bluuebunny/crossref_metadata_2025_split huggingface dataset:
Bayesian Adaptive Randomized Trial Design for Patients With Recurrent Glioblastoma
Authors: Trippa Lorenzo , Lee Eudocia Q. , Wen Patrick Y. , Batchelor Tracy T. , Cloughesy Timothy , Parmigiani Giovanni , Alexander Brian M. 
Published: May 2012

Purpose To evaluate whether the use of Bayesian adaptive randomized (AR) designs in clinical trials for glioblastoma is feasible and would allow for more efficient trials. Patients and Methods We generated an adaptive randomization procedure that was retrospectively applied to primary patient data from four separate phase II clinical trials in patients with recurrent glioblastoma. We then compared AR designs with more conventional trial designs by using realistic hypothetical scenarios consistent with survival data reported in the literature. Our primary end point was the number of patients needed to achieve a desired statistical power. Results If our phase II trials had been a single, multiarm trial using AR design, 30 fewer patients would have been needed compared with a multiarm balanced randomized (BR) design to attain the same power level. More generally, Bayesian AR trial design for patients with glioblastoma would result in trials with fewer overall patients with no loss in statistical power and in more patients being randomly assigned to effective treatment arms. For a 140-patient trial with a control arm, two ineffective arms, and one effective arm with a hazard ratio of 0.6, a median of 47 patients would be randomly assigned to the effective arm compared with 35 in a BR trial design. Conclusion Given the desire for control arms in phase II trials, an increasing number of experimental therapeutics, and a relatively short time for events, Bayesian AR designs are attractive for clinical trials in glioblastoma.
A Phase II Study of Trastuzumab Emtansine in Patients With Human Epidermal Growth Factor Receptor 2–Positive Metastatic Breast Cancer Who Were Previously Treated With Trastuzumab, Lapatinib, an Anthracycline, a Taxane, and Capecitabine
Authors: Krop Ian E. , LoRusso Patricia , Miller Kathy D. , Modi Shanu , Yardley Denise , Rodriguez Gladys , Guardino Ellie , Lu Michael , Zheng Maoxia , Girish Sandhya , Amler Lukas , Winer Eric P. , Rugo Hope S. 
Published: May 2012

Purpose To determine whether the antibody-drug conjugate trastuzumab emtansine (T-DM1), which combines human epidermal growth factor receptor 2 (HER2) –targeted delivery of the potent antimicrotubule agent DM1 with the antitumor activity of trastuzumab, is effective in patients with HER2-positive metastatic breast cancer (MBC) who have previously received all standard HER2-directed therapies. Patients and Methods In this single-arm phase II study, T-DM1 3.6 mg/kg was administered intravenously every 3 weeks to patients with HER2-positive MBC who had prior treatment with trastuzumab, lapatinib, an anthracycline, a taxane, and capecitabine. The primary objectives were overall response rate (ORR) by independent review and safety. Results Among 110 pretreated patients (median, seven prior agents for MBC; median follow-up, 17.4 months), the ORR was 34.5% (95% CI, 26.1% to 43.9%), clinical benefit rate was 48.2% (95% CI, 38.8% to 57.9%), median progression-free survival (PFS) was 6.9 months (95% CI, 4.2 to 8.4 months), and median duration of response was 7.2 months (95% CI, 4.6 months to not estimable). In patients with confirmed HER2-positive tumors (n = 80 by retrospective central testing), the response rate was 41.3% (95% CI, 30.4% to 52.8%), and median PFS was 7.3 months (95% CI, 4.6 to 12.3 months). Most adverse events were grades 1 to 2; the most frequent grade ≥ 3 events were thrombocytopenia (9.1%), fatigue (4.5%), and cellulitis (3.6%). Conclusion T-DM1 is well tolerated and has single-agent activity in patients with HER2-positive MBC who have previously received both approved HER2-directed therapies and multiple chemotherapy agents. T-DM1 may be an effective new treatment for this patient population.
Discordance Between Conclusions Stated in the Abstract and Conclusions in the Article: Analysis of Published Randomized Controlled Trials of Systemic Therapy in Lung Cancer
Authors: Altwairgi Abdullah K. , Booth Christopher M. , Hopman Wilma M. , Baetz Tara D. 
Published: May 2012

Purpose Clinicians may read only the abstract of an article to keep abreast of newly published randomized controlled trials (RCTs). However, discordances have been noticed in summary conclusions in the abstracts and the main body of some articles. This article evaluated such discordances in detail. Methods RCTs of systemic therapy for lung cancer published between 2004 and 2009 were considered. Conclusions in the body of the articles and those in the abstracts were graded by using a 7-point Likert scale; 1 for strong endorsement of the control arm, 4 for a neutral statement, and 7 for strong endorsement of the experimental arm. Conclusions were classified as discordant if the difference in scores was ≥ 2. χ2 tests and logistic regression were used to identify factors associated with discordance. Results From among 114 eligible RCTs identified (90 for non–small-cell and 24 for small-cell lung cancer), 11 (10%) articles presented discordant conclusions in the abstract and in the body of the articles. Discordance was most common when the experimental arm was strongly supported in the abstract but not in the body of the article (nine of 11; 82%); however, the converse was much less common (two of 11; 18%; P < .001). Intraclass correlations for the two reviewers were ≥ 0.9. The discordances were found to be independent of trial-related factors. Conclusion Conclusive statements in the abstract can differ from those in the full text. Clinicians should use caution when they consider making changes in their practice on the basis of reading only the abstract of a published RCT.
Enantioselective Ring-Opening Reaction of Epoxides with MeOH Catalyzed by Homochiral Metal–Organic Framework
Authors: Tanaka Koichi , Otani Ken-ichi , Murase Takanori , Nishihote Shyota , Urbanczyk-Lipkowska Zofia 
Published: May 2012

Abstract
Two new copper metal–organic frameworks containing 2,2′-dihydroxy-1,1′-binaphthalene-5,5′-dicarboxylic acid (5,5′-H2BDA) and 2,2′-dihydroxy-1,1′-binaphthalene-4,4′-dicarboxylic acid (4,4′-H2BDA) have been prepared. X-ray structure determination of [Cu2(5,5′-BDA)2(H2O)2]·MeOH·2H2O (MOF-1) and [Cu2(4,4′-BDA)2(H2O)2]·4H2O (MOF-2) revealed similar 2D sheet structures, containing square-grid coordination networks, but differences in the stacking motif. The desolvated MOF-1 and -2 were used as Lewis acid catalysts in the asymmetric ring-opening reaction of epoxides with MeOH.
Solid-State Photochromism of 5-tert-Butyl-2-hydroxyisophthalaldehyde
Authors: Tanaka Koichi , Watanabe Yuta , Kalicki Przemysaw , Urbanczyk-Lipkowska Zofia 
Published: May 2012

Abstract
Colorless crystals of 5-tert-butyl-2-hydroxyisophthalaldehyde change to an orange-red color upon brief exposure to UV–vis radiation (λ &gt; 300 nm). The colored crystals revert to colorless in the dark. X-ray diffraction revealed different packing patterns for the crystals of nonphotochromic and photochromic compounds.
Development of Novel and Highly Efficient Methods to Construct Carbon–Carbon Bonds Using Group 7 Transition-Metal Catalysts
Authors: Kuninobu Yoichiro , Takai Kazuhiko 
Published: May 2012

Abstract
Rhenium- or manganese-catalyzed transformations based on the cleavage of inactive bonds, such as carbon–hydrogen and carbon–carbon bonds are discussed. Such transformations are recognized as key methods to realize efficient and powerful reactions. We also reveal novel regio- and/or stereodefined cycloaddition reactions using a rhenium or manganese catalyst. Most of the catalytic activities are typical of rhenium and manganese carbonyl complexes.
Kinetic Assessment and Numerical Modeling of Photocatalytic Water Splitting toward Efficient Solar Hydrogen Production
Authors: Hisatomi Takashi , Minegishi Tsutomu , Domen Kazunari 
Published: May 2012

Abstract
Photocatalytic water splitting has been studied extensively as a promising technology for scalable and cost-efficient hydrogen production using solar energy. Although overall water splitting has been achieved under visible light irradiation, significant progress in reaction efficiencies at longer wavelengths is needed to enable practical solar energy conversion. This article reports recent advancements in kinetic investigation and numerical modeling of photocatalytic water splitting to understand problems with existing photocatalysts and develop strategies to boost the reaction efficiency. Kinetic investigation based on cocatalyst loading, light intensity, hydrogen/deuterium isotopes, and reaction temperature suggests that the majority of photoexcited carriers recombine before contributing to the water splitting reaction on the surface in most cases, and that improvement in semiconducting properties of photocatalysts by decreasing defect and donor concentrations is beneficial to boost photocatalytic performance. It is demonstrated that an appropriate material design to suppress generation of donor species actually improves photocatalytic activity. Numerical modeling of steady state carrier concentrations suggests that an asymmetric built-in potential in photocatalyst particles enhances charge separation and thus extends the lifetimes of photoexcited carriers. On the basis of the recent findings, we suggest strategies to improve the reaction efficiency of photocatalytic water splitting.
Type 2 diabetes from pediatric to geriatric age: analysis of gender and obesity among 120 183 patients from the German/Austrian DPV database
Authors: Awa Wendy L , Fach E , Krakow D , Welp R , Kunder J , Voll A , Zeyfang A , Wagner C , Schütt M , Boehm B , de Souza M , Holl R W 
Published: May 2012

AimTo characterize the clinical phenotype of type 2 diabetes mellitus (T2DM) with respect to age, gender, and BMI.MethodAnonymized data of 120 183 people with T2DM from the German/Austrian multicenter Diabetes Patienten Verlaufsdokumentation database were analyzed based on chronological age or age at diagnosis (0–19, 20–39, 40–59, 60–79, and ≥80 years). Age, gender, and BMI comparisons with clinical phenotype were made using χ2 and Kruskal–Wallis tests (SAS V9.2).ResultsOf all the patients, 51.3% were male, average age was 67.1±12.7 years, and average disease duration was 9.9±9.1 years. More girls than boys were diagnosed during adolescence and more men than women during adulthood (20–60 years). No gender differences existed when age at diagnosis was ≥60 years. Patients were obese on average (BMI: 30.5±6.1 kg/m2) and had significantly higher BMI values than German population peers. The BMI gap was widest in the younger age categories and closed with increasing age. Adult women were significantly more obese than men. Obese patients more often had elevated HbA1c (≥7.5%), hypertension or dyslipidemia (irrespective of age), microalbuminuria (adults), or retinopathy (elderly) than nonobese patients. More men than women (20–60 years) had hypertension, dyslipidemia, or microalbuminuria while more women than men (≥60 years) had hypertension or dyslipidemia.ConclusionDuring puberty, more girls than boys were diagnosed with T2DM while during adulthood males predominated. T2DM manifested at comparatively lower BMI in males, and younger patients were more obese at diagnosis. Age, gender, and BMI were also associated with poor metabolic control and cardiovascular disease comorbidities/complications.
Approval Summary: Imatinib Mesylate for One or Three Years in the Adjuvant Treatment of Gastrointestinal Stromal Tumors
Authors: Cohen Martin H. , Johnson John R. , Justice Robert , Pazdur Richard 
Published: May 2012

Abstract
On January 31, 2012, the U.S. Food and Drug Administration granted regular approval of imatinib mesylate tablets (Gleevec®; Novartis Pharmaceuticals Corporation, East Hanover, NJ) for the adjuvant treatment of adult patients following complete gross resection of Kit+ (CD117+) gastrointestinal stromal tumors (GISTs). The recommended dose of imatinib is 400 mg/day administered daily for 3 years.
Three hundred ninety-seven patients were enrolled in a randomized adjuvant, multicenter, open label, phase III trial comparing 12 months with 36 months of imatinib treatment. Eligible patients had one of the following: tumor diameter &gt;5 cm and mitotic count &gt;5 per 50 high power fields (HPFs); tumor diameter &gt;10 cm and any mitotic count; tumor of any size with mitotic count &gt;10/50 HPFs; or tumor ruptured into the peritoneal cavity. The primary endpoint was the recurrence-free survival (RFS) interval.
The median follow-up for patients without an RFS event was 42 months. There were 84 (42%) RFS events in the 12-month treatment arm and 50 (25%) RFS events in the 36-month treatment arm. Thirty-six months of imatinib treatment led to a significantly longer RFS interval than with 12 months of treatment.
The median follow-up for overall survival (OS) evaluation in patients still living was 48 months. Thirty-six months of imatinib treatment led to a significantly longer OS time than with 12 months of imatinib treatment.
The most common adverse reactions, as noted in previous imatinib studies, were diarrhea, fatigue, nausea, edema, decreased hemoglobin, rash, vomiting, and abdominal pain.
An Exhaustive Study of Scaling in the Canadian Bakken: Failure Mechanisms and Innovative Mitigation Strategies From Over 400 Wells
Authors: Wylde Jonathan J. , Slayer Jubal L. , Frehlick Brent , Petro-Chem Praire 
Published: May 2012

Abstract
The Canadian Bakken has been produced for over 40 years but with advances in fracturing technology during the last 10 years, there has been an exponential increase in Bakken activity. Concurrent with this, there has been a step-change in frequency and severity of scale formation from high value, high productivity wells. This paper summarizes the scaling observations made over the producing life of this high producing formation drawn from treating and servicing over 400 wells through Southern Manitoba and Saskatchewan.
The most common scale types are calcite and anhydrite, although there is also evidence of siderite and iron sulfide. Formation of scale in Bakken wells is seen from the bottom of the tubing and open-hole sections up through the casing and rods. Formation water salinity can reach over 250,000 mg/L with up to 20,000 mg/L calcium. When combined with the high down-hole temperature, this brine causes a significant challenge for selection and application of scale inhibitor chemistries.
A typical scaling life cycle is given for a Bakken extended reach horizontal well. With production reaching maturity, the severity of scaling in this formation has been found to increase. The influence of fracturing and frequent well interventions has been discussed in terms of the profound effect these activities have on the onset of scale formation.
The experiences and strategies of over a dozen different operators have been combined, and the lessons learned from these activities used to determine a common approach in the management of scale in these challenging wells.
The paper concludes with several detailed case histories. These show how the development of an innovative scale management philosophy has been successfully put to the test in proactively preventing scale, thereby reducing the overall failure rate for the Bakken operating companies.
Successful Deployment of a Green Multifunctional Scale Inhibitor, A Case Study From the Rockies
Authors: Spicka K. J. , Hirst M. C. , Hochhalter G. E. , Steppler D. J. , Haag J. T. 
Published: May 2012

Abstract
This paper will highlight the effectiveness of a novel, environmentally friendly multifunctional polymeric scale inhibitor that inhibits carbonate and sulfate scales as well as halite.
The deposition of halite in the oilfield can present a challenge for operators in fields with high TDS brines. The large amounts of halite that can deposit in a short amount of time can lead to reduced production as well as a costly and logistically cumbersome remediation. A customer was controlling halite deposition by injecting a low salinity water source to dilute/dissolve the deposits. However, this remedial solution also presented an additional problem to the customer as the injection of the fresh water source led to calcium carbonate deposition due to brine incompatibility.
This paper will present laboratory test results which highlight the effectiveness of this novel multifunctional scale inhibitor against halite, carbonate and sulfate scales. These results will be compared to traditional scale inhibitors. Following laboratory testing, this environmentally acceptable scale inhibitor product was deployed in high TDS wells where halite deposition was occurring. This paper will also demonstrate the successful implementation of the product, which provided calcium carbonate inhibition and a reduction in the volume of fresh water needed for control of halite deposition. This reduction in water consumption led to significant cost savings for the customer.
The value this case study brings to the industry is an overview of the challenges halite and associated scales present to hydrocarbon recovery and the development/implementation of a multifunctional molecule rather than a chemical blend for scale control. Results of this paper have implications for other fields across the world where halite scale is a flow assurance challenge.
Phosphorus Functionalised Polymeric Scale Inhibitors, Further Developments and Field Deployment
Authors: Todd M. J. , Thornton A. R. , Wylde J. , Strachan C. J. , Moir G. , Goulding J. R. 
Published: May 2012

Abstract
As the oil and gas industry strives to replace ageing, environmentally undesirable scale inhibitors there is an ever increasing use of polymeric inhibitors. Incorporation of phosphorus functionality into a polymer backbone has been shown to improve inhibition efficiency, enhance adsorption characteristics and allow the polymer concentration to be analysed by elemental phosphorus. It is known that some phosphorus tagged polymers can be problematic to analyse in oil field brines as they typically have a low phosphorus content which is difficult to determine from the background.
The development of novel phosphorus functionalised polymeric scale inhibitors was previously described (SPE 130733). This paper follows the development of the inhibitor class. Utilising extensive laboratory testing the interactive nature of the scale inhibitors and reservoir lithology was studied. These novel phosphorus functionalised inhibitors were compared to a number of other available P-containing polymers.
Following successful development, one of the phosphorus functionalised polymeric inhibitors was subject to sequential field-trial in a harsh BaSO4 scaling, highly naturally fractured North Sea carbonate reservoir. The phosphorus functionalised inhibitor provided improved performance compared to the incumbent product. Following the successful deployment in a carbonate reservoir the novel inhibitor class was also deployed in a number of North Sea sandstone reservoirs and one field wide case study is reported with details on the innovative management and implementation strategy presented. Focus has been given to the application of these products and a detailed analysis of field proven benefits given.
This paper concludes with a detailed comparison of these Phosphorus functionalized scale inhibitors with the incumbent products they have replaced in the case histories described. The benefits that these novel, innovative products have given to the operator are described along with a technical synopsis of incremental performance benefits.
Qualification Procedure For Continuous Injection Of Chemicals In The Well -Method Development
Authors: Goodwin Neil J. , Svela Odd Geir , Olsen John Helge , Tjomsland Tore , Hustad Britt Marie , Graham Gordon M. 
Published: May 2012

Abstract
Method development of laboratory bench and rig tests for assessing the suitability for application of chemicals via down-hole pressure tube systems is presented. Areas of interest include precipitation or viscosity changes due to solvent loss both in bulk samples and samples in capillaries, and long term product stability in capillaries using new flow rigs designed to more fully replicate pressure tube injection phenomena (particularly chemical stability under extreme T and P conditions). Indeed fluid stability and other challenges relating to down-hole continuous injection have led to a number of failures being recorded in recent years indicating that the physical properties rather than the absolute performance of the chemicals is often key to their successful deployment.
Continuous chemical injection systems for down-hole application are being included in more well completions as their usefulness is recognised. While the initial capital costs are increased, such systems provide a number of benefits over reliance on squeeze treatments for down-hole application. These may include the opportunity to use chemicals unsuitable for squeeze treatment due to the risk of formation damage, the ability to maintain higher doses, and avoiding the need to interrupt production to apply chemicals in complex subsea wells.
Using the developed methods we have identified a number of ways in which formulated scale inhibitors may produce problems within continual injection systems. These include particulate formation and line plugging in capillaries, and solid formation or viscosity increases in response to solvent loss within a tube (as opposed to bulk samples).
These methods will form the basis for future qualification procedures for chemicals intended for down-hole chemical injection with the aim of avoiding application issues in the field. They have been developed both to better understand chemical / fluid stability under down-hole continuous injection conditions following a number of recorded field deployment problems, and then to provide improved qualification for new chemicals and systems.