dataesr/scientific-paragraphs-categorization huggingface dataset:
Various transitions induced by the intense geomagnetic activity during this period are better differentiated by β(t) transitions than the associated magnetograms represented in Fig. 6. Once again, we observe that the amplitude fluctuations vary with the observatory magnetic coordinates, viewing a slight decay in spectral exponent fluctuations towards lower latitudes (HER compared with THL). For all three observatories, the exponent value curves appear smoother from a high to a low latitude, when analyzing data according to their geographical locations, with β(t) values in  [1, 3]. These values confirm that the geomagnetic time series are qualitatively analogous to fBms. This is expected to lead to either persistence or antipersistence in the system. Indeed, as can be distinguished in Fig. 6 , the dynamics of the exponent time series shows a spiky activity when β(t) values increase indicating a transition to an intense storm.
Interestingly, the three minimum peak values clearly noticed on magnetograms, around 11:00 UT and 22:00 UT on September 8, and around 15:00 UT on September 9, are indicated by an abrupt increase of β(t), marked T2-T4 on Fig. 8 (b) left. The intense disturbed period during 7-10 November, 2004  (Wintoft et al. , 2005)  is characterized by the three largest magnetic storms (SYM-H < -220 nT) for which the CLF and HER H-component data were severely disturbed (Fig. 8 (b) right). Dashed lines indicate the onset of the principal geomagnetic events. At the onset of the first storm, which started around 21:55 UT, the spectral exponents feature a rapid change from a smaller to a larger value at 22:00 UT, clearly illustrated by the transition T1 at the CLF and HER observatories. Looking at the details, we note that this transition coincides with the first part of the main phase, followed by some fluctuations with an average value β(t) > 2 until the end of November 8.
The emergence of longrange correlations, i. e. the appearance of memory effects, implies a multi-time-scale communal activity of numerous activated units. Following  Chang (1999)  and  Consolini and Chang (2001, 2002) , these observations suggest that under the influence of the solar wind, the magnetosphere can be considered to be in a globally non-equilibrium critical state. Finally, this study indicates that the dynamics in the magnetosphere can be characterised in more detail when highresolution data are used and more objective mathematical tools are applied. The estimation of the persistence charac-ter of the magnetic field fluctuations linked to the magnetic storms can be proposed as an indicator for forecasting magnetic activity. This is an ongoing study to assess the robustness of the approach by considering a larger raw dataset.
Methods: We examined the prospective association between physical activity and symptoms of mental ill-health in younger, mid-life and older working women. Participants were 26 913 women from the ongoing cohort Finnish Public Sector Study with complete data at two phases, excluding those who screened positive for mental ill-health at baseline. Mental health was assessed using the 12-item General Health Questionnaire. Self-reported physical activity was expressed in metabolic equivalent task (MET) hours per week. Logistic regression models were used to analyse associations between physical activity levels and subsequent mental health. Results: There was an inverse dose-response relationship between physical activity and future symptoms of mental ill-health. This association is consistent with a protective effect of physical activity and remained after adjustments for socio-demographic, work-related and lifestyle factors, health and body mass index.
Acknowledgements This work was partially funded by the grant " Mag-CorPnic " of the  Réseau Thématique de Recherche Avancée "Triangle de la Physique" du Plateau de Saclay , by the  Agence Nationale de la Recherche  grant " PNIC-TIDES ", and by the support of the  ECOS-Sud-MINCyT France-Argentina bilateral program , Grant No. A09E03. Work done in Bariloche was partially funded by PICT  2007-00890  and  PICT 2008-294.
Acknowledgments. The author is grateful to  J. Frédéric Bonnans ,  Damien Lamberton  and  Nizar Touzi  for fruitful discussions and two anonymous referees for helpful comments and suggestions. This research is supported by the  Chair Financial Risks of the Risk Foundation  sponsored by  Société Générale , the Chair Derivatives of the Future sponsored by the  Fédération Bancaire Française , and the Chair Finance and Sustainable Development sponsored by  EDF  and  CA-CIB.
Acknowledgements: We would like to thank  Florent Barret ,  Dirk Blömker ,  Martin Hairer ,  Arnulf Jentzen  and  Dan Stein  for helpful discussions. BG thanks the  MAPMO, Orléans , and NB thanks the  CRC 701 Spectral Structures  and  Topological Methods in Mathematics at the University of Bielefeld , for kind hospitality and financial support.
He reports that low inflation environment in many industrialized countries, which was brought about by more credible monetary policies, has successfully reduced the degree of the Exchange Rate Pass-Through (ERPT) to domestic prices. He document that ERPT is primarily a function of the persistence of exchange rate and price shocks, which tend to be reduced in an environment where inflation is low and monetary policy is credible. This result was later on claimed by  Gagnon and Ihrig (2004)  asserting that there has been a secular decline in pass-through from exchange rates to consumer prices in industrial countries over the past 35 years linking this decline to monetary policy credibility. Choudhri and Hakura (2001)  examine this hypothesis. They derive a pass-through relation based on new open economy macroeconomic models with a large database covering 71 countries over the period 1979-2000.
Data and Variables Description The main interest of the study is to examine the inflation dynamics and track its determinants. Inflation is tracked as a function of a set of macroeconomic and policy-related determinants. The study is conducted in a Markov-switching analysis. It uses monthly observations over the period running from January 2001 to December 2009. The frequency of the data (from 2001 to 2009) lets us to have 108 observations, which is very satisfactory from an econometric point of view. Up to our knowledge, our data correspond to the largest sample used in the literature in order to track the inflation determinants in Tunisia. Moreover, the robustness of our empirical findings are evidenced by two significant inflation regimes in mean and variance for both FTP and TVTP approaches as discussed in details in the results section.
All the tests and the subsequent estimations were carried out using GAUSS software, version 3. 2. 32. The summary results of the KPSS test, reported in tables 2-a and 2-b. , show that all variables are not stationary except for inflation. In fact, the first column of table 2-a shows that the KPSS statistic for the inflation variable with a minimum residual lag of 0 and a maximum of lag 8, is respectively equal to 0. 359 and 0. 239, for level stationarity (NAU Test) , which is lower than the 5% critical value (0. 463). Concerning the trend stationarity, this statistic is respectively equal to 0. 046 and 0. 035, which is similarly lower than the 5% critical value (0. 146). Therefore, we can accept the null hypothesis of both level and trend stationarity for inflation. In contrast, we can observe from the table 2-a, that the all the remaining variables are not trend, nor level stationary.
Background In 2010, after regulatory review of rosiglitazone licensing, the US Food and Drug Administration (FDA) requested a reevaluation of cardiovascular end points in the RECORD trial. Methods Automated screening of the original clinical trial database and manual case report form review were performed to identify all potential cardiovascular and noncardiovascular deaths, and nonfatal myocardial infarction (MI) and stroke events. Search techniques were used to find participants lost to follow-up, and sites were queried for additional source documents. Suspected events underwent blinded adjudication using both original RECORD end point definitions and new FDA end point definitions, before analysis by the Duke Clinical Research Institute.
Results The reevaluation effort included an additional 328 person-years of follow-up. Automated screening identified 396 suspected deaths, 2,052 suspected MIs, and 468 suspected strokes. Manual review of documents by Duke Clinical Research Institute clinical events classification (CEC) coordinators identified an additional 31 suspected deaths, 49 suspected MIs, and 28 suspected strokes. There were 127 CEC queries issued requesting additional information on suspected deaths; 43 were closed with no site response, 61 were closed with a response that no additional data were available, and additional data were received for 23. Seventy CEC queries were issued requesting additional information for suspected MI and stroke events; 31 were closed with no site response, 20 were closed with a response that no additional data were available, and 19 resulted in additional data.
Identification of suspected clinical end points using prespecified event definitions is critical to event adjudication efforts in multinational clinical trials. 1  The RECORD trial was a randomized, open-label trial comparing rosiglitazone-containing combination therapy for type 2 diabetes with the dual oral combination of metformin and a sulfonylurea. The trial (ClinicalTrials. gov, NCT00379769) was conducted from 2001 to 2008. 2  The results of the RECORD trial, together with other data, were reviewed and discussed in July 2010 by an Advisory Committee of the US Food and Drug Administration (FDA). After the review, the FDA required the sponsor of the RECORD trial, GlaxoSmithKline (GSK), to commission a comprehensive, reevaluation of the cause of deaths and of 2 nonfatal events: myocardial infarction (MI) and stroke.
The Duke Clinical Research Institute (DCRI) was selected to conduct the review. Results of the reevaluation are presented separately. 3 This article reports the methods that were developed to perform the reevaluation effort. The key objectives of this effort were to (1) systematically identify all deaths, suspected MIs, and strokes blinded to treatment; (2) derive end-of-follow-up dates; (3) adjudicate all suspected events by original RECORD definitions and by contemporary definitions under development by the FDA (Standardized Data Collection for Cardiovascular Trials Initiative); and (4) report event rates and time-to-event analyses by treatment group.
Planning The DCRI coordinated all clinical events classification (CEC) operations for the RECORD reevaluation protocol in collaboration with the sponsor. In the planning phase, leadership from the sponsor, the FDA, and the DCRI discussed critical issues to design the reevaluation effort, particularly the event identification ("triggering") strategy, the need for collection of additional source documents, and additional ascertainment of lost-tofollow-up patients. The original RECORD principal investigator and trial CEC chairman reviewed and commented on the draft protocol for the reevaluation effort. The DCRI CEC team created and maintained the CEC charter for RECORD reevaluation, as well as the adjudication pages used to capture key data required for the efficient and accurate adjudication and final analysis of end point events.
The DCRI CEC charter (online Appendix A) describes the operations followed for identification of suspected events, collection of data and source documents, DCRI reevaluation, and quality control. It also details the organization, roles, and activities of the DCRI CEC group, including the physicians who formed the DCRI CEC Committee. The DCRI CEC group systematically identified, adjudicated, and classified the following suspected events using prespecified criteria: cause of death, MI, and stroke.
Identification of suspected events A comprehensive process to "trigger" all potential death, MI, and stroke events included both automated and manual trigger procedures (Figure  1 ). This process was designed to systematically identify events from investigator-identified events, case report forms (CRFs), and adverse event (AE), and serious AE (SAE) reporting; to try to mitigate any potential reporting bias (RECORD was open label); and to ensure that all potential events were identified and reviewed. Vital status in those participants lost to follow-up was ascertained, as detailed below. Automated trigger procedures. The automated procedures included a computer program (trigger program) that was applied to the original RECORD CRF clinical database, looking for evidence that an event may have occurred.
The following CRFs and CRF subforms were screened by the automated trigger program: Adverse Event Form, Serious Adverse Event Form, Death Form, Study Continuation/Withdrawal Form, Tracking Form for Completely Withdrawn Patients, Survival Status Form, Third Party Survival Data Form, and Cardiovascular Procedure/Amputation End Point Form. All Medical Dictionary for Regulatory Activities-coded AE and SAE terms in the clinical database were electronically screened to identify potential cardiovascular end points. Determination of which terms would be used to identify cardiovascular end points was made by DCRI clinical and safety experts. Details of the automated procedures and trigger specifications are contained within the RECORD reevaluation CEC trigger specifications (online Appendix B). Each potential event was tracked throughout the process using a unique identifier.
All new data were identified as such to allow evaluation both with the original and the original plus new data, and thus, after completion of readjudication and database lock, comparisons between original and new adjudication of events. Documents not in English were translated by an outside vendor. Ascertainment of vital status. Using the RECORD study data supplied by GSK, DCRI identified patients whose vital status at the end of the study was not known or documented. MediciGlobal (King of Prussia, PA), was contracted to search globally for vital status information for these patients. Data were updated for newly discovered deaths, known deaths with new information, and new "last-known-alive" dates.
Database transfers and conversion for end points reevaluation Electronic data containing the raw CRF data were transferred as SAS data sets in prespecified format from GSK to the DCRI in 3 phases. Phase 1 transfer included the raw CRF data sets needed to provide electronic identification of events for referral to the DCRI CEC. DCRI programmers checked and, where necessary, requested further redaction and data retransfer. Phase 2 transfer occurred after completion of DCRI electronic identification of potential events; this transfer included treatment start and stop dates (blinded) and a data set containing the identification numbers for deaths, as originally reported. Phase 3 transfer included treatment information (unblinded); these data were kept firewalled from the clinical team until all DCRI adjudications were completed.
Quality control of the evaluation process A random sample of adjudicated events was re-reviewed by a committee of at least 3 DCRI CEC faculty physicians who were blind to the initial decision. The quality control plan was based on a 5% random sample of adjudicated events (but greater than the square root of the number of events plus 1) generated by the DCRI CEC statistician. The sample was weighted toward the earlier part of the adjudication process for mortality events. A "major" discrepancy was declared when there was disagreement on whether a defined event had occurred. A "minor" discrepancy involved disagreement on the date, time, type, or evidence. Major discrepancies were allowed to update the adjudication database but only after further committee review and discussion with the CEC principal investigator.
Death queries A total of 127 CEC queries were issued for additional information to follow up on death events classified as "unknown" and "insufficient information. " The queries for these 127 patients resulted in 43 with no response from the site, 61 with a response that no additional data were available, and 23 closed with additional data received from the site. Of these 23 queries, 16 deaths were re-reviewed with no change to the adjudication result, and 7 events were re-reviewed with a change to the adjudication result from unknown to a known cause of death.
Quality control findings A medical review of 100 randomly selected stroke and MI events was performed blind to treatment assignment and original DCRI CEC adjudication outcome. In 93 events, there was no discrepancy in the determination. There was 1 major discrepancy (change of event classification), 2 discrepancies involving Q-wave classification, and 4 other discrepancies involving event date/ time. A medical review of 25 randomly selected death events were also performed as part of the quality control process. There were 2 major discrepancies on cause of death. Both of them occurred in the first 10 quality control death cases and were originally called sudden cardiac deaths; after the quality control review, they were changed to unknown cause in the database. There were no major discrepancies in the subsequent 15 quality control death cases.
Discussion 7] [8]  The direct health care costs of diabetes range from 2. 5% to 15% of annual health care budgets. 9 lthough intensive glucose control has been associated with lower rates of MI, it also has been associated with higher mortality rates, including cardiovascular mortality. 10, 11 Conventional therapies for diabetes have not been tested for cardiovascular outcomes in long-term clinical trials. In this context, the RECORD study, planned in 2000 and begun in 2001, and later consistent with the FDA's December 2008 recommendation for study of new treatments for type 2 diabetes, 2 evaluated the cardiovascular safety of rosiglitazone. The available data on risk of myocardial ischemia among patients using rosiglitazone are inconclusive. A metaanalysis of 42 short-term clinical studies (most of which compared rosiglitazone with placebo), including 14,237 patients with a mean duration follow-up of 6 months, suggested an association between rosiglitazone use and an increased risk of myocardial ischemic events.
Conclusions A comprehensive, systematic, and blinded, program was designed to reevaluate event ascertainment and adjudication in the RECORD trial at the request of the FDA. Procedures included rigorous blinding of randomized treatment assign-ment, collection of additional information about patients previously lost to follow-up, and systematic identification of all deaths and suspected MI and stroke events using the raw data set. These procedures used in this unique situation were consistent with other common approaches in the field, were enhanced to address the FDA concerns about the original RECORD trial results, and could be considered by clinical trialists designing event readjudication protocols for drug development programs that have been completed. Representatives from the FDA and GSK have previously agreed that the readjudication effort will have 2 phases.
• Prespecified Medical Dictionary for Regulatory Activities coded terms will be used. The coded preferred terms were reviewed by clinical, CEC, and safety experts to identify terms that would potentially be indicative of an end point with a low threshold. A similar approach has been used in previous readjudication efforts. • Death Form (Form D) when present in the database. Initial trigger specifications will be defined at the start of the program; however, they may be modified during the course of the readjudication process, as needed. Any modifications will be documented and a rationale provided. The trigger specifications will be detailed in a separate document, titled RECORD Readjudication Trigger Specifications. 4. 1. 2. Manual trigger procedures. The RECORD CEC coordinators will perform a manual review of paper documents as well as reviewing the output from the automated trigger program.
The CEC coordinators reviewing the paper documents have extensive experience in cardiology event reporting and CEC methodologies. A quality control (QC) process will be implemented for the manual review. Paper sources that the CEC coordinators will review to identify potential end points include, but are not limited to, the following: Both SAEs and AEs that were deleted by RECORD investigators will be identified from the audit trail of the study's electronic data sets, which GSK provided to DCRI. The electronic data sets will be sent to the DCRI before the event packet files, which include data from the CRF and source documents. • Each CEC trigger will have a unique identifier assigned to it to track each event through the CEC process. Specific Manual Trigger Procedures will be documented in a separate document, titled RECORD Readjudication Trigger Specifications.
Event packets that will include the contents that were used in the original adjudication process will be provided to the CEC. When additional information is needed to aid in the CEC adjudication, sites will be contacted directly by DCRI CEC for supporting documentation or data clarification to help render an adjudicated result. Duke Clinical Research Institute CEC will generate a request for source documents for end points that were previously adjudicated as well as for all new end points. Duke Clinical Research Institute CEC will also request any documents from sites that were missing from the previous adjudication process. Requests sent by the DCRI CEC coordinator will also be directly entered in the CEC tracking database. Sites will submit the additional information directly to the DCRI CEC RECORD e-mail inbox.
If additional information is received after the adjudication has been completed that might affect the adjudication result, the event will be re-reviewed. The CEC adjudication form and database will be subsequently updated to reflect any changes to the initial adjudication. The DCRI will accept documents that are not in English. Duke Clinical Research Institute will contract with an independent vendor for translation services. For new events identified by the DCRI RECORD CEC Group, the following source documents are recommended: • Death events: • Death summary If all recommended source documents are not present and cannot be obtained from the site through the process described in Section 4. 2, the event will be sent for adjudication with the available documentation. 4. 3. CEC adjudication. The DCRI RECORD CEC physicians will adjudicate each suspected event using the prespecified end point criteria based on the preponderance of the evidence and clinical knowledge and experience.
The initial random sample is generated after there are 50 adjudicated events in the database. Additional random samples will be generated after the first 100, 200, and 300 mortality events are adjudicated. The same approach will be used for the MI and stroke events. A sample will be generated after 100, 200, and 300 MI or stroke events are completed. The events selected are reviewed by RECORD CEC physicians who are blinded to the original adjudicated result. The results of the QC review are compared with the original adjudication result. These results are summarized and reviewed by the RECORD CEC chairperson, and the findings were distributed to all committee members. A "major" discrepancy occurs when there is a disagreement as to whether an event did, or did not, occur. A "minor" discrepancy occurs when there was agreement on whether an event occurred, but disagreement on the date, time, type, or evidence.