site, or other Web site established for the purpose of registration...

16 CFR 1130.7 - Requirements for Web site registration or alternative e-mail registration.

Code of Federal Regulations, 2014 CFR

2014-01-01

... 16 Commercial Practices 2 2014-01-01 2014-01-01 false Requirements for Web site registration or... PRODUCTS § 1130.7 Requirements for Web site registration or alternative e-mail registration. (a) Link to registration page. The manufacturer's Web site, or other Web site established for the purpose of registration...

Scalable High Performance Image Registration Framework by Unsupervised Deep Feature Representations Learning

PubMed Central

Wu, Guorong; Kim, Minjeong; Wang, Qian; Munsell, Brent C.

2015-01-01

Feature selection is a critical step in deformable image registration. In particular, selecting the most discriminative features that accurately and concisely describe complex morphological patterns in image patches improves correspondence detection, which in turn improves image registration accuracy. Furthermore, since more and more imaging modalities are being invented to better identify morphological changes in medical imaging data,, the development of deformable image registration method that scales well to new image modalities or new image applications with little to no human intervention would have a significant impact on the medical image analysis community. To address these concerns, a learning-based image registration framework is proposed that uses deep learning to discover compact and highly discriminative features upon observed imaging data. Specifically, the proposed feature selection method uses a convolutional stacked auto-encoder to identify intrinsic deep feature representations in image patches. Since deep learning is an unsupervised learning method, no ground truth label knowledge is required. This makes the proposed feature selection method more flexible to new imaging modalities since feature representations can be directly learned from the observed imaging data in a very short amount of time. Using the LONI and ADNI imaging datasets, image registration performance was compared to two existing state-of-the-art deformable image registration methods that use handcrafted features. To demonstrate the scalability of the proposed image registration framework image registration experiments were conducted on 7.0-tesla brain MR images. In all experiments, the results showed the new image registration framework consistently demonstrated more accurate registration results when compared to state-of-the-art. PMID:26552069

Scalable High-Performance Image Registration Framework by Unsupervised Deep Feature Representations Learning.

PubMed

Wu, Guorong; Kim, Minjeong; Wang, Qian; Munsell, Brent C; Shen, Dinggang

2016-07-01

Feature selection is a critical step in deformable image registration. In particular, selecting the most discriminative features that accurately and concisely describe complex morphological patterns in image patches improves correspondence detection, which in turn improves image registration accuracy. Furthermore, since more and more imaging modalities are being invented to better identify morphological changes in medical imaging data, the development of deformable image registration method that scales well to new image modalities or new image applications with little to no human intervention would have a significant impact on the medical image analysis community. To address these concerns, a learning-based image registration framework is proposed that uses deep learning to discover compact and highly discriminative features upon observed imaging data. Specifically, the proposed feature selection method uses a convolutional stacked autoencoder to identify intrinsic deep feature representations in image patches. Since deep learning is an unsupervised learning method, no ground truth label knowledge is required. This makes the proposed feature selection method more flexible to new imaging modalities since feature representations can be directly learned from the observed imaging data in a very short amount of time. Using the LONI and ADNI imaging datasets, image registration performance was compared to two existing state-of-the-art deformable image registration methods that use handcrafted features. To demonstrate the scalability of the proposed image registration framework, image registration experiments were conducted on 7.0-T brain MR images. In all experiments, the results showed that the new image registration framework consistently demonstrated more accurate registration results when compared to state of the art.

14 CFR 47.15 - Registration number.

Code of Federal Regulations, 2011 CFR

2011-01-01

... REGISTRATION General § 47.15 Registration number. (a) Number required. An applicant for aircraft registration must place a U.S. registration number (registration mark) on the Aircraft Registration Application, AC... Dealer's Aircraft Registration Certificate, AC Form 8050-6, who applies for a temporary registration...

14 CFR 47.15 - Registration number.

Code of Federal Regulations, 2013 CFR

2013-01-01

... REGISTRATION General § 47.15 Registration number. (a) Number required. An applicant for aircraft registration must place a U.S. registration number (registration mark) on the Aircraft Registration Application, AC... Dealer's Aircraft Registration Certificate, AC Form 8050-6, who applies for a temporary registration...

14 CFR 47.15 - Registration number.

Code of Federal Regulations, 2014 CFR

2014-01-01

... REGISTRATION General § 47.15 Registration number. (a) Number required. An applicant for aircraft registration must place a U.S. registration number (registration mark) on the Aircraft Registration Application, AC... Dealer's Aircraft Registration Certificate, AC Form 8050-6, who applies for a temporary registration...

14 CFR 47.15 - Registration number.

Code of Federal Regulations, 2012 CFR

2012-01-01

... REGISTRATION General § 47.15 Registration number. (a) Number required. An applicant for aircraft registration must place a U.S. registration number (registration mark) on the Aircraft Registration Application, AC... Dealer's Aircraft Registration Certificate, AC Form 8050-6, who applies for a temporary registration...

Registration performance on EUV masks using high-resolution registration metrology

NASA Astrophysics Data System (ADS)

Steinert, Steffen; Solowan, Hans-Michael; Park, Jinback; Han, Hakseung; Beyer, Dirk; Scherübl, Thomas

2016-10-01

Next-generation lithography based on EUV continues to move forward to high-volume manufacturing. Given the technical challenges and the throughput concerns a hybrid approach with 193 nm immersion lithography is expected, at least in the initial state. Due to the increasing complexity at smaller nodes a multitude of different masks, both DUV (193 nm) and EUV (13.5 nm) reticles, will then be required in the lithography process-flow. The individual registration of each mask and the resulting overlay error are of crucial importance in order to ensure proper functionality of the chips. While registration and overlay metrology on DUV masks has been the standard for decades, this has yet to be demonstrated on EUV masks. Past generations of mask registration tools were not necessarily limited in their tool stability, but in their resolution capabilities. The scope of this work is an image placement investigation of high-end EUV masks together with a registration and resolution performance qualification. For this we employ a new generation registration metrology system embedded in a production environment for full-spec EUV masks. This paper presents excellent registration performance not only on standard overlay markers but also on more sophisticated e-beam calibration patterns.

75 FR 52859 - Re-Registration and Renewal of Aircraft Registration; OMB Approval of Information Collection

Federal Register 2010, 2011, 2012, 2013, 2014

2010-08-30

... Aircraft Registration; OMB Approval of Information Collection AGENCY: Federal Aviation Administration, DOT... final rule, ``Re-Registration and Renewal of Aircraft Registration,'' which was published on July 20..., the FAA published the final rule, ``Re-Registration and Renewal of Aircraft Registration'' (75 FR...

Feature-Based Retinal Image Registration Using D-Saddle Feature

PubMed Central

Hasikin, Khairunnisa; A. Karim, Noor Khairiah; Ahmedy, Fatimah

2017-01-01

Retinal image registration is important to assist diagnosis and monitor retinal diseases, such as diabetic retinopathy and glaucoma. However, registering retinal images for various registration applications requires the detection and distribution of feature points on the low-quality region that consists of vessels of varying contrast and sizes. A recent feature detector known as Saddle detects feature points on vessels that are poorly distributed and densely positioned on strong contrast vessels. Therefore, we propose a multiresolution difference of Gaussian pyramid with Saddle detector (D-Saddle) to detect feature points on the low-quality region that consists of vessels with varying contrast and sizes. D-Saddle is tested on Fundus Image Registration (FIRE) Dataset that consists of 134 retinal image pairs. Experimental results show that D-Saddle successfully registered 43% of retinal image pairs with average registration accuracy of 2.329 pixels while a lower success rate is observed in other four state-of-the-art retinal image registration methods GDB-ICP (28%), Harris-PIIFD (4%), H-M (16%), and Saddle (16%). Furthermore, the registration accuracy of D-Saddle has the weakest correlation (Spearman) with the intensity uniformity metric among all methods. Finally, the paired t-test shows that D-Saddle significantly improved the overall registration accuracy of the original Saddle. PMID:29204257

75 FR 58292 - Re-Registration and Renewal of Aircraft Registration; OMB Approval of Information Collection...

Federal Register 2010, 2011, 2012, 2013, 2014

2010-09-24

...-0188; Amdt. No. 47-29A] RIN 2120-AI89 Re-Registration and Renewal of Aircraft Registration; OMB... contained in the ``Re-Registration and Renewal of Aircraft Registration'' final rule. The final rule was... Renewal of Aircraft Registration'' (75 FR 41968). The final rule contained information collection...

28 CFR 12.3 - Prior registration with the Foreign Agents Registration Unit.

Code of Federal Regulations, 2013 CFR

2013-07-01

... 28 Judicial Administration 1 2013-07-01 2013-07-01 false Prior registration with the Foreign Agents Registration Unit. 12.3 Section 12.3 Judicial Administration DEPARTMENT OF JUSTICE REGISTRATION OF CERTAIN PERSONS HAVING KNOWLEDGE OF FOREIGN ESPIONAGE, COUNTERESPIONAGE, OR SABOTAGE MATTERS UNDER THE ACT...

28 CFR 12.3 - Prior registration with the Foreign Agents Registration Unit.

Code of Federal Regulations, 2014 CFR

2014-07-01

... 28 Judicial Administration 1 2014-07-01 2014-07-01 false Prior registration with the Foreign Agents Registration Unit. 12.3 Section 12.3 Judicial Administration DEPARTMENT OF JUSTICE REGISTRATION OF CERTAIN PERSONS HAVING KNOWLEDGE OF FOREIGN ESPIONAGE, COUNTERESPIONAGE, OR SABOTAGE MATTERS UNDER THE ACT...

28 CFR 12.3 - Prior registration with the Foreign Agents Registration Unit.

Code of Federal Regulations, 2010 CFR

2010-07-01

... 28 Judicial Administration 1 2010-07-01 2010-07-01 false Prior registration with the Foreign Agents Registration Unit. 12.3 Section 12.3 Judicial Administration DEPARTMENT OF JUSTICE REGISTRATION OF CERTAIN PERSONS HAVING KNOWLEDGE OF FOREIGN ESPIONAGE, COUNTERESPIONAGE, OR SABOTAGE MATTERS UNDER THE ACT...

28 CFR 12.3 - Prior registration with the Foreign Agents Registration Unit.

Code of Federal Regulations, 2011 CFR

2011-07-01

... 28 Judicial Administration 1 2011-07-01 2011-07-01 false Prior registration with the Foreign Agents Registration Unit. 12.3 Section 12.3 Judicial Administration DEPARTMENT OF JUSTICE REGISTRATION OF CERTAIN PERSONS HAVING KNOWLEDGE OF FOREIGN ESPIONAGE, COUNTERESPIONAGE, OR SABOTAGE MATTERS UNDER THE ACT...

28 CFR 12.3 - Prior registration with the Foreign Agents Registration Unit.

Code of Federal Regulations, 2012 CFR

2012-07-01

... 28 Judicial Administration 1 2012-07-01 2012-07-01 false Prior registration with the Foreign Agents Registration Unit. 12.3 Section 12.3 Judicial Administration DEPARTMENT OF JUSTICE REGISTRATION OF CERTAIN PERSONS HAVING KNOWLEDGE OF FOREIGN ESPIONAGE, COUNTERESPIONAGE, OR SABOTAGE MATTERS UNDER THE ACT...

Robust non-rigid registration algorithm based on local affine registration

NASA Astrophysics Data System (ADS)

Wu, Liyang; Xiong, Lei; Du, Shaoyi; Bi, Duyan; Fang, Ting; Liu, Kun; Wu, Dongpeng

2018-04-01

Aiming at the problem that the traditional point set non-rigid registration algorithm has low precision and slow convergence speed for complex local deformation data, this paper proposes a robust non-rigid registration algorithm based on local affine registration. The algorithm uses a hierarchical iterative method to complete the point set non-rigid registration from coarse to fine. In each iteration, the sub data point sets and sub model point sets are divided and the shape control points of each sub point set are updated. Then we use the control point guided affine ICP algorithm to solve the local affine transformation between the corresponding sub point sets. Next, the local affine transformation obtained by the previous step is used to update the sub data point sets and their shape control point sets. When the algorithm reaches the maximum iteration layer K, the loop ends and outputs the updated sub data point sets. Experimental results demonstrate that the accuracy and convergence of our algorithm are greatly improved compared with the traditional point set non-rigid registration algorithms.

Scene-based nonuniformity correction with video sequences and registration.

PubMed

Hardie, R C; Hayat, M M; Armstrong, E; Yasuda, B

2000-03-10

We describe a new, to our knowledge, scene-based nonuniformity correction algorithm for array detectors. The algorithm relies on the ability to register a sequence of observed frames in the presence of the fixed-pattern noise caused by pixel-to-pixel nonuniformity. In low-to-moderate levels of nonuniformity, sufficiently accurate registration may be possible with standard scene-based registration techniques. If the registration is accurate, and motion exists between the frames, then groups of independent detectors can be identified that observe the same irradiance (or true scene value). These detector outputs are averaged to generate estimates of the true scene values. With these scene estimates, and the corresponding observed values through a given detector, a curve-fitting procedure is used to estimate the individual detector response parameters. These can then be used to correct for detector nonuniformity. The strength of the algorithm lies in its simplicity and low computational complexity. Experimental results, to illustrate the performance of the algorithm, include the use of visible-range imagery with simulated nonuniformity and infrared imagery with real nonuniformity.

A Systematic Narrative Review of Effects of Community-Based Intervention on Rates of Organ Donor Registration.

PubMed

Golding, Sarah Elizabeth; Cropley, Mark

2017-09-01

The demand for organ donation is increasing worldwide. One possible way of increasing the pool of potential posthumous donors is to encourage more members of the general public to join an organ donor registry. A systematic review was conducted to investigate the effectiveness of psychological interventions designed to increase the number of individuals in the community who register as organ donors. PsycINFO and PubMed databases were searched. No date limits were set. Randomized and nonrandomized controlled trials exploring the effects of community-based interventions on organ donor registration rates were included. Methodological quality was assessed using the "Quality Assessment Tool for Quantitative Studies." Twenty-four studies met the inclusion criteria; 19 studies found a positive intervention effect on registration. Only 8 studies were assessed as having reasonable methodological robustness. A narrative synthesis was conducted. Factors influencing registration rates include providing an immediate registration opportunity and using brief interventions to challenge misconceptions and concerns about organ donation. Community-based interventions can be effective at increasing organ donor registrations among the general public. Factors that may increase effectiveness include brief interventions to address concerns and providing an immediate registration opportunity. Particular consideration should be paid to the fidelity of intervention delivery. Protocol registration number: CRD42014012975.

16 CFR 1130.8 - Requirements for Web site registration or alternative e-mail registration.

Code of Federal Regulations, 2010 CFR

2010-01-01

... 16 Commercial Practices 2 2010-01-01 2010-01-01 false Requirements for Web site registration or... PRODUCTS (Eff. June 28, 2010) § 1130.8 Requirements for Web site registration or alternative e-mail registration. (a) Link to registration page. The manufacturer's Web site, or other Web site established for the...

User Registration Systems for Distributed Systems

NASA Astrophysics Data System (ADS)

Murphy, K. J.; Cechini, M.; Pilone, D.; Mitchell, A.

2010-12-01

As NASA’s Earth Observing System Data and Information System (EOSDIS) systems have evolved over the years, most of the EOSDIS data are now available to users via anonymous on-line access. Although the changes have improved the dissemination efficiency of earth science data, the anonymous access has made it difficult to characterize users, capture metrics on the value of EOSDIS and provide customized services that benefit users. As the number of web-based applications continues to grow, data centers and application providers have implemented their own user registration systems and provided new tools and interfaces for their registered users. This has led to the creation of independent registration systems for accessing data and interacting with online tools and services. The user profile information maintained at each of these registration systems is not consistent and the registration enforcement varies by system as well. This problem is in no way unique to EOSDIS and represents a general challenge to the distributed computing community. In a study done in 2007(http://www2007.org/papers/paper620.pd), the average user has approximately 7 passwords for about 25 accounts and enters a password 8 times a day. These numbers have only increased in the last three years. To try and address this, a number of solutions have been offered including Single Sign-On solutions using a common backend like Microsoft Active Directory or an LDAP server, trust based identity providers like OpenID, and various forms of authorization delegation like OAuth or SAML/XACML. This talk discusses the differences between authentication and authorization, the state of the more popular user registration solutions available for distributed use, and some of the technical and policy drivers that need to be considered when incorporating a user registration system into your application.

High School Voter Registration.

ERIC Educational Resources Information Center

Institute for Political/Legal Education, Sewell, NJ.

Methods for conducting peer voter registration of high school students cover establishing a permanent voter registration committee and identifying and registering eligible students. The permanent voter registration committee, made up of student body representatives, class representatives, and selected teachers, guarantees comprehensive…

37 CFR 7.41 - Renewal of international registration and extension of protection.

Code of Federal Regulations, 2011 CFR

2011-07-01

... 3.85 New certificate of registration may be issued to 2.171 Not domiciled in U.S. 3.61 Right to take... of Director or Trademark Trial and Appeal Board 2.145(d) Waiver of right to proceed by civil action... disclosed but not tried in inter partes case 2.131 Express abandonment of application or mark: During...

78 FR 5497 - Importer of Controlled Substances; Notice of Registration; Fisher Clinical Services, Inc.

Federal Register 2010, 2011, 2012, 2013, 2014

2013-01-25

... Registration; Fisher Clinical Services, Inc. By Notice dated November 1, 2012, and published in the Federal Register on November 9, 2012, 77 FR 67396, Fisher Clinical Services, Inc., 7554 Schantz Road, Allentown... plans to import the listed controlled substance to conduct clinical trials. No comments or objections...

HIV prevention trial design in an era of effective pre-exposure prophylaxis.

PubMed

Cutrell, Amy; Donnell, Deborah; Dunn, David T; Glidden, David V; Grobler, Anneke; Hanscom, Brett; Stancil, Britt S; Meyer, R Daniel; Wang, Ronnie; Cuffe, Robert L

2017-01-01

Pre-exposure prophylaxis (PrEP) has demonstrated remarkable effectiveness protecting at-risk individuals from HIV-1 infection. Despite this record of effectiveness, concerns persist about the diminished protective effect observed in women compared with men and the influence of adherence and risk behaviors on effectiveness in targeted subpopulations. Furthermore, the high prophylactic efficacy of the first PrEP agent, tenofovir disoproxil fumarate/emtricitabine (TDF/FTC), presents challenges for demonstrating the efficacy of new candidates. Trials of new agents would typically require use of non-inferiority (NI) designs in which acceptable efficacy for an experimental agent is determined using pre-defined margins based on the efficacy of the proven active comparator (i.e. TDF/FTC) in placebo-controlled trials. Setting NI margins is a critical step in designing registrational studies. Under- or over-estimation of the margin can call into question the utility of the study in the registration package. The dependence on previous placebo-controlled trials introduces the same issues as external/historical controls. These issues will need to be addressed using trial design features such as re-estimated NI margins, enrichment strategies, run-in periods, crossover between study arms, and adaptive re-estimation of sample sizes. These measures and other innovations can help to ensure that new PrEP agents are made available to the public using stringent standards of evidence.

14 CFR 47.43 - Invalid registration.

Code of Federal Regulations, 2010 CFR

2010-01-01

... REGISTRATION Certificates of Aircraft Registration § 47.43 Invalid registration. (a) The registration of an...) compliance with 49 U.S.C. 44101-44104. (b) If the registration of an aircraft is invalid under paragraph (a) of this section, the holder of the invalid Certificate of Aircraft Registration shall return it as...

21 CFR 1301.52 - Termination of registration; transfer of registration; distribution upon discontinuance of business.

Code of Federal Regulations, 2010 CFR

2010-04-01

... discontinues business or professional practice. Any registrant who ceases legal existence or discontinues... registration; distribution upon discontinuance of business. 1301.52 Section 1301.52 Food and Drugs DRUG... of registration; transfer of registration; distribution upon discontinuance of business. (a) Except...

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.

PubMed

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 <18 years old) conducted in 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.

46 CFR 58.01-30 - Trial-trip observance.

Code of Federal Regulations, 2010 CFR

2010-10-01

... 46 Shipping 2 2010-10-01 2010-10-01 false Trial-trip observance. 58.01-30 Section 58.01-30 Shipping COAST GUARD, DEPARTMENT OF HOMELAND SECURITY (CONTINUED) MARINE ENGINEERING MAIN AND AUXILIARY... each new vessel and all deficiencies which affect the safety of the vessel shall be corrected to the...

46 CFR 58.01-30 - Trial-trip observance.

Code of Federal Regulations, 2013 CFR

2013-10-01

... 46 Shipping 2 2013-10-01 2013-10-01 false Trial-trip observance. 58.01-30 Section 58.01-30 Shipping COAST GUARD, DEPARTMENT OF HOMELAND SECURITY (CONTINUED) MARINE ENGINEERING MAIN AND AUXILIARY... each new vessel and all deficiencies which affect the safety of the vessel shall be corrected to the...

46 CFR 58.01-30 - Trial-trip observance.

Code of Federal Regulations, 2012 CFR

2012-10-01

... 46 Shipping 2 2012-10-01 2012-10-01 false Trial-trip observance. 58.01-30 Section 58.01-30 Shipping COAST GUARD, DEPARTMENT OF HOMELAND SECURITY (CONTINUED) MARINE ENGINEERING MAIN AND AUXILIARY... each new vessel and all deficiencies which affect the safety of the vessel shall be corrected to the...

46 CFR 58.01-30 - Trial-trip observance.

Code of Federal Regulations, 2014 CFR

2014-10-01

... 46 Shipping 2 2014-10-01 2014-10-01 false Trial-trip observance. 58.01-30 Section 58.01-30 Shipping COAST GUARD, DEPARTMENT OF HOMELAND SECURITY (CONTINUED) MARINE ENGINEERING MAIN AND AUXILIARY... each new vessel and all deficiencies which affect the safety of the vessel shall be corrected to the...

46 CFR 58.01-30 - Trial-trip observance.

Code of Federal Regulations, 2011 CFR

2011-10-01

... 46 Shipping 2 2011-10-01 2011-10-01 false Trial-trip observance. 58.01-30 Section 58.01-30 Shipping COAST GUARD, DEPARTMENT OF HOMELAND SECURITY (CONTINUED) MARINE ENGINEERING MAIN AND AUXILIARY... each new vessel and all deficiencies which affect the safety of the vessel shall be corrected to the...

14 CFR 47.43 - Invalid registration.

Code of Federal Regulations, 2013 CFR

2013-01-01

... REGISTRATION Certificates of Aircraft Registration § 47.43 Invalid registration. (a) The registration of an...) compliance with 49 U.S.C. 44101-44104. (b) If the registration of an aircraft is invalid under paragraph (a) of this section, the holder of the invalid Certificate of Aircraft Registration, AC Form 8050-3, must...

14 CFR 47.43 - Invalid registration.

Code of Federal Regulations, 2014 CFR

2014-01-01

... REGISTRATION Certificates of Aircraft Registration § 47.43 Invalid registration. (a) The registration of an...) compliance with 49 U.S.C. 44101-44104. (b) If the registration of an aircraft is invalid under paragraph (a) of this section, the holder of the invalid Certificate of Aircraft Registration, AC Form 8050-3, must...

Comparison of Registered and Reported Outcomes in Randomized Clinical Trials Published in Anesthesiology Journals.

PubMed

Jones, Philip M; Chow, Jeffrey T Y; Arango, Miguel F; Fridfinnson, Jason A; Gai, Nan; Lam, Kevin; Turkstra, Timothy P

2017-10-01

Randomized clinical trials (RCTs) provide high-quality evidence for clinical decision-making. Trial registration is one of the many tools used to improve the reporting of RCTs by reducing publication bias and selective outcome reporting bias. The purpose of our study is to examine whether RCTs published in the top 6 general anesthesiology journals were adequately registered and whether the reported primary and secondary outcomes corresponded to the originally registered outcomes. Following a prespecified protocol, an electronic database was used to systematically screen and extract data from RCTs published in the top 6 general anesthesiology journals by impact factor (Anaesthesia, Anesthesia & Analgesia, Anesthesiology, British Journal of Anaesthesia, Canadian Journal of Anesthesia, and European Journal of Anaesthesiology) during the years 2007, 2010, 2013, and 2015. A manual search of each journal's Table of Contents was performed (in duplicate) to identify eligible RCTs. An adequately registered trial was defined as being registered in a publicly available trials registry before the first patient being enrolled with an unambiguously defined primary outcome. For adequately registered trials, the outcomes registered in the trial registry were compared with the outcomes reported in the article, with outcome discrepancies documented and analyzed by the type of discrepancy. During the 4 years studied, there were 860 RCTs identified, with 102 RCTs determined to be adequately registered (12%). The proportion of adequately registered trials increased over time, with 38% of RCTs being adequately registered in 2015. The most common reason in 2015 for inadequate registration was registering the RCT after the first patient had already been enrolled. Among adequately registered trials, 92% had at least 1 primary or secondary outcome discrepancy. In 2015, 42% of RCTs had at least 1 primary outcome discrepancy, while 90% of RCTs had at least 1 secondary outcome discrepancy

77 FR 38084 - Importer of Controlled Substances; Notice of Registration; Clinical Supplies Management, Inc.

Federal Register 2010, 2011, 2012, 2013, 2014

2012-06-26

... Registration; Clinical Supplies Management, Inc. By Notice dated April 17, 2012, and published in the Federal Register on April 26, 2012, 77 FR 24984, Clinical Supplies Management, Inc., 342 42nd Street South, Fargo..., labeling, and distributing to customers which are qualified clinical sites conducting clinical trials under...

77 FR 75670 - Importer of Controlled Substances; Notice of Registration; Fisher Clinical Services,Inc.

Federal Register 2010, 2011, 2012, 2013, 2014

2012-12-21

... Registration; Fisher Clinical Services,Inc. By Notice dated September 20, 2012, and published in the Federal Register on October 2, 2012, 77 FR 60143, Fisher Clinical Services, Inc., 7554 Schantz Road, Allentown... company plans to import the listed substances for analytical research and clinical trials. No comments or...

32 CFR 1615.1 - Registration.

Code of Federal Regulations, 2010 CFR

2010-07-01

... registration card or other method of registration prescribed by the Director of Selective Service by a person... method of registration prescribed by the Director, he shall advise in writing the Selective Service System, P.O. Box 94638, Palatine, IL 60094-4638. (c) The methods of registration prescribed by the...

Improving registration accuracy.

PubMed

Murphy, J Patrick; Shorrosh, Paul

2008-04-01

A registration quality assurance initiative--whether manual or automated--can result in benefits such as: Cleaner claims, Reduced cost to collect, Enhanced revenue, Decreased registration, error rates, Improved staff morale, Fewer customer complaints

Spacecraft camera image registration

NASA Technical Reports Server (NTRS)

Kamel, Ahmed A. (Inventor); Graul, Donald W. (Inventor); Chan, Fred N. T. (Inventor); Gamble, Donald W. (Inventor)

1987-01-01

A system for achieving spacecraft camera (1, 2) image registration comprises a portion external to the spacecraft and an image motion compensation system (IMCS) portion onboard the spacecraft. Within the IMCS, a computer (38) calculates an image registration compensation signal (60) which is sent to the scan control loops (84, 88, 94, 98) of the onboard cameras (1, 2). At the location external to the spacecraft, the long-term orbital and attitude perturbations on the spacecraft are modeled. Coefficients (K, A) from this model are periodically sent to the onboard computer (38) by means of a command unit (39). The coefficients (K, A) take into account observations of stars and landmarks made by the spacecraft cameras (1, 2) themselves. The computer (38) takes as inputs the updated coefficients (K, A) plus synchronization information indicating the mirror position (AZ, EL) of each of the spacecraft cameras (1, 2), operating mode, and starting and stopping status of the scan lines generated by these cameras (1, 2), and generates in response thereto the image registration compensation signal (60). The sources of periodic thermal errors on the spacecraft are discussed. The system is checked by calculating measurement residuals, the difference between the landmark and star locations predicted at the external location and the landmark and star locations as measured by the spacecraft cameras (1, 2).

Troponin elevation in acute ischemic stroke (TRELAS) - protocol of a prospective observational trial

PubMed Central

2011-01-01

Background Levels of the cardiac muscle regulatory protein troponin T (cTnT) are frequently elevated in patients with acute ischemic stroke and elevated cTnT predicts poor outcome and mortality. The pathomechanism of troponin release may relate to co-morbid coronary artery disease and myocardial ischemia or, alternatively, to neurogenic cardiac damage due to autonomic activation after acute ischemic stroke. Therefore, there is uncertainty about how acute ischemic stroke patients with increased cTnT levels should be managed regarding diagnostic and therapeutic workup. Methods/Design The primary objective of the prospective observational trial TRELAS (TRoponin ELevation in Acute ischemic Stroke) is to investigate the frequency and underlying pathomechanism of cTnT elevation in acute ischemic stroke patients in order to give guidance for clinical practice. All consecutive patients with acute ischemic stroke admitted within 72 hours after symptom onset to the Department of Neurology at the Campus Benjamin Franklin of the University Hospital Charité will be screened for cTnT elevations (i.e. >= 0.05 μg/l) on admission and again on the following day. Patients with increased cTnT will undergo coronary angiography within 72 hours. Diagnostic findings of coronary angiograms will be compared with age- and gender-matched patients presenting with Non-ST-Elevation myocardial infarction to the Department of Cardiology. The primary endpoint of the study will be the occurrence of culprit lesions in the coronary angiogram indicating underlying co-morbid obstructive coronary artery disease. Secondary endpoints will be the localization of stroke in the cerebral imaging and left ventriculographic findings of wall motion abnormalities suggestive of stroke-induced global cardiac dysfunction. Discussion TRELAS will prospectively determine the frequency and possible etiology of troponin elevation in a large cohort of ischemic stroke patients. The findings are expected to contribute to

Overlay improvement by exposure map based mask registration optimization

NASA Astrophysics Data System (ADS)

Shi, Irene; Guo, Eric; Chen, Ming; Lu, Max; Li, Gordon; Li, Rivan; Tian, Eric

2015-03-01

Along with the increased miniaturization of semiconductor electronic devices, the design rules of advanced semiconductor devices shrink dramatically. [1] One of the main challenges of lithography step is the layer-to-layer overlay control. Furthermore, DPT (Double Patterning Technology) has been adapted for the advanced technology node like 28nm and 14nm, corresponding overlay budget becomes even tighter. [2][3] After the in-die mask registration (pattern placement) measurement is introduced, with the model analysis of a KLA SOV (sources of variation) tool, it's observed that registration difference between masks is a significant error source of wafer layer-to-layer overlay at 28nm process. [4][5] Mask registration optimization would highly improve wafer overlay performance accordingly. It was reported that a laser based registration control (RegC) process could be applied after the pattern generation or after pellicle mounting and allowed fine tuning of the mask registration. [6] In this paper we propose a novel method of mask registration correction, which can be applied before mask writing based on mask exposure map, considering the factors of mask chip layout, writing sequence, and pattern density distribution. Our experiment data show if pattern density on the mask keeps at a low level, in-die mask registration residue error in 3sigma could be always under 5nm whatever blank type and related writer POSCOR (position correction) file was applied; it proves random error induced by material or equipment would occupy relatively fixed error budget as an error source of mask registration. On the real production, comparing the mask registration difference through critical production layers, it could be revealed that registration residue error of line space layers with higher pattern density is always much larger than the one of contact hole layers with lower pattern density. Additionally, the mask registration difference between layers with similar pattern density

Petition for Rulemaking to Evaluate Synergestic Effects of Pesticides during Registration and Registration Review

EPA Pesticide Factsheets

This petition from the Center for Biological Diversity asks that the Agency require all applicants and registrants to provide data on the potential synergistic effects of pesticides during the registration and registration review processes.

Off-Campus Registration Procedures.

ERIC Educational Resources Information Center

Maas, Michael L.

Registration is one of the more critical functions that a college staff encounters each semester. To have a smooth, efficient, college-wide registration, it is essential that all segments of the college be aware of registration procedures as well as data control operations. This packet was designed to acquaint interested parties with the…

Registration Review Process

EPA Pesticide Factsheets

EPA will review each registered pesticide at least every 15 years to determine whether it continues to meet the Federal Insecticide, Fungicide, and Rodenticide Act (FIFRA) standard for registration. There are currently 745 registration review cases.

16 CFR § 1130.8 - Requirements for Web site registration or alternative e-mail registration.

Code of Federal Regulations, 2013 CFR

2013-01-01

... 16 Commercial Practices 2 2013-01-01 2013-01-01 false Requirements for Web site registration or... OR TODDLER PRODUCTS § 1130.8 Requirements for Web site registration or alternative e-mail registration. (a) Link to registration page. The manufacturer's Web site, or other Web site established for the...

Silk garments plus standard care compared with standard care for treating eczema in children: A randomised, controlled, observer-blind, pragmatic trial (CLOTHES Trial)

PubMed Central

Thomas, Kim S.; Lawton, Sandra; Ahmed, Amina; Dean, Taraneh; Burrows, Nigel P.; Pollock, Ian; Grundy, Jane D.; Guiness, Juliet

2017-01-01

and standard care groups, respectively. Even if the small observed treatment effect was genuine, the incremental cost per quality-adjusted life year was £56,811 in the base case analysis from a National Health Service perspective, suggesting that silk garments are unlikely to be cost-effective using currently accepted thresholds. The main limitation of the study is that use of an objective primary outcome, whilst minimising detection bias, may have underestimated treatment effects. Conclusions Silk clothing is unlikely to provide additional benefit over standard care in children with moderate to severe eczema. Trial registration Current Controlled Trials ISRCTN77261365 PMID:28399154

Improving multispectral satellite image compression using onboard subpixel registration

NASA Astrophysics Data System (ADS)

Albinet, Mathieu; Camarero, Roberto; Isnard, Maxime; Poulet, Christophe; Perret, Jokin

2013-09-01

Future CNES earth observation missions will have to deal with an ever increasing telemetry data rate due to improvements in resolution and addition of spectral bands. Current CNES image compressors implement a discrete wavelet transform (DWT) followed by a bit plane encoding (BPE) but only on a mono spectral basis and do not profit from the multispectral redundancy of the observed scenes. Recent CNES studies have proven a substantial gain on the achievable compression ratio, +20% to +40% on selected scenarios, by implementing a multispectral compression scheme based on a Karhunen Loeve transform (KLT) followed by the classical DWT+BPE. But such results can be achieved only on perfectly registered bands; a default of registration as low as 0.5 pixel ruins all the benefits of multispectral compression. In this work, we first study the possibility to implement a multi-bands subpixel onboard registration based on registration grids generated on-the-fly by the satellite attitude control system and simplified resampling and interpolation techniques. Indeed bands registration is usually performed on ground using sophisticated techniques too computationally intensive for onboard use. This fully quantized algorithm is tuned to meet acceptable registration performances within stringent image quality criteria, with the objective of onboard real-time processing. In a second part, we describe a FPGA implementation developed to evaluate the design complexity and, by extrapolation, the data rate achievable on a spacequalified ASIC. Finally, we present the impact of this approach on the processing chain not only onboard but also on ground and the impacts on the design of the instrument.

40 CFR 155.42 - Registration review cases.

Code of Federal Regulations, 2012 CFR

2012-07-01

... 40 Protection of Environment 25 2012-07-01 2012-07-01 false Registration review cases. 155.42... REGISTRATION STANDARDS AND REGISTRATION REVIEW Registration Review Procedures § 155.42 Registration review cases. (a) Establishing registration review cases. A registration review case will be composed of one or...

40 CFR 155.42 - Registration review cases.

Code of Federal Regulations, 2013 CFR

2013-07-01

... 40 Protection of Environment 25 2013-07-01 2013-07-01 false Registration review cases. 155.42... REGISTRATION STANDARDS AND REGISTRATION REVIEW Registration Review Procedures § 155.42 Registration review cases. (a) Establishing registration review cases. A registration review case will be composed of one or...

40 CFR 155.42 - Registration review cases.

Code of Federal Regulations, 2011 CFR

2011-07-01

... 40 Protection of Environment 24 2011-07-01 2011-07-01 false Registration review cases. 155.42... REGISTRATION STANDARDS AND REGISTRATION REVIEW Registration Review Procedures § 155.42 Registration review cases. (a) Establishing registration review cases. A registration review case will be composed of one or...

40 CFR 155.42 - Registration review cases.

Code of Federal Regulations, 2014 CFR

2014-07-01

... 40 Protection of Environment 24 2014-07-01 2014-07-01 false Registration review cases. 155.42... REGISTRATION STANDARDS AND REGISTRATION REVIEW Registration Review Procedures § 155.42 Registration review cases. (a) Establishing registration review cases. A registration review case will be composed of one or...

40 CFR 155.42 - Registration review cases.

Code of Federal Regulations, 2010 CFR

2010-07-01

... 40 Protection of Environment 23 2010-07-01 2010-07-01 false Registration review cases. 155.42... REGISTRATION STANDARDS AND REGISTRATION REVIEW Registration Review Procedures § 155.42 Registration review cases. (a) Establishing registration review cases. A registration review case will be composed of one or...

Hybrid registration of PET/CT in thoracic region with pre-filtering PET sinogram

NASA Astrophysics Data System (ADS)

Mokri, S. S.; Saripan, M. I.; Marhaban, M. H.; Nordin, A. J.; Hashim, S.

2015-11-01

The integration of physiological (PET) and anatomical (CT) images in cancer delineation requires an accurate spatial registration technique. Although hybrid PET/CT scanner is used to co-register these images, significant misregistrations exist due to patient and respiratory/cardiac motions. This paper proposes a hybrid feature-intensity based registration technique for hybrid PET/CT scanner. First, simulated PET sinogram was filtered with a 3D hybrid mean-median before reconstructing the image. The features were then derived from the segmented structures (lung, heart and tumor) from both images. The registration was performed based on modified multi-modality demon registration with multiresolution scheme. Apart from visual observations improvements, the proposed registration technique increased the normalized mutual information index (NMI) between the PET/CT images after registration. All nine tested datasets show marked improvements in mutual information (MI) index than free form deformation (FFD) registration technique with the highest MI increase is 25%.

Image registration with uncertainty analysis

DOEpatents

Simonson, Katherine M [Cedar Crest, NM

2011-03-22

In an image registration method, edges are detected in a first image and a second image. A percentage of edge pixels in a subset of the second image that are also edges in the first image shifted by a translation is calculated. A best registration point is calculated based on a maximum percentage of edges matched. In a predefined search region, all registration points other than the best registration point are identified that are not significantly worse than the best registration point according to a predetermined statistical criterion.

Image Registration Workshop Proceedings

NASA Technical Reports Server (NTRS)

LeMoigne, Jacqueline (Editor)

1997-01-01

Automatic image registration has often been considered as a preliminary step for higher-level processing, such as object recognition or data fusion. But with the unprecedented amounts of data which are being and will continue to be generated by newly developed sensors, the very topic of automatic image registration has become and important research topic. This workshop presents a collection of very high quality work which has been grouped in four main areas: (1) theoretical aspects of image registration; (2) applications to satellite imagery; (3) applications to medical imagery; and (4) image registration for computer vision research.

A Remote Registration Based on MIDAS

NASA Astrophysics Data System (ADS)

JIN, Xin

2017-04-01

We often need for software registration to protect the interests of the software developers. This article narrated one kind of software long-distance registration technology. The registration method is: place the registration information in a database table, after the procedure starts in check table registration information, if it has registered then the procedure may the normal operation; Otherwise, the customer must input the sequence number and registers through the network on the long-distance server. If it registers successfully, then records the registration information in the database table. This remote registration method can protect the rights of software developers.

DIRBoost-an algorithm for boosting deformable image registration: application to lung CT intra-subject registration.

PubMed

Muenzing, Sascha E A; van Ginneken, Bram; Viergever, Max A; Pluim, Josien P W

2014-04-01

We introduce a boosting algorithm to improve on existing methods for deformable image registration (DIR). The proposed DIRBoost algorithm is inspired by the theory on hypothesis boosting, well known in the field of machine learning. DIRBoost utilizes a method for automatic registration error detection to obtain estimates of local registration quality. All areas detected as erroneously registered are subjected to boosting, i.e. undergo iterative registrations by employing boosting masks on both the fixed and moving image. We validated the DIRBoost algorithm on three different DIR methods (ANTS gSyn, NiftyReg, and DROP) on three independent reference datasets of pulmonary image scan pairs. DIRBoost reduced registration errors significantly and consistently on all reference datasets for each DIR algorithm, yielding an improvement of the registration accuracy by 5-34% depending on the dataset and the registration algorithm employed. Copyright © 2014 Elsevier B.V. All rights reserved.

14 CFR 47.43 - Invalid registration.

Code of Federal Regulations, 2012 CFR

2012-01-01

... REGISTRATION Certificates of Aircraft Registration § 47.43 Invalid registration. Link to an amendment published... registration of an aircraft is invalid if, at the time it is made— (1) The aircraft is registered in a foreign... knowledge) compliance with 49 U.S.C. 44101-44104. (b) If the registration of an aircraft is invalid under...

Image Registration: A Necessary Evil

NASA Technical Reports Server (NTRS)

Bell, James; McLachlan, Blair; Hermstad, Dexter; Trosin, Jeff; George, Michael W. (Technical Monitor)

1995-01-01

Registration of test and reference images is a key component of nearly all PSP data reduction techniques. This is done to ensure that a test image pixel viewing a particular point on the model is ratioed by the reference image pixel which views the same point. Typically registration is needed to account for model motion due to differing airloads when the wind-off and wind-on images are taken. Registration is also necessary when two cameras are used for simultaneous acquisition of data from a dual-frequency paint. This presentation will discuss the advantages and disadvantages of several different image registration techniques. In order to do so, it is necessary to propose both an accuracy requirement for image registration and a means for measuring the accuracy of a particular technique. High contrast regions in the unregistered images are most sensitive to registration errors, and it is proposed that these regions be used to establish the error limits for registration. Once this is done, the actual registration error can be determined by locating corresponding points on the test and reference images, and determining how well a particular registration technique matches them. An example of this procedure is shown for three transforms used to register images of a semispan model. Thirty control points were located on the model. A subset of the points were used to determine the coefficients of each registration transform, and the error with which each transform aligned the remaining points was determined. The results indicate the general superiority of a third-order polynomial over other candidate transforms, as well as showing how registration accuracy varies with number of control points. Finally, it is proposed that image registration may eventually be done away with completely. As more accurate image resection techniques and more detailed model surface grids become available, it will be possible to map raw image data onto the model surface accurately. Intensity

PROFESSIONAL REGISTRATION OF GOVERNMENT ENGINEERS.

USGS Publications Warehouse

Buchanan, Thomas J.

1985-01-01

The American Society of Civil Engineers views professional registration as an appropriate requirement for engineers, including those in government. The National Society of Professional Engineers makes registration a requirement for the grade of member and full privileges in the society. Some Federal agencies require engineering registration for certain positions in their agencies. Engineers in government service should consider the value of engineering registration to themselves and to their agencies and take pride in their professions and in their own capabilities by becoming registered engineers. They should also take steps to encourage their agencies to give more attention to engineering registration.

Automatic three-dimensional registration of intravascular optical coherence tomography images

NASA Astrophysics Data System (ADS)

Ughi, Giovanni J.; Adriaenssens, Tom; Larsson, Matilda; Dubois, Christophe; Sinnaeve, Peter R.; Coosemans, Mark; Desmet, Walter; D'hooge, Jan

2012-02-01

Intravascular optical coherence tomography (IV-OCT) is a catheter-based high-resolution imaging technique able to visualize the inner wall of the coronary arteries and implanted devices in vivo with an axial resolution below 20 μm. IV-OCT is being used in several clinical trials aiming to quantify the vessel response to stent implantation over time. However, stent analysis is currently performed manually and corresponding images taken at different time points are matched through a very labor-intensive and subjective procedure. We present an automated method for the spatial registration of IV-OCT datasets. Stent struts are segmented through consecutive images and three-dimensional models of the stents are created for both datasets to be registered. The two models are initially roughly registered through an automatic initialization procedure and an iterative closest point algorithm is subsequently applied for a more precise registration. To correct for nonuniform rotational distortions (NURDs) and other potential acquisition artifacts, the registration is consecutively refined on a local level. The algorithm was first validated by using an in vitro experimental setup based on a polyvinyl-alcohol gel tubular phantom. Subsequently, an in vivo validation was obtained by exploiting stable vessel landmarks. The mean registration error in vitro was quantified to be 0.14 mm in the longitudinal axis and 7.3-deg mean rotation error. In vivo validation resulted in 0.23 mm in the longitudinal axis and 10.1-deg rotation error. These results indicate that the proposed methodology can be used for automatic registration of in vivo IV-OCT datasets. Such a tool will be indispensable for larger studies on vessel healing pathophysiology and reaction to stent implantation. As such, it will be valuable in testing the performance of new generations of intracoronary devices and new therapeutic drugs.

40 CFR 155.57 - Registration review decision.

Code of Federal Regulations, 2010 CFR

2010-07-01

... 40 Protection of Environment 23 2010-07-01 2010-07-01 false Registration review decision. 155.57... REGISTRATION STANDARDS AND REGISTRATION REVIEW Registration Review Procedures § 155.57 Registration review decision. A registration review decision is the Agency's determination whether a pesticide meets, or does...

TU-B-19A-01: Image Registration II: TG132-Quality Assurance for Image Registration

DOE Office of Scientific and Technical Information (OSTI.GOV)

Brock, K; Mutic, S

2014-06-15

AAPM Task Group 132 was charged with a review of the current approaches and solutions for image registration in radiotherapy and to provide recommendations for quality assurance and quality control of these clinical processes. As the results of image registration are always used as the input of another process for planning or delivery, it is important for the user to understand and document the uncertainty associate with the algorithm in general and the Result of a specific registration. The recommendations of this task group, which at the time of abstract submission are currently being reviewed by the AAPM, include themore » following components. The user should understand the basic image registration techniques and methods of visualizing image fusion. The disclosure of basic components of the image registration by commercial vendors is critical in this respect. The physicists should perform end-to-end tests of imaging, registration, and planning/treatment systems if image registration is performed on a stand-alone system. A comprehensive commissioning process should be performed and documented by the physicist prior to clinical use of the system. As documentation is important to the safe implementation of this process, a request and report system should be integrated into the clinical workflow. Finally, a patient specific QA practice should be established for efficient evaluation of image registration results. The implementation of these recommendations will be described and illustrated during this educational session. Learning Objectives: Highlight the importance of understanding the image registration techniques used in their clinic. Describe the end-to-end tests needed for stand-alone registration systems. Illustrate a comprehensive commissioning program using both phantom data and clinical images. Describe a request and report system to ensure communication and documentation. Demonstrate an clinically-efficient patient QA practice for efficient evaluation

UK Dermatology Clinical Trials Network’s STOP GAP trial (a multicentre trial of prednisolone versus ciclosporin for pyoderma gangrenosum): protocol for a randomised controlled trial

PubMed Central

2012-01-01

lesion size, and presence or absence of underlying systemic disease (for example, rheumatoid arthritis). Patients who require topical therapy are asked to enter a parallel observational study (case series). If topical therapy fails and systemic therapy is required, participants are then considered for inclusion in the randomised trial. Trial registration Current controlled trials: ISRCTN35898459. Eudract No.2008-008291-14. PMID:22540770

Statistical analysis plan for the family-led rehabilitation after stroke in India (ATTEND) trial: A multicenter randomized controlled trial of a new model of stroke rehabilitation compared to usual care.

PubMed

Billot, Laurent; Lindley, Richard I; Harvey, Lisa A; Maulik, Pallab K; Hackett, Maree L; Murthy, Gudlavalleti Vs; Anderson, Craig S; Shamanna, Bindiganavale R; Jan, Stephen; Walker, Marion; Forster, Anne; Langhorne, Peter; Verma, Shweta J; Felix, Cynthia; Alim, Mohammed; Gandhi, Dorcas Bc; Pandian, Jeyaraj Durai

2017-02-01

Background In low- and middle-income countries, few patients receive organized rehabilitation after stroke, yet the burden of chronic diseases such as stroke is increasing in these countries. Affordable models of effective rehabilitation could have a major impact. The ATTEND trial is evaluating a family-led caregiver delivered rehabilitation program after stroke. Objective To publish the detailed statistical analysis plan for the ATTEND trial prior to trial unblinding. Methods Based upon the published registration and protocol, the blinded steering committee and management team, led by the trial statistician, have developed a statistical analysis plan. The plan has been informed by the chosen outcome measures, the data collection forms and knowledge of key baseline data. Results The resulting statistical analysis plan is consistent with best practice and will allow open and transparent reporting. Conclusions Publication of the trial statistical analysis plan reduces potential bias in trial reporting, and clearly outlines pre-specified analyses. Clinical Trial Registrations India CTRI/2013/04/003557; Australian New Zealand Clinical Trials Registry ACTRN1261000078752; Universal Trial Number U1111-1138-6707.

Spatially weighted mutual information image registration for image guided radiation therapy.

PubMed

Park, Samuel B; Rhee, Frank C; Monroe, James I; Sohn, Jason W

2010-09-01

To develop a new metric for image registration that incorporates the (sub)pixelwise differential importance along spatial location and to demonstrate its application for image guided radiation therapy (IGRT). It is well known that rigid-body image registration with mutual information is dependent on the size and location of the image subset on which the alignment analysis is based [the designated region of interest (ROI)]. Therefore, careful review and manual adjustments of the resulting registration are frequently necessary. Although there were some investigations of weighted mutual information (WMI), these efforts could not apply the differential importance to a particular spatial location since WMI only applies the weight to the joint histogram space. The authors developed the spatially weighted mutual information (SWMI) metric by incorporating an adaptable weight function with spatial localization into mutual information. SWMI enables the user to apply the selected transform to medically "important" areas such as tumors and critical structures, so SWMI is neither dominated by, nor neglects the neighboring structures. Since SWMI can be utilized with any weight function form, the authors presented two examples of weight functions for IGRT application: A Gaussian-shaped weight function (GW) applied to a user-defined location and a structures-of-interest (SOI) based weight function. An image registration example using a synthesized 2D image is presented to illustrate the efficacy of SWMI. The convergence and feasibility of the registration method as applied to clinical imaging is illustrated by fusing a prostate treatment planning CT with a clinical cone beam CT (CBCT) image set acquired for patient alignment. Forty-one trials are run to test the speed of convergence. The authors also applied SWMI registration using two types of weight functions to two head and neck cases and a prostate case with clinically acquired CBCT/ MVCT image sets. The SWMI registration with

21 CFR 1301.36 - Suspension or revocation of registration; suspension of registration pending final order...

Code of Federal Regulations, 2010 CFR

2010-04-01

... 21 Food and Drugs 9 2010-04-01 2010-04-01 false Suspension or revocation of registration... Section 1301.36 Food and Drugs DRUG ENFORCEMENT ADMINISTRATION, DEPARTMENT OF JUSTICE REGISTRATION OF MANUFACTURERS, DISTRIBUTORS, AND DISPENSERS OF CONTROLLED SUBSTANCES Action on Application for Registration...

40 CFR 79.23 - Registration.

Code of Federal Regulations, 2011 CFR

2011-07-01

... OF FUELS AND FUEL ADDITIVES Additive Registration Procedures § 79.23 Registration. (a) If the... additive which includes all of the information and assurances required by § 79.21 and has satisfactorily... the fuel additive and notify the fuel manufacturer of such registration. (b) The Administrator shall...

40 CFR 79.23 - Registration.

Code of Federal Regulations, 2014 CFR

2014-07-01

... OF FUELS AND FUEL ADDITIVES Additive Registration Procedures § 79.23 Registration. (a) If the... additive which includes all of the information and assurances required by § 79.21 and has satisfactorily... the fuel additive and notify the fuel manufacturer of such registration. (b) The Administrator shall...

40 CFR 79.23 - Registration.

Code of Federal Regulations, 2012 CFR

2012-07-01

... OF FUELS AND FUEL ADDITIVES Additive Registration Procedures § 79.23 Registration. (a) If the... additive which includes all of the information and assurances required by § 79.21 and has satisfactorily... the fuel additive and notify the fuel manufacturer of such registration. (b) The Administrator shall...

40 CFR 79.23 - Registration.

Code of Federal Regulations, 2013 CFR

2013-07-01

... OF FUELS AND FUEL ADDITIVES Additive Registration Procedures § 79.23 Registration. (a) If the... additive which includes all of the information and assurances required by § 79.21 and has satisfactorily... the fuel additive and notify the fuel manufacturer of such registration. (b) The Administrator shall...

40 CFR 79.23 - Registration.

Code of Federal Regulations, 2010 CFR

2010-07-01

... OF FUELS AND FUEL ADDITIVES Additive Registration Procedures § 79.23 Registration. (a) If the... additive which includes all of the information and assurances required by § 79.21 and has satisfactorily... the fuel additive and notify the fuel manufacturer of such registration. (b) The Administrator shall...

Multimodal Image Registration through Simultaneous Segmentation.

PubMed

Aganj, Iman; Fischl, Bruce

2017-11-01

Multimodal image registration facilitates the combination of complementary information from images acquired with different modalities. Most existing methods require computation of the joint histogram of the images, while some perform joint segmentation and registration in alternate iterations. In this work, we introduce a new non-information-theoretical method for pairwise multimodal image registration, in which the error of segmentation - using both images - is considered as the registration cost function. We empirically evaluate our method via rigid registration of multi-contrast brain magnetic resonance images, and demonstrate an often higher registration accuracy in the results produced by the proposed technique, compared to those by several existing methods.

Effectiveness of a Web-Based Self-Help Program for Suicidal Thinking in an Australian Community Sample: Randomized Controlled Trial

PubMed Central

van Spijker, Bregje AJ; Werner-Seidler, Aliza; Batterham, Philip J; Mackinnon, Andrew; Calear, Alison L; Gosling, John A; Reynolds, Julia; Kerkhof, Ad JFM; Solomon, Daniela; Shand, Fiona

2018-01-01

Background Treatment for suicidality can be delivered online, but evidence for its effectiveness is needed. Objective The goal of our study was to examine the effectiveness of an online self-help intervention for suicidal thinking compared to an attention-matched control program. Methods A 2-arm randomized controlled trial was conducted with assessment at postintervention, 6, and, 12 months. Through media and community advertizing, 418 suicidal adults were recruited to an online portal and were delivered the intervention program (Living with Deadly Thoughts) or a control program (Living Well). The primary outcome was severity of suicidal thinking, assessed using the Columbia Suicide Severity Rating Scale. Results Intention-to-treat analyses showed significant reductions in the severity of suicidal thinking at postintervention, 6, and 12 months. However, no overall group differences were found. Conclusions Living with Deadly Thoughts was of no greater effectiveness than the control group. Further investigation into the conditions under which this program may be beneficial is now needed. Limitations of this trial include it being underpowered given the effect size ultimately observed, a high attrition rate, and the inability of determining suicide deaths or of verifying self-reported suicide attempts. Trial Registration Australian New Zealand Clinical Trials Registry ACTRN12613000410752; https://www.anzctr.org.au/ Trial/Registration/TrialReview.aspx?id=364016 (Archived by WebCite at http://www.webcitation.org/6vK5FvQXy); Universal Trial Number U1111-1141-6595 PMID:29444769

Morphological Feature Extraction for Automatic Registration of Multispectral Images

NASA Technical Reports Server (NTRS)

Plaza, Antonio; LeMoigne, Jacqueline; Netanyahu, Nathan S.

2007-01-01

The task of image registration can be divided into two major components, i.e., the extraction of control points or features from images, and the search among the extracted features for the matching pairs that represent the same feature in the images to be matched. Manual extraction of control features can be subjective and extremely time consuming, and often results in few usable points. On the other hand, automated feature extraction allows using invariant target features such as edges, corners, and line intersections as relevant landmarks for registration purposes. In this paper, we present an extension of a recently developed morphological approach for automatic extraction of landmark chips and corresponding windows in a fully unsupervised manner for the registration of multispectral images. Once a set of chip-window pairs is obtained, a (hierarchical) robust feature matching procedure, based on a multiresolution overcomplete wavelet decomposition scheme, is used for registration purposes. The proposed method is validated on a pair of remotely sensed scenes acquired by the Advanced Land Imager (ALI) multispectral instrument and the Hyperion hyperspectral instrument aboard NASA's Earth Observing-1 satellite.

The hidden KPI registration accuracy.

PubMed

Shorrosh, Paul

2011-09-01

Determining the registration accuracy rate is fundamental to improving revenue cycle key performance indicators. A registration quality assurance (QA) process allows errors to be corrected before bills are sent and helps registrars learn from their mistakes. Tools are available to help patient access staff who perform registration QA manually.

14 CFR 47.16 - Temporary registration numbers.

Code of Federal Regulations, 2010 CFR

2010-01-01

... AIRCRAFT REGISTRATION General § 47.16 Temporary registration numbers. (a) Temporary registration numbers... Registration Certificates for temporary display on aircraft during flight allowed under Subpart C of this part. (b) The holder of a Dealer's Aircraft Registration Certificate may apply to the FAA Aircraft Registry...

Realistic simulated MRI and SPECT databases. Application to SPECT/MRI registration evaluation.

PubMed

Aubert-Broche, Berengere; Grova, Christophe; Reilhac, Anthonin; Evans, Alan C; Collins, D Louis

2006-01-01

This paper describes the construction of simulated SPECT and MRI databases that account for realistic anatomical and functional variability. The data is used as a gold-standard to evaluate four SPECT/MRI similarity-based registration methods. Simulation realism was accounted for using accurate physical models of data generation and acquisition. MRI and SPECT simulations were generated from three subjects to take into account inter-subject anatomical variability. Functional SPECT data were computed from six functional models of brain perfusion. Previous models of normal perfusion and ictal perfusion observed in Mesial Temporal Lobe Epilepsy (MTLE) were considered to generate functional variability. We studied the impact noise and intensity non-uniformity in MRI simulations and SPECT scatter correction may have on registration accuracy. We quantified the amount of registration error caused by anatomical and functional variability. Registration involving ictal data was less accurate than registration involving normal data. MR intensity nonuniformity was the main factor decreasing registration accuracy. The proposed simulated database is promising to evaluate many functional neuroimaging methods, involving MRI and SPECT data.

14 CFR 47.16 - Temporary registration numbers.

Code of Federal Regulations, 2012 CFR

2012-01-01

... AIRCRAFT REGISTRATION General § 47.16 Temporary registration numbers. (a) Temporary registration numbers... Registration Certificates, AC Form 8050-6, for temporary display on aircraft during flight allowed under Subpart C of this part. (b) The holder of a Dealer's Aircraft Registration Certificate may apply to the...

14 CFR 47.16 - Temporary registration numbers.

Code of Federal Regulations, 2011 CFR

2011-01-01

... AIRCRAFT REGISTRATION General § 47.16 Temporary registration numbers. (a) Temporary registration numbers... Registration Certificates, AC Form 8050-6, for temporary display on aircraft during flight allowed under Subpart C of this part. (b) The holder of a Dealer's Aircraft Registration Certificate may apply to the...

14 CFR 47.16 - Temporary registration numbers.

Code of Federal Regulations, 2013 CFR

2013-01-01

... AIRCRAFT REGISTRATION General § 47.16 Temporary registration numbers. (a) Temporary registration numbers... Registration Certificates, AC Form 8050-6, for temporary display on aircraft during flight allowed under Subpart C of this part. (b) The holder of a Dealer's Aircraft Registration Certificate may apply to the...

14 CFR 47.16 - Temporary registration numbers.

Code of Federal Regulations, 2014 CFR

2014-01-01

... AIRCRAFT REGISTRATION General § 47.16 Temporary registration numbers. (a) Temporary registration numbers... Registration Certificates, AC Form 8050-6, for temporary display on aircraft during flight allowed under Subpart C of this part. (b) The holder of a Dealer's Aircraft Registration Certificate may apply to the...

12 CFR 583.18 - Registrant.

Code of Federal Regulations, 2010 CFR

2010-01-01

... 12 Banks and Banking 5 2010-01-01 2010-01-01 false Registrant. 583.18 Section 583.18 Banks and Banking OFFICE OF THRIFT SUPERVISION, DEPARTMENT OF THE TREASURY DEFINITIONS FOR REGULATIONS AFFECTING SAVINGS AND LOAN HOLDING COMPANIES § 583.18 Registrant. The term registrant means a savings and loan...

Accurate registration of temporal CT images for pulmonary nodules detection

NASA Astrophysics Data System (ADS)

Yan, Jichao; Jiang, Luan; Li, Qiang

2017-02-01

Interpretation of temporal CT images could help the radiologists to detect some subtle interval changes in the sequential examinations. The purpose of this study was to develop a fully automated scheme for accurate registration of temporal CT images for pulmonary nodule detection. Our method consisted of three major registration steps. Firstly, affine transformation was applied in the segmented lung region to obtain global coarse registration images. Secondly, B-splines based free-form deformation (FFD) was used to refine the coarse registration images. Thirdly, Demons algorithm was performed to align the feature points extracted from the registered images in the second step and the reference images. Our database consisted of 91 temporal CT cases obtained from Beijing 301 Hospital and Shanghai Changzheng Hospital. The preliminary results showed that approximately 96.7% cases could obtain accurate registration based on subjective observation. The subtraction images of the reference images and the rigid and non-rigid registered images could effectively remove the normal structures (i.e. blood vessels) and retain the abnormalities (i.e. pulmonary nodules). This would be useful for the screening of lung cancer in our future study.

Pesticide Registration Information System

EPA Pesticide Factsheets

PRISM provides an integrated, web portal for all pesticide related data, communications, registrations and transactions for OPP and its stakeholders, partners and customers. PRISM supports Strategic Goal 4 by automating pesticide registration processes.

14 CFR 47.3 - Registration required.

Code of Federal Regulations, 2013 CFR

2013-01-01

... REGISTRATION General § 47.3 Registration required. (a) An aircraft may be registered under 49 U.S.C. 44103 only... person may operate an aircraft that is eligible for registration under 49 U.S.C. 44101-44104, unless the... 14 Aeronautics and Space 1 2013-01-01 2013-01-01 false Registration required. 47.3 Section 47.3...

14 CFR 47.3 - Registration required.

Code of Federal Regulations, 2011 CFR

2011-01-01

... REGISTRATION General § 47.3 Registration required. (a) An aircraft may be registered under 49 U.S.C. 44103 only... person may operate an aircraft that is eligible for registration under 49 U.S.C. 44101-44104, unless the... 14 Aeronautics and Space 1 2011-01-01 2011-01-01 false Registration required. 47.3 Section 47.3...

14 CFR 47.3 - Registration required.

Code of Federal Regulations, 2010 CFR

2010-01-01

... REGISTRATION General § 47.3 Registration required. (a) An aircraft may be registered under 49 U.S.C. 44103 only... eligible for registration under 49 U.S.C. 44101-44104, unless the aircraft— (1) Has been registered by its... 14 Aeronautics and Space 1 2010-01-01 2010-01-01 false Registration required. 47.3 Section 47.3...

14 CFR 47.3 - Registration required.

Code of Federal Regulations, 2014 CFR

2014-01-01

... REGISTRATION General § 47.3 Registration required. (a) An aircraft may be registered under 49 U.S.C. 44103 only... person may operate an aircraft that is eligible for registration under 49 U.S.C. 44101-44104, unless the... 14 Aeronautics and Space 1 2014-01-01 2014-01-01 false Registration required. 47.3 Section 47.3...

14 CFR 47.3 - Registration required.

Code of Federal Regulations, 2012 CFR

2012-01-01

... REGISTRATION General § 47.3 Registration required. (a) An aircraft may be registered under 49 U.S.C. 44103 only... person may operate an aircraft that is eligible for registration under 49 U.S.C. 44101-44104, unless the... 14 Aeronautics and Space 1 2012-01-01 2012-01-01 false Registration required. 47.3 Section 47.3...

Effectiveness of recruitment to a smartphone-delivered nutrition intervention in New Zealand: analysis of a randomised controlled trial

PubMed Central

Volkova, Ekaterina; Michie, Jo; Corrigan, Callie; Sundborn, Gerhard; Eyles, Helen; Jiang, Yannan; Mhurchu, Cliona Ni

2017-01-01

Objectives Delivery of interventions via smartphone is a relatively new initiative in public health, and limited evidence exists regarding optimal strategies for recruitment. We describe the effectiveness of approaches used to recruit participants to a smartphone-enabled nutrition intervention trial. Methods Internet and social media advertising, mainstream media advertising and research team networks were used to recruit New Zealand adults to a fully automated smartphone-delivered nutrition labelling trial (no face-to-face visits were required). Recruitment of Māori and Pacific participants was a key focus and ethically relevant recruitment materials and approaches were used where possible. The effectiveness of recruitment strategies was evaluated using Google Analytics, monitoring of study website registrations and randomisations, and self-reported participant data. The cost of the various strategies and associations with participant demographics were assessed. Results Over a period of 13 months, there were 2448 registrations on the study website, and 1357 eligible individuals were randomised into the study (55%). Facebook campaigns were the most successful recruitment strategy overall (43% of all randomised participants) and for all ethnic groups (Māori 44%, Pacific 44% and other 43%). Significant associations were observed between recruitment strategy and age (p<0.001), household size (p<0.001), ethnicity (p<0.001), gender (p=0.005) and interest in healthy eating (p=0.022). Facebook campaigns resulted in the highest absolute numbers of study registrations and randomisations (966 and 584, respectively). Network strategies and Facebook campaigns cost least per randomised participant (NZ$4 and NZ$5, respectively), whereas radio advertising costs most (NZ$179 per participant). Conclusion Internet and social media advertising were the most effective and least costly approaches to recruiting participants to a smartphone-delivered trial. These approaches also

40 CFR 152.135 - Transfer of registration.

Code of Federal Regulations, 2011 CFR

2011-07-01

... wishes to transfer data rights at the same time as he transfers the registration, he may submit a single... 40 Protection of Environment 24 2011-07-01 2011-07-01 false Transfer of registration. 152.135... Transfer of registration. (a) A registrant may transfer the registration of a product to another person...

40 CFR 152.135 - Transfer of registration.

Code of Federal Regulations, 2014 CFR

2014-07-01

... wishes to transfer data rights at the same time as he transfers the registration, he may submit a single... 40 Protection of Environment 24 2014-07-01 2014-07-01 false Transfer of registration. 152.135... Transfer of registration. (a) A registrant may transfer the registration of a product to another person...

3D-2D registration for surgical guidance: effect of projection view angles on registration accuracy

NASA Astrophysics Data System (ADS)

Uneri, A.; Otake, Y.; Wang, A. S.; Kleinszig, G.; Vogt, S.; Khanna, A. J.; Siewerdsen, J. H.

2014-01-01

An algorithm for intensity-based 3D-2D registration of CT and x-ray projections is evaluated, specifically using single- or dual-projection views to provide 3D localization. The registration framework employs the gradient information similarity metric and covariance matrix adaptation evolution strategy to solve for the patient pose in six degrees of freedom. Registration performance was evaluated in an anthropomorphic phantom and cadaver, using C-arm projection views acquired at angular separation, Δθ, ranging from ˜0°-180° at variable C-arm magnification. Registration accuracy was assessed in terms of 2D projection distance error and 3D target registration error (TRE) and compared to that of an electromagnetic (EM) tracker. The results indicate that angular separation as small as Δθ ˜10°-20° achieved TRE <2 mm with 95% confidence, comparable or superior to that of the EM tracker. The method allows direct registration of preoperative CT and planning data to intraoperative fluoroscopy, providing 3D localization free from conventional limitations associated with external fiducial markers, stereotactic frames, trackers and manual registration.

22 CFR 122.3 - Registration fees.

Code of Federal Regulations, 2010 CFR

2010-04-01

... registration. (4) For registrants, including universities, exempt from income taxation pursuant to 26 U.S.C... eligible, the registrant and all of its subsidiaries/affiliates must be exempt from income taxation...

Registration Documents for Enlist Duo Herbicide (2014)

EPA Pesticide Factsheets

See details of the registration of Enlist Duo in 2014, including the notification to the registrant, the details of the assessment and registration decision, and the response to public comment on the proposed registration.

Public Participation Process for Registration Actions

EPA Pesticide Factsheets

Describes the process for registration actions which provides the opportunity for the public to comment on major registration decisions at a point in the registration process when comprehensive information and analysis are available.

Predictors of support for juvenile sex offender registration: educated individuals recognize the flaws of juvenile registration.

PubMed

Stevenson, Margaret C; Smith, Amy C; Sekely, Ady; Farnum, Katlyn S

2013-01-01

We investigated demographic predictors of support for juvenile sex offender registration policies, including education level, gender, political orientation, and age. Participants were 168 individuals recruited from public places in a Midwest community (45% women; M age = 42). In line with hypotheses, as education level increased, support for juvenile registration decreased, as did the belief that juvenile registration protects the community. In addition, as education level increased, belief that the juvenile understood his actions decreased, as did support for juvenile registration when it is framed as ineffective at reducing sex crime. These beliefs mediated the relationship between education level and diminished support for juvenile registration. Implications of these results for the advancement of effective juvenile sex offender policy are discussed.

17 CFR 240.6a-1 - Application for registration as a national securities exchange or exemption from registration...

Code of Federal Regulations, 2010 CFR

2010-04-01

... as a national securities exchange or exemption from registration based on limited volume. 240.6a-1... national securities exchange or exemption from registration based on limited volume. (a) An application for registration as a national securities exchange, or for exemption from such registration based on limited volume...

17 CFR 240.6a-1 - Application for registration as a national securities exchange or exemption from registration...

Code of Federal Regulations, 2011 CFR

2011-04-01

... as a national securities exchange or exemption from registration based on limited volume. 240.6a-1... national securities exchange or exemption from registration based on limited volume. (a) An application for registration as a national securities exchange, or for exemption from such registration based on limited volume...

Dosimetric impact of contouring and image registration variability on dynamic 125I prostate brachytherapy.

PubMed

Westendorp, Hendrik; Surmann, Kathrin; van de Pol, Sandrine M G; Hoekstra, Carel J; Kattevilder, Robert A J; Nuver, Tonnis T; Moerland, Marinus A; Slump, Cornelis H; Minken, André W

The quality of permanent prostate brachytherapy can be increased by addition of imaging modalities in the intraoperative procedure. This addition involves image registration, which inherently has inter- and intraobserver variabilities. We sought to quantify the inter- and intraobserver variabilities in geometry and dosimetry for contouring and image registration and analyze the results for our dynamic 125 I brachytherapy procedure. Five observers contoured 11 transrectal ultrasound (TRUS) data sets three times and 11 CT data sets one time. The observers registered 11 TRUS and MRI data sets to cone beam CT (CBCT) using fiducial gold markers. Geometrical and dosimetrical inter- and intraobserver variabilities were assessed. For the contouring study, structures were subdivided into three parts along the craniocaudal axis. We analyzed 165 observations. Interobserver geometrical variability for prostate was 1.1 mm, resulting in a dosimetric variability of 1.6% for V 100 and 9.3% for D 90 . The geometric intraobserver variability was 0.6 mm with a V 100 of 0.7% and D 90 of 1.1%. TRUS-CBCT registration showed an interobserver variability in V 100 of 2.0% and D 90 of 3.1%. Intraobserver variabilities were 0.9% and 1.6%, respectively. For MRI-CBCT registration, V 100 and D 90 were 1.3% and 2.1%. Intraobserver variabilities were 0.7% and 1.1% for the same. Prostate dosimetry is affected by interobserver contouring and registration variability. The observed variability is smaller than underdosages that are adapted during our dynamic brachytherapy procedure. Copyright © 2017 American Brachytherapy Society. Published by Elsevier Inc. All rights reserved.

14 CFR 47.39 - Effective date of registration.

Code of Federal Regulations, 2012 CFR

2012-01-01

... AIRCRAFT REGISTRATION Certificates of Aircraft Registration § 47.39 Effective date of registration. An... this part. The effective date of registration is shown by a date stamp on the Aircraft Registration Application, AC Form 8050-1, and as the date of issue on the Certificate of Aircraft Registration, AC Form...

14 CFR 47.39 - Effective date of registration.

Code of Federal Regulations, 2013 CFR

2013-01-01

... AIRCRAFT REGISTRATION Certificates of Aircraft Registration § 47.39 Effective date of registration. An... this part. The effective date of registration is shown by a date stamp on the Aircraft Registration Application, AC Form 8050-1, and as the date of issue on the Certificate of Aircraft Registration, AC Form...

14 CFR 47.39 - Effective date of registration.

Code of Federal Regulations, 2011 CFR

2011-01-01

... AIRCRAFT REGISTRATION Certificates of Aircraft Registration § 47.39 Effective date of registration. An... this part. The effective date of registration is shown by a date stamp on the Aircraft Registration Application, AC Form 8050-1, and as the date of issue on the Certificate of Aircraft Registration, AC Form...

14 CFR 47.39 - Effective date of registration.

Code of Federal Regulations, 2014 CFR

2014-01-01

... AIRCRAFT REGISTRATION Certificates of Aircraft Registration § 47.39 Effective date of registration. An... this part. The effective date of registration is shown by a date stamp on the Aircraft Registration Application, AC Form 8050-1, and as the date of issue on the Certificate of Aircraft Registration, AC Form...

Responsible Translation of Stem Cell Research: An Assessment of Clinical Trial Registration and Publications.

PubMed

Fung, Moses; Yuan, Yan; Atkins, Harold; Shi, Qian; Bubela, Tania

2017-05-09

We assessed the extent to which the publication of clinical trial results of innovative cell-based interventions reflects International Society for Stem Cell Research best practice guidelines. We assessed: (1) characteristics and time to publication of completed trials; (2) quality of reported trials; and (3) results of published trials. We identified and analyzed publications from 1,052 novel stem cell clinical trials: 179 (45.4%) of 393 completed trials had published results; 48 trials were registered by known stem cell tourism clinics, none of which reported results. Completed non-industry-sponsored trials initially published more rapidly, but differences with industry-sponsored trials decreased over time. Most publications reported safety, and 67.3% (mainly early-stage trials) reported positive outcomes. A higher proportion of industry trials reported positive efficacy. Heightened patient expectations for stem cell therapies give rise to ethical obligations for the transparent conduct of clinical trials. Reporting guidelines need to be developed that are specific to early-phase clinical trials. Copyright © 2017 The Author(s). Published by Elsevier Inc. All rights reserved.

Cost-efficiency of knowledge creation: randomized controlled trials vs. observational studies.

PubMed

Struck, Rafael; Baumgarten, Georg; Wittmann, Maria

2014-04-01

This article reviews traditional and current perspectives on randomized, controlled trials (RCTs) and observational studies relative to the economic implications for public healthcare stakeholders. It takes an average of 17 years to bring 14% of original research into clinical practice. Results from high-quality observational studies may complement limited RCTs in primary and secondary literature bases, and enhance the incorporation of sound evidence-based guidelines. Observational findings from comprehensive medical databases may offer valuable clues on the effectiveness and relevance of public healthcare interventions. Major expenditures associated with RCTs relate to recruitment, inappropriate site selection, conduct and reporting. Application of business strategies and economic evaluation tools, in addition to the planning and conduct of RCTs, may enhance clinical trial site performances. Considering the strengths and limitations of each study type, clinical researchers should explore the contextual worthiness of either design in promulgating knowledge. They should focus on quality of conduct and reporting that may allow for the liberation of limited public and private clinical research funding.

21 CFR 607.35 - Notification of registrant; blood product establishment registration number and NDC Labeler Code.

Code of Federal Regulations, 2013 CFR

2013-04-01

... 21 Food and Drugs 7 2013-04-01 2013-04-01 false Notification of registrant; blood product... PRODUCT LISTING FOR MANUFACTURERS OF HUMAN BLOOD AND BLOOD PRODUCTS Procedures for Domestic Blood Product Establishments § 607.35 Notification of registrant; blood product establishment registration number and NDC...

21 CFR 607.35 - Notification of registrant; blood product establishment registration number and NDC Labeler Code.

Code of Federal Regulations, 2012 CFR

2012-04-01

... 21 Food and Drugs 7 2012-04-01 2012-04-01 false Notification of registrant; blood product... PRODUCT LISTING FOR MANUFACTURERS OF HUMAN BLOOD AND BLOOD PRODUCTS Procedures for Domestic Blood Product Establishments § 607.35 Notification of registrant; blood product establishment registration number and NDC...

21 CFR 607.35 - Notification of registrant; blood product establishment registration number and NDC Labeler Code.

Code of Federal Regulations, 2014 CFR

2014-04-01

... 21 Food and Drugs 7 2014-04-01 2014-04-01 false Notification of registrant; blood product... PRODUCT LISTING FOR MANUFACTURERS OF HUMAN BLOOD AND BLOOD PRODUCTS Procedures for Domestic Blood Product Establishments § 607.35 Notification of registrant; blood product establishment registration number and NDC...

Directly manipulated free-form deformation image registration.

PubMed

Tustison, Nicholas J; Avants, Brian B; Gee, James C

2009-03-01

Previous contributions to both the research and open source software communities detailed a generalization of a fast scalar field fitting technique for cubic B-splines based on the work originally proposed by Lee . One advantage of our proposed generalized B-spline fitting approach is its immediate application to a class of nonrigid registration techniques frequently employed in medical image analysis. Specifically, these registration techniques fall under the rubric of free-form deformation (FFD) approaches in which the object to be registered is embedded within a B-spline object. The deformation of the B-spline object describes the transformation of the image registration solution. Representative of this class of techniques, and often cited within the relevant community, is the formulation of Rueckert who employed cubic splines with normalized mutual information to study breast deformation. Similar techniques from various groups provided incremental novelty in the form of disparate explicit regularization terms, as well as the employment of various image metrics and tailored optimization methods. For several algorithms, the underlying gradient-based optimization retained the essential characteristics of Rueckert's original contribution. The contribution which we provide in this paper is two-fold: 1) the observation that the generic FFD framework is intrinsically susceptible to problematic energy topographies and 2) that the standard gradient used in FFD image registration can be modified to a well-understood preconditioned form which substantially improves performance. This is demonstrated with theoretical discussion and comparative evaluation experimentation.

Coping with missing data in phase III pivotal registration trials: Tolvaptan in subjects with kidney disease, a case study.

PubMed

Ouyang, John; Carroll, Kevin J; Koch, Gary; Li, Junfang

2017-07-01

Missing data cause challenging issues, particularly in phase III registration trials, as highlighted by the European Medicines Agency (EMA) and the US National Research Council. We explore, as a case study, how the issues from missing data were tackled in a double-blind phase III trial in subjects with autosomal dominant polycystic kidney disease. A total of 1445 subjects were randomized in a 2:1 ratio to receive active treatment (tolvaptan), or placebo. The primary outcome, the rate of change in total kidney volume, favored tolvaptan (P < .0001). The key secondary efficacy endpoints of clinical progression of disease and rate of decline in kidney function also favored tolvaptan. However, as highlighted by Food and Drug Administration and EMA, the interpretation of results was hampered by a high number of unevenly distributed dropouts, particularly early dropouts. In this paper, we outline the analyses undertaken to address the issue of missing data thoroughly. "Tipping point analyses" were performed to explore how extreme and detrimental outcomes among subjects with missing data must be to overturn the positive treatment effect attained in those subjects who had complete data. Nonparametric rank-based analyses were also performed accounting for missing data. In conclusion, straightforward and transparent analyses directly taking into account missing data convincingly support the robustness of the preplanned analyses on the primary and secondary endpoints. Tolvaptan was confirmed to be effective in slowing total kidney volume growth, which is considered an efficacy endpoint by EMA, and in lessening the decline in renal function in patients with autosomal dominant polycystic kidney disease. Copyright © 2017 John Wiley & Sons, Ltd.

Observed and Predicted Risk of Breast Cancer Death in Randomized Trials on Breast Cancer Screening

PubMed Central

Autier, Philippe; Sullivan, Richard; Boyle, Peter

2016-01-01

Background The role of breast screening in breast cancer mortality declines is debated. Screening impacts cancer mortality through decreasing the number of advanced cancers with poor diagnosis, while cancer treatment works through decreasing the case-fatality rate. Hence, reductions in cancer death rates thanks to screening should directly reflect reductions in advanced cancer rates. We verified whether in breast screening trials, the observed reductions in the risk of breast cancer death could be predicted from reductions of advanced breast cancer rates. Patients and Methods The Greater New York Health Insurance Plan trial (HIP) is the only breast screening trial that reported stage-specific cancer fatality for the screening and for the control group separately. The Swedish Two-County trial (TCT)) reported size-specific fatalities for cancer patients in both screening and control groups. We computed predicted numbers of breast cancer deaths, from which we calculated predicted relative risks (RR) and (95% confidence intervals). The Age trial in England performed its own calculations of predicted relative risk. Results The observed and predicted RR of breast cancer death were 0.72 (0.56–0.94) and 0.98 (0.77–1.24) in the HIP trial, and 0.79 (0.78–1.01) and 0.90 (0.80–1.01) in the Age trial. In the TCT, the observed RR was 0.73 (0.62–0.87), while the predicted RR was 0.89 (0.75–1.05) if overdiagnosis was assumed to be negligible and 0.83 (0.70–0.97) if extra cancers were excluded. Conclusions In breast screening trials, factors other than screening have contributed to reductions in the risk of breast cancer death most probably by reducing the fatality of advanced cancers in screening groups. These factors were the better management of breast cancer patients and the underreporting of breast cancer as the underlying cause of death. Breast screening trials should publish stage-specific fatalities observed in each group. PMID:27100174

Observed and Predicted Risk of Breast Cancer Death in Randomized Trials on Breast Cancer Screening.

PubMed

Autier, Philippe; Boniol, Mathieu; Smans, Michel; Sullivan, Richard; Boyle, Peter

2016-01-01

The role of breast screening in breast cancer mortality declines is debated. Screening impacts cancer mortality through decreasing the number of advanced cancers with poor diagnosis, while cancer treatment works through decreasing the case-fatality rate. Hence, reductions in cancer death rates thanks to screening should directly reflect reductions in advanced cancer rates. We verified whether in breast screening trials, the observed reductions in the risk of breast cancer death could be predicted from reductions of advanced breast cancer rates. The Greater New York Health Insurance Plan trial (HIP) is the only breast screening trial that reported stage-specific cancer fatality for the screening and for the control group separately. The Swedish Two-County trial (TCT)) reported size-specific fatalities for cancer patients in both screening and control groups. We computed predicted numbers of breast cancer deaths, from which we calculated predicted relative risks (RR) and (95% confidence intervals). The Age trial in England performed its own calculations of predicted relative risk. The observed and predicted RR of breast cancer death were 0.72 (0.56-0.94) and 0.98 (0.77-1.24) in the HIP trial, and 0.79 (0.78-1.01) and 0.90 (0.80-1.01) in the Age trial. In the TCT, the observed RR was 0.73 (0.62-0.87), while the predicted RR was 0.89 (0.75-1.05) if overdiagnosis was assumed to be negligible and 0.83 (0.70-0.97) if extra cancers were excluded. In breast screening trials, factors other than screening have contributed to reductions in the risk of breast cancer death most probably by reducing the fatality of advanced cancers in screening groups. These factors were the better management of breast cancer patients and the underreporting of breast cancer as the underlying cause of death. Breast screening trials should publish stage-specific fatalities observed in each group.

Methodological reporting of randomized clinical trials in respiratory research in 2010.

PubMed

Lu, Yi; Yao, Qiuju; Gu, Jie; Shen, Ce

2013-09-01

Although randomized controlled trials (RCTs) are considered the highest level of evidence, they are also subject to bias, due to a lack of adequately reported randomization, and therefore the reporting should be as explicit as possible for readers to determine the significance of the contents. We evaluated the methodological quality of RCTs in respiratory research in high ranking clinical journals, published in 2010. We assessed the methodological quality, including generation of the allocation sequence, allocation concealment, double-blinding, sample-size calculation, intention-to-treat analysis, flow diagrams, number of medical centers involved, diseases, funding sources, types of interventions, trial registration, number of times the papers have been cited, journal impact factor, journal type, and journal endorsement of the CONSORT (Consolidated Standards of Reporting Trials) rules, in RCTs published in 12 top ranking clinical respiratory journals and 5 top ranking general medical journals. We included 176 trials, of which 93 (53%) reported adequate generation of the allocation sequence, 66 (38%) reported adequate allocation concealment, 79 (45%) were double-blind, 123 (70%) reported adequate sample-size calculation, 88 (50%) reported intention-to-treat analysis, and 122 (69%) included a flow diagram. Multivariate logistic regression analysis revealed that journal impact factor ≥ 5 was the only variable that significantly influenced adequate allocation sequence generation. Trial registration and journal impact factor ≥ 5 significantly influenced adequate allocation concealment. Medical interventions, trial registration, and journal endorsement of the CONSORT statement influenced adequate double-blinding. Publication in one of the general medical journal influenced adequate sample-size calculation. The methodological quality of RCTs in respiratory research needs improvement. Stricter enforcement of the CONSORT statement should enhance the quality of RCTs.

Non-rigid image registration using a statistical spline deformation model.

PubMed

Loeckx, Dirk; Maes, Frederik; Vandermeulen, Dirk; Suetens, Paul

2003-07-01

We propose a statistical spline deformation model (SSDM) as a method to solve non-rigid image registration. Within this model, the deformation is expressed using a statistically trained B-spline deformation mesh. The model is trained by principal component analysis of a training set. This approach allows to reduce the number of degrees of freedom needed for non-rigid registration by only retaining the most significant modes of variation observed in the training set. User-defined transformation components, like affine modes, are merged with the principal components into a unified framework. Optimization proceeds along the transformation components rather then along the individual spline coefficients. The concept of SSDM's is applied to the temporal registration of thorax CR-images using pattern intensity as the registration measure. Our results show that, using 30 training pairs, a reduction of 33% is possible in the number of degrees of freedom without deterioration of the result. The same accuracy as without SSDM's is still achieved after a reduction up to 66% of the degrees of freedom.

Poor reporting of scientific leadership information in clinical trial registers.

PubMed

Sekeres, Melanie; Gold, Jennifer L; Chan, An-Wen; Lexchin, Joel; Moher, David; Van Laethem, Marleen L P; Maskalyk, James; Ferris, Lorraine; Taback, Nathan; Rochon, Paula A

2008-02-20

In September 2004, the International Committee of Medical Journal Editors (ICMJE) issued a Statement requiring that all clinical trials be registered at inception in a public register in order to be considered for publication. The World Health Organization (WHO) and ICMJE have identified 20 items that should be provided before a trial is considered registered, including contact information. Identifying those scientifically responsible for trial conduct increases accountability. The objective is to examine the proportion of registered clinical trials providing valid scientific leadership information. We reviewed clinical trial entries listing Canadian investigators in the two largest international and public trial registers, the International Standard Randomized Controlled Trial Number (ISRCTN) register, and ClinicalTrials.gov. The main outcome measures were the proportion of clinical trials reporting valid contact information for the trials' Principal Investigator (PI)/Co-ordinating Investigator/Study Chair/Site PI, and trial e-mail contact address, stratified by funding source, recruiting status, and register. A total of 1388 entries (142 from ISRCTN and 1246 from ClinicalTrials.gov) comprised our sample. We found non-compliance with mandatory registration requirements regarding scientific leadership and trial contact information. Non-industry and partial industry funded trials were significantly more likely to identify the individual responsible for scientific leadership (OR = 259, 95% CI: 95-701) and to provide a contact e-mail address (OR = 9.6, 95% CI: 6.6-14) than were solely industry funded trials. Despite the requirements set by WHO and ICMJE, data on scientific leadership and contact e-mail addresses are frequently omitted from clinical trials registered in the two leading public clinical trial registers. To promote accountability and transparency in clinical trials research, public clinical trials registers should ensure adequate monitoring of trial

14 CFR 47.61 - Dealer's Aircraft Registration Certificates.

Code of Federal Regulations, 2014 CFR

2014-01-01

... 14 Aeronautics and Space 1 2014-01-01 2014-01-01 false Dealer's Aircraft Registration Certificates... TRANSPORTATION AIRCRAFT AIRCRAFT REGISTRATION Dealers' Aircraft Registration Certificate § 47.61 Dealer's Aircraft Registration Certificates. (a) The FAA issues a Dealer's Aircraft Registration Certificate, AC...

14 CFR 47.61 - Dealer's Aircraft Registration Certificates.

Code of Federal Regulations, 2013 CFR

2013-01-01

... 14 Aeronautics and Space 1 2013-01-01 2013-01-01 false Dealer's Aircraft Registration Certificates... TRANSPORTATION AIRCRAFT AIRCRAFT REGISTRATION Dealers' Aircraft Registration Certificate § 47.61 Dealer's Aircraft Registration Certificates. (a) The FAA issues a Dealer's Aircraft Registration Certificate, AC...

14 CFR 47.61 - Dealer's Aircraft Registration Certificates.

Code of Federal Regulations, 2011 CFR

2011-01-01

... 14 Aeronautics and Space 1 2011-01-01 2011-01-01 false Dealer's Aircraft Registration Certificates... TRANSPORTATION AIRCRAFT AIRCRAFT REGISTRATION Dealers' Aircraft Registration Certificate § 47.61 Dealer's Aircraft Registration Certificates. (a) The FAA issues a Dealer's Aircraft Registration Certificate, AC...

14 CFR 47.61 - Dealer's Aircraft Registration Certificates.

Code of Federal Regulations, 2012 CFR

2012-01-01

... 14 Aeronautics and Space 1 2012-01-01 2012-01-01 false Dealer's Aircraft Registration Certificates... TRANSPORTATION AIRCRAFT AIRCRAFT REGISTRATION Dealers' Aircraft Registration Certificate § 47.61 Dealer's Aircraft Registration Certificates. (a) The FAA issues a Dealer's Aircraft Registration Certificate, AC...

14 CFR 47.61 - Dealers' Aircraft Registration Certificates.

Code of Federal Regulations, 2010 CFR

2010-01-01

... 14 Aeronautics and Space 1 2010-01-01 2010-01-01 false Dealers' Aircraft Registration Certificates... TRANSPORTATION AIRCRAFT AIRCRAFT REGISTRATION Dealers' Aircraft Registration Certificate § 47.61 Dealers' Aircraft Registration Certificates. (a) The FAA issues a Dealers' Aircraft Registration Certificate, AC...

40 CFR 164.21 - Contents of a denial of registration, notice of intent to cancel a registration, or notice of...

Code of Federal Regulations, 2010 CFR

2010-07-01

..., notice of intent to cancel a registration, or notice of intent to change a classification. 164.21 Section... denial of registration, notice of intent to cancel a registration, or notice of intent to change a classification. (a) Contents. The denial of registration or a notice of intent to cancel a registration or to...

Assessing validity of observational intervention studies - the Benchmarking Controlled Trials.

PubMed

Malmivaara, Antti

2016-09-01

Benchmarking Controlled Trial (BCT) is a concept which covers all observational studies aiming to assess impact of interventions or health care system features to patients and populations. To create and pilot test a checklist for appraising methodological validity of a BCT. The checklist was created by extracting the most essential elements from the comprehensive set of criteria in the previous paper on BCTs. Also checklists and scientific papers on observational studies and respective systematic reviews were utilized. Ten BCTs published in the Lancet and in the New England Journal of Medicine were used to assess feasibility of the created checklist. The appraised studies seem to have several methodological limitations, some of which could be avoided in planning, conducting and reporting phases of the studies. The checklist can be used for planning, conducting, reporting, reviewing, and critical reading of observational intervention studies. However, the piloted checklist should be validated in further studies. Key messages Benchmarking Controlled Trial (BCT) is a concept which covers all observational studies aiming to assess impact of interventions or health care system features to patients and populations. This paper presents a checklist for appraising methodological validity of BCTs and pilot-tests the checklist with ten BCTs published in leading medical journals. The appraised studies seem to have several methodological limitations, some of which could be avoided in planning, conducting and reporting phases of the studies. The checklist can be used for planning, conducting, reporting, reviewing, and critical reading of observational intervention studies.

ADAPTIVE MATCHING IN RANDOMIZED TRIALS AND OBSERVATIONAL STUDIES

PubMed Central

van der Laan, Mark J.; Balzer, Laura B.; Petersen, Maya L.

2014-01-01

SUMMARY In many randomized and observational studies the allocation of treatment among a sample of n independent and identically distributed units is a function of the covariates of all sampled units. As a result, the treatment labels among the units are possibly dependent, complicating estimation and posing challenges for statistical inference. For example, cluster randomized trials frequently sample communities from some target population, construct matched pairs of communities from those included in the sample based on some metric of similarity in baseline community characteristics, and then randomly allocate a treatment and a control intervention within each matched pair. In this case, the observed data can neither be represented as the realization of n independent random variables, nor, contrary to current practice, as the realization of n/2 independent random variables (treating the matched pair as the independent sampling unit). In this paper we study estimation of the average causal effect of a treatment under experimental designs in which treatment allocation potentially depends on the pre-intervention covariates of all units included in the sample. We define efficient targeted minimum loss based estimators for this general design, present a theorem that establishes the desired asymptotic normality of these estimators and allows for asymptotically valid statistical inference, and discuss implementation of these estimators. We further investigate the relative asymptotic efficiency of this design compared with a design in which unit-specific treatment assignment depends only on the units’ covariates. Our findings have practical implications for the optimal design and analysis of pair matched cluster randomized trials, as well as for observational studies in which treatment decisions may depend on characteristics of the entire sample. PMID:25097298

40 CFR 155.56 - Interim registration review decision.

Code of Federal Regulations, 2010 CFR

2010-07-01

... 40 Protection of Environment 23 2010-07-01 2010-07-01 false Interim registration review decision... PROGRAMS REGISTRATION STANDARDS AND REGISTRATION REVIEW Registration Review Procedures § 155.56 Interim registration review decision. The Agency may issue, when it determines it to be appropriate, an interim...

14 CFR 47.40 - Registration expiration and renewal.

Code of Federal Regulations, 2014 CFR

2014-01-01

... AIRCRAFT REGISTRATION Certificates of Aircraft Registration § 47.40 Registration expiration and renewal. (a) Re-registration. Each aircraft registered under this part before October 1, 2010, must be re-registered in accordance with this paragraph (a). (1) A Certificate of Aircraft Registration issued before...

14 CFR 47.40 - Registration expiration and renewal.

Code of Federal Regulations, 2012 CFR

2012-01-01

... AIRCRAFT REGISTRATION Certificates of Aircraft Registration § 47.40 Registration expiration and renewal. (a) Re-registration. Each aircraft registered under this part before October 1, 2010, must be re-registered in accordance with this paragraph (a). (1) A Certificate of Aircraft Registration issued before...

14 CFR 47.40 - Registration expiration and renewal.

Code of Federal Regulations, 2013 CFR

2013-01-01

... AIRCRAFT REGISTRATION Certificates of Aircraft Registration § 47.40 Registration expiration and renewal. (a) Re-registration. Each aircraft registered under this part before October 1, 2010, must be re-registered in accordance with this paragraph (a). (1) A Certificate of Aircraft Registration issued before...

Observational studies are complementary to randomized controlled trials.

PubMed

Grootendorst, Diana C; Jager, Kitty J; Zoccali, Carmine; Dekker, Friedo W

2010-01-01

Randomized controlled trials (RCTs) are considered the gold standard study design to investigate the effect of health interventions, including treatment. However, in some situations, it may be unnecessary, inappropriate, impossible, or inadequate to perform an RCT. In these special situations, well-designed observational studies, including cohort and case-control studies, may provide an alternative to doing nothing in order to obtain estimates of treatment effect. It should be noted that such studies should be performed with caution and correctly. The aims of this review are (1) to explain why RCTs are considered the optimal study design to evaluate treatment effects, (2) to describe the situations in which an RCT is not possible and observational studies are an adequate alternative, and (3) to explain when randomization is not needed and can be approximated in observational studies. Examples from the nephrology literature are used for illustration. Copyright 2009 S. Karger AG, Basel.

18 CFR 390.1 - Electronic registration.

Code of Federal Regulations, 2013 CFR

2013-04-01

... 18 Conservation of Power and Water Resources 1 2013-04-01 2013-04-01 false Electronic registration. 390.1 Section 390.1 Conservation of Power and Water Resources FEDERAL ENERGY REGULATORY COMMISSION, DEPARTMENT OF ENERGY PROCEDURAL RULES ELECTRONIC REGISTRATION § 390.1 Electronic registration. Any person who...

18 CFR 390.1 - Electronic registration.

Code of Federal Regulations, 2011 CFR

2011-04-01

... 18 Conservation of Power and Water Resources 1 2011-04-01 2011-04-01 false Electronic registration. 390.1 Section 390.1 Conservation of Power and Water Resources FEDERAL ENERGY REGULATORY COMMISSION, DEPARTMENT OF ENERGY PROCEDURAL RULES ELECTRONIC REGISTRATION § 390.1 Electronic registration. Any person who...

18 CFR 390.1 - Electronic registration.

Code of Federal Regulations, 2010 CFR

2010-04-01

... 18 Conservation of Power and Water Resources 1 2010-04-01 2010-04-01 false Electronic registration. 390.1 Section 390.1 Conservation of Power and Water Resources FEDERAL ENERGY REGULATORY COMMISSION, DEPARTMENT OF ENERGY PROCEDURAL RULES ELECTRONIC REGISTRATION § 390.1 Electronic registration. Any person who...

18 CFR 390.1 - Electronic registration.

Code of Federal Regulations, 2014 CFR

2014-04-01

... 18 Conservation of Power and Water Resources 1 2014-04-01 2014-04-01 false Electronic registration. 390.1 Section 390.1 Conservation of Power and Water Resources FEDERAL ENERGY REGULATORY COMMISSION, DEPARTMENT OF ENERGY PROCEDURAL RULES ELECTRONIC REGISTRATION § 390.1 Electronic registration. Any person who...

18 CFR 390.1 - Electronic registration.

Code of Federal Regulations, 2012 CFR

2012-04-01

... 18 Conservation of Power and Water Resources 1 2012-04-01 2012-04-01 false Electronic registration. 390.1 Section 390.1 Conservation of Power and Water Resources FEDERAL ENERGY REGULATORY COMMISSION, DEPARTMENT OF ENERGY PROCEDURAL RULES ELECTRONIC REGISTRATION § 390.1 Electronic registration. Any person who...

A survey of medical image registration - under review.

PubMed

Viergever, Max A; Maintz, J B Antoine; Klein, Stefan; Murphy, Keelin; Staring, Marius; Pluim, Josien P W

2016-10-01

A retrospective view on the past two decades of the field of medical image registration is presented, guided by the article "A survey of medical image registration" (Maintz and Viergever, 1998). It shows that the classification of the field introduced in that article is still usable, although some modifications to do justice to advances in the field would be due. The main changes over the last twenty years are the shift from extrinsic to intrinsic registration, the primacy of intensity-based registration, the breakthrough of nonlinear registration, the progress of inter-subject registration, and the availability of generic image registration software packages. Two problems that were called urgent already 20 years ago, are even more urgent nowadays: Validation of registration methods, and translation of results of image registration research to clinical practice. It may be concluded that the field of medical image registration has evolved, but still is in need of further development in various aspects. Copyright © 2016 Elsevier B.V. All rights reserved.

37 CFR 201.7 - Cancellation of completed registrations.

Code of Federal Regulations, 2010 CFR

2010-07-01

... registration number is eliminated and a new registration is made under a different class and number. (b...; or (3) An existing registration in the wrong class is to be replaced by a new registration in the correct class. (c) Circumstances under which a registration will be cancelled. (1) Where the Copyright...

Spherical Demons: Fast Surface Registration

PubMed Central

Yeo, B.T. Thomas; Sabuncu, Mert; Vercauteren, Tom; Ayache, Nicholas; Fischl, Bruce; Golland, Polina

2009-01-01

We present the fast Spherical Demons algorithm for registering two spherical images. By exploiting spherical vector spline interpolation theory, we show that a large class of regularizers for the modified demons objective function can be efficiently implemented on the sphere using convolution. Based on the one parameter subgroups of diffeomorphisms, the resulting registration is diffeomorphic and fast – registration of two cortical mesh models with more than 100k nodes takes less than 5 minutes, comparable to the fastest surface registration algorithms. Moreover, the accuracy of our method compares favorably to the popular FreeSurfer registration algorithm. We validate the technique in two different settings: (1) parcellation in a set of in-vivo cortical surfaces and (2) Brodmann area localization in ex-vivo cortical surfaces. PMID:18979813

Spherical demons: fast surface registration.

PubMed

Yeo, B T Thomas; Sabuncu, Mert; Vercauteren, Tom; Ayache, Nicholas; Fischl, Bruce; Golland, Polina

2008-01-01

We present the fast Spherical Demons algorithm for registering two spherical images. By exploiting spherical vector spline interpolation theory, we show that a large class of regularizers for the modified demons objective function can be efficiently implemented on the sphere using convolution. Based on the one parameter subgroups of diffeomorphisms, the resulting registration is diffeomorphic and fast - registration of two cortical mesh models with more than 100k nodes takes less than 5 minutes, comparable to the fastest surface registration algorithms. Moreover, the accuracy of our method compares favorably to the popular FreeSurfer registration algorithm. We validate the technique in two different settings: (1) parcellation in a set of in-vivo cortical surfaces and (2) Brodmann area localization in ex-vivo cortical surfaces.

Comparison of reporting phase III randomized controlled trials of antibiotic treatment for common bacterial infections in ClinicalTrials.gov and matched publications.

PubMed

Shepshelovich, D; Yelin, D; Gafter-Gvili, A; Goldman, S; Avni, T; Yahav, D

2018-02-15

Discrepancies between ClinicalTrials.gov entries and matching publications were previously described in general medicine. We aimed to evaluate the consistency of reporting in trials addressing systemic antibiotic therapy. We searched ClinicalTrials.gov for completed phase III trials comparing antibiotic regimens until May 2017. Matched publications were identified in PubMed. Two independent reviewers extracted data and identified inconsistencies. Reporting was assessed among studies started before and after 1 July 2005, when the International Committee of Medical Journal Editors (ICMJE) required mandatory registration as a prerequisite for considering a trial for publication. Matching publications were identified for 75 (70%) of 107 ClinicalTrials.gov entries. Median time from study completion to publication was 26 months (interquartile range 19-42). Primary outcome definition was inconsistent between ClinicalTrials.gov and publications in seven trials (7/72, 10%) and reporting of the primary outcome timeframe was inconsistent in 14 (14/71, 20%). Secondary outcomes definitions were inconsistent in 36 trials (36/66, 55%). Reporting of inclusion criteria and study timeline were inconsistent in 17% (13/65) and 3% (2/65), respectively. Trials started after July 2005 were significantly less likely to have reporting inconsistencies and were published in higher impact factor journals. We found a lower inconsistency rate of outcome reporting compared with other medical disciplines. Reporting completeness and consistency were significantly better after July 2005. The ICMJE requirement for mandatory registration was associated with significant improvement in reporting quality in infectious diseases trials. Prolonged time lag to publication and missing data from unpublished trials should raise a discussion on current reporting and publishing procedures. Copyright © 2018 European Society of Clinical Microbiology and Infectious Diseases. Published by Elsevier Ltd. All rights

[Differences between clinical trials according to the German law on pharmaceuticals (Arzneimittelgesetz) and trials according to the German law on medical products (Medizinproduktegesetz)].

PubMed

Krummenauer, F

2003-02-01

Similar to the registration process for pharmaceutical agents, medical devices have to undergo standardized clinical evaluation before being marketed and used in routine therapy or diagnostics. However, conduction, submission, and reporting of such clinical evaluations to authorities has to follow the German law on medical products(Medizinproduktegesetz,MPG), which in some central aspects differs remarkably from the German law on pharmaceuticals (Arzneimittelgesetz,AMG). Relevant deviations of MPG requirements from those of the AMG are reviewed with particular emphasis on submission, conduction, and reporting of trials to the authorities in charge. Whereas AMG-based trials focus on the proof of efficacy of pharmaceutical agents, the MPG demands instead proof of functionality of the medical devices; the MPG therefore concentrates more on technically satisfactory results in the context of function and patient safety. The aim of MPG trials is thus CE marking instead of AMG-based registration. However, this focus on functionality implies that medical devices need not necessarily be tested in a clinical trial--in some settings evidence-based evaluation alone will be sufficient. The decision on the necessity of a clinical trial is based mainly on the risk profile and invasive character of the device at hand. The early consideration of differences between AMG and MPG concerning the role and conduction of clinical trials will remarkably increase the (CE) certification process's outcome quality and juridical validity.

Research on land registration procedure ontology of China

NASA Astrophysics Data System (ADS)

Zhao, Zhongjun; Du, Qingyun; Zhang, Weiwei; Liu, Tao

2009-10-01

Land registration is public act which is to record the state-owned land use right, collective land ownership, collective land use right and land mortgage, servitude, as well as other land rights required the registration according to laws and regulations onto land registering books. Land registration is one of the important government affairs , so it is very important to standardize, optimize and humanize the process of land registration. The management works of organization are realized through a variety of workflows. Process knowledge is in essence a kind of methodology knowledge and a system which including the core and the relational knowledge. In this paper, the ontology is introduced into the field of land registration and management, trying to optimize the flow of land registration, to promote the automation-building and intelligent Service of land registration affairs, to provide humanized and intelligent service for multi-types of users . This paper tries to build land registration procedure ontology by defining the land registration procedure ontology's key concepts which represent the kinds of processes of land registration and mapping the kinds of processes to OWL-S. The land registration procedure ontology shall be the start and the basis of the Web service.

Prostate cancer - evidence of exercise and nutrition trial (PrEvENT): study protocol for a randomised controlled feasibility trial.

PubMed

Hackshaw-McGeagh, Lucy; Lane, J Athene; Persad, Raj; Gillatt, David; Holly, Jeff M P; Koupparis, Anthony; Rowe, Edward; Johnston, Lyndsey; Cloete, Jenny; Shiridzinomwa, Constance; Abrams, Paul; Penfold, Chris M; Bahl, Amit; Oxley, Jon; Perks, Claire M; Martin, Richard

2016-03-07

A growing body of observational evidence suggests that nutritional and physical activity interventions are associated with beneficial outcomes for men with prostate cancer, including brisk walking, lycopene intake, increased fruit and vegetable intake and reduced dairy consumption. However, randomised controlled trial data are limited. The 'Prostate Cancer: Evidence of Exercise and Nutrition Trial' investigates the feasibility of recruiting and randomising men diagnosed with localised prostate cancer and eligible for radical prostatectomy to interventions that modify nutrition and physical activity. The primary outcomes are randomisation rates and adherence to the interventions at 6 months following randomisation. The secondary outcomes are intervention tolerability, trial retention, change in prostate specific antigen level, change in diet, change in general physical activity levels, insulin-like growth factor levels, and a range of related outcomes, including quality of life measures. The trial is factorial, randomising men to both a physical activity (brisk walking or control) and nutritional (lycopene supplementation or increased fruit and vegetables with reduced dairy consumption or control) intervention. The trial has two phases: men are enrolled into a cohort study prior to radical prostatectomy, and then consented after radical prostatectomy into a randomised controlled trial. Data are collected at four time points (cohort baseline, true trial baseline and 3 and 6 months post-randomisation). The Prostate Cancer: Evidence of Exercise and Nutrition Trial aims to determine whether men with localised prostate cancer who are scheduled for radical prostatectomy can be recruited into a cohort and subsequently randomised to a 6-month nutrition and physical activity intervention trial. If successful, this feasibility trial will inform a larger trial to investigate whether this population will gain clinical benefit from long-term nutritional and physical activity

Image registration with auto-mapped control volumes

DOE Office of Scientific and Technical Information (OSTI.GOV)

Schreibmann, Eduard; Xing Lei

2006-04-15

Many image registration algorithms rely on the use of homologous control points on the two input image sets to be registered. In reality, the interactive identification of the control points on both images is tedious, difficult, and often a source of error. We propose a two-step algorithm to automatically identify homologous regions that are used as a priori information during the image registration procedure. First, a number of small control volumes having distinct anatomical features are identified on the model image in a somewhat arbitrary fashion. Instead of attempting to find their correspondences in the reference image through user interaction,more » in the proposed method, each of the control regions is mapped to the corresponding part of the reference image by using an automated image registration algorithm. A normalized cross-correlation (NCC) function or mutual information was used as the auto-mapping metric and a limited memory Broyden-Fletcher-Goldfarb-Shanno algorithm (L-BFGS) was employed to optimize the function to find the optimal mapping. For rigid registration, the transformation parameters of the system are obtained by averaging that derived from the individual control volumes. In our deformable calculation, the mapped control volumes are treated as the nodes or control points with known positions on the two images. If the number of control volumes is not enough to cover the whole image to be registered, additional nodes are placed on the model image and then located on the reference image in a manner similar to the conventional BSpline deformable calculation. For deformable registration, the established correspondence by the auto-mapped control volumes provides valuable guidance for the registration calculation and greatly reduces the dimensionality of the problem. The performance of the two-step registrations was applied to three rigid registration cases (two PET-CT registrations and a brain MRI-CT registration) and one deformable

Observer variability in the assessment of CT coronary angiography and coronary artery calcium score: substudy of the Scottish COmputed Tomography of the HEART (SCOT-HEART) trial

PubMed Central

Williams, Michelle C; Golay, Saroj K; Hunter, Amanda; Weir-McCall, Jonathan R; Mlynska, Lucja; Dweck, Marc R; Uren, Neal G; Reid, John H; Lewis, Steff C; Berry, Colin; van Beek, Edwin J R; Roditi, Giles; Newby, David E; Mirsadraee, Saeed

2015-01-01

Introduction Observer variability can influence the assessment of CT coronary angiography (CTCA) and the subsequent diagnosis of angina pectoris due to coronary heart disease. Methods We assessed 210 CTCAs from the Scottish COmputed Tomography of the HEART (SCOT-HEART) trial for intraobserver and interobserver variability. Calcium score, coronary angiography and image quality were evaluated. Coronary artery disease was defined as none (<10%), mild (10–49%), moderate (50–70%) and severe (>70%) luminal stenosis and classified as no (<10%), non-obstructive (10–70%) or obstructive (>70%) coronary artery disease. Post-CTCA diagnosis of angina pectoris due to coronary heart disease was classified as yes, probable, unlikely or no. Results Patients had a mean body mass index of 29 (28, 30) kg/m2, heart rate of 58 (57, 60)/min and 62% were men. Intraobserver and interobserver agreements for the presence or absence of coronary artery disease were excellent (95% agreement, κ 0.884 (0.817 to 0.951) and good (91%, 0.791 (0.703 to 0.879)). Intraobserver and interobserver agreement for the presence or absence of angina pectoris due to coronary heart disease were excellent (93%, 0.842 (0.918 to 0.755) and good (86%, 0.701 (0.799 to 0.603)), respectively. Observer variability of calcium score was excellent for calcium scores below 1000. More segments were categorised as uninterpretable with 64-multidetector compared to 320-multidetector CTCA (10.1% vs 2.6%, p<0.001) but there was no difference in observer variability. Conclusions Multicentre multidetector CTCA has excellent agreement in patients under investigation for suspected angina due to coronary heart disease. Trial registration number NCT01149590. PMID:26019881

A randomized trial comparing the efficacy and safety of intravitreal triamcinolone with observation to treat vision loss associated with macular edema secondary to central retinal vein occlusion: the Standard Care vs Corticosteroid for Retinal Vein Occlusion (SCORE) study report 5.

PubMed

Ip, Michael S; Scott, Ingrid U; VanVeldhuisen, Paul C; Oden, Neal L; Blodi, Barbara A; Fisher, Marian; Singerman, Lawrence J; Tolentino, Michael; Chan, Clement K; Gonzalez, Victor H

2009-09-01

To compare the efficacy and safety of 1-mg and 4-mg doses of preservative-free intravitreal triamcinolone with observation for eyes with vision loss associated with macular edema secondary to perfused central retinal vein occlusion (CRVO). Multicenter, randomized, clinical trial of 271 participants. Gain in visual acuity letter score of 15 or more from baseline to month 12. Seven percent, 27%, and 26% of participants achieved the primary outcome in the observation, 1-mg, and 4-mg groups, respectively. The odds of achieving the primary outcome were 5.0 times greater in the 1-mg group than the observation group (odds ratio [OR], 5.0; 95% confidence interval [CI], 1.8-14.1; P = .001) and 5.0 times greater in 4-mg group than the observation group (OR, 5.0; 95% CI, 1.8-14.4; P = .001); there was no difference identified between the 1-mg and 4-mg groups (OR, 1.0; 95% CI, 0.5-2.1; P = .97). The rates of elevated intraocular pressure and cataract were similar for the observation and 1-mg groups, but higher in the 4-mg group. Intravitreal triamcinolone is superior to observation for treating vision loss associated with macular edema secondary to CRVO in patients who have characteristics similar to those in the SCORE-CRVO trial. The 1-mg dose has a safety profile superior to that of the 4-mg dose. Application to Clinical Practice Intravitreal triamcinolone in a 1-mg dose, following the retreatment criteria applied in the SCORE Study, should be considered for up to 1 year, and possibly 2 years, for patients with characteristics similar to those in the SCORE-CRVO trial. Trial Registration clinicaltrials.gov Identifier: NCT00105027.

40 CFR 155.50 - Initiate a pesticide's registration review.

Code of Federal Regulations, 2013 CFR

2013-07-01

... 40 Protection of Environment 25 2013-07-01 2013-07-01 false Initiate a pesticide's registration...) PESTICIDE PROGRAMS REGISTRATION STANDARDS AND REGISTRATION REVIEW Registration Review Procedures § 155.50 Initiate a pesticide's registration review. The Agency will initiate a pesticide's registration review by...

40 CFR 155.50 - Initiate a pesticide's registration review.

Code of Federal Regulations, 2014 CFR

2014-07-01

... 40 Protection of Environment 24 2014-07-01 2014-07-01 false Initiate a pesticide's registration...) PESTICIDE PROGRAMS REGISTRATION STANDARDS AND REGISTRATION REVIEW Registration Review Procedures § 155.50 Initiate a pesticide's registration review. The Agency will initiate a pesticide's registration review by...

40 CFR 155.50 - Initiate a pesticide's registration review.

Code of Federal Regulations, 2012 CFR

2012-07-01

... 40 Protection of Environment 25 2012-07-01 2012-07-01 false Initiate a pesticide's registration...) PESTICIDE PROGRAMS REGISTRATION STANDARDS AND REGISTRATION REVIEW Registration Review Procedures § 155.50 Initiate a pesticide's registration review. The Agency will initiate a pesticide's registration review by...

40 CFR 155.50 - Initiate a pesticide's registration review.

Code of Federal Regulations, 2011 CFR

2011-07-01

... 40 Protection of Environment 24 2011-07-01 2011-07-01 false Initiate a pesticide's registration...) PESTICIDE PROGRAMS REGISTRATION STANDARDS AND REGISTRATION REVIEW Registration Review Procedures § 155.50 Initiate a pesticide's registration review. The Agency will initiate a pesticide's registration review by...

A Multistage Approach for Image Registration.

PubMed

Bowen, Francis; Hu, Jianghai; Du, Eliza Yingzi

2016-09-01

Successful image registration is an important step for object recognition, target detection, remote sensing, multimodal content fusion, scene blending, and disaster assessment and management. The geometric and photometric variations between images adversely affect the ability for an algorithm to estimate the transformation parameters that relate the two images. Local deformations, lighting conditions, object obstructions, and perspective differences all contribute to the challenges faced by traditional registration techniques. In this paper, a novel multistage registration approach is proposed that is resilient to view point differences, image content variations, and lighting conditions. Robust registration is realized through the utilization of a novel region descriptor which couples with the spatial and texture characteristics of invariant feature points. The proposed region descriptor is exploited in a multistage approach. A multistage process allows the utilization of the graph-based descriptor in many scenarios thus allowing the algorithm to be applied to a broader set of images. Each successive stage of the registration technique is evaluated through an effective similarity metric which determines subsequent action. The registration of aerial and street view images from pre- and post-disaster provide strong evidence that the proposed method estimates more accurate global transformation parameters than traditional feature-based methods. Experimental results show the robustness and accuracy of the proposed multistage image registration methodology.

Effect of bivalent human papillomavirus vaccination on pregnancy outcomes: long term observational follow-up in the Costa Rica HPV Vaccine Trial.

PubMed

Panagiotou, Orestis A; Befano, Brian L; Gonzalez, Paula; Rodríguez, Ana Cecilia; Herrero, Rolando; Schiller, John T; Kreimer, Aimée R; Schiffman, Mark; Hildesheim, Allan; Wilcox, Allen J; Wacholder, Sholom

2015-09-07

To examine the effect of the bivalent human papillomavirus (HPV) vaccine on miscarriage. Observational long term follow-up of a randomized, double blinded trial combined with an independent unvaccinated population based cohort. Single center study in Costa Rica. 7466 women in the trial and 2836 women in the unvaccinated cohort enrolled at the end of the randomized trial and in parallel with the observational trial component. Women in the trial were assigned to receive three doses of bivalent HPV vaccine (n=3727) or the control hepatitis A vaccine (n=3739). Crossover bivalent HPV vaccination occurred in the hepatitis A vaccine arm at the end of the trial. Women in the unvaccinated cohort received (n=2836) no vaccination. Risk of miscarriage, defined by the US Centers for Disease Control and Prevention as fetal loss within 20 weeks of gestation, in pregnancies exposed to bivalent HPV vaccination in less than 90 days and any time from vaccination compared with pregnancies exposed to hepatitis A vaccine and pregnancies in the unvaccinated cohort. Of 3394 pregnancies conceived at any time since bivalent HPV vaccination, 381 pregnancies were conceived less than 90 days from vaccination. Unexposed pregnancies comprised 2507 pregnancies conceived after hepatitis A vaccination and 720 conceived in the unvaccinated cohort. Miscarriages occurred in 451 (13.3%) of all exposed pregnancies, in 50 (13.1%) of the pregnancies conceived less than 90 days from bivalent HPV vaccination, and in 414 (12.8%) of the unexposed pregnancies, of which 316 (12.6%) were in the hepatitis A vaccine group and 98 (13.6%) in the unvaccinated cohort. The relative risk of miscarriage for pregnancies conceived less than 90 days from vaccination compared with all unexposed pregnancies was 1.02 (95% confidence interval 0.78 to 1.34, one sided P=0.436) in unadjusted analyses. Results were similar after adjusting for age at vaccination (relative risk 1.15, one sided P=0.17), age at conception (1.03, P=0

The utility of observational studies in clinical decision making: lessons learned from statin trials.

PubMed

Foody, JoAnne M; Mendys, Phillip M; Liu, Larry Z; Simpson, Ross J

2010-05-01

Contemporary clinical decision making is well supported by a wide variety of information sources, including clinical practice guidelines, position papers, and insights from randomized controlled trials (RCTs). Much of our fundamental understanding of cardiovascular risk factors is based on multiple observations from major epidemiologic studies, such as The Seven Country Studies and the US-based Framingham Heart Study. These studies provided the framework for the development of clinical practice guidelines, including the National Cholesterol Education Program Adult Treatment Panel series. The objective of this article is to highlight the value of observational studies as a complement to clinical trial data for clinical decision making in real-world practice. Although RCTs are still the benchmark for assessing clinical efficacy and safety of a specific therapeutic approach, they may be of limited utility to practitioners who must then adapt the lessons learned from the trial into the patient care environment. The use of well-structured observational studies can improve our understanding of the translation of clinical trials into clinical practice, as demonstrated here with the example of statins. Although such studies have their own limitations, improved techniques for design and analysis have reduced the impact of bias and confounders. The introduction of the Strengthening the Reporting of Observational Studies in Epidemiology (STROBE) guidelines has provided more uniformity for such studies. When used together with RCTs, observational studies can enhance our understanding of effectiveness and utility in real-world clinical practice. In the examples of statin observational studies, the results suggest that relative effectiveness of different statins and potential impact of switching statins should be carefully considered in treating individual patients by practicing physicians.

Victoria's review of registration for health practitioners.

PubMed

Scotts, H; Carter, M

1988-01-01

This article discusses some of the issues raised in the Interim Report of the current Review of Registration of Health Practitioners being conducted for the Victorian Health Department. The Report attempts to develop the framework in which the registration Boards will operate as part of a cohesive registration system. It proposed a mechanism and criteria for the registration of new groups as well as principles which can be applied to the ongoing review of each existing Board. The Review takes the perspective that registration of health practitioners carries with it both advantages and disadvantages for the general community. Under the proposed new system the controls exercised over health care providers by Registration Boards would be evaluated on the basis of to what extent the benefits to the public outweighed the potential costs. It is in this context that the Report addresses issues such as consumer complaints handling, registration of individual practitioners and controls over professional advertising and other business practices.

Automatic image registration performance for two different CBCT systems; variation with imaging dose

NASA Astrophysics Data System (ADS)

Barber, J.; Sykes, J. R.; Holloway, L.; Thwaites, D. I.

2014-03-01

The performance of an automatic image registration algorithm was compared on image sets collected with two commercial CBCT systems, and the relationship with imaging dose was explored. CBCT images of a CIRS Virtually Human Male Pelvis phantom (VHMP) were collected on Varian TrueBeam/OBI and Elekta Synergy/XVI linear accelerators, across a range of mAs settings. Each CBCT image was registered 100 times, with random initial offsets introduced. Image registration was performed using the grey value correlation ratio algorithm in the Elekta XVI software, to a mask of the prostate volume with 5 mm expansion. Residual registration errors were calculated after correcting for the initial introduced phantom set-up error. Registration performance with the OBI images was similar to that of XVI. There was a clear dependence on imaging dose for the XVI images with residual errors increasing below 4mGy. It was not possible to acquire images with doses lower than ~5mGy with the OBI system and no evidence of reduced performance was observed at this dose. Registration failures (maximum target registration error > 3.6 mm on the surface of a 30mm sphere) occurred in 5% to 9% of registrations except for the lowest dose XVI scan (31%). The uncertainty in automatic image registration with both OBI and XVI images was found to be adequate for clinical use within a normal range of acquisition settings.

Electronic patient registration and tracking at mass vaccination clinics: a clinical study.

PubMed

Billittier, Anthony J; Lupiani, Patrick; Masterson, Gary; Masterson, Tim; Zak, Christopher

2003-01-01

To protect the citizens of the United States from the use of dangerous biological agents, the Center for Disease Control and Prevention (CDC) has been actively preparing to deal with the consequences of such an attack. Their plans include the deployment of mass immunization clinics to handle postevent vaccinations. As part of the planning efforts by the Western New York Public Health Alliance, a Web-based electronic patient registration and tracking system was developed and tested at a recent trial smallpox vaccination clinic. Initial goals were to determine what the pitfalls and benefits of using such a system might be in comparison to other methods of data collection. This exercise proved that use of an electronic system capable of scanning two-dimensional bar codes was superior to both paper-based and optical character recognition (OCR) methods of data collection and management. Major improvements in speed and/or accuracy were evident in all areas of the clinic, especially in patient registration, vaccine tracking and postclinic data analysis.

Quality standards for real-world research. Focus on observational database studies of comparative effectiveness.

PubMed

Roche, Nicolas; Reddel, Helen; Martin, Richard; Brusselle, Guy; Papi, Alberto; Thomas, Mike; Postma, Dirjke; Thomas, Vicky; Rand, Cynthia; Chisholm, Alison; Price, David

2014-02-01

Real-world research can use observational or clinical trial designs, in both cases putting emphasis on high external validity, to complement the classical efficacy randomized controlled trials (RCTs) with high internal validity. Real-world research is made necessary by the variety of factors that can play an important a role in modulating effectiveness in real life but are often tightly controlled in RCTs, such as comorbidities and concomitant treatments, adherence, inhalation technique, access to care, strength of doctor-caregiver communication, and socio-economic and other organizational factors. Real-world studies belong to two main categories: pragmatic trials and observational studies, which can be prospective or retrospective. Focusing on comparative database observational studies, the process aimed at ensuring high-quality research can be divided into three parts: preparation of research, analyses and reporting, and discussion of results. Key points include a priori planning of data collection and analyses, identification of appropriate database(s), proper outcomes definition, study registration with commitment to publish, bias minimization through matching and adjustment processes accounting for potential confounders, and sensitivity analyses testing the robustness of results. When these conditions are met, observational database studies can reach a sufficient level of evidence to help create guidelines (i.e., clinical and regulatory decision-making).

Linking quality indicators to clinical trials: an automated approach

PubMed Central

Coiera, Enrico; Choong, Miew Keen; Tsafnat, Guy; Hibbert, Peter; Runciman, William B.

2017-01-01

Abstract Objective Quality improvement of health care requires robust measurable indicators to track performance. However identifying which indicators are supported by strong clinical evidence, typically from clinical trials, is often laborious. This study tests a novel method for automatically linking indicators to clinical trial registrations. Design A set of 522 quality of care indicators for 22 common conditions drawn from the CareTrack study were automatically mapped to outcome measures reported in 13 971 trials from ClinicalTrials.gov. Intervention Text mining methods extracted phrases mentioning indicators and outcome phrases, and these were compared using the Levenshtein edit distance ratio to measure similarity. Main Outcome Measure Number of care indicators that mapped to outcome measures in clinical trials. Results While only 13% of the 522 CareTrack indicators were thought to have Level I or II evidence behind them, 353 (68%) could be directly linked to randomized controlled trials. Within these 522, 50 of 70 (71%) Level I and II evidence-based indicators, and 268 of 370 (72%) Level V (consensus-based) indicators could be linked to evidence. Of the indicators known to have evidence behind them, only 5.7% (4 of 70) were mentioned in the trial reports but were missed by our method. Conclusions We automatically linked indicators to clinical trial registrations with high precision. Whilst the majority of quality indicators studied could be directly linked to research evidence, a small portion could not and these require closer scrutiny. It is feasible to support the process of indicator development using automated methods to identify research evidence. PMID:28651340

Clinical trial transparency: many gains but access to evidence for new medicines remains imperfect.

PubMed

Mintzes, Barbara; Lexchin, Joel; Quintano, Ancella Santos

2015-01-01

Although selective and incomplete publication is widely acknowledged to be a problem, full access to clinical trial data remains illusive. Authors' personal files, key documents from Food and Drug Administration and European Medicines Agency and focussed searches of PubMed. Existing sources of information provide an incomplete overview of scientific research. Persistent arguments about commercial confidentiality and the potential difficulties in de-identifying raw data can block important progress. Current industry efforts are voluntary and only partially satisfy the need for complete data. Requirements for trial registration are increasing. Important regulatory changes in particular in Europe have the potential to result in the release of more information. Documenting the effects of prospective trial registration and requirements for proactive clinical trial publication on healthcare decisions, public health and rational resource allocation. © The Author 2015. Published by Oxford University Press. All rights reserved. For permissions, please e-mail: journals.permissions@oup.com.

Benchmarking Controlled Trial--a novel concept covering all observational effectiveness studies.

PubMed

Malmivaara, Antti

2015-06-01

The Benchmarking Controlled Trial (BCT) is a novel concept which covers all observational studies aiming to assess effectiveness. BCTs provide evidence of the comparative effectiveness between health service providers, and of effectiveness due to particular features of the health and social care systems. BCTs complement randomized controlled trials (RCTs) as the sources of evidence on effectiveness. This paper presents a definition of the BCT; compares the position of BCTs in assessing effectiveness with that of RCTs; presents a checklist for assessing methodological validity of a BCT; and pilot-tests the checklist with BCTs published recently in the leading medical journals.

The feasibility of manual parameter tuning for deformable breast MR image registration from a multi-objective optimization perspective.

PubMed

Pirpinia, Kleopatra; Bosman, Peter A N; Loo, Claudette E; Winter-Warnars, Gonneke; Janssen, Natasja N Y; Scholten, Astrid N; Sonke, Jan-Jakob; van Herk, Marcel; Alderliesten, Tanja

2017-06-23

Deformable image registration is typically formulated as an optimization problem involving a linearly weighted combination of terms that correspond to objectives of interest (e.g. similarity, deformation magnitude). The weights, along with multiple other parameters, need to be manually tuned for each application, a task currently addressed mainly via trial-and-error approaches. Such approaches can only be successful if there is a sensible interplay between parameters, objectives, and desired registration outcome. This, however, is not well established. To study this interplay, we use multi-objective optimization, where multiple solutions exist that represent the optimal trade-offs between the objectives, forming a so-called Pareto front. Here, we focus on weight tuning. To study the space a user has to navigate during manual weight tuning, we randomly sample multiple linear combinations. To understand how these combinations relate to desirability of registration outcome, we associate with each outcome a mean target registration error (TRE) based on expert-defined anatomical landmarks. Further, we employ a multi-objective evolutionary algorithm that optimizes the weight combinations, yielding a Pareto front of solutions, which can be directly navigated by the user. To study how the complexity of manual weight tuning changes depending on the registration problem, we consider an easy problem, prone-to-prone breast MR image registration, and a hard problem, prone-to-supine breast MR image registration. Lastly, we investigate how guidance information as an additional objective influences the prone-to-supine registration outcome. Results show that the interplay between weights, objectives, and registration outcome makes manual weight tuning feasible for the prone-to-prone problem, but very challenging for the harder prone-to-supine problem. Here, patient-specific, multi-objective weight optimization is needed, obtaining a mean TRE of 13.6 mm without guidance

The feasibility of manual parameter tuning for deformable breast MR image registration from a multi-objective optimization perspective

NASA Astrophysics Data System (ADS)

Pirpinia, Kleopatra; Bosman, Peter A. N.; E Loo, Claudette; Winter-Warnars, Gonneke; Y Janssen, Natasja N.; Scholten, Astrid N.; Sonke, Jan-Jakob; van Herk, Marcel; Alderliesten, Tanja

2017-07-01

Deformable image registration is typically formulated as an optimization problem involving a linearly weighted combination of terms that correspond to objectives of interest (e.g. similarity, deformation magnitude). The weights, along with multiple other parameters, need to be manually tuned for each application, a task currently addressed mainly via trial-and-error approaches. Such approaches can only be successful if there is a sensible interplay between parameters, objectives, and desired registration outcome. This, however, is not well established. To study this interplay, we use multi-objective optimization, where multiple solutions exist that represent the optimal trade-offs between the objectives, forming a so-called Pareto front. Here, we focus on weight tuning. To study the space a user has to navigate during manual weight tuning, we randomly sample multiple linear combinations. To understand how these combinations relate to desirability of registration outcome, we associate with each outcome a mean target registration error (TRE) based on expert-defined anatomical landmarks. Further, we employ a multi-objective evolutionary algorithm that optimizes the weight combinations, yielding a Pareto front of solutions, which can be directly navigated by the user. To study how the complexity of manual weight tuning changes depending on the registration problem, we consider an easy problem, prone-to-prone breast MR image registration, and a hard problem, prone-to-supine breast MR image registration. Lastly, we investigate how guidance information as an additional objective influences the prone-to-supine registration outcome. Results show that the interplay between weights, objectives, and registration outcome makes manual weight tuning feasible for the prone-to-prone problem, but very challenging for the harder prone-to-supine problem. Here, patient-specific, multi-objective weight optimization is needed, obtaining a mean TRE of 13.6 mm without guidance

28 CFR 5.200 - Registration.

Code of Federal Regulations, 2014 CFR

2014-07-01

... supplemental statement at intervals of 6 months for the duration of the principal-agent relationship requiring registration. (b) The initial statement shall be filed on a form provided by the Registration Unit. (28 U.S.C...

28 CFR 5.200 - Registration.

Code of Federal Regulations, 2012 CFR

2012-07-01

... supplemental statement at intervals of 6 months for the duration of the principal-agent relationship requiring registration. (b) The initial statement shall be filed on a form provided by the Registration Unit. (28 U.S.C...

28 CFR 5.200 - Registration.

Code of Federal Regulations, 2011 CFR

2011-07-01

... supplemental statement at intervals of 6 months for the duration of the principal-agent relationship requiring registration. (b) The initial statement shall be filed on a form provided by the Registration Unit. (28 U.S.C...

28 CFR 5.200 - Registration.

Code of Federal Regulations, 2010 CFR

2010-07-01

... supplemental statement at intervals of 6 months for the duration of the principal-agent relationship requiring registration. (b) The initial statement shall be filed on a form provided by the Registration Unit. (28 U.S.C...

28 CFR 5.200 - Registration.

Code of Federal Regulations, 2013 CFR

2013-07-01

... supplemental statement at intervals of 6 months for the duration of the principal-agent relationship requiring registration. (b) The initial statement shall be filed on a form provided by the Registration Unit. (28 U.S.C...

Suspension of Registrations under FIFRA

EPA Pesticide Factsheets

Under FIFRA Section 3(c)(2)(B), this generally halts further distribution and sale of the suspended pesticide product by the registrant. Find suspension listings by product name, active ingredient, registrant name, date, and contact information.

17 CFR 249.1300 - Form MA, for registration as a municipal advisor, and for amendments to registration.

Code of Federal Regulations, 2014 CFR

2014-04-01

... 17 Commodity and Securities Exchanges 4 2014-04-01 2014-04-01 false Form MA, for registration as a... Form MA, for registration as a municipal advisor, and for amendments to registration. The form shall be... affecting Form MA, see the List of CFR Sections Affected, which appears in the Finding Aids section of the...

Intensity-Based Registration for Lung Motion Estimation

NASA Astrophysics Data System (ADS)

Cao, Kunlin; Ding, Kai; Amelon, Ryan E.; Du, Kaifang; Reinhardt, Joseph M.; Raghavan, Madhavan L.; Christensen, Gary E.

Image registration plays an important role within pulmonary image analysis. The task of registration is to find the spatial mapping that brings two images into alignment. Registration algorithms designed for matching 4D lung scans or two 3D scans acquired at different inflation levels can catch the temporal changes in position and shape of the region of interest. Accurate registration is critical to post-analysis of lung mechanics and motion estimation. In this chapter, we discuss lung-specific adaptations of intensity-based registration methods for 3D/4D lung images and review approaches for assessing registration accuracy. Then we introduce methods for estimating tissue motion and studying lung mechanics. Finally, we discuss methods for assessing and quantifying specific volume change, specific ventilation, strain/ stretch information and lobar sliding.

EVALUATION OF REGISTRATION, COMPRESSION AND CLASSIFICATION ALGORITHMS

NASA Technical Reports Server (NTRS)

Jayroe, R. R.

1994-01-01

evaluation criteria basically compare the observed results with the expected results. For the image reconstruction processes of registration and compression, the expected results are usually the original data or some selected characteristics of the original data. For classification processes the expected result is the ground truth of the scene. Thus, the comparison process consists of determining what changes occur in processing, where the changes occur, how much change occurs, and the amplitude of the change. The package includes evaluation routines for performing such comparisons as average uncertainty, average information transfer, chi-square statistics, multidimensional histograms, and computation of contingency matrices. This collection of routines is written in FORTRAN IV for batch execution and has been implemented on an IBM 360 computer with a central memory requirement of approximately 662K of 8 bit bytes. This collection of image processing and evaluation routines was developed in 1979.

21 CFR 1301.51 - Modification in registration.

Code of Federal Regulations, 2011 CFR

2011-04-01

... DEA Mailing Addresses in § 1321.01 of this chapter for the current mailing address. The letter shall... registration (DEA Form 223) to the registrant, who shall maintain it with the old certificate of registration...

21 CFR 1301.51 - Modification in registration.

Code of Federal Regulations, 2010 CFR

2010-04-01

... DEA Mailing Addresses in § 1321.01 of this chapter for the current mailing address. The letter shall... registration (DEA Form 223) to the registrant, who shall maintain it with the old certificate of registration...

The plant virus microscope image registration method based on mismatches removing.

PubMed

Wei, Lifang; Zhou, Shucheng; Dong, Heng; Mao, Qianzhuo; Lin, Jiaxiang; Chen, Riqing

2016-01-01

The electron microscopy is one of the major means to observe the virus. The view of virus microscope images is limited by making specimen and the size of the camera's view field. To solve this problem, the virus sample is produced into multi-slice for information fusion and image registration techniques are applied to obtain large field and whole sections. Image registration techniques have been developed in the past decades for increasing the camera's field of view. Nevertheless, these approaches typically work in batch mode and rely on motorized microscopes. Alternatively, the methods are conceived just to provide visually pleasant registration for high overlap ratio image sequence. This work presents a method for virus microscope image registration acquired with detailed visual information and subpixel accuracy, even when overlap ratio of image sequence is 10% or less. The method proposed focus on the correspondence set and interimage transformation. A mismatch removal strategy is proposed by the spatial consistency and the components of keypoint to enrich the correspondence set. And the translation model parameter as well as tonal inhomogeneities is corrected by the hierarchical estimation and model select. In the experiments performed, we tested different registration approaches and virus images, confirming that the translation model is not always stationary, despite the fact that the images of the sample come from the same sequence. The mismatch removal strategy makes building registration of virus microscope images at subpixel accuracy easier and optional parameters for building registration according to the hierarchical estimation and model select strategies make the proposed method high precision and reliable for low overlap ratio image sequence. Copyright © 2015 Elsevier Ltd. All rights reserved.

Practical issues and lessons learned from multi-regional clinical trials via case examples: a Japanese perspective.

PubMed

Ando, Yuki; Hamasaki, Toshimitsu

2010-01-01

The multi-regional clinical trials (MRCTs) being administered in different regions of the world now play a major role in providing evidence for the efficacy and safety of new drugs amidst the simultaneous global development and worldwide registration of such drugs, in support of the expeditious availability of medical products to patients. However, such trials present considerable challenges as far as quality, design, implementation, analysis, and interpretation are concerned. In this article, we share our observations and lessons learned from the design, implementation, analysis, and interpretation of some MRCTs with case examples. Current Japanese regulatory guidance on MRCTs is introduced along with some suggestions for design, implementation, and interpretation. Copyright © 2010 John Wiley & Sons, Ltd.

Automated brainstem co-registration (ABC) for MRI.

PubMed

Napadow, Vitaly; Dhond, Rupali; Kennedy, David; Hui, Kathleen K S; Makris, Nikos

2006-09-01

Group data analysis in brainstem neuroimaging is predicated on accurate co-registration of anatomy. As the brainstem is comprised of many functionally heterogeneous nuclei densely situated adjacent to one another, relatively small errors in co-registration can manifest in increased variance or decreased sensitivity (or significance) in detecting activations. We have devised a 2-stage automated, reference mask guided registration technique (Automated Brainstem Co-registration, or ABC) for improved brainstem co-registration. Our approach utilized a brainstem mask dataset to weight an automated co-registration cost function. Our method was validated through measurement of RMS error at 12 manually defined landmarks. These landmarks were also used as guides for a secondary manual co-registration option, intended for outlier individuals that may not adequately co-register with our automated method. Our methodology was tested on 10 healthy human subjects and compared to traditional co-registration techniques (Talairach transform and automated affine transform to the MNI-152 template). We found that ABC had a significantly lower mean RMS error (1.22 +/- 0.39 mm) than Talairach transform (2.88 +/- 1.22 mm, mu +/- sigma) and the global affine (3.26 +/- 0.81 mm) method. Improved accuracy was also found for our manual-landmark-guided option (1.51 +/- 0.43 mm). Visualizing individual brainstem borders demonstrated more consistent and uniform overlap for ABC compared to traditional global co-registration techniques. Improved robustness (lower susceptibility to outliers) was demonstrated with ABC through lower inter-subject RMS error variance compared with traditional co-registration methods. The use of easily available and validated tools (AFNI and FSL) for this method should ease adoption by other investigators interested in brainstem data group analysis.

Surface-based prostate registration with biomechanical regularization

NASA Astrophysics Data System (ADS)

van de Ven, Wendy J. M.; Hu, Yipeng; Barentsz, Jelle O.; Karssemeijer, Nico; Barratt, Dean; Huisman, Henkjan J.

2013-03-01

Adding MR-derived information to standard transrectal ultrasound (TRUS) images for guiding prostate biopsy is of substantial clinical interest. A tumor visible on MR images can be projected on ultrasound by using MRUS registration. A common approach is to use surface-based registration. We hypothesize that biomechanical modeling will better control deformation inside the prostate than a regular surface-based registration method. We developed a novel method by extending a surface-based registration with finite element (FE) simulation to better predict internal deformation of the prostate. For each of six patients, a tetrahedral mesh was constructed from the manual prostate segmentation. Next, the internal prostate deformation was simulated using the derived radial surface displacement as boundary condition. The deformation field within the gland was calculated using the predicted FE node displacements and thin-plate spline interpolation. We tested our method on MR guided MR biopsy imaging data, as landmarks can easily be identified on MR images. For evaluation of the registration accuracy we used 45 anatomical landmarks located in all regions of the prostate. Our results show that the median target registration error of a surface-based registration with biomechanical regularization is 1.88 mm, which is significantly different from 2.61 mm without biomechanical regularization. We can conclude that biomechanical FE modeling has the potential to improve the accuracy of multimodal prostate registration when comparing it to regular surface-based registration.

14 CFR 47.51 - Triennial aircraft registration report.

Code of Federal Regulations, 2010 CFR

2010-01-01

... 14 Aeronautics and Space 1 2010-01-01 2010-01-01 false Triennial aircraft registration report. 47... AIRCRAFT AIRCRAFT REGISTRATION Certificates of Aircraft Registration § 47.51 Triennial aircraft... occurred within the preceding 36 calendar months, the holder of each Certificate of Aircraft Registration...

Comparison of subpixel image registration algorithms

NASA Astrophysics Data System (ADS)

Boye, R. R.; Nelson, C. L.

2009-02-01

Research into the use of multiframe superresolution has led to the development of algorithms for providing images with enhanced resolution using several lower resolution copies. An integral component of these algorithms is the determination of the registration of each of the low resolution images to a reference image. Without this information, no resolution enhancement can be attained. We have endeavored to find a suitable method for registering severely undersampled images by comparing several approaches. To test the algorithms, an ideal image is input to a simulated image formation program, creating several undersampled images with known geometric transformations. The registration algorithms are then applied to the set of low resolution images and the estimated registration parameters compared to the actual values. This investigation is limited to monochromatic images (extension to color images is not difficult) and only considers global geometric transformations. Each registration approach will be reviewed and evaluated with respect to the accuracy of the estimated registration parameters as well as the computational complexity required. In addition, the effects of image content, specifically spatial frequency content, as well as the immunity of the registration algorithms to noise will be discussed.

Registration of Laser Scanning Point Clouds: A Review

PubMed Central

Cheng, Liang; Chen, Song; Xu, Hao; Wu, Yang; Li, Manchun

2018-01-01

The integration of multi-platform, multi-angle, and multi-temporal LiDAR data has become important for geospatial data applications. This paper presents a comprehensive review of LiDAR data registration in the fields of photogrammetry and remote sensing. At present, a coarse-to-fine registration strategy is commonly used for LiDAR point clouds registration. The coarse registration method is first used to achieve a good initial position, based on which registration is then refined utilizing the fine registration method. According to the coarse-to-fine framework, this paper reviews current registration methods and their methodologies, and identifies important differences between them. The lack of standard data and unified evaluation systems is identified as a factor limiting objective comparison of different methods. The paper also describes the most commonly-used point cloud registration error analysis methods. Finally, avenues for future work on LiDAR data registration in terms of applications, data, and technology are discussed. In particular, there is a need to address registration of multi-angle and multi-scale data from various newly available types of LiDAR hardware, which will play an important role in diverse applications such as forest resource surveys, urban energy use, cultural heritage protection, and unmanned vehicles. PMID:29883397

Registration of Laser Scanning Point Clouds: A Review.

PubMed

Cheng, Liang; Chen, Song; Liu, Xiaoqiang; Xu, Hao; Wu, Yang; Li, Manchun; Chen, Yanming

2018-05-21

The integration of multi-platform, multi-angle, and multi-temporal LiDAR data has become important for geospatial data applications. This paper presents a comprehensive review of LiDAR data registration in the fields of photogrammetry and remote sensing. At present, a coarse-to-fine registration strategy is commonly used for LiDAR point clouds registration. The coarse registration method is first used to achieve a good initial position, based on which registration is then refined utilizing the fine registration method. According to the coarse-to-fine framework, this paper reviews current registration methods and their methodologies, and identifies important differences between them. The lack of standard data and unified evaluation systems is identified as a factor limiting objective comparison of different methods. The paper also describes the most commonly-used point cloud registration error analysis methods. Finally, avenues for future work on LiDAR data registration in terms of applications, data, and technology are discussed. In particular, there is a need to address registration of multi-angle and multi-scale data from various newly available types of LiDAR hardware, which will play an important role in diverse applications such as forest resource surveys, urban energy use, cultural heritage protection, and unmanned vehicles.

Optical registration of spaceborne low light remote sensing camera

NASA Astrophysics Data System (ADS)

Li, Chong-yang; Hao, Yan-hui; Xu, Peng-mei; Wang, Dong-jie; Ma, Li-na; Zhao, Ying-long

2018-02-01

For the high precision requirement of spaceborne low light remote sensing camera optical registration, optical registration of dual channel for CCD and EMCCD is achieved by the high magnification optical registration system. System integration optical registration and accuracy of optical registration scheme for spaceborne low light remote sensing camera with short focal depth and wide field of view is proposed in this paper. It also includes analysis of parallel misalignment of CCD and accuracy of optical registration. Actual registration results show that imaging clearly, MTF and accuracy of optical registration meet requirements, it provide important guarantee to get high quality image data in orbit.

Randomized controlled trials vs. observational studies: why not just live together?

PubMed

Faraoni, David; Schaefer, Simon Thomas

2016-10-21

Randomized controlled trials (RCTs) are considered the gold standard for clinical research, thus having a high impact on clinical guidelines and our daily patients' care. However, various treatment strategies which we consider "evidence based" have never been subject to a prospective RCT, as we would rate it unethical to withheld an established treatment to individuals in an placebo controlled trial.In a recent BMC Anesthesiology publication, Trentino et al. analyzed the usefulness of observational studies in assessing benefit and risk of different transfusion strategies. The authors nicely reviewed and summarized similarities and differences, advantages and limitations, between different study types frequently used in transfusion medicine. In this interesting article, the authors conclude, that 'when comparing the results of observational studies with RCTs assessing transfusion outcomes, it is important that one consider not only the study method, but also the key elements of the study design'. Thus, in this commentary we now discuss the pro's and con's of different study types, even irrespective of transfusion medicine.

Skull registration for prone patient position using tracked ultrasound

NASA Astrophysics Data System (ADS)

Underwood, Grace; Ungi, Tamas; Baum, Zachary; Lasso, Andras; Kronreif, Gernot; Fichtinger, Gabor

2017-03-01

PURPOSE: Tracked navigation has become prevalent in neurosurgery. Problems with registration of a patient and a preoperative image arise when the patient is in a prone position. Surfaces accessible to optical tracking on the back of the head are unreliable for registration. We investigated the accuracy of surface-based registration using points accessible through tracked ultrasound. Using ultrasound allows access to bone surfaces that are not available through optical tracking. Tracked ultrasound could eliminate the need to work (i) under the table for registration and (ii) adjust the tracker between surgery and registration. In addition, tracked ultrasound could provide a non-invasive method in comparison to an alternative method of registration involving screw implantation. METHODS: A phantom study was performed to test the feasibility of tracked ultrasound for registration. An initial registration was performed to partially align the pre-operative computer tomography data and skull phantom. The initial registration was performed by an anatomical landmark registration. Surface points accessible by tracked ultrasound were collected and used to perform an Iterative Closest Point Algorithm. RESULTS: When the surface registration was compared to a ground truth landmark registration, the average TRE was found to be 1.6+/-0.1mm and the average distance of points off the skull surface was 0.6+/-0.1mm. CONCLUSION: The use of tracked ultrasound is feasible for registration of patients in prone position and eliminates the need to perform registration under the table. The translational component of error found was minimal. Therefore, the amount of TRE in registration is due to a rotational component of error.

28 CFR 10.2 - Language of registration statement.

Code of Federal Regulations, 2011 CFR

2011-07-01

... 28 Judicial Administration 1 2011-07-01 2011-07-01 false Language of registration statement. 10.2... ON ACTIVITIES WITHIN THE UNITED STATES Registration Statement § 10.2 Language of registration statement. Registration statements must be in English if possible. If in a foreign language they must be...

Development of PD-1 and PD-L1 inhibitors as a form of cancer immunotherapy: a comprehensive review of registration trials and future considerations.

PubMed

Gong, Jun; Chehrazi-Raffle, Alexander; Reddi, Srikanth; Salgia, Ravi

2018-01-23

Early preclinical evidence provided the rationale for programmed cell death 1 (PD-1) and programmed death ligand 1 (PD-L1) blockade as a potential form of cancer immunotherapy given that activation of the PD-1/PD-L1 axis putatively served as a mechanism for tumor evasion of host tumor antigen-specific T-cell immunity. Early-phase studies investigating several humanized monoclonal IgG4 antibodies targeting PD-1 and PD-L1 in advanced solid tumors paved way for the development of the first PD-1 inhibitors, nivolumab and pembrolizumab, approved by the Food and Drug Administration (FDA) in 2014. The number of FDA-approved agents of this class is rapidly enlarging with indications for treatment spanning across a spectrum of malignancies. The purpose of this review is to highlight the clinical development of PD-1 and PD-L1 inhibitors in cancer therapy to date. In particular, we focus on detailing the registration trials that have led to FDA-approved indications of anti-PD-1 and anti-PD-L1 therapies in cancer. As the number of PD-1/PD-L1 inhibitors continues to grow, predictive biomarkers, mechanisms of resistance, hyperprogressors, treatment duration and treatment beyond progression, immune-related toxicities, and clinical trial design are key concepts in need of further consideration to optimize the anticancer potential of this class of immunotherapy.

17 CFR 249b.200 - Form CA-1, 1 form for registration or for exemption from registration as a clearing agency and...

Code of Federal Regulations, 2010 CFR

2010-04-01

... EXCHANGE ACT OF 1934 § 249b.200 Form CA-1, 1 form for registration or for exemption from registration as a... 17 Commodity and Securities Exchanges 3 2010-04-01 2010-04-01 false Form CA-1, 1 form for registration or for exemption from registration as a clearing agency and for amendment to registration as a...

17 CFR 249b.200 - Form CA-1, 1 form for registration or for exemption from registration as a clearing agency and...

Code of Federal Regulations, 2012 CFR

2012-04-01

... EXCHANGE ACT OF 1934 § 249b.200 Form CA-1, 1 form for registration or for exemption from registration as a... 17 Commodity and Securities Exchanges 3 2012-04-01 2012-04-01 false Form CA-1, 1 form for registration or for exemption from registration as a clearing agency and for amendment to registration as a...

17 CFR 249b.200 - Form CA-1, 1 form for registration or for exemption from registration as a clearing agency and...

Code of Federal Regulations, 2014 CFR

2014-04-01

... EXCHANGE ACT OF 1934 § 249b.200 Form CA-1, 1 form for registration or for exemption from registration as a... 17 Commodity and Securities Exchanges 4 2014-04-01 2014-04-01 false Form CA-1, 1 form for registration or for exemption from registration as a clearing agency and for amendment to registration as a...

17 CFR 249b.200 - Form CA-1, 1 form for registration or for exemption from registration as a clearing agency and...

Code of Federal Regulations, 2011 CFR

2011-04-01

... EXCHANGE ACT OF 1934 § 249b.200 Form CA-1, 1 form for registration or for exemption from registration as a... 17 Commodity and Securities Exchanges 3 2011-04-01 2011-04-01 false Form CA-1, 1 form for registration or for exemption from registration as a clearing agency and for amendment to registration as a...

17 CFR 249b.200 - Form CA-1, 1 form for registration or for exemption from registration as a clearing agency and...

Code of Federal Regulations, 2013 CFR

2013-04-01

... EXCHANGE ACT OF 1934 § 249b.200 Form CA-1, 1 form for registration or for exemption from registration as a... 17 Commodity and Securities Exchanges 3 2013-04-01 2013-04-01 false Form CA-1, 1 form for registration or for exemption from registration as a clearing agency and for amendment to registration as a...

Mass preserving registration for lung CT

NASA Astrophysics Data System (ADS)

Gorbunova, Vladlena; Lo, Pechin; Loeve, Martine; Tiddens, Harm A.; Sporring, Jon; Nielsen, Mads; de Bruijne, Marleen

2009-02-01

In this paper, we evaluate a novel image registration method on a set of expiratory-inspiratory pairs of computed tomography (CT) lung scans. A free-form multi resolution image registration technique is used to match two scans of the same subject. To account for the differences in the lung intensities due to differences in inspiration level, we propose to adjust the intensity of lung tissue according to the local expansion or compression. An image registration method without intensity adjustment is compared to the proposed method. Both approaches are evaluated on a set of 10 pairs of expiration and inspiration CT scans of children with cystic fibrosis lung disease. The proposed method with mass preserving adjustment results in significantly better alignment of the vessel trees. Analysis of local volume change for regions with trapped air compared to normally ventilated regions revealed larger differences between these regions in the case of mass preserving image registration, indicating that mass preserving registration is better at capturing localized differences in lung deformation.

Alternative radiation-free registration technique for image-guided pedicle screw placement in deformed cervico-thoracic segments.

PubMed

Kantelhardt, Sven R; Neulen, Axel; Keric, Naureen; Gutenberg, Angelika; Conrad, Jens; Giese, Alf

2017-10-01

Image-guided pedicle screw placement in the cervico-thoracic region is a commonly applied technique. In some patients with deformed cervico-thoracic segments, conventional or 3D fluoroscopy based registration of image-guidance might be difficult or impossible because of the anatomic/pathological conditions. Landmark based registration has been used as an alternative, mostly using separate registration of each vertebra. We here investigated a routine for landmark based registration of rigid spinal segments as single objects, using cranial image-guidance software. Landmark based registration of image-guidance was performed using cranial navigation software. After surgical exposure of the spinous processes, lamina and facet joints and fixation of a reference marker array, up to 26 predefined landmarks were acquired using a pointer. All pedicle screws were implanted using image guidance alone. Following image-guided screw placement all patients underwent postoperative CT scanning. Screw positions as well as intraoperative and clinical parameters were retrospectively analyzed. Thirteen patients received 73 pedicle screws at levels C6 to Th8. Registration of spinal segments, using the cranial image-guidance succeeded in all cases. Pedicle perforations were observed in 11.0%, severe perforations of >2 mm occurred in 5.4%. One patient developed a transient C8 syndrome and had to be revised for deviation of the C7 pedicle screw. No other pedicle screw-related complications were observed. In selected patients suffering from pathologies of the cervico-thoracic region, which impair intraoperative fluoroscopy or 3D C-arm imaging, landmark based registration of image-guidance using cranial software is a feasible, radiation-saving and a safe alternative.

Pesticide Registration Manual: Chapter 10 - Data Compensation Requirements

EPA Pesticide Factsheets

This chapter provides information about data compensation requirements, procedures, and obligations when submitting an application for registration, amended registration, reregistration or registration review.

46 CFR 389.3 - Registration.

Code of Federal Regulations, 2011 CFR

2011-10-01

... 46 Shipping 8 2011-10-01 2011-10-01 false Registration. 389.3 Section 389.3 Shipping MARITIME ADMINISTRATION, DEPARTMENT OF TRANSPORTATION MISCELLANEOUS DETERMINATION OF AVAILABILITY OF COASTWISE-QUALIFIED VESSELS FOR TRANSPORTATION OF PLATFORM JACKETS § 389.3 Registration. In order to provide timely...

40 CFR 68.160 - Registration.

Code of Federal Regulations, 2010 CFR

2010-07-01

... 40 Protection of Environment 15 2010-07-01 2010-07-01 false Registration. 68.160 Section 68.160 Protection of Environment ENVIRONMENTAL PROTECTION AGENCY (CONTINUED) AIR PROGRAMS (CONTINUED) CHEMICAL ACCIDENT PREVENTION PROVISIONS Risk Management Plan § 68.160 Registration. (a) The owner or operator shall...

17 CFR 3.43 - Relationship to registration.

Code of Federal Regulations, 2010 CFR

2010-04-01

... 17 Commodity and Securities Exchanges 1 2010-04-01 2010-04-01 false Relationship to registration. 3.43 Section 3.43 Commodity and Securities Exchanges COMMODITY FUTURES TRADING COMMISSION REGISTRATION Temporary Licenses § 3.43 Relationship to registration. (a) A temporary license shall not be...

17 CFR 3.47 - Relationship to registration.

Code of Federal Regulations, 2010 CFR

2010-04-01

... 17 Commodity and Securities Exchanges 1 2010-04-01 2010-04-01 false Relationship to registration. 3.47 Section 3.47 Commodity and Securities Exchanges COMMODITY FUTURES TRADING COMMISSION REGISTRATION Temporary Licenses § 3.47 Relationship to registration. (a) A temporary license shall not be...

14 CFR 294.20 - Applying for registration.

Code of Federal Regulations, 2011 CFR

2011-01-01

... PROCEEDINGS) ECONOMIC REGULATIONS CANADIAN CHARTER AIR TAXI OPERATORS Registration for Exemption § 294.20 Applying for registration. To apply for registration under this part, a Canadian charter air taxi operator... shall be certified by a responsible officer of the applicant Canadian charter air taxi operator...

14 CFR 294.20 - Applying for registration.

Code of Federal Regulations, 2010 CFR

2010-01-01

... PROCEEDINGS) ECONOMIC REGULATIONS CANADIAN CHARTER AIR TAXI OPERATORS Registration for Exemption § 294.20 Applying for registration. To apply for registration under this part, a Canadian charter air taxi operator... shall be certified by a responsible officer of the applicant Canadian charter air taxi operator...

Unstaffed trail registration compliance in a backcountry recreation area.

Treesearch

Earl C. Leatherberry; David W. Lime

1981-01-01

Presents findings from a study in Michigan's Upper Peninsula to evaluate the effectiveness of unstaffed trail registration stations to obtain recreation use information. Two registration approaches were evaluated: (1) self-issued voluntary registration form, and (2) self-issued mandatory registration form. The paper also cites factors influencing registration...

Unified Modeling Language (UML) for hospital-based cancer registration processes.

PubMed

Shiki, Naomi; Ohno, Yuko; Fujii, Ayumi; Murata, Taizo; Matsumura, Yasushi

2008-01-01

Hospital-based cancer registry involves complex processing steps that span across multiple departments. In addition, management techniques and registration procedures differ depending on each medical facility. Establishing processes for hospital-based cancer registry requires clarifying specific functions and labor needed. In recent years, the business modeling technique, in which management evaluation is done by clearly spelling out processes and functions, has been applied to business process analysis. However, there are few analytical reports describing the applications of these concepts to medical-related work. In this study, we initially sought to model hospital-based cancer registration processes using the Unified Modeling Language (UML), to clarify functions. The object of this study was the cancer registry of Osaka University Hospital. We organized the hospital-based cancer registration processes based on interview and observational surveys, and produced an As-Is model using activity, use-case, and class diagrams. After drafting every UML model, it was fed-back to practitioners to check its validity and improved. We were able to define the workflow for each department using activity diagrams. In addition, by using use-case diagrams we were able to classify each department within the hospital as a system, and thereby specify the core processes and staff that were responsible for each department. The class diagrams were effective in systematically organizing the information to be used for hospital-based cancer registries. Using UML modeling, hospital-based cancer registration processes were broadly classified into three separate processes, namely, registration tasks, quality control, and filing data. An additional 14 functions were also extracted. Many tasks take place within the hospital-based cancer registry office, but the process of providing information spans across multiple departments. Moreover, additional tasks were required in comparison to using a

40 CFR 152.115 - Conditions of registration.

Code of Federal Regulations, 2010 CFR

2010-07-01

... specify any provisions for sale and distribution of existing stocks of the pesticide product. (3) The... PESTICIDE REGISTRATION AND CLASSIFICATION PROCEDURES Agency Review of Applications § 152.115 Conditions of registration. (a) Substantially similar products and new uses. Each registration issued under § 152.113 shall...

SU-E-J-29: Automatic Image Registration Performance of Three IGRT Systems for Prostate Radiotherapy

DOE Office of Scientific and Technical Information (OSTI.GOV)

Barber, J; University of Sydney, Sydney, NSW; Sykes, J

Purpose: To compare the performance of an automatic image registration algorithm on image sets collected on three commercial image guidance systems, and explore its relationship with imaging parameters such as dose and sharpness. Methods: Images of a CIRS Virtually Human Male Pelvis phantom (VHMP) were collected on the CBCT systems of Varian TrueBeam/OBI and Elekta Synergy/XVI linear accelerators, across a range of mAs settings; and MVCT on a Tomotherapy Hi-ART accelerator with a range of pitch. Using the 6D correlation ratio algorithm of XVI, each image was registered to a mask of the prostate volume with a 5 mm expansion.more » Registrations were repeated 100 times, with random initial offsets introduced to simulate daily matching. Residual registration errors were calculated by correcting for the initial phantom set-up error. Automatic registration was also repeated after reconstructing images with different sharpness filters. Results: All three systems showed good registration performance, with residual translations <0.5mm (1σ) for typical clinical dose and reconstruction settings. Residual rotational error had larger range, with 0.8°, 1.2° and 1.9° for 1σ in XVI, OBI and Tomotherapy respectively. The registration accuracy of XVI images showed a strong dependence on imaging dose, particularly below 4mGy. No evidence of reduced performance was observed at the lowest dose settings for OBI and Tomotherapy, but these were above 4mGy. Registration failures (maximum target registration error > 3.6 mm on the surface of a 30mm sphere) occurred in 5% to 10% of registrations. Changing the sharpness of image reconstruction had no significant effect on registration performance. Conclusions: Using the present automatic image registration algorithm, all IGRT systems tested provided satisfactory registrations for clinical use, within a normal range of acquisition settings.« less

Characterization and utilization of an international neurofibromatosis web-based, patient–entered registry: An observational study

PubMed Central

Korf, Bruce; Rangel Miller, Vanessa; Viskochil, David

2017-01-01

The neurofibromatoses (neurofibromatosis type 1, neurofibromatosis type 2 and schwannomatosis) are rare disorders having clinical manifestations that vary greatly from patient to patient. The rarity and variability of these disorders has made it challenging for investigators to identify sufficient numbers of patients with particular clinical characteristics or specific germline mutations for participation in interventional studies. Similarly, because the natural history of all types of neurofibromatosis (NF) is variable and unique for each individual, it is difficult to identify meaningful clinical outcome measures for potential therapeutic interventions. In 2012, the Children’s Tumor Foundation created a web-based patient-entered database, the NF Registry, to inform patients of research opportunities for which they fit general eligibility criteria and enable patients to contact investigators who are seeking to enroll patients in approved trials. Registrants were recruited through CTF-affiliated NF clinics and conferences, through its website, and by word-of-mouth and social media. Following online consent, demographic information and details regarding manifestations of NF were solicited on the Registry website. Statistical analyses were performed on data from a cohort of 4680 registrants (the number of registrants as of October 9, 2015) who met diagnostic criteria for one of the 3 NF conditions. The analyses support our hypothesis that patient-reported symptom incidences in the NF Registry are congruent with published clinician-sourced data. Between April 26, 2013 and July 8, 2016, the registry has been useful to investigators in recruitment, particularly for observational trials, especially those for development of patient-reported outcomes. PMID:28644838

Characterization and utilization of an international neurofibromatosis web-based, patient-entered registry: An observational study.

PubMed

Seidlin, Mindell; Holzman, Robert; Knight, Pamela; Korf, Bruce; Rangel Miller, Vanessa; Viskochil, David; Bakker, Annette

2017-01-01

The neurofibromatoses (neurofibromatosis type 1, neurofibromatosis type 2 and schwannomatosis) are rare disorders having clinical manifestations that vary greatly from patient to patient. The rarity and variability of these disorders has made it challenging for investigators to identify sufficient numbers of patients with particular clinical characteristics or specific germline mutations for participation in interventional studies. Similarly, because the natural history of all types of neurofibromatosis (NF) is variable and unique for each individual, it is difficult to identify meaningful clinical outcome measures for potential therapeutic interventions. In 2012, the Children's Tumor Foundation created a web-based patient-entered database, the NF Registry, to inform patients of research opportunities for which they fit general eligibility criteria and enable patients to contact investigators who are seeking to enroll patients in approved trials. Registrants were recruited through CTF-affiliated NF clinics and conferences, through its website, and by word-of-mouth and social media. Following online consent, demographic information and details regarding manifestations of NF were solicited on the Registry website. Statistical analyses were performed on data from a cohort of 4680 registrants (the number of registrants as of October 9, 2015) who met diagnostic criteria for one of the 3 NF conditions. The analyses support our hypothesis that patient-reported symptom incidences in the NF Registry are congruent with published clinician-sourced data. Between April 26, 2013 and July 8, 2016, the registry has been useful to investigators in recruitment, particularly for observational trials, especially those for development of patient-reported outcomes.

Are large clinical trials in orthopaedic trauma justified?

PubMed

Sprague, Sheila; Tornetta, Paul; Slobogean, Gerard P; O'Hara, Nathan N; McKay, Paula; Petrisor, Brad; Jeray, Kyle J; Schemitsch, Emil H; Sanders, David; Bhandari, Mohit

2018-04-20

The objective of this analysis is to evaluate the necessity of large clinical trials using FLOW trial data. The FLOW pilot study and definitive trial were factorial trials evaluating the effect of different irrigation solutions and pressures on re-operation. To explore treatment effects over time, we analyzed data from the pilot and definitive trial in increments of 250 patients until the final sample size of 2447 patients was reached. At each increment we calculated the relative risk (RR) and associated 95% confidence interval (CI) for the treatment effect, and compared the results that would have been reported at the smaller enrolments with those seen in the final, adequately powered study. The pilot study analysis of 89 patients and initial incremental enrolments in the FLOW definitive trial favored low pressure compared to high pressure (RR: 1.50, 95% CI: 0.75-3.04; RR: 1.39, 95% CI: 0.60-3.23, respectively), which is in contradiction to the final enrolment, which found no difference between high and low pressure (RR: 1.04, 95% CI: 0.81-1.33). In the soap versus saline comparison, the FLOW pilot study suggested that re-operation rate was similar in both the soap and saline groups (RR: 0.98, 95% CI: 0.50-1.92), whereas the FLOW definitive trial found that the re-operation rate was higher in the soap treatment arm (RR: 1.28, 95% CI: 1.04-1.57). Our findings suggest that studies with smaller sample sizes would have led to erroneous conclusions in the management of open fracture wounds. NCT01069315 (FLOW Pilot Study) Date of Registration: February 17, 2010, NCT00788398 (FLOW Definitive Trial) Date of Registration: November 10, 2008.

46 CFR 389.3 - Registration

Code of Federal Regulations, 2010 CFR

2010-10-01

... 46 Shipping 8 2010-10-01 2010-10-01 false Registration 389.3 Section 389.3 Shipping MARITIME ADMINISTRATION, DEPARTMENT OF TRANSPORTATION MISCELLANEOUS DETERMINATION OF AVAILABILITY OF COASTWISE-QUALIFIED LAUNCH BARGES § 389.3 Registration In order to provide timely notification and to identify the potential...

Implementation of Remote 3-Dimensional Image Guided Radiation Therapy Quality Assurance for Radiation Therapy Oncology Group Clinical Trials

DOE Office of Scientific and Technical Information (OSTI.GOV)

Cui Yunfeng; Galvin, James M.; Radiation Therapy Oncology Group, American College of Radiology, Philadelphia, Pennsylvania

2013-01-01

Purpose: To report the process and initial experience of remote credentialing of three-dimensional (3D) image guided radiation therapy (IGRT) as part of the quality assurance (QA) of submitted data for Radiation Therapy Oncology Group (RTOG) clinical trials; and to identify major issues resulting from this process and analyze the review results on patient positioning shifts. Methods and Materials: Image guided radiation therapy datasets including in-room positioning CT scans and daily shifts applied were submitted through the Image Guided Therapy QA Center from institutions for the IGRT credentialing process, as required by various RTOG trials. A centralized virtual environment is establishedmore » at the RTOG Core Laboratory, containing analysis tools and database infrastructure for remote review by the Physics Principal Investigators of each protocol. The appropriateness of IGRT technique and volumetric image registration accuracy were evaluated. Registration accuracy was verified by repeat registration with a third-party registration software system. With the accumulated review results, registration differences between those obtained by the Physics Principal Investigators and from the institutions were analyzed for different imaging sites, shift directions, and imaging modalities. Results: The remote review process was successfully carried out for 87 3D cases (out of 137 total cases, including 2-dimensional and 3D) during 2010. Frequent errors in submitted IGRT data and challenges in the review of image registration for some special cases were identified. Workarounds for these issues were developed. The average differences of registration results between reviewers and institutions ranged between 2 mm and 3 mm. Large discrepancies in the superior-inferior direction were found for megavoltage CT cases, owing to low spatial resolution in this direction for most megavoltage CT cases. Conclusion: This first experience indicated that remote review for 3D IGRT as

32 CFR 635.27 - Vehicle Registration System.

Code of Federal Regulations, 2012 CFR

2012-07-01

... 32 National Defense 4 2012-07-01 2011-07-01 true Vehicle Registration System. 635.27 Section 635... ENFORCEMENT AND CRIMINAL INVESTIGATIONS LAW ENFORCEMENT REPORTING Offense Reporting § 635.27 Vehicle Registration System. The Vehicle Registration System (VRS) is a module within COPS. Use of VRS to register...

32 CFR 635.27 - Vehicle Registration System.

Code of Federal Regulations, 2011 CFR

2011-07-01

... 32 National Defense 4 2011-07-01 2011-07-01 false Vehicle Registration System. 635.27 Section 635... ENFORCEMENT AND CRIMINAL INVESTIGATIONS LAW ENFORCEMENT REPORTING Offense Reporting § 635.27 Vehicle Registration System. The Vehicle Registration System (VRS) is a module within COPS. Use of VRS to register...

32 CFR 635.27 - Vehicle Registration System.

Code of Federal Regulations, 2013 CFR

2013-07-01

... 32 National Defense 4 2013-07-01 2013-07-01 false Vehicle Registration System. 635.27 Section 635... ENFORCEMENT AND CRIMINAL INVESTIGATIONS LAW ENFORCEMENT REPORTING Offense Reporting § 635.27 Vehicle Registration System. The Vehicle Registration System (VRS) is a module within COPS. Use of VRS to register...

32 CFR 635.27 - Vehicle Registration System.

Code of Federal Regulations, 2014 CFR

2014-07-01

... 32 National Defense 4 2014-07-01 2013-07-01 true Vehicle Registration System. 635.27 Section 635... ENFORCEMENT AND CRIMINAL INVESTIGATIONS LAW ENFORCEMENT REPORTING Offense Reporting § 635.27 Vehicle Registration System. The Vehicle Registration System (VRS) is a module within COPS. Use of VRS to register...

28 CFR 5.205 - Termination of registration.

Code of Federal Regulations, 2012 CFR

2012-07-01

... supplemental statement form with the Registration Unit for the final period of the agency relationship not... of the agency relationship with the foreign principals. (d) Registration under the Act may be terminated upon a finding that the registrant is unable to file the appropriate forms to terminate the...

28 CFR 5.205 - Termination of registration.

Code of Federal Regulations, 2014 CFR

2014-07-01

... supplemental statement form with the Registration Unit for the final period of the agency relationship not... of the agency relationship with the foreign principals. (d) Registration under the Act may be terminated upon a finding that the registrant is unable to file the appropriate forms to terminate the...

28 CFR 5.205 - Termination of registration.

Code of Federal Regulations, 2013 CFR

2013-07-01

... supplemental statement form with the Registration Unit for the final period of the agency relationship not... of the agency relationship with the foreign principals. (d) Registration under the Act may be terminated upon a finding that the registrant is unable to file the appropriate forms to terminate the...

28 CFR 5.205 - Termination of registration.

Code of Federal Regulations, 2011 CFR

2011-07-01

... supplemental statement form with the Registration Unit for the final period of the agency relationship not... of the agency relationship with the foreign principals. (d) Registration under the Act may be terminated upon a finding that the registrant is unable to file the appropriate forms to terminate the...

28 CFR 5.205 - Termination of registration.

Code of Federal Regulations, 2010 CFR

2010-07-01

... supplemental statement form with the Registration Unit for the final period of the agency relationship not... of the agency relationship with the foreign principals. (d) Registration under the Act may be terminated upon a finding that the registrant is unable to file the appropriate forms to terminate the...

21 CFR 710.7 - Inspection of registrations.

Code of Federal Regulations, 2011 CFR

2011-04-01

... 21 Food and Drugs 7 2011-04-01 2010-04-01 true Inspection of registrations. 710.7 Section 710.7 Food and Drugs FOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN SERVICES (CONTINUED) COSMETICS VOLUNTARY REGISTRATION OF COSMETIC PRODUCT ESTABLISHMENTS § 710.7 Inspection of registrations. A...

21 CFR 710.7 - Inspection of registrations.

Code of Federal Regulations, 2013 CFR

2013-04-01

... 21 Food and Drugs 7 2013-04-01 2013-04-01 false Inspection of registrations. 710.7 Section 710.7 Food and Drugs FOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN SERVICES (CONTINUED) COSMETICS VOLUNTARY REGISTRATION OF COSMETIC PRODUCT ESTABLISHMENTS § 710.7 Inspection of registrations. A...

21 CFR 710.7 - Inspection of registrations.

Code of Federal Regulations, 2012 CFR

2012-04-01

... 21 Food and Drugs 7 2012-04-01 2012-04-01 false Inspection of registrations. 710.7 Section 710.7 Food and Drugs FOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN SERVICES (CONTINUED) COSMETICS VOLUNTARY REGISTRATION OF COSMETIC PRODUCT ESTABLISHMENTS § 710.7 Inspection of registrations. A...

21 CFR 710.7 - Inspection of registrations.

Code of Federal Regulations, 2010 CFR

2010-04-01

... 21 Food and Drugs 7 2010-04-01 2010-04-01 false Inspection of registrations. 710.7 Section 710.7 Food and Drugs FOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN SERVICES (CONTINUED) COSMETICS VOLUNTARY REGISTRATION OF COSMETIC PRODUCT ESTABLISHMENTS § 710.7 Inspection of registrations. A...

21 CFR 710.7 - Inspection of registrations.

Code of Federal Regulations, 2014 CFR

2014-04-01

... 21 Food and Drugs 7 2014-04-01 2014-04-01 false Inspection of registrations. 710.7 Section 710.7 Food and Drugs FOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN SERVICES (CONTINUED) COSMETICS VOLUNTARY REGISTRATION OF COSMETIC PRODUCT ESTABLISHMENTS § 710.7 Inspection of registrations. A...

14 CFR 103.7 - Certification and registration.

Code of Federal Regulations, 2013 CFR

2013-01-01

... registration. (a) Notwithstanding any other section pertaining to certification of aircraft or their parts or... registration and marking of aircraft, ultralight vehicles are not required to be registered or to bear markings... 14 Aeronautics and Space 2 2013-01-01 2013-01-01 false Certification and registration. 103.7...

14 CFR 103.7 - Certification and registration.

Code of Federal Regulations, 2014 CFR

2014-01-01

... registration. (a) Notwithstanding any other section pertaining to certification of aircraft or their parts or... registration and marking of aircraft, ultralight vehicles are not required to be registered or to bear markings... 14 Aeronautics and Space 2 2014-01-01 2014-01-01 false Certification and registration. 103.7...

14 CFR 103.7 - Certification and registration.

Code of Federal Regulations, 2012 CFR

2012-01-01

... registration. (a) Notwithstanding any other section pertaining to certification of aircraft or their parts or... registration and marking of aircraft, ultralight vehicles are not required to be registered or to bear markings... 14 Aeronautics and Space 2 2012-01-01 2012-01-01 false Certification and registration. 103.7...

Image Registration for Stability Testing of MEMS

NASA Technical Reports Server (NTRS)

Memarsadeghi, Nargess; LeMoigne, Jacqueline; Blake, Peter N.; Morey, Peter A.; Landsman, Wayne B.; Chambers, Victor J.; Moseley, Samuel H.

2011-01-01

Image registration, or alignment of two or more images covering the same scenes or objects, is of great interest in many disciplines such as remote sensing, medical imaging. astronomy, and computer vision. In this paper, we introduce a new application of image registration algorithms. We demonstrate how through a wavelet based image registration algorithm, engineers can evaluate stability of Micro-Electro-Mechanical Systems (MEMS). In particular, we applied image registration algorithms to assess alignment stability of the MicroShutters Subsystem (MSS) of the Near Infrared Spectrograph (NIRSpec) instrument of the James Webb Space Telescope (JWST). This work introduces a new methodology for evaluating stability of MEMS devices to engineers as well as a new application of image registration algorithms to computer scientists.

40 CFR 80.1650 - Registration.

Code of Federal Regulations, 2014 CFR

2014-07-01

... the first date that such person will blend oxygenate into RBOB, whichever is earlier. (4) Any ethanol... advance of the first date that such person will produce or import ethanol denaturant, whichever is earlier... inaccurate. (h) Certified ethanol denaturant producer registration. (1) Registration shall be on forms and...

28 CFR 3.3 - Registration.

Code of Federal Regulations, 2010 CFR

2010-07-01

... 28 Judicial Administration 1 2010-07-01 2010-07-01 false Registration. 3.3 Section 3.3 Judicial Administration DEPARTMENT OF JUSTICE GAMBLING DEVICES § 3.3 Registration. Persons required to register pursuant to section 3 of the Act shall register with the Assistant Attorney General, Criminal Division...

28 CFR 3.3 - Registration.

Code of Federal Regulations, 2011 CFR

2011-07-01

... 28 Judicial Administration 1 2011-07-01 2011-07-01 false Registration. 3.3 Section 3.3 Judicial Administration DEPARTMENT OF JUSTICE GAMBLING DEVICES § 3.3 Registration. Persons required to register pursuant to section 3 of the Act shall register with the Assistant Attorney General, Criminal Division...

28 CFR 3.3 - Registration.

Code of Federal Regulations, 2012 CFR

2012-07-01

... 28 Judicial Administration 1 2012-07-01 2012-07-01 false Registration. 3.3 Section 3.3 Judicial Administration DEPARTMENT OF JUSTICE GAMBLING DEVICES § 3.3 Registration. Persons required to register pursuant to section 3 of the Act shall register with the Assistant Attorney General, Criminal Division...

28 CFR 3.3 - Registration.

Code of Federal Regulations, 2014 CFR

2014-07-01

... 28 Judicial Administration 1 2014-07-01 2014-07-01 false Registration. 3.3 Section 3.3 Judicial Administration DEPARTMENT OF JUSTICE GAMBLING DEVICES § 3.3 Registration. Persons required to register pursuant to section 3 of the Act shall register with the Assistant Attorney General, Criminal Division...

28 CFR 3.3 - Registration.

Code of Federal Regulations, 2013 CFR

2013-07-01

... 28 Judicial Administration 1 2013-07-01 2013-07-01 false Registration. 3.3 Section 3.3 Judicial Administration DEPARTMENT OF JUSTICE GAMBLING DEVICES § 3.3 Registration. Persons required to register pursuant to section 3 of the Act shall register with the Assistant Attorney General, Criminal Division...

Rendering-based video-CT registration with physical constraints for image-guided endoscopic sinus surgery

NASA Astrophysics Data System (ADS)

Otake, Y.; Leonard, S.; Reiter, A.; Rajan, P.; Siewerdsen, J. H.; Ishii, M.; Taylor, R. H.; Hager, G. D.

2015-03-01

We present a system for registering the coordinate frame of an endoscope to pre- or intra- operatively acquired CT data based on optimizing the similarity metric between an endoscopic image and an image predicted via rendering of CT. Our method is robust and semi-automatic because it takes account of physical constraints, specifically, collisions between the endoscope and the anatomy, to initialize and constrain the search. The proposed optimization method is based on a stochastic optimization algorithm that evaluates a large number of similarity metric functions in parallel on a graphics processing unit. Images from a cadaver and a patient were used for evaluation. The registration error was 0.83 mm and 1.97 mm for cadaver and patient images respectively. The average registration time for 60 trials was 4.4 seconds. The patient study demonstrated robustness of the proposed algorithm against a moderate anatomical deformation.

Supervoxels for graph cuts-based deformable image registration using guided image filtering

NASA Astrophysics Data System (ADS)

Szmul, Adam; Papież, Bartłomiej W.; Hallack, Andre; Grau, Vicente; Schnabel, Julia A.

2017-11-01

We propose combining a supervoxel-based image representation with the concept of graph cuts as an efficient optimization technique for three-dimensional (3-D) deformable image registration. Due to the pixels/voxels-wise graph construction, the use of graph cuts in this context has been mainly limited to two-dimensional (2-D) applications. However, our work overcomes some of the previous limitations by posing the problem on a graph created by adjacent supervoxels, where the number of nodes in the graph is reduced from the number of voxels to the number of supervoxels. We demonstrate how a supervoxel image representation combined with graph cuts-based optimization can be applied to 3-D data. We further show that the application of a relaxed graph representation of the image, followed by guided image filtering over the estimated deformation field, allows us to model "sliding motion." Applying this method to lung image registration results in highly accurate image registration and anatomically plausible estimations of the deformations. Evaluation of our method on a publicly available computed tomography lung image dataset leads to the observation that our approach compares very favorably with state of the art methods in continuous and discrete image registration, achieving target registration error of 1.16 mm on average per landmark.

Supervoxels for Graph Cuts-Based Deformable Image Registration Using Guided Image Filtering.

PubMed

Szmul, Adam; Papież, Bartłomiej W; Hallack, Andre; Grau, Vicente; Schnabel, Julia A

2017-10-04

In this work we propose to combine a supervoxel-based image representation with the concept of graph cuts as an efficient optimization technique for 3D deformable image registration. Due to the pixels/voxels-wise graph construction, the use of graph cuts in this context has been mainly limited to 2D applications. However, our work overcomes some of the previous limitations by posing the problem on a graph created by adjacent supervoxels, where the number of nodes in the graph is reduced from the number of voxels to the number of supervoxels. We demonstrate how a supervoxel image representation, combined with graph cuts-based optimization can be applied to 3D data. We further show that the application of a relaxed graph representation of the image, followed by guided image filtering over the estimated deformation field, allows us to model 'sliding motion'. Applying this method to lung image registration, results in highly accurate image registration and anatomically plausible estimations of the deformations. Evaluation of our method on a publicly available Computed Tomography lung image dataset (www.dir-lab.com) leads to the observation that our new approach compares very favorably with state-of-the-art in continuous and discrete image registration methods achieving Target Registration Error of 1.16mm on average per landmark.

Pairwise domain adaptation module for CNN-based 2-D/3-D registration.

PubMed

Zheng, Jiannan; Miao, Shun; Jane Wang, Z; Liao, Rui

2018-04-01

Accurate two-dimensional to three-dimensional (2-D/3-D) registration of preoperative 3-D data and intraoperative 2-D x-ray images is a key enabler for image-guided therapy. Recent advances in 2-D/3-D registration formulate the problem as a learning-based approach and exploit the modeling power of convolutional neural networks (CNN) to significantly improve the accuracy and efficiency of 2-D/3-D registration. However, for surgery-related applications, collecting a large clinical dataset with accurate annotations for training can be very challenging or impractical. Therefore, deep learning-based 2-D/3-D registration methods are often trained with synthetically generated data, and a performance gap is often observed when testing the trained model on clinical data. We propose a pairwise domain adaptation (PDA) module to adapt the model trained on source domain (i.e., synthetic data) to target domain (i.e., clinical data) by learning domain invariant features with only a few paired real and synthetic data. The PDA module is designed to be flexible for different deep learning-based 2-D/3-D registration frameworks, and it can be plugged into any pretrained CNN model such as a simple Batch-Norm layer. The proposed PDA module has been quantitatively evaluated on two clinical applications using different frameworks of deep networks, demonstrating its significant advantages of generalizability and flexibility for 2-D/3-D medical image registration when a small number of paired real-synthetic data can be obtained.

32 CFR 635.27 - Vehicle Registration System.

Code of Federal Regulations, 2010 CFR

2010-07-01

... 32 National Defense 4 2010-07-01 2010-07-01 true Vehicle Registration System. 635.27 Section 635.27 National Defense Department of Defense (Continued) DEPARTMENT OF THE ARMY (CONTINUED) LAW ENFORCEMENT AND CRIMINAL INVESTIGATIONS LAW ENFORCEMENT REPORTING Offense Reporting § 635.27 Vehicle Registration System. The Vehicle Registration System (VR...

37 CFR 1.293 - Statutory invention registration.

Code of Federal Regulations, 2010 CFR

2010-07-01

... the date of publication of the statutory invention registration; (2) The required fee for filing a request for publication of a statutory invention registration as provided for in § 1.17 (n) or (o); (3) A... application. (b) Any request for publication of a statutory invention registration must include the following...

Towards operational multisensor registration

NASA Technical Reports Server (NTRS)

Rignot, Eric J. M.; Kwok, Ronald; Curlander, John C.

1991-01-01

To use data from a number of different remote sensors in a synergistic manner, a multidimensional analysis of the data is necessary. However, prior to this analysis, processing to correct for the systematic geometric distortion characteristic of each sensor is required. Furthermore, the registration process must be fully automated to handle a large volume of data and high data rates. A conceptual approach towards an operational multisensor registration algorithm is presented. The performance requirements of the algorithm are first formulated given the spatially, temporally, and spectrally varying factors that influence the image characteristics and the science requirements of various applications. Several registration techniques that fit within the structure of this algorithm are also presented. Their performance was evaluated using a multisensor test data set assembled from LANDSAT TM, SEASAT, SIR-B, Thermal Infrared Multispectral Scanner (TIMS), and SPOT sensors.

Evaluation of an Automatic Registration-Based Algorithm for Direct Measurement of Volume Change in Tumors

DOE Office of Scientific and Technical Information (OSTI.GOV)

Sarkar, Saradwata; Johnson, Timothy D.; Ma, Bing

2012-07-01

Purpose: Assuming that early tumor volume change is a biomarker for response to therapy, accurate quantification of early volume changes could aid in adapting an individual patient's therapy and lead to shorter clinical trials. We investigated an image registration-based approach for tumor volume change quantification that may more reliably detect smaller changes that occur in shorter intervals than can be detected by existing algorithms. Methods and Materials: Variance and bias of the registration-based approach were evaluated using retrospective, in vivo, very-short-interval diffusion magnetic resonance imaging scans where true zero tumor volume change is unequivocally known and synthetic data, respectively. Themore » interval scans were nonlinearly registered using two similarity measures: mutual information (MI) and normalized cross-correlation (NCC). Results: The 95% confidence interval of the percentage volume change error was (-8.93% to 10.49%) for MI-based and (-7.69%, 8.83%) for NCC-based registrations. Linear mixed-effects models demonstrated that error in measuring volume change increased with increase in tumor volume and decreased with the increase in the tumor's normalized mutual information, even when NCC was the similarity measure being optimized during registration. The 95% confidence interval of the relative volume change error for the synthetic examinations with known changes over {+-}80% of reference tumor volume was (-3.02% to 3.86%). Statistically significant bias was not demonstrated. Conclusion: A low-noise, low-bias tumor volume change measurement algorithm using nonlinear registration is described. Errors in change measurement were a function of tumor volume and the normalized mutual information content of the tumor.« less

46 CFR 401.220 - Registration of pilots.

Code of Federal Regulations, 2011 CFR

2011-10-01

... 46 Shipping 8 2011-10-01 2011-10-01 false Registration of pilots. 401.220 Section 401.220 Shipping... Registration of Pilots § 401.220 Registration of pilots. (a) The Director shall determine the number of pilots... waters of the Great Lakes and to provide for equitable participation of United States Registered Pilots...

46 CFR 401.220 - Registration of pilots.

Code of Federal Regulations, 2010 CFR

2010-10-01

... 46 Shipping 8 2010-10-01 2010-10-01 false Registration of pilots. 401.220 Section 401.220 Shipping... Registration of Pilots § 401.220 Registration of pilots. (a) The Director shall determine the number of pilots... waters of the Great Lakes and to provide for equitable participation of United States Registered Pilots...

14 CFR 298.24 - Cancellation of the registration.

Code of Federal Regulations, 2010 CFR

2010-01-01

... PROCEEDINGS) ECONOMIC REGULATIONS EXEMPTIONS FOR AIR TAXI AND COMMUTER AIR CARRIER OPERATIONS Registration for Exemption by Air Taxi Operators § 298.24 Cancellation of the registration. The registration of an air taxi...

14 CFR 298.24 - Cancellation of the registration.

Code of Federal Regulations, 2011 CFR

2011-01-01

... PROCEEDINGS) ECONOMIC REGULATIONS EXEMPTIONS FOR AIR TAXI AND COMMUTER AIR CARRIER OPERATIONS Registration for Exemption by Air Taxi Operators § 298.24 Cancellation of the registration. The registration of an air taxi...

Real-time automatic registration in optical surgical navigation

NASA Astrophysics Data System (ADS)

Lin, Qinyong; Yang, Rongqian; Cai, Ken; Si, Xuan; Chen, Xiuwen; Wu, Xiaoming

2016-05-01

An image-guided surgical navigation system requires the improvement of the patient-to-image registration time to enhance the convenience of the registration procedure. A critical step in achieving this aim is performing a fully automatic patient-to-image registration. This study reports on a design of custom fiducial markers and the performance of a real-time automatic patient-to-image registration method using these markers on the basis of an optical tracking system for rigid anatomy. The custom fiducial markers are designed to be automatically localized in both patient and image spaces. An automatic localization method is performed by registering a point cloud sampled from the three dimensional (3D) pedestal model surface of a fiducial marker to each pedestal of fiducial markers searched in image space. A head phantom is constructed to estimate the performance of the real-time automatic registration method under four fiducial configurations. The head phantom experimental results demonstrate that the real-time automatic registration method is more convenient, rapid, and accurate than the manual method. The time required for each registration is approximately 0.1 s. The automatic localization method precisely localizes the fiducial markers in image space. The averaged target registration error for the four configurations is approximately 0.7 mm. The automatic registration performance is independent of the positions relative to the tracking system and the movement of the patient during the operation.

31 CFR 352.3 - Registration and issue.

Code of Federal Regulations, 2010 CFR

2010-07-01

... 31 Money and Finance: Treasury 2 2010-07-01 2010-07-01 false Registration and issue. 352.3 Section....3 Registration and issue. (a) Registration. Series HH bonds may be registered as set forth in.... 3-80. (b) Validity of issue. A bond is validly issued when it is registered as provided 31 CFR part...

Focus Meetings for Pesticide Registration Review

EPA Pesticide Factsheets

Focus meetings with affected registrants and possibly other stakeholders are based around the information needs identified by the EPA chemical review team and management for consideration during our registration reevaluation of a pesticide.

Assessing validity of observational intervention studies – the Benchmarking Controlled Trials

PubMed Central

Malmivaara, Antti

2016-01-01

Abstract Background: Benchmarking Controlled Trial (BCT) is a concept which covers all observational studies aiming to assess impact of interventions or health care system features to patients and populations. Aims: To create and pilot test a checklist for appraising methodological validity of a BCT. Methods: The checklist was created by extracting the most essential elements from the comprehensive set of criteria in the previous paper on BCTs. Also checklists and scientific papers on observational studies and respective systematic reviews were utilized. Ten BCTs published in the Lancet and in the New England Journal of Medicine were used to assess feasibility of the created checklist. Results: The appraised studies seem to have several methodological limitations, some of which could be avoided in planning, conducting and reporting phases of the studies. Conclusions: The checklist can be used for planning, conducting, reporting, reviewing, and critical reading of observational intervention studies. However, the piloted checklist should be validated in further studies.Key messagesBenchmarking Controlled Trial (BCT) is a concept which covers all observational studies aiming to assess impact of interventions or health care system features to patients and populations.This paper presents a checklist for appraising methodological validity of BCTs and pilot-tests the checklist with ten BCTs published in leading medical journals. The appraised studies seem to have several methodological limitations, some of which could be avoided in planning, conducting and reporting phases of the studies.The checklist can be used for planning, conducting, reporting, reviewing, and critical reading of observational intervention studies. PMID:27238631

Fuels Registration, Reporting, and Compliance Help

EPA Pesticide Factsheets

Information about the requirements for registration and health effects testing of new fuels or fuel additives and mandatory registration for fuels reporting and about mandatory reporting forms for parties regulated under EPA fuel programs.

21 CFR 710.5 - Amendments to registration.

Code of Federal Regulations, 2012 CFR

2012-04-01

... 21 Food and Drugs 7 2012-04-01 2012-04-01 false Amendments to registration. 710.5 Section 710.5 Food and Drugs FOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN SERVICES (CONTINUED) COSMETICS VOLUNTARY REGISTRATION OF COSMETIC PRODUCT ESTABLISHMENTS § 710.5 Amendments to registration. Within 30 days after a change in any of the...

21 CFR 710.5 - Amendments to registration.

Code of Federal Regulations, 2010 CFR

2010-04-01

... 21 Food and Drugs 7 2010-04-01 2010-04-01 false Amendments to registration. 710.5 Section 710.5 Food and Drugs FOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN SERVICES (CONTINUED) COSMETICS VOLUNTARY REGISTRATION OF COSMETIC PRODUCT ESTABLISHMENTS § 710.5 Amendments to registration. Within 30 days after a change in any of the...

21 CFR 710.5 - Amendments to registration.

Code of Federal Regulations, 2011 CFR

2011-04-01

... 21 Food and Drugs 7 2011-04-01 2010-04-01 true Amendments to registration. 710.5 Section 710.5 Food and Drugs FOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN SERVICES (CONTINUED) COSMETICS VOLUNTARY REGISTRATION OF COSMETIC PRODUCT ESTABLISHMENTS § 710.5 Amendments to registration. Within 30 days after a change in any of the...

21 CFR 710.5 - Amendments to registration.

Code of Federal Regulations, 2014 CFR

2014-04-01

... 21 Food and Drugs 7 2014-04-01 2014-04-01 false Amendments to registration. 710.5 Section 710.5 Food and Drugs FOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN SERVICES (CONTINUED) COSMETICS VOLUNTARY REGISTRATION OF COSMETIC PRODUCT ESTABLISHMENTS § 710.5 Amendments to registration. Within 30 days after a change in any of the...

21 CFR 710.5 - Amendments to registration.

Code of Federal Regulations, 2013 CFR

2013-04-01

... 21 Food and Drugs 7 2013-04-01 2013-04-01 false Amendments to registration. 710.5 Section 710.5 Food and Drugs FOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN SERVICES (CONTINUED) COSMETICS VOLUNTARY REGISTRATION OF COSMETIC PRODUCT ESTABLISHMENTS § 710.5 Amendments to registration. Within 30 days after a change in any of the...

SU-E-J-264: Comparison of Two Commercially Available Software Platforms for Deformable Image Registration

DOE Office of Scientific and Technical Information (OSTI.GOV)

Tuohy, R; Stathakis, S; Mavroidis, P

2014-06-01

Purpose: To evaluate and compare the deformable image registration algorithms available in the Velocity (Velocity Medical Solutions, Atlanta, GA) and RayStation (RaySearch Americas, Inc., Garden city NY). Methods: Ten consecutive patient cone beam CTs (CBCT) for each fraction were collected. The CBCTs along with the simulation CT were exported to the Velocity and the RayStation software. Each CBCT was registered using deformable image registration to the simulation CT and the resulting deformable vector matrix was generated. Each registration was visually inspected by a physicist and the prescribing physician. The volumes of the critical organs were calculated for each deformable CTmore » and used for comparison. Results: The resulting deformable registrations revealed differences between the two algorithms. These differences were realized when the organs at risk were contoured on each deformed CBCT. Differences in the order of 10% ±30% in volume were observed for bladder, 17 ±21% for rectum and 16±10% for sigmoid. The prostate and PTV volume differences were in the order of 3±5%. The volumetric differences observed had a respective impact on the DVHs of all organs at risk. Differences of 8–10% in the mean dose were observed for all organs above. Conclusion: Deformable registration is a powerful tool that aids in the definition of critical structures and is often used for the evaluation of daily dose delivered to the patient. It should be noted that extended QA should be performed before clinical implementation of the software and the users should be aware of advantages and limitations of the methods.« less

31 CFR 357.21 - Registration.

Code of Federal Regulations, 2010 CFR

2010-07-01

... an existing account, the security will be registered in the same name and form of registration that... (other than a registration under paragraph (b)(2)(ii) of this section), will be presumed to be a request... owner, the security will be deemed to be registered in the owner's name alone. (3) Minors—(i) General. A...

40 CFR 155.50 - Initiate a pesticide's registration review.

Code of Federal Regulations, 2010 CFR

2010-07-01

... 40 Protection of Environment 23 2010-07-01 2010-07-01 false Initiate a pesticide's registration review. 155.50 Section 155.50 Protection of Environment ENVIRONMENTAL PROTECTION AGENCY (CONTINUED) PESTICIDE PROGRAMS REGISTRATION STANDARDS AND REGISTRATION REVIEW Registration Review Procedures § 155.50...

40 CFR 155.44 - Establish schedules for registration review.

Code of Federal Regulations, 2010 CFR

2010-07-01

... 40 Protection of Environment 23 2010-07-01 2010-07-01 false Establish schedules for registration review. 155.44 Section 155.44 Protection of Environment ENVIRONMENTAL PROTECTION AGENCY (CONTINUED) PESTICIDE PROGRAMS REGISTRATION STANDARDS AND REGISTRATION REVIEW Registration Review Procedures § 155.44...

40 CFR 79.24 - Termination of registration of additives.

Code of Federal Regulations, 2014 CFR

2014-07-01

... additives. 79.24 Section 79.24 Protection of Environment ENVIRONMENTAL PROTECTION AGENCY (CONTINUED) AIR PROGRAMS (CONTINUED) REGISTRATION OF FUELS AND FUEL ADDITIVES Additive Registration Procedures § 79.24 Termination of registration of additives. Registration may be terminated by the Administrator if the additive...

40 CFR 79.24 - Termination of registration of additives.

Code of Federal Regulations, 2010 CFR

2010-07-01

... additives. 79.24 Section 79.24 Protection of Environment ENVIRONMENTAL PROTECTION AGENCY (CONTINUED) AIR PROGRAMS (CONTINUED) REGISTRATION OF FUELS AND FUEL ADDITIVES Additive Registration Procedures § 79.24 Termination of registration of additives. Registration may be terminated by the Administrator if the additive...

40 CFR 79.24 - Termination of registration of additives.

Code of Federal Regulations, 2012 CFR

2012-07-01

... additives. 79.24 Section 79.24 Protection of Environment ENVIRONMENTAL PROTECTION AGENCY (CONTINUED) AIR PROGRAMS (CONTINUED) REGISTRATION OF FUELS AND FUEL ADDITIVES Additive Registration Procedures § 79.24 Termination of registration of additives. Registration may be terminated by the Administrator if the additive...

40 CFR 79.24 - Termination of registration of additives.

Code of Federal Regulations, 2013 CFR

2013-07-01

... additives. 79.24 Section 79.24 Protection of Environment ENVIRONMENTAL PROTECTION AGENCY (CONTINUED) AIR PROGRAMS (CONTINUED) REGISTRATION OF FUELS AND FUEL ADDITIVES Additive Registration Procedures § 79.24 Termination of registration of additives. Registration may be terminated by the Administrator if the additive...

40 CFR 79.24 - Termination of registration of additives.

Code of Federal Regulations, 2011 CFR

2011-07-01

... additives. 79.24 Section 79.24 Protection of Environment ENVIRONMENTAL PROTECTION AGENCY (CONTINUED) AIR PROGRAMS (CONTINUED) REGISTRATION OF FUELS AND FUEL ADDITIVES Additive Registration Procedures § 79.24 Termination of registration of additives. Registration may be terminated by the Administrator if the additive...

Relevance of randomised controlled trials in oncology.

PubMed

Tannock, Ian F; Amir, Eitan; Booth, Christopher M; Niraula, Saroj; Ocana, Alberto; Seruga, Bostjan; Templeton, Arnoud J; Vera-Badillo, Francisco

2016-12-01

Well-designed randomised controlled trials (RCTs) can prevent bias in the comparison of treatments and provide a sound basis for changes in clinical practice. However, the design and reporting of many RCTs can render their results of little relevance to clinical practice. In this Personal View, we discuss the limitations of RCT data and suggest some ways to improve the clinical relevance of RCTs in the everyday management of patients with cancer. RCTs should ask questions of clinical rather than commercial interest, avoid non-validated surrogate endpoints in registration trials, and have entry criteria that allow inclusion of all patients who are fit to receive treatment. Furthermore, RCTs should be reported with complete accounting of frequency and management of toxicities, and with strict guidelines to ensure freedom from bias. Premature reporting of results should be avoided. The bar for clinical benefit should be raised for drug registration, which should require publication and review of mature data from RCTs, post-marketing health outcome studies, and value-based pricing. Copyright © 2016 Elsevier Ltd. All rights reserved.

Sulcal set optimization for cortical surface registration.

PubMed

Joshi, Anand A; Pantazis, Dimitrios; Li, Quanzheng; Damasio, Hanna; Shattuck, David W; Toga, Arthur W; Leahy, Richard M

2010-04-15

Flat mapping based cortical surface registration constrained by manually traced sulcal curves has been widely used for inter subject comparisons of neuroanatomical data. Even for an experienced neuroanatomist, manual sulcal tracing can be quite time consuming, with the cost increasing with the number of sulcal curves used for registration. We present a method for estimation of an optimal subset of size N(C) from N possible candidate sulcal curves that minimizes a mean squared error metric over all combinations of N(C) curves. The resulting procedure allows us to estimate a subset with a reduced number of curves to be traced as part of the registration procedure leading to optimal use of manual labeling effort for registration. To minimize the error metric we analyze the correlation structure of the errors in the sulcal curves by modeling them as a multivariate Gaussian distribution. For a given subset of sulci used as constraints in surface registration, the proposed model estimates registration error based on the correlation structure of the sulcal errors. The optimal subset of constraint curves consists of the N(C) sulci that jointly minimize the estimated error variance for the subset of unconstrained curves conditioned on the N(C) constraint curves. The optimal subsets of sulci are presented and the estimated and actual registration errors for these subsets are computed. Copyright 2009 Elsevier Inc. All rights reserved.

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

PubMed

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

3D point cloud analysis of structured light registration in computer-assisted navigation in spinal surgeries

NASA Astrophysics Data System (ADS)

Gupta, Shaurya; Guha, Daipayan; Jakubovic, Raphael; Yang, Victor X. D.

2017-02-01

Computer-assisted navigation is used by surgeons in spine procedures to guide pedicle screws to improve placement accuracy and in some cases, to better visualize patient's underlying anatomy. Intraoperative registration is performed to establish a correlation between patient's anatomy and the pre/intra-operative image. Current algorithms rely on seeding points obtained directly from the exposed spinal surface to achieve clinically acceptable registration accuracy. Registration of these three dimensional surface point-clouds are prone to various systematic errors. The goal of this study was to evaluate the robustness of surgical navigation systems by looking at the relationship between the optical density of an acquired 3D point-cloud and the corresponding surgical navigation error. A retrospective review of a total of 48 registrations performed using an experimental structured light navigation system developed within our lab was conducted. For each registration, the number of points in the acquired point cloud was evaluated relative to whether the registration was acceptable, the corresponding system reported error and target registration error. It was demonstrated that the number of points in the point cloud neither correlates with the acceptance/rejection of a registration or the system reported error. However, a negative correlation was observed between the number of the points in the point-cloud and the corresponding sagittal angular error. Thus, system reported total registration points and accuracy are insufficient to gauge the accuracy of a navigation system and the operating surgeon must verify and validate registration based on anatomical landmarks prior to commencing surgery.

A pragmatic multi-centre randomised controlled trial of fluid loading and level of dependency in high-risk surgical patients undergoing major elective surgery: trial protocol

PubMed Central

2010-01-01

Background Patients undergoing major elective or urgent surgery are at high risk of death or significant morbidity. Measures to reduce this morbidity and mortality include pre-operative optimisation and use of higher levels of dependency care after surgery. We propose a pragmatic multi-centre randomised controlled trial of level of dependency and pre-operative fluid therapy in high-risk surgical patients undergoing major elective surgery. Methods/Design A multi-centre randomised controlled trial with a 2 * 2 factorial design. The first randomisation is to pre-operative fluid therapy or standard regimen and the second randomisation is to routine intensive care versus high dependency care during the early post-operative period. We intend to recruit 204 patients undergoing major elective and urgent abdominal and thoraco-abdominal surgery who fulfil high-risk surgical criteria. The primary outcome for the comparison of level of care is cost-effectiveness at six months and for the comparison of fluid optimisation is the number of hospital days after surgery. Discussion We believe that the results of this study will be invaluable in determining the future care and clinical resource utilisation for this group of patients and thus will have a major impact on clinical practice. Trial Registration Trial registration number - ISRCTN32188676 PMID:20398378

40 CFR 155.53 - Conduct of a pesticide's registration review.

Code of Federal Regulations, 2012 CFR

2012-07-01

... 40 Protection of Environment 25 2012-07-01 2012-07-01 false Conduct of a pesticide's registration...) PESTICIDE PROGRAMS REGISTRATION STANDARDS AND REGISTRATION REVIEW Registration Review Procedures § 155.53 Conduct of a pesticide's registration review. The Agency will review data and information described in...

40 CFR 155.53 - Conduct of a pesticide's registration review.

Code of Federal Regulations, 2011 CFR

2011-07-01

... 40 Protection of Environment 24 2011-07-01 2011-07-01 false Conduct of a pesticide's registration...) PESTICIDE PROGRAMS REGISTRATION STANDARDS AND REGISTRATION REVIEW Registration Review Procedures § 155.53 Conduct of a pesticide's registration review. The Agency will review data and information described in...

40 CFR 155.53 - Conduct of a pesticide's registration review.

Code of Federal Regulations, 2014 CFR

2014-07-01

... 40 Protection of Environment 24 2014-07-01 2014-07-01 false Conduct of a pesticide's registration...) PESTICIDE PROGRAMS REGISTRATION STANDARDS AND REGISTRATION REVIEW Registration Review Procedures § 155.53 Conduct of a pesticide's registration review. The Agency will review data and information described in...

40 CFR 155.53 - Conduct of a pesticide's registration review.

Code of Federal Regulations, 2013 CFR

2013-07-01

... 40 Protection of Environment 25 2013-07-01 2013-07-01 false Conduct of a pesticide's registration...) PESTICIDE PROGRAMS REGISTRATION STANDARDS AND REGISTRATION REVIEW Registration Review Procedures § 155.53 Conduct of a pesticide's registration review. The Agency will review data and information described in...

Efficacy of electroacupuncture for symptoms of menopausal transition: study protocol for a randomized controlled trial.

PubMed

Liu, Zhishun; Wang, Yang; Xu, Huanfang; Wu, Jiani; He, Liyun; Jiang, John Yi; Yan, Shiyan; Du, Ruosang; Liu, Baoyan

2014-06-21

Previous studies have shown that acupuncture can alleviate postmenopausal symptoms, such as hot flashes, but few studies have assessed symptoms during the menopausal transition (MT) period. Thus, the effect of acupuncture upon MT symptoms is unclear. We designed a large-scale trial aimed at evaluating the efficacy of electroacupuncture for MT symptoms compared with sham electroacupuncture and at observing the safety of electroacupuncture. In this multicenter randomized controlled trial, 360 women will be randomized to either an electroacupuncture group or a sham electroacupuncture group. During the 8-week-long treatment, a menopause rating scale, average 24-hour hot flash score, Menopause-Specific Quality of Life Questionnaire score, and level of female hormones will be observed. Follow-ups at the 20th and 32nd week will be made. Though there is no completely inert placebo acupuncture and blinding is difficult in acupuncture trials, the placebo effect of EA can still be partially excluded in this study. For the placebo control, we use non-points and a tailor-made sham needle. This needle is different from a retractable needle, which is usually used for sham acupuncture. The needle in this trial is more simply constructed and more acceptable to Chinese people. We expect to evaluate the efficacy of electroacupuncture for MT symptoms and clarify its effect on these symptoms. ClinicalTrials.gov Identifier: NCT01849172 (Date of registration: 05/05/2013).

Landsat image registration for agricultural applications

NASA Technical Reports Server (NTRS)

Wolfe, R. H., Jr.; Juday, R. D.; Wacker, A. G.; Kaneko, T.

1982-01-01

An image registration system has been developed at the NASA Johnson Space Center (JSC) to spatially align multi-temporal Landsat acquisitions for use in agriculture and forestry research. Working in conjunction with the Master Data Processor (MDP) at the Goddard Space Flight Center, it functionally replaces the long-standing LACIE Registration Processor as JSC's data supplier. The system represents an expansion of the techniques developed for the MDP and LACIE Registration Processor, and it utilizes the experience gained in an IBM/JSC effort evaluating the performance of the latter. These techniques are discussed in detail. Several tests were developed to evaluate the registration performance of the system. The results indicate that 1/15-pixel accuracy (about 4m for Landsat MSS) is achievable in ideal circumstances, sub-pixel accuracy (often to 0.2 pixel or better) was attained on a representative set of U.S. acquisitions, and a success rate commensurate with the LACIE Registration Processor was realized. The system has been employed in a production mode on U.S. and foreign data, and a performance similar to the earlier tests has been noted.

Computer-aided vs. tutor-delivered teaching of exposure therapy for phobia/panic: randomized controlled trial with pre-registration nursing students.

PubMed

Gega, L; Norman, I J; Marks, I M

2007-03-01

Exposure therapy is effective for phobic anxiety disorders (specific phobias, agoraphobia, social phobia) and panic disorder. Despite their high prevalence in the community, sufferers often get no treatment or if they do, it is usually after a long delay. This is largely due to the scarcity of healthcare professionals trained in exposure therapy, which is due, in part, to the high cost of training. Traditional teaching methods employed are labour intensive, being based mainly on role-play in small groups with feedback and coaching from experienced trainers. In an attempt to increase knowledge and skills in exposure therapy, there is now some interest in providing relevant teaching as part of pre-registration nurse education. Computers have been developed to teach terminology and simulate clinical scenarios for health professionals, and offer a potentially cost effective alternative to traditional teaching methods. To test whether student nurses would learn about exposure therapy for phobia/panic as well by computer-aided self-instruction as by face-to-face teaching, and to compare the individual and combined effects of two educational methods, traditional face-to-face teaching comprising a presentation with discussion and questions/answers by a specialist cognitive behaviour nurse therapist, and a computer-aided self-instructional programme based on a self-help programme for patients with phobia/panic called FearFighter, on students' knowledge, skills and satisfaction. Randomised controlled trial, with a crossover, completed in 2 consecutive days over a period of 4h per day. Ninety-two mental health pre-registration nursing students, of mixed gender, age and ethnic origin, with no previous training in cognitive behaviour therapy studying at one UK university. The two teaching methods led to similar improvements in knowledge and skills, and to similar satisfaction, when used alone. Using them in tandem conferred no added benefit. Computer-aided self-instruction was

Non-rigid image registration using graph-cuts.

PubMed

Tang, Tommy W H; Chung, Albert C S

2007-01-01

Non-rigid image registration is an ill-posed yet challenging problem due to its supernormal high degree of freedoms and inherent requirement of smoothness. Graph-cuts method is a powerful combinatorial optimization tool which has been successfully applied into image segmentation and stereo matching. Under some specific constraints, graph-cuts method yields either a global minimum or a local minimum in a strong sense. Thus, it is interesting to see the effects of using graph-cuts in non-rigid image registration. In this paper, we formulate non-rigid image registration as a discrete labeling problem. Each pixel in the source image is assigned a displacement label (which is a vector) indicating which position in the floating image it is spatially corresponding to. A smoothness constraint based on first derivative is used to penalize sharp changes in displacement labels across pixels. The whole system can be optimized by using the graph-cuts method via alpha-expansions. We compare 2D and 3D registration results of our method with two state-of-the-art approaches. It is found that our method is more robust to different challenging non-rigid registration cases with higher registration accuracy.

Supervoxels for Graph Cuts-Based Deformable Image Registration Using Guided Image Filtering

PubMed Central

Szmul, Adam; Papież, Bartłomiej W.; Hallack, Andre; Grau, Vicente; Schnabel, Julia A.

2017-01-01

In this work we propose to combine a supervoxel-based image representation with the concept of graph cuts as an efficient optimization technique for 3D deformable image registration. Due to the pixels/voxels-wise graph construction, the use of graph cuts in this context has been mainly limited to 2D applications. However, our work overcomes some of the previous limitations by posing the problem on a graph created by adjacent supervoxels, where the number of nodes in the graph is reduced from the number of voxels to the number of supervoxels. We demonstrate how a supervoxel image representation, combined with graph cuts-based optimization can be applied to 3D data. We further show that the application of a relaxed graph representation of the image, followed by guided image filtering over the estimated deformation field, allows us to model ‘sliding motion’. Applying this method to lung image registration, results in highly accurate image registration and anatomically plausible estimations of the deformations. Evaluation of our method on a publicly available Computed Tomography lung image dataset (www.dir-lab.com) leads to the observation that our new approach compares very favorably with state-of-the-art in continuous and discrete image registration methods achieving Target Registration Error of 1.16mm on average per landmark. PMID:29225433

Reliability Stress-Strength Models for Dependent Observations with Applications in Clinical Trials

NASA Technical Reports Server (NTRS)

Kushary, Debashis; Kulkarni, Pandurang M.

1995-01-01

We consider the applications of stress-strength models in studies involving clinical trials. When studying the effects and side effects of certain procedures (treatments), it is often the case that observations are correlated due to subject effect, repeated measurements and observing many characteristics simultaneously. We develop maximum likelihood estimator (MLE) and uniform minimum variance unbiased estimator (UMVUE) of the reliability which in clinical trial studies could be considered as the chances of increased side effects due to a particular procedure compared to another. The results developed apply to both univariate and multivariate situations. Also, for the univariate situations we develop simple to use lower confidence bounds for the reliability. Further, we consider the cases when both stress and strength constitute time dependent processes. We define the future reliability and obtain methods of constructing lower confidence bounds for this reliability. Finally, we conduct simulation studies to evaluate all the procedures developed and also to compare the MLE and the UMVUE.

Public titles of clinical trials should have ethics review.

PubMed

Saenz, Carla; Reveiz, Ludovic; Tisdale, John F

2015-09-01

A key aspect to guarantee that research with human subjects is ethical is being overlooked. Ethics review committees invest great effort examining the informed consent documents of research protocols to ensure that potential participants can provide consent validly and are not deluded into thinking that the experimental intervention they may sign up for is already known to be therapeutic. However, these efforts to avoid what is called the "therapeutic misconception" might be in vain if the title with which the studies are being introduced to the potential participants escapes ethics review. Research participants might be deceived by clinical trials entitled "novel therapy" when the point of the trial is precisely to find out whether the intervention at stake is therapeutic or not. Providing potential research participants with such misleading information hampers their ability to make informed decisions. The well-established scrutiny that ethics review committees exercise with regard to consent forms is limited if the registration of clinical trials, for which a public title is chosen, constitutes a process that is independent from the ethics review. In this article, we examine this problem, assess recent measures to integrate clinical trial registration with ethics review processes, and provide specific recommendations to solve the problem and ultimately enhance the accountability, transparency, and ethics of research with human subjects. Copyright © 2015 Pan American Health Organization. Published by Elsevier Inc. All rights reserved.

Developing an observing attitude: A qualitative analysis of meditation diaries in a MBSR clinical trial

PubMed Central

Kerr, Catherine E.; Josyula, Krishnapriya; Littenberg, Ronnie

2011-01-01

Mindfulness-based stress reduction (MBSR) is an 8-week training that is designed to teach participants mindful awareness of the present moment. In randomized clinical trials (RCTs), MBSR has demonstrated efficacy in various conditions including reducing chronic pain related distress and improving quality of life in healthy individuals. There have, however, been no qualitative studies investigating participants’ descriptions of changes experienced over multiple time-points during the course of the program. This qualitative study of a MBSR cohort (N=8 healthy individuals) in a larger RCT examined participants’ daily diary descriptions of their home-practice experiences. The study used a two-part method, combining grounded theory with a close-ended coding approach. The grounded theory analysis revealed that during the trial, all participants, to varying degrees, described moments of distress related to practice; at the end of the course, all participants who completed the training demonstrated greater detail and clarity in their descriptions, improved affect, and the emergence of an observing self. The closed-ended coding schema carried out to shed light on the development of an observing self, revealed that the emergence of an observing self was not related to the valence of participants’ experiential descriptions: even participants whose diaries contained predominantly negative characterizations of their experience throughout the trial were able, by the end of the trial, to demonstrate an observing, witnessing attitude towards their own distress. Conclusion Progress in MBSR may rely less on the valence of participants’ experiences and more on the way participants describe and relate to their own inner experience. PMID:21226129

Language proficiency and nursing registration.

PubMed

Müller, Amanda

2016-02-01

This discussion paper focuses on English proficiency standards for nursing registration in Australia, how Australia has dealt with the issue of language proficiency, and the factors which have led to the establishment of the current language standards. Also, this paper will provide a comparison of the two language tests that are currently accepted in Australia (OET and IELTS), including the appropriateness of these tests and the minimum standards used. The paper will also examine the use of educational background as an indicator of language proficiency. Finally, communication-based complaints in the post-registration environment will be explored, and some discussion will be provided about why pre-registration measures might have failed to prevent such problematic situations from occurring. Copyright © 2015 Elsevier Ltd. All rights reserved.

Post-trial follow-up methodology in large randomized controlled trials: a systematic review protocol.

PubMed

Llewellyn-Bennett, Rebecca; Bowman, Louise; Bulbulia, Richard

2016-12-15

Clinical trials typically have a relatively short follow-up period, and may both underestimate potential benefits of treatments investigated, and fail to detect hazards, which can take much longer to emerge. Prolonged follow-up of trial participants after the end of the scheduled trial period can provide important information on both efficacy and safety outcomes. This protocol describes a systematic review to qualitatively compare methods of post-trial follow-up used in large randomized controlled trials. A systematic search of electronic databases and clinical trial registries will use a predefined search strategy. All large (more than 1000 adult participants) randomized controlled trials will be evaluated. Two reviewers will screen and extract data according to this protocol with the aim of 95% concordance of papers checked and discrepancies will be resolved by a third reviewer. Trial methods, participant retention rates and prevalence of missing data will be recorded and compared. The potential for bias will be evaluated using the Cochrane Risk of Bias tool (applied to the methods used during the in-trial period) with the aim of investigating whether the quality of the post-trial follow-up methodology might be predicted by the quality of the methods used for the original trial. Post-trial follow-up can provide valuable information about the long-term benefits and hazards of medical interventions. However, it can be logistically challenging and costly. The aim of this systematic review is to describe how trial participants have been followed-up post-trial in order to inform future post-trial follow-up designs. Not applicable for PROSPERO registration.

Inverse consistent non-rigid image registration based on robust point set matching

PubMed Central

2014-01-01

. The determinant of the Jacobian matrix of the deformation field is used to analyse the smoothness of the forward and backward transformations. The forward and backward transformations estimated by our algorithm are smooth for small deformation. For registration of lung slices and individual brain slices, large or small determinant of the Jacobian matrix of the deformation fields are observed. Conclusions Results indicate the improvement of the proposed algorithm in bi-directional image registration and the decrease of the inverse consistent errors of the forward and the reverse transformations between two images. PMID:25559889

Evaluation of Efficacy and Safety of Longterm Feeding with Amino Acid-Based Formula in Infants with Cow’s Milk Protein Allergy: Results of the Open-Label Prospective Controlled Post-Registration Trial.

PubMed

Novik, G A; Khaleva, E G; Bychkova, N V; Zdanova, M V

The cow’s milk allergy (CMA) prevalence is 2−3% in children under one year. Approximately in 5% of cases transferring to extensively hydrolysed formula (eHF) doesn’t lead to disappearance of CMA symptoms. Evaluation of efficacy and safety of amino-acid formula (AAF) longterm feeding in children under one year and development of predictors of successful transfer from AAF to eHF. In open-label prospective post-registration trial duration of 365 days were included 43 children aged from 3 to 12 months with CMA. CMA was based on Russian and international guidelines. When a patient was included in the trial, child received eHF for 4 weeks with the evaluation of the effect of elimination diet (ED): in case of absence of effect, for diagnostic purposes child feed with AAF for 2 weeks and upon receiving the effect, child continued to receive it for at least 6 months. Diet was considered effective if there were observed disappearance of clinical manifestations of CMA during of formula using. Children fed with AAF gain weight and increased height statistically higher during the first 6 months, compared with children receiving eHF, but without subsequent difference in a year. After 4 weeks’ of AAF feeding, there was a significant decrease in SCORAD index from 46.84 (SD 4.164) to 2.52 (SD 2.204) (p=0.005); disappearance of gastrointestinal manifestations of CMA from 3 to 14 day. After 4 weeks, the 100% normalization of previously elevated faecal calprotectin (p<0.05) was observed; and after 6months. ED, in 60% of children normalization of the index of activation of basophils with milk was observed. 38.7% of children were transferred to eHF in 6 months, 12.9% and 25.8% in 9 and 12 months respectively. Use of AAF for children with CMA is an effective and safe treatment without lengthening the period of elimination, which is necessary for the formation of tolerance to cow’s milk protein and has a positive impact on weight and height. Normalization of specific activation

48 CFR 52.204-7 - Central Contractor Registration.

Code of Federal Regulations, 2010 CFR

2010-10-01

... 48 Federal Acquisition Regulations System 2 2010-10-01 2010-10-01 false Central Contractor....204-7 Central Contractor Registration. As prescribed in 4.1105, use the following clause: Central Contractor Registration (APR 2008) (a) Definitions. As used in this clause— Central Contractor Registration...

Reforming the household registration system: a preliminary glimpse of the blue chop household registration system in Shanghai and Shenzhen.

PubMed

Wong, L; Wai-po, H

1998-01-01

"For decades, the household registration system has functioned as a powerful device in halting rural influxes into Chinese cities. The exigencies of the reform call for reform of the hukou system [China's household registration]. One of the many attempts is the blue chop household registration system. Both Shanghai and Shenzhen have introduced this practice. In addition to promotion of real estate and investment, it creams off those more desirable migrants into the permanent population of the two cities. In view of the present situation of linking welfare provision with household registration status, this selective migration policy seems to be a sensible step forward." excerpt

Local-search based prediction of medical image registration error

NASA Astrophysics Data System (ADS)

Saygili, Görkem

2018-03-01

Medical image registration is a crucial task in many different medical imaging applications. Hence, considerable amount of work has been published recently that aim to predict the error in a registration without any human effort. If provided, these error predictions can be used as a feedback to the registration algorithm to further improve its performance. Recent methods generally start with extracting image-based and deformation-based features, then apply feature pooling and finally train a Random Forest (RF) regressor to predict the real registration error. Image-based features can be calculated after applying a single registration but provide limited accuracy whereas deformation-based features such as variation of deformation vector field may require up to 20 registrations which is a considerably high time-consuming task. This paper proposes to use extracted features from a local search algorithm as image-based features to estimate the error of a registration. The proposed method comprises a local search algorithm to find corresponding voxels between registered image pairs and based on the amount of shifts and stereo confidence measures, it predicts the amount of registration error in millimetres densely using a RF regressor. Compared to other algorithms in the literature, the proposed algorithm does not require multiple registrations, can be efficiently implemented on a Graphical Processing Unit (GPU) and can still provide highly accurate error predictions in existence of large registration error. Experimental results with real registrations on a public dataset indicate a substantially high accuracy achieved by using features from the local search algorithm.

Robust video super-resolution with registration efficiency adaptation

NASA Astrophysics Data System (ADS)

Zhang, Xinfeng; Xiong, Ruiqin; Ma, Siwei; Zhang, Li; Gao, Wen

2010-07-01

Super-Resolution (SR) is a technique to construct a high-resolution (HR) frame by fusing a group of low-resolution (LR) frames describing the same scene. The effectiveness of the conventional super-resolution techniques, when applied on video sequences, strongly relies on the efficiency of motion alignment achieved by image registration. Unfortunately, such efficiency is limited by the motion complexity in the video and the capability of adopted motion model. In image regions with severe registration errors, annoying artifacts usually appear in the produced super-resolution video. This paper proposes a robust video super-resolution technique that adapts itself to the spatially-varying registration efficiency. The reliability of each reference pixel is measured by the corresponding registration error and incorporated into the optimization objective function of SR reconstruction. This makes the SR reconstruction highly immune to the registration errors, as outliers with higher registration errors are assigned lower weights in the objective function. In particular, we carefully design a mechanism to assign weights according to registration errors. The proposed superresolution scheme has been tested with various video sequences and experimental results clearly demonstrate the effectiveness of the proposed method.

Effect Sizes and Primary Outcomes in Large-Budget, Cardiovascular-Related Behavioral Randomized Controlled Trials Funded by NIH Since 1980

PubMed Central

Irvin, Veronica L.; Kaplan, Robert M.

2015-01-01

Purpose We reviewed large-budget, National Institutes of Health (NIH)-supported randomized controlled trials (RCTs) with behavioral interventions to assess (1) publication rates, (2) trial registration, (3) use of objective measures, (4) significant behavior and physiological change, and (5) effect sizes. Methods We identified large-budget grants (>$500,000/year) funded by NIH (National Heart Lung and Blood Institute (NHLBI) or National Institute of Diabetes & Digestive and Kidney Diseases (NIDDK)) for cardiovascular disease (dates January 1, 1980 to December 31, 2012). Among 106 grants that potentially met inclusion criteria, 20 studies were not published and 48 publications were excluded, leaving 38 publications for analysis. ClinicalTrials.gov abstracts were used to determine whether outcome measures had been pre-specified. Results Three fourths of trials were registered in ClinicalTrials.gov and all published pre-specified outcomes. Twenty-six trials reported a behavioral outcome with 81 % reporting significant improvements for the target behavior. Thirty-two trials reported a physiological outcome. All were objectively measured, and 81 % reported significant benefit. Seventeen trials reported morbidity outcomes, and seven reported a significant benefit. Nine trials assessed mortality, and all were null for this outcome. Conclusions Behavioral trials complied with trial registration standards. Most reported a physiological benefit, but few documented morbidity or mortality benefits. PMID:26507906

Evaluation of 4D-CT lung registration.

PubMed

Kabus, Sven; Klinder, Tobias; Murphy, Keelin; van Ginneken, Bram; van Lorenz, Cristian; Pluim, Josien P W

2009-01-01

Non-rigid registration accuracy assessment is typically performed by evaluating the target registration error at manually placed landmarks. For 4D-CT lung data, we compare two sets of landmark distributions: a smaller set primarily defined on vessel bifurcations as commonly described in the literature and a larger set being well-distributed throughout the lung volume. For six different registration schemes (three in-house schemes and three schemes frequently used by the community) the landmark error is evaluated and found to depend significantly on the distribution of the landmarks. In particular, lung regions near to the pleura show a target registration error three times larger than near-mediastinal regions. While the inter-method variability on the landmark positions is rather small, the methods show discriminating differences with respect to consistency and local volume change. In conclusion, both a well-distributed set of landmarks and a deformation vector field analysis are necessary for reliable non-rigid registration accuracy assessment.

Mammogram registration using the Cauchy-Navier spline

NASA Astrophysics Data System (ADS)

Wirth, Michael A.; Choi, Christopher

2001-07-01

The process of comparative analysis involves inspecting mammograms for characteristic signs of potential cancer by comparing various analogous mammograms. Factors such as the deformable behavior of the breast, changes in breast positioning, and the amount/geometry of compression may contribute to spatial differences between corresponding structures in corresponding mammograms, thereby significantly complicating comparative analysis. Mammogram registration is a process whereby spatial differences between mammograms can be reduced. Presented in this paper is a nonrigid approach to matching corresponding mammograms based on a physical registration model. Many of the earliest approaches to mammogram registration used spatial transformations which were innately rigid or affine in nature. More recently algorithms have incorporated radial basis functions such as the Thin-Plate Spline to match mammograms. The approach presented here focuses on the use of the Cauchy-Navier Spline, a deformable registration model which offers approximate nonrigid registration. The utility of the Cauchy-Navier Spline is illustrated by matching both temporal and bilateral mammograms.

Deformable Medical Image Registration: A Survey

PubMed Central

Sotiras, Aristeidis; Davatzikos, Christos; Paragios, Nikos

2013-01-01

Deformable image registration is a fundamental task in medical image processing. Among its most important applications, one may cite: i) multi-modality fusion, where information acquired by different imaging devices or protocols is fused to facilitate diagnosis and treatment planning; ii) longitudinal studies, where temporal structural or anatomical changes are investigated; and iii) population modeling and statistical atlases used to study normal anatomical variability. In this paper, we attempt to give an overview of deformable registration methods, putting emphasis on the most recent advances in the domain. Additional emphasis has been given to techniques applied to medical images. In order to study image registration methods in depth, their main components are identified and studied independently. The most recent techniques are presented in a systematic fashion. The contribution of this paper is to provide an extensive account of registration techniques in a systematic manner. PMID:23739795

Contacts in the Office of Pesticide Programs, Registration Division

EPA Pesticide Factsheets

The Registration Division (RD) is responsible product registrations, amendments, registrations, tolerances, experimental use permits, and emergency exemptions for conventional chemical pesticides. Find contacts in this division.

Hardware implementation of hierarchical volume subdivision-based elastic registration.

PubMed

Dandekar, Omkar; Walimbe, Vivek; Shekhar, Raj

2006-01-01

Real-time, elastic and fully automated 3D image registration is critical to the efficiency and effectiveness of many image-guided diagnostic and treatment procedures relying on multimodality image fusion or serial image comparison. True, real-time performance will make many 3D image registration-based techniques clinically viable. Hierarchical volume subdivision-based image registration techniques are inherently faster than most elastic registration techniques, e.g. free-form deformation (FFD)-based techniques, and are more amenable for achieving real-time performance through hardware acceleration. Our group has previously reported an FPGA-based architecture for accelerating FFD-based image registration. In this article we show how our existing architecture can be adapted to support hierarchical volume subdivision-based image registration. A proof-of-concept implementation of the architecture achieved speedups of 100 for elastic registration against an optimized software implementation on a 3.2 GHz Pentium III Xeon workstation. Due to inherent parallel nature of the hierarchical volume subdivision-based image registration techniques further speedup can be achieved by using several computing modules in parallel.

21 CFR 607.35 - Notification of registrant; blood product establishment registration number and NDC Labeler Code.

Code of Federal Regulations, 2011 CFR

2011-04-01

... 21 Food and Drugs 7 2011-04-01 2010-04-01 true Notification of registrant; blood product establishment registration number and NDC Labeler Code. 607.35 Section 607.35 Food and Drugs FOOD AND DRUG... PRODUCT LISTING FOR MANUFACTURERS OF HUMAN BLOOD AND BLOOD PRODUCTS Procedures for Domestic Blood Product...

21 CFR 607.35 - Notification of registrant; blood product establishment registration number and NDC Labeler Code.

Code of Federal Regulations, 2010 CFR

2010-04-01

... 21 Food and Drugs 7 2010-04-01 2010-04-01 false Notification of registrant; blood product establishment registration number and NDC Labeler Code. 607.35 Section 607.35 Food and Drugs FOOD AND DRUG... PRODUCT LISTING FOR MANUFACTURERS OF HUMAN BLOOD AND BLOOD PRODUCTS Procedures for Domestic Blood Product...

A prospective comparison between auto-registration and manual registration of real-time ultrasound with MR images for percutaneous ablation or biopsy of hepatic lesions.

PubMed

Cha, Dong Ik; Lee, Min Woo; Song, Kyoung Doo; Oh, Young-Taek; Jeong, Ja-Yeon; Chang, Jung-Woo; Ryu, Jiwon; Lee, Kyong Joon; Kim, Jaeil; Bang, Won-Chul; Shin, Dong Kuk; Choi, Sung Jin; Koh, Dalkwon; Seo, Bong Koo; Kim, Kyunga

2017-06-01

To compare the accuracy and required time for image fusion of real-time ultrasound (US) with pre-procedural magnetic resonance (MR) images between positioning auto-registration and manual registration for percutaneous radiofrequency ablation or biopsy of hepatic lesions. This prospective study was approved by the institutional review board, and all patients gave written informed consent. Twenty-two patients (male/female, n = 18/n = 4; age, 61.0 ± 7.7 years) who were referred for planning US to assess the feasibility of radiofrequency ablation (n = 21) or biopsy (n = 1) for focal hepatic lesions were included. One experienced radiologist performed the two types of image fusion methods in each patient. The performance of auto-registration and manual registration was evaluated. The accuracy of the two methods, based on measuring registration error, and the time required for image fusion for both methods were recorded using in-house software and respectively compared using the Wilcoxon signed rank test. Image fusion was successful in all patients. The registration error was not significantly different between the two methods (auto-registration: median, 3.75 mm; range, 1.0-15.8 mm vs. manual registration: median, 2.95 mm; range, 1.2-12.5 mm, p = 0.242). The time required for image fusion was significantly shorter with auto-registration than with manual registration (median, 28.5 s; range, 18-47 s, vs. median, 36.5 s; range, 14-105 s, p = 0.026). Positioning auto-registration showed promising results compared with manual registration, with similar accuracy and even shorter registration time.

47 CFR 90.121 - Canadian registration.

Code of Federal Regulations, 2010 CFR

2010-10-01

... 47 Telecommunication 5 2010-10-01 2010-10-01 false Canadian registration. 90.121 Section 90.121 Telecommunication FEDERAL COMMUNICATIONS COMMISSION (CONTINUED) SAFETY AND SPECIAL RADIO SERVICES PRIVATE LAND MOBILE RADIO SERVICES Applications and Authorizations § 90.121 Canadian registration. Form 410 shall be...

Intrasubject multimodal groupwise registration with the conditional template entropy.

PubMed

Polfliet, Mathias; Klein, Stefan; Huizinga, Wyke; Paulides, Margarethus M; Niessen, Wiro J; Vandemeulebroucke, Jef

2018-05-01

Image registration is an important task in medical image analysis. Whereas most methods are designed for the registration of two images (pairwise registration), there is an increasing interest in simultaneously aligning more than two images using groupwise registration. Multimodal registration in a groupwise setting remains difficult, due to the lack of generally applicable similarity metrics. In this work, a novel similarity metric for such groupwise registration problems is proposed. The metric calculates the sum of the conditional entropy between each image in the group and a representative template image constructed iteratively using principal component analysis. The proposed metric is validated in extensive experiments on synthetic and intrasubject clinical image data. These experiments showed equivalent or improved registration accuracy compared to other state-of-the-art (dis)similarity metrics and improved transformation consistency compared to pairwise mutual information. Copyright © 2018 The Authors. Published by Elsevier B.V. All rights reserved.

Result Publication of Chinese Trials in World Health Organization Primary Registries

PubMed Central

Xuemei, Liu; Youping, Li; Senlin, Yin; Shangqi, Song

2010-01-01

Background Result publication is the key step to improve the transparency of clinical trials. Objective To investigate the result publication rate of Chinese trials registered in World Health Organization (WHO) primary registries. Method We searched 11 WHO primary registries for Chinese trials records. The progress of each trial was analyzed. We searched for the full texts of result publications cited in the registration records. For completed trials without citations, we searched PubMed, Embase, Chinese Biomedical Literature Database (Chinese), China Knowledge Resource Integrated Database, and Chinese Science and Technology Periodicals Database for result publications. The search was conducted on July 14, 2009. We also called the investigators of completed trials to ask about results publication. Results We identified 1294 Chinese trials records (428 in ChiCTR,743 in clinicaltrials.gov,55 in ISRCTN, 21 in ACTRN). A total of 443 trials had been completed. The publication rate of the Chinese trials in WHO primary registries is 35.2%(156/443).The publication rate of Chinese trials in clinicaltrials.gov, ChiCTR, ISRCTN, and ACRTN was 36.5% (53/145), 36.3% (89/245), 26.0%(9/44), and 55.6%(5/9), respectively. The publication rate of trials sponsored by industry(23.8%) was lower than that of sponsored by central and local government(31.7%), hospital(35.1%), and universities (40.7%). The publication rate for randomized trials was higher than that of cohort study and case-control study (33.2% versus 16.7%, 22.2%). The publication rate for interventional studies and observational studies was similar(33.4% versus 33.3%). Conclusion The publication rate of the registered Chinese trials was low, with no significant difference between ChiCTR and clinicaltrials.gov. An effective mechanism is needed to promote publication of results for registered trials in China. PMID:20856888

Introduction to Remote Sensing Image Registration

NASA Technical Reports Server (NTRS)

Le Moigne, Jacqueline

2017-01-01

For many applications, accurate and fast image registration of large amounts of multi-source data is the first necessary step before subsequent processing and integration. Image registration is defined by several steps and each step can be approached by various methods which all present diverse advantages and drawbacks depending on the type of data, the type of applications, the a prior information known about the data and the type of accuracy that is required. This paper will first present a general overview of remote sensing image registration and then will go over a few specific methods and their applications

Effects and Safety of Gyejibongnyeong-Hwan on Dysmenorrhea Caused by Blood Stagnation: A Randomized Controlled Trial

PubMed Central

Park, Jeong-Su; Park, Sunju; Cheon, Chun-Hoo; Jo, Seong-Cheon; Cho, Han Baek; Lim, Eun-Mee; Lim, Hyung Ho; Shin, Yong-Cheol; Ko, Seong-Gyu

2013-01-01

Objective. This study was a multicenter, randomized, double-blind, and controlled trial with two parallel arms: the GJBNH group and the placebo group. This trial recruited 100 women aging 18 to 35 years with primary dysmenorrhea caused by blood stagnation. The investigational drugs, GJBNH or placebo, were administered for two menstrual periods (8 weeks) to the participants three times per day. The participants were followed up for two menstrual cycles after the administration. Results. The results were analyzed by the intention-to-treat (ITT) dataset and the per-protocol (PP) dataset. In the ITT dataset, the change of the average menstrual pain VAS score in the GJBNH group was statistically significantly lower than that in the control group. Significant difference was not observed in the SF-MPQ score change between the GJBNH group and the placebo group. No significant difference was observed in the PP analyses. In the follow-up phase, the VAS scores of the average menstrual pain and the maximum menstrual pain continually decreased in the placebo group, but they increased in the GJBNH group. Conclusion. GJBNH treatment for eight weeks improved the pain of the dysmenorrhea caused by blood stagnation, but it should be successively administered for more than two menstrual cycles. Trial Registration. This trial is registered with Current Controlled Trials no. ISRCTN30426947. PMID:24191165

Lesson 6: Registration

EPA Pesticide Factsheets

Lesson 6 provides CROMERR checklist items grouped under the Registration Process, where users establish their accounts in the system. This process typically requires users to provide information about them.

Registration of interferometric SAR images

NASA Technical Reports Server (NTRS)

Lin, Qian; Vesecky, John F.; Zebker, Howard A.

1992-01-01

Interferometric synthetic aperture radar (INSAR) is a new way of performing topography mapping. Among the factors critical to mapping accuracy is the registration of the complex SAR images from repeated orbits. A new algorithm for registering interferometric SAR images is presented. A new figure of merit, the average fluctuation function of the phase difference image, is proposed to evaluate the fringe pattern quality. The process of adjusting the registration parameters according to the fringe pattern quality is optimized through a downhill simplex minimization algorithm. The results of applying the proposed algorithm to register two pairs of Seasat SAR images with a short baseline (75 m) and a long baseline (500 m) are shown. It is found that the average fluctuation function is a very stable measure of fringe pattern quality allowing very accurate registration.

28 CFR 811.10 - Changes in registration information.

Code of Federal Regulations, 2012 CFR

2012-07-01

... DISTRICT OF COLUMBIA SEX OFFENDER REGISTRATION § 811.10 Changes in registration information. (a)(1) A sex... notify CSOSA if there is a significant change in the sex offender's appearance and report as directed for... 28 Judicial Administration 2 2012-07-01 2012-07-01 false Changes in registration information. 811...

28 CFR 811.10 - Changes in registration information.

Code of Federal Regulations, 2010 CFR

2010-07-01

... DISTRICT OF COLUMBIA SEX OFFENDER REGISTRATION § 811.10 Changes in registration information. (a)(1) A sex... notify CSOSA if there is a significant change in the sex offender's appearance and report as directed for... 28 Judicial Administration 2 2010-07-01 2010-07-01 false Changes in registration information. 811...

28 CFR 811.10 - Changes in registration information.

Code of Federal Regulations, 2011 CFR

2011-07-01

... DISTRICT OF COLUMBIA SEX OFFENDER REGISTRATION § 811.10 Changes in registration information. (a)(1) A sex... notify CSOSA if there is a significant change in the sex offender's appearance and report as directed for... 28 Judicial Administration 2 2011-07-01 2011-07-01 false Changes in registration information. 811...

28 CFR 811.10 - Changes in registration information.

Code of Federal Regulations, 2014 CFR

2014-07-01

... DISTRICT OF COLUMBIA SEX OFFENDER REGISTRATION § 811.10 Changes in registration information. (a)(1) A sex... notify CSOSA if there is a significant change in the sex offender's appearance and report as directed for... 28 Judicial Administration 2 2014-07-01 2014-07-01 false Changes in registration information. 811...