bluuebunny/crossref_metadata_2025_split huggingface dataset:
Designing phase II studies in cancer with time-to-event endpoints
Authors: Owzar Kouros , Jung Sin-Ho 
Published: June 2008

Background: The primary clinical endpoint in many phase II studies in cancer is a time-to-event outcome subject to potential censoring. The decision in favor of abandoning or continuing investigation of the protocol regimen is typically based on the amount of statistical evidence suggesting an improvement compared to a given historical control. The primary statistical endpoint would typically be the median of the time-to-event distribution of the clinical endpoint. For the purpose of sample size or power calculations, software implementing parametric and nonparametric median tests, is freely available. The main assumptions are those of Exponential survival and a Uniform right-censoring mechanism. Purpose: The performance of the parametric and nonparametric methods is compared to that of using a binomial endpoint based on dichotomizing the event time at a clinically relevant landmark. As sufficient details on the various methods and related designs for phase II clinical design with survival endpoints are provided, this article should also serve as a comparative reference on these three methods for designing phase II studies in cancer with time-to-event endpoints. Methods: The statistical performance, by virtue of considering the type I and II error rates, of the three methods is compared by carrying out a comprehensive simulation study. Results: The parametric method may fail to control the type I error rate if the underlying survival distribution is not Exponential, while the nonparametric method may fail to control the type I error rate as the sample sizes for phase II studies are typically small. Both of these methods may be sensitive to the distribution of the censoring variable. Limitations: The results provided in this article are mostly discussed in the framework of specific examples and by using specific implementations of the tests. As such the results may not be universally generalizable. The recommended method has some drawbacks if patients are censored before the landmark of interest. Conclusion: A method that should be considered for the purpose of the statistical design and decision rule for phase II studies in cancer is the employment of a binomial endpoint based on dichotomizing the event time at a clinically relevant landmark. Clinical Trials 2008; 5: 209—221. http://ctj.sagepub.com
Validity of diabetes self-reports in the Women's Health Initiative: comparison with medication inventories and fasting glucose measurements
Authors: Margolis Karen L , Lihong Qi  , Brzyski Robert , Bonds Denise E , Howard Barbara V , Kempainen Sarah , Simin Liu  , Robinson Jennifer G , Safford Monika M , Tinker Lesley T , Phillips Lawrence S 
Published: June 2008

Objective: Although diabetes is conveniently assessed by self-report, few validation studies have been performed. Therefore, we studied whether self-report of prevalent and incident diabetes in Women's Health Initiative (WHI) participants was concordant with other diagnostic evidence of diabetes. Study Design and Setting: A total of 161 808 postmenopausal women aged 50—79 were enrolled at 40 clinical centers in the U.S. in 1993—1998 and followed prospectively. At baseline, prevalent medication treated diabetes was defined as a self-report of physician diagnosis and treatment with insulin or oral antidiabetic drugs. During followup, incident treated diabetes was defined as a self-report of a new physician diagnosis of diabetes treated with insulin or oral drugs. Diabetes self-reports were compared with medication inventories and fasting glucose levels at baseline and during follow-up. Results: At baseline, self-reported treated diabetes was concordant with the medication inventory in 79% of clinical trial, and 77% of observational study participants. Self-reported incident treated diabetes was concordant with the medication inventory in 78% between baseline and Year 1 in the clinical trials, in 62% between Year 1 and Year 3 in the clinical trials, and in 72% between baseline and Year 3 in the observational study. Over similar periods, 99.9% of those who did not report treated diabetes had no oral antidiabetic drugs or insulin in the medication inventory. At baseline, about 3% not reporting diabetes had fasting glucose >126 mg/dl, and 88% of these subjects subsequently reported treated diabetes during 6.9 years of follow-up. Limitations: Incident self-reported diabetes treated by lifestyle alone was not determined in WHI. Medication inventories may have been incomplete and fasting glucose may have been lowered by treatment; therefore, concordance with self-reported treatment or fasting glucose ≥ 126 may have been underestimated. Conclusion: In the WHI, self-reported prevalent and incident diabetes was consistent with medication inventories, and a high proportion of those with undiagnosed diabetes subsequently reported diabetes treatment. Self-reports of `treated diabetes' are sufficiently accurate to allow use in epidemiologic studies. Clinical Trials 2008; 5: 240—247. http://ctj.sagepub.com
Bayesian adaptive design for targeted therapy development in lung cancer — a step toward personalized medicine
Authors: Xian Zhou  , Suyu Liu  , Kim Edward S , Herbst Roy S , Lee J Jack 
Published: June 2008

Background: With the advancement in biomedicine, many biologically targeted therapies have been developed. These targeted agents, however, may not work for everyone. Biomarker profiles can be used to identify effective targeted therapies. Our goals are to characterize the molecular signature of individual tumors, offer the best-fit targeted therapies to patients in a study, and identify promising agents for future development. Methods: We propose an outcome-based adaptive randomization trial design for patients with advanced stage non-small cell lung cancer. All patients have baseline biopsy samples taken for biomarker assessment prior to randomization to treatments. The primary endpoint of this study is the disease control rate at 8 weeks after randomization. The Bayesian probit model is used to characterize the disease control rate. Patients are adaptively randomized to one of four treatments with the randomization rate based on the updated disease control rate from the accumulated data in the trial. For each biomarker profile, high-performing treatments have higher randomization rates, and vice versa. An early stopping rule is implemented to suspend low-performing treatments from randomization. Results: Based on extensive simulation studies, with a total of 200 evaluable patients, our trial has desirable operating characteristics to: (1) identify effective agents with a high probability; (2) suspend ineffective agents; and (3) treat more patients with effective agents that correspond to their biomarker profiles. Our trial design continues to update and refine the estimates as the trial progresses. Limitations: This biomarker-based trial requires biopsible tumors and a two-week turn around time for biomarker profiling before randomization. Additionally, in order to learn from the interim data and adjust the randomization rate accordingly, the outcome-based adaptive randomization design is applicable only for trials when the endpoint can be assessed in a relative short period of time. Conclusion: Bayesian adaptive randomization trial design is a smart, novel, and ethical design. In conjunction with an early stopping rule, it can be used to efficiently identify effective agents, eliminate ineffective ones, and match effective treatments with patients' biomarker profiles. The proposed design is suitable for the development of targeted therapies and provides a rational design for personalized medicine. Clinical Trials 2008; 5: 181—193. http://ctj.sagepub.com
Addressing the challenges of a cross-national investigation: lessons from the Pittsburgh-Pisa study of treatment-relevant phenotypes of unipolar depression
Authors: Frank Ellen , Cassano Giovanni B , Rucci Paola , Fagiolini Andrea , Maggi Luca , Kraemer Helena C , Kupfer David J , Pollock Bruce , Bies Robert , Nimgaonkar Vishwajit , Pilkonis Paul , Shear M Katherine , Thompson Wesley K , Grochocinski Victoria J , Scocco Paolo , Buttenfield Joan , Forgione Rocco Nicola 
Published: June 2008

Background: To date, no cross-national RCT has addressed the mechanisms underlying the relative success of pharmacological and psychotherapeutic interventions for depression. A multi-site clinical trial that includes psychotherapy as one of the treatments presents numerous challenges related to cross-site consistency and communication. Purpose: This report describes how those challenges were met in the study ``Depression: The Search for Treatment Relevant Phenotypes'', being carried out at the University of Pittsburgh and the University of Pisa, Italy. Methods: Implementing the study required the investigators to address methodological and practical challenges related to the different requirements of the two Institutional Review Boards (IRBs), psychotherapy training, independent evaluator training, patient recruitment, development of common tools for data entry, quality control and generation of weekly reports of patient progress as well as establishing a similar clinical and research framework in two countries with substantially different health care systems. Results: By having bilingual investigators and staff members who spent time at one another's sites, making use of frequent conference-call staff meetings and being flexible within the bounds of the sometimes contradictory requirements of the IRBs, the investigators were able to meet the human subjects protection requirements of both institutions, surmount language barriers to consistent therapist and evaluator training and develop common tools for study management. As a result, recruitment goals were met at both sites and retention rates were high. One instance of inconsistent implementation of the protocol was corrected within the first year. Limitations: This study was conducted in two Western cultures by researchers with long-standing collaboration. Our findings may not be generalizable to other countries or research settings. Conclusions: The implementation of a cross-national protocol and the adoption and maintenance of common procedures is possible when investigators are aware of the challenges this may present and are proactive in trying to address them. Clinical Trials 2008; 5: 253—261. http://ctj.sagepub.com
Mono-cyclopropanated Fullerene Dimer C120O and Its Application in a Bulk Heterojunction Solar Cell
Authors: Weber Lars , Sensfuss Steffi , Ritter Uwe , Scharff Peter 
Published: June 2008

Abstract
Mono-cyclopropanated C120O was prepared to obtain soluble, longish electron acceptor opening the possibility to make organic photoactive layers of supra-molecular and anisotropic order. The C120O derivative was characterized by UV–vis spectroscopy, cyclic voltammetry, and thermogravimetric analyses, and applied as electron acceptor in a bulk-heterojunction polymer solar cell. The C120O derivative is appraised to be a valuable electron acceptor.
Preparation of Plywood-like Fe3BO5 Nanorods by a Facile Hydrothermal Method at Low Temperature
Authors: Qi Haiping , Chen Qianwang 
Published: June 2008

Abstract
Single-crystal plywood-like vonsenite (Fe3BO5) nanorods were prepared through a facile hydrothermal method at 140 °C for 40 h with K4Fe(CN)6 and NaBH4 as starting materials. The Fe3BO5 nanorods, which are composed of 5 to 7 nanobelts, have a diameter of about 250 nm and length ranging from 7 to 15 μm. The nanorods are identified to grow along the [001] direction. On the basis of the results, the formation process of the Fe3BO5 nanorods is discussed. The magnetic measurement indicates that TN=140 K.
Oxidation States of Antimony and Arsenic in Marine Ferromanganese Oxides Related to Their Fractionation in Oxic Marine Environment
Authors: Kashiwabara Teruhiko , Mitsunobu Satoshi , Das Anirban , Itai Takaaki , Tanimizu Masaharu , Takahashi Yoshio 
Published: June 2008

Abstract
Oxidation states of Sb and As in marine ferromanganese oxides determined by X-ray absorption near-edge structure showed that both As and Sb are pentavalent in the ferromanganese oxides. The concentration ratios of As/Sb in the ferromanganese oxides are similar to those in seawater. There results are consistent with the fact that As and Sb behave similarly, especially under oxic conditions as suggested from other studies in soil–water and river–sediment systems.
Stabilization of DNA Multiassembly by Addition of a Phosphate Group at the 5′-Sticky End
Authors: Tanaka Aya , Matsuo Yasutaka , Niikura Kenichi , Ijiro Kuniharu 
Published: June 2008

Abstract
The effect of 5′-phosphorylation at nicks on DNA stabilization was measured through the formation of DNA multiassemblies consisting of 40-mer half-sliding complementary oligonucleotides, which had overlapping complementary 20-mer base sequences. 5′-Phosphorylated oligonucleotides formed longer DNA multiassemblies than 5′-hydroxylated ones. This result indicated that the 5′-phosphorylated sticky ends contribute to the stabilization of the DNA association due to the hydrogen bonds between 3′-hydroxy groups and 5′-phosphate groups at the nick positions.
Spin-crossover Transition Coupled with Another Solid–Solid Phase Transition for Iron(II) Thiocyanate Complexes Chelated with Alkylated N-(Di-2-pyridylmethylene)anilines
Authors: Oso Yuya , Kanatsuki Daisuke , Saito Shuichi , Nogami Takashi , Ishida Takayuki 
Published: June 2008

Abstract
We have prepared spin-crossover [FeL2(NCS)2] complexes chelated with alkylated N-(di-2-pyridylmethylene)anilines. The wider irreversible thermal loop across room temperature was observed with the longer alkyl chain introduced (ΔTC = ca. 90 K for a n-C16H33 derivative). Pressurization prohibits the solid–solid phase transition, leading to the reversible spin crossover.
Hydrothermal Synthesis of GdVO4:Ho3+ Nanorods with a Novel White-light Emission
Authors: Su Yiguo , Li Guangshe , Chen Xiaobo , Liu Junjie , Li Liping 
Published: June 2008

Abstract
A novel white-light phosphor GdVO4:Ho3+ was prepared via a simple hydrothermal reaction route. Under ultraviolet excitation, the as-prepared nanocrystals showed a broad band emission and sharp lines, which are associated with the oxygen vacancies around V4+ ions and the typical f–f transitions of Ho3+ ions, respectively. The coexistence of broad emission and sharp lines results in the bright white light with a quantum yield of 28%.
Miniaturization of Nanofibers Composed of Melamine-appended Perylene Bisimides and Cyanurates
Authors: Seki Tomohiro , Yagai Shiki , Karatsu Takashi , Kitamura Akihide 
Published: June 2008

Abstract
Miniaturization of nanofibers formed from melamine-appended perylene bisimides and cyanurates are achieved by elongating the linker moieties between perylene bisimide core and melamine moieties. The resulting nanofibers gelate aliphatic solvents with low concentrations and the resulting gels are optically transparent, which are advantageous for photonic devices because no scattering of visible light takes place.
Preparation, Characterization, and Field-effect Transistor Performance of Benzo[1,2-d:4,5-d′]bisthiazole Derivatives
Authors: Mamada Masashi , Nishida Jun-ichi , Tokito Shizuo , Yamashita Yoshiro 
Published: June 2008

Abstract
Benzo[1,2-d:4,5-d′]bisthiazole (BBT) derivatives were newly synthesized, and the crystal structure, optical and electrochemical properties were investigated. They were applied for organic field-effect transistors (OFET) as n-channel semiconductors. Although their thin films have relatively rough surface, the devices showed high-performance OFET characteristics. The thin film of 2 exhibited the electron mobility of 0.24 cm2 V−1 s−1.
Bis(1-methylimidazole) Complex of Iron(III) Oxypyriporphyrin Adopting an Intermediate-spin State
Authors: Eguchi Hajime , Ohgo Yoshiki , Ikezaki Akira , Neya Saburo , Nakamura Mikio 
Published: June 2008

Abstract
Bis(1-methylimidazole) complex of iron(III) oxypyriporphyrin adopts an essentially pure intermediate-spin (S=3⁄2) state at 298 K, which is the first example of the iron(III) porphyrinoid adopting the S=3⁄2 in spite of the bis-coordination of imidazole ligand.
Stereocontrolled Total Synthesis of (−)-Gleenol Using Claisen Rearrangement of Sterically Congested Dihydropyran
Authors: Nakazaki Atsuo , Era Tomohiro , Kobayashi Susumu 
Published: June 2008

Abstract
A stereocontrolled total synthesis of enantiomerically pure (−)-gleenol using an improved substrate to construct the spiro[4.5]decane through Claisen rearrangement has been achieved. The most striking feature of this synthesis is that the rearrangement of sterically congested dihydropyran, bearing all requisite substituents with proper stereochemistry, afforded the fully functionalized spiro[4.5]decane in a single step.
A New Amphiphilic and Thermoresponsive Polysilsesquioxane Having Alkoxyethylamide Group
Authors: Matsuoka Tomonori , Yamamoto Shin-ichi , Moriya Osamu 
Published: June 2008

Abstract
The polysilsesquioxanes (PSQ) having alkoxyethylamide groups were prepared from the silane coupling reagents, prepared by addition reaction of alkoxyethylamines to (3-isocyanatopropyl)triethoxysilane, by condensation under acidic conditions. In the obtained PSQs, those having bis(methoxyethyl)amide or bis(ethoxyethyl)amide group showed reversible thermoresponsive phase separation in an aqueous solution. The PSQs formed by the co-condensation of such silane coupling reagents, the feed mole ratio of which were changed, also showed the thermoresponsive aggregation at the temperatures reflected with the ratios of alkoxyethyl groups.
Integrated Care Pathway for Acute Coronary Syndromes: Does It Help?
Authors: Levelt Eylem , Thwaites Barnaby , Yadegarfar Ghasem 
Published: June 2008

The use of integrated care pathways (ICPs) to enhance quality and consistency of patient care has increased in the last decade. In two closely related studies, we first assessed the benefit of a new ICP for acute coronary syndrome in our district hospital, and secondly assessed the impact of ICPs in UK coronary care units, correlating with data from the Myocardial Infarction National Audit Programme, MINAP. The new local ICP produced statistically improved admission medication, with the chance of correctly prescribing aspirin increasing by 63% ( P < 0.002), and borderline increase for clopidogrel of 28% ( P > 0.10), and enoxaparin of 21% ( P > 0.06), in a completed audit cycle study totalling 100 patients. A national telephone survey showed that of 210 UK coronary care units, only 40% had an ICP in place, and this made no difference to either door-to-needle time for thrombolysis or to rates of discharge medication with aspirin, beta-blockers or statins. While these results fail to raise enthusiasm for implementing an ICP, other potential benefits of their use may be important such as optimizing data collection, improving consistency of care and unifying the different clinical teams in planning the care of the patient.
The good collusion defeats the Lone Ranger
Authors: Holland Andrea 
Published: June 2008

We all collaborate from birth, in learning language for instance, in learning to play, and, of course, as writers. This paper discusses collaborative practice, how creative writers work with each other, including composite authorship as collaboration, as well as collaborative projects with visual and/or sound artists to generate material outside of conventional forms. Various questions are explored; what issues emerge in creative collaboration, especially cross-arts? How might one's voice, or aesthetics, affect creative text? How might this kind of creativity be a social process?I will utilize examples from my own writing (mostly poetry) with visual/sound artists (e.g. short films) and from established collaborative partnerships. The paper addresses the concept and practicalities of collaboration, the issues and processes, and gives a brief discussion of theoretical ideas around these issues.
In the Café Flaubert
Authors: Francis Mary Anne 
Published: June 2008

Developing my long-held contention that an artist might write art-theory differently from non-artist theorists, this paper offers an instantiation of one possible approach. First and foremost, it proposes that an artist's art-theory might utilize their understanding of aesthetic
form and functioning to conceive of writing as another art-form, now taking place in words and referencing the structures associated with that medium.
With a nod to Plato's dialogues, the text adopts the format of a fictional conversation offered as reportage, which takes place between
the artist-writer and a philosopher an expert on the subject of truth regimes. The artist consults him in order to progress a project. What ensues puts the artist-writer's preference for a realist approach to writing (representation as reflection) into play with the academic's overview of
this and other truth regimes. Introduced to Richard Rorty's pragmatism and hence the idea of truth as use-value, the artist is initially bewildered, only later realizing that it takes her project in a new direction.
Given that the text's departure from the form of conventional art-theory
is embodied (not just represented), the issues that it raises are implicit, but include: the (dis)advantages of fictional dialogue as theory. (On the one hand both the reader and the writer imaginatively inhabit different points of view more readily than happens with non-fictional prose. On
the other hand, fictional dialogue may indulge unreliable spokespersons for particular theoretical positions.) Another point for debate concerns the recourse to the Renaissance pedagogic concept of teaching through delight. (While aesthetic pleasure-in-the-text is a spur for both the writer
and the reader, the sensuous dimensions of dramatic embodiment may offer a distraction from more substantial issues.)
As much as this text is an instance of a writing-as-an-art-form as theory, it also proposes, reciprocally, that theory may be found outside non-fictional, non-aesthetic
academic discourse. When this is the oblique logic of the writing's form, it is also explicitly elaborated in the article, as Drer's woodcut The Draughtsman and the Lute is seen to comprise observations about the conditions of representation that re-appear in the picture that is the
fictional discussion in the Caf Flaubert.