bluuebunny/crossref_metadata_2025_split huggingface dataset:
Dynamic Contrast-Enhanced Magnetic Resonance Imaging As a Pharmacodynamic Measure of Response After Acute Dosing of AG-013736, an Oral Angiogenesis Inhibitor, in Patients With Advanced Solid Tumors: Results From a Phase I Study
Authors: Liu Glenn , Rugo Hope S. , Wilding George , McShane Teresa M. , Evelhoch Jeffrey L. , Ng Chaan , Jackson Edward , Kelcz Frederick , Yeh Benjamin M. , Lee Fred T. , Charnsangavej Chusilp , Park John W. , Ashton Edward A. , Steinfeldt Heidi M. , Pithavala Yazdi K. , Reich Steven D. , Herbst Roy S. 
Published: July 2005

Purpose Identifying suitable markers of biologic activity is important when assessing novel compounds such as angiogenesis inhibitors to optimize the dose and schedule of therapy. Here we present the pharmacodynamic response to acute dosing of AG-013736 measured by dynamic contrast-enhanced magnetic resonance imaging (DCE-MRI). Patients and Methods Thirty-six patients with advanced solid tumors were treated with various doses of AG-013736. In addition to standard measures of objective disease response and pharmacokinetic analysis, DCE-MRI scans were acquired at baseline and repeated at cycle 1—day 2 after the scheduled morning dose of the AG-013736 in 26 patients. Indicators of a vascular response, such as the volume transfer constant (Ktrans) and initial area under the curve (IAUC), were calculated to assess the effect of treatment on tumor vascular function. Results Evaluable vascular response data were obtained in 17 (65%) of 26 patients. A linear correlation was found in which the percentage change from baseline to day 2 in Ktrans and IAUC was inversely proportional to AG-013736 exposure. Using a conservative a priori assumption that a ≥ 50% decrease in Ktrans was indicative of an objective vascular response, a 50% decrease in Ktrans was achieved and corresponded to a plasma AUC0-24 of > 200 ng · h/mL. Conclusion A sufficient decrease in tumor vascular parameters was observed at a dose chosen for additional phase II testing by conventional toxicity criteria. In addition, the day 2 vascular response measured using DCE-MRI seems to be a useful indicator of drug pharmacology, and additional research is needed to determine if it is a suitable marker for predicting clinical activity.
Randomized Trial of Antioxidant Vitamins to Prevent Acute Adverse Effects of Radiation Therapy in Head and Neck Cancer Patients
Authors: Bairati Isabelle , Meyer François , Gélinas Michel , Fortin André , Nabid Abdenour , Brochet François , Mercier Jean-Philippe , Têtu Bernard , Harel François , Abdous Belkacem , Vigneault Éric , Vass Sylvie , del Vecchio Pierre , Roy Jean 
Published: July 2005

Purpose Many cancer patients take antioxidant vitamin supplements with the hope of improving the outcome of conventional therapies and of reducing the adverse effects of these treatments. A randomized trial was conducted to determine whether supplementation with antioxidant vitamins could reduce the occurrence and severity of acute adverse effects of radiation therapy and improve quality of life without compromising treatment efficacy. Patients and Methods We conducted a randomized, double-blind, placebo-controlled trial among 540 head and neck cancer patients treated with radiation therapy. Patients were randomly assigned into two arms. The supplementation with α-tocopherol (400 IU/d) and β-carotene (30 mg/d) or placebos was administered during radiation therapy and for 3 years thereafter. During the course of the trial, supplementation with β-carotene was discontinued because of ethical concerns. Results Patients randomly assigned in the supplement arm tended to have less severe acute adverse effects during radiation therapy (odds ratio [OR], 0.72; 95% CI, 0.52 to 1.02). The reduction was statistically significant when the supplementation combined α-tocopherol and β-carotene for adverse effects to the larynx (OR, 0.38; 95% CI, 0.21 to 0.71) and overall at any site (OR, 0.38; 95% CI, 0.20 to 0.74). Quality of life was not improved by the supplementation. The rate of local recurrence of the head and neck tumor tended to be higher in the supplement arm of the trial (hazard ratio, 1.37; 95% CI, 0.93 to 2.02). Conclusion Supplementation with high doses of α-tocopherol and β-carotene during radiation therapy could reduce the severity of treatment adverse effects. However, this trial suggests that use of high doses of antioxidants as adjuvant therapy might compromise radiation treatment efficacy.
Explaining the phase behaviour of the pharmaceutically relevant polymers poly(ethylene glycol) and poly(vinyl pyrrolidone) in semi-fluorinated liquids
Authors: Paul Alison , Griffiths Peter C , James Robert , Willock David J , Rogueda Philippe G 
Published: July 2005

Abstract
Phase behaviour studies of low molecular weight poly(ethylene glycol) (denoted PEG 600 and PEG 1000, corresponding to molecular weights of 600 and 1000 g mol−1, respectively) have been carried out in 2H, 3H-perfluoropentane (HPFP) with and without added poly(vinyl pyrrolidone). The concentration and temperature dependencies of their phase behaviour and the effect of moisture on these systems have been established. Furthermore, the solubility of PEG 600 in binary mixtures of HPFP and per-fluoropentane (PFP), as well as HPFP and perfluorodecalin (PFD) have been considered at high HPFP contents. A phase separation phenomenon in fluorinated non-aqueous media is reported for the first time: PEG 600 and PEG 1000 both show a lower critical solution temperature type phase separation boundary. The size of the PEGs was obtained from small-angle neutron scattering (radius of gyration) and pulsed-gradient spin-echo NMR (hydrodynamic radius) measurements. It is shown that polymer conformation follows a regular trend with solution concentration; the size increases from &lt;10 Å at 3wt% in HPFP to 45 ± 2 Å at 20wt% PEG. On changing the solvent composition by substitution of HPFP by PFP or PFD, the size decreases, consistent with a decrease in the hydrogen-bonding capacity of the solvent mixture. Computer modelling indicates an interaction between the PEG oxygen and the hydrogen of HPFP, an interaction that is absent for the fully fluorinated solvents. This indicates that hydrogen bonding is the driving force for polymer solubility in these solvents.
Intranasal immunization using biphasic lipid vesicles as delivery systems for OmlA bacterial protein antigen and CpG oligonucleotides adjuvant in a mouse model
Authors: Alcón V L , Baca-Estrada M , Vega-López M A , Willson P , Babiuk L A , Kumar P , Foldvari M 
Published: July 2005

Abstract
The nasal mucosa is an important arm of the mucosal system since it is often the first point of contact for inhaled antigens. The ineffectiveness of the simple delivery of soluble antigens to mucosal membranes for immunization has stimulated extensive studies in appropriate delivery systems and adjuvants. We have evaluated biphasic lipid vesicles as a novel intranasal (i.n.) delivery system (designated as vaccine targeting adjuvant, VTA) containing bacterial antigens and CpG oligode-oxynucleotides (ODNs). Results show that administration of antigen and CpG ODNs in biphasic lipid vesicles resulted in greater induction of IgA levels in serum (P&lt;0.05) and mucosal antibody responses such as IgA in nasal secretions and lung (P&lt;0.01) after immunization with a combined subcutaneous (s.c.)/i.n. as compared to s.c./s.c. approach. Based on antibody responses, VTA formulations were found to be suitable as delivery systems for antigens and CpG ODNs by the intranasal route, resulting in a Th2-type of immune response, characterized by IgG1 and IL-4 production at the systemic level.
Evaluation of Channel Catfish Virus Latency on Fingerling Production Farms in Mississippi
Authors: Thompson David J. , Khoo Lester H. , Wise David J. , Hanson Larry A. 
Published: July 2005

Abstract
Channel catfish virus disease (CCVD) is an economically important disease to the channel catfish Ictalurus punctatus industry. Channel catfish virus develops a latent infection and is vertically transmitted from broodstock to offspring. In this study, the presence of latent channel catfish virus (CCV) in fry at 3–5 d of age was evaluated, via polymerase chain reaction, on five farms in the Delta region of Mississippi. We found over 10% of the fry sampled were positive for latent CCV on all five farms. Additionally, on one of those farms the presence of latent CCV was evaluated in three ponds through a typical CCVD season. Regression analysis of the CCV carrier level demonstrated an increase, but no overt CCVD outbreaks occurred and no CCV was cultured from the fish tissues in cell culture. Our results indicate that CCV is endemic in most channel catfish populations under commercial production in Mississippi and suggests that subclinical transmission of CCV does occur.
Impact of Invalid Biological Assumptions and Misapplication of Maturity Criteria on Size‐at‐Maturity Estimates for American Lobster
Authors: Waddy S. L. , Aiken D. E. 
Published: July 2005

AbstractSize at maturity is an important tool for fishery management of the American lobster Homarus americanus, but many of the size‐at‐maturity assessments conducted to date have been confounded by errors of biological fact, misinterpretations of results, and misapplications of maturity assessment criteria. The result has been considerable uncertainty about the magnitude of egg production for various stocks of the American lobster, an undesirable situation for fishery managers. Size‐at‐maturity studies require an in‐depth understanding of the biology of molting and reproduction. The investigator must first determine the physiological state of the captured lobster and then estimate when molting or spawning will occur. Conclusions can then be drawn regarding the maturity of the animal. Three elements are important in the design of maturity studies: The criteria used to discriminate between immature and mature lobsters, the time of year the study is conducted, and the sizes and numbers of lobsters sampled. Maturity assessments should be conducted in the late spring, prior to the onset of the spawning and egg hatching seasons, when almost all mature lobsters are either ovigerous or preovigerous. Cement gland development should be used initially to separate preovigerous (mature) lobsters from those of uncertain reproductive status. Those of uncertain status can then be classified on the basis of ovary stage. If lobster ovaries are at stage 1 or 2, the lobsters are immature and will molt to a larger size before spawning. If lobster ovaries are at stage 3 or 4a, the lobsters are immature if their oviducts are clear and mature if the distal portion of their oviducts is yellow. Lobsters with ovaries at stages 4b to 6 are mature and should spawn within a few weeks. Once fishery biologists adopt a standard sampling protocol and begin applying validated maturity assessment criteria, size‐at‐maturity estimates will become comparable, reliable, and repeatable.
Manufacturing Uncertainty: Contested Science and the Protection of the Public’s Health and Environment
Authors: Michaels David , Monforton Celeste 
Published: July 2005

Opponents of public health and environmental regulations often try to “manufacture uncertainty” by questioning the validity of scientific evidence on which the regulations are based. Though most identified with the tobacco industry, this strategy has also been used by producers of other hazardous products. Its proponents use the label “junk science” to ridicule research that threatens powerful interests. This strategy of manufacturing uncertainty is antithetical to the public health principle that decisions be made using the best evidence available. The public health system must ensure that scientific evidence is evaluated in a manner that assures the public’s health and environment will be adequately protected.
Trial and Error: The Supreme Court’s Philosophy of Science
Authors: Haack Susan 
Published: July 2005

Apparently equating the question of whether expert testimony is reliable with the question of whether it is genuinely scientific, in Daubert v Merrell Dow Pharmaceuticals, Inc (1993) the US Supreme Court ran together Karl Popper’s and Carl Hempel’s incompatible philosophies of science. But there can be no criterion discriminating scientific, and hence reliable, testimony from the unscientific and unreliable; for not all, and not only, scientific evidence is reliable. In subsequent rulings (General Electric Co v Joiner, 1997; Kumho Tire Co v Carmichael, 1999) the Court has backed quietly away from Daubert’s confused philosophy of science, but not from federal judges’ responsibilities for screening expert testimony. Efforts to educate judges scientifically, and increased use of court-appointed experts are, at best, only partial solutions to the problems with scientific testimony.
A Cognitive Scientist Looks at Daubert
Authors: Lakoff George P. 
Published: July 2005

Our system of justice requires that trials be maximally fair. It is part of what holds this society together. Indeed, it is part of the genius of the justice system to have a kind of balance between strict and nurturant morality within the judicial system, so that the system itself provides a kind of moral and political balance. Daubert v Merrell Dow Pharmaceuticals, Inc (1993) has upset that balance and has made our judicial system significantly less fair and more politically conservative. Daubert is not just about the application of some procedural rule (Rule 702). Daubert functions in its application as a strategic initiative that significantly moves America in a conservative direction, in the moral and political spheres, as well as in the legal sphere.
The Weight of Scientific Evidence in Policy and Law
Authors: Krimsky Sheldon 
Published: July 2005

The term “weight of evidence” (WOE) appears in regulatory rules and decisions. However, there has been little discussion about the meaning, variations of use, and epistemic significance of WOE for setting health and safety standards. This article gives an overview of the role of WOE in regulatory science, discusses alternative views about the methodology underlying the concept, and places WOE in the context of the Supreme Court’s decision in Daubert v Merrell Dow Pharmaceuticals, Inc (1993). I argue that whereas the WOE approach to evaluating scientific evidence is gaining favor among regulators, its applications in judicial processes may be in conflict with some interpretations of how the Daubert criteria for judging reliable evidence should be applied.
Ten Years of Judicial Gatekeeping Under Daubert
Authors: Cecil Joe S. 
Published: July 2005

In the ten years since Daubert v Merrell Dow Pharmaceuticals, Inc, the standards for admissibility at trial of expert testimony in general and scientific evidence in particular have become more demanding. Reviews of recent cases and empirical studies of federal judges’ and attorneys’ practices indicate that judges are more likely to consider the admissibility of expert evidence prior to trial, to inquire more deeply into the reasoning and methodology that supports the expert opinions, and to limit or exclude such evidence from presentation at trial. Studies of published cases confirm this finding. Recent cases consider more difficult questions arising from the differing methodologies used in various areas of science. The current legal framework that assesses admissibility in terms of professional practice outside the courtroom is poorly suited to cases that require expertise across a wide range of specialties and force judges to choose from among different scientific methodologies. Future research should focus on the pretrial screening of expert testimony and interactions between the attorneys and experts in shaping that testimony.
How Tobacco-Friendly Science Escapes Scrutiny in the Courtroom
Authors: Friedman Lissy C. , Daynard Richard A. , Banthin Christopher N. 
Published: July 2005

Although the tobacco industry helped fund the attack on “junk science,” it has created its own dubious scientific scholarship for its expert witnesses. We suggest that plaintiffs’ counsel should be proactive in using Daubert hearings to exclude the tobacco industry defendants’ scientific expert witnesses by introducing documentation, such as we have found through researching previously privileged internal industry documents, to prove that much of their proposed testimony was developed by and for their lawyers.
A Daubert Motion: A Legal Strategy to Exclude Essential Scientific Evidence in Toxic Tort Litigation
Authors: Melnick Ronald L. 
Published: July 2005

In the US Supreme Court’s Daubert v Merrell Dow Pharmaceuticals, Inc decision, federal judges were directed to examine the scientific method underlying expert evidence and admit that which is scientifically reliable and relevant. However, if a judge does not have adequate training or experience in dealing with scientific uncertainty, understand the full value or limit of currently used methodologies, or recognize hidden assumptions, misrepresentations of scientific data, or the strengths of scientific inferences, he or she may reach an incorrect decision on the reliability and relevance of evidence linking environmental factors to human disease. This could lead to the unfair exclusion of valid scientific evidence, particularly that which is essential to a plaintiff’s case in toxic tort litigation.
Legal Causation and Responsibility for Causing Harm
Authors: Ozonoff David 
Published: July 2005

In the legal setting, “cause” is composed of at least two distinct components, of which only one is related to “causality” as scientists understand it. I argue that the alleged separation of the social issue of “scope of responsibility” from the objective question of scientific causality is illusory. “Scientific causality” also plays an essential social role in the legal setting.
Epistemology in the Courtroom: A Little “Knowledge” Is a Dangerous Thing
Authors: Ozonoff David 
Published: July 2005

Core epistemological questions—questions about what we know, how we know it, and when we are justified in saying we know it—have a long and deep history. The US Supreme Court broached the subject in the 1993 decision Daubert v Merrell Dow Pharmaceuticals, Inc, with references to Hempel, Popper, and other scholars. We comment here on the articles of Rothman and Greenland, who are scientists, and Haack, who is a philosopher. Their views suggest that questions of causation are neither as simple nor as difficult as many scientists and philosophers have made them.
Banded gas and nongray surface radiation models for high‐emissivity coatings
Authors: Heynderickx Geraldine J. , Nozawa Masatsugu 
Published: July 2005

AbstractThe efficiency of the application of high‐emissivity coatings on reactor tubes and furnace walls in steam‐cracking technology can be evaluated only on the basis of a description of radiative heat transfer in frequency bands. For the flue gases in the furnace, a radiation model is introduced in which the gas emits and absorbs radiation in discrete bands only; for the surfaces a nongray surface approach is applied. First, the influence of the model changes on the calculated radiative energy exchange is evaluated theoretically. Next, different furnace simulations are performed to do a numerical evaluation of the introduction of banded radiation models. The changes in the furnace thermal efficiency, attributed to the application of high‐emissivity coatings on furnace walls and tube skins in steam‐cracking furnaces, are calculated. © 2005 American Institute of Chemical Engineers AIChE J, 2005
Functional‐cranial approach to the influence of economic strategy on skull morphology
Authors: González‐José Rolando , Ramírez‐Rozzi Fernando , Sardi Marina , Martínez‐Abadías Neus , Hernández Miquel , Pucciarelli Hector M. 
Published: July 2005

AbstractEnvironmental factors are assumed to play an important role in the shaping of craniofacial morphology. Here we propose a statistical approach which can be of utility in estimating the magnitude and localization of a particular nongenetic factor upon the specific functional components of the skull. Our analysis is a combination of previous attempts of apportionment of variance and the application of craniofunctional theory. The effect of subsistence strategy on craniofacial functional components was studied on 18 populations of hunter‐gatherers and farmers from South America. Results demonstrate that the environmental factors studied likely influenced the masticatory component's size and shape. Even when this effect is not large enough to clearly differentiate among subsistence strategies (since whole craniofacial variation among populations remains greater), the method used here provides interesting clues to localize plastic or adaptive responses to external stimuli. Am J Phys Anthropol, 2005. © 2005 Wiley‐Liss, Inc.
Late Pleistocene/Holocene craniofacial morphology in Mesoamerican Paleoindians: Implications for the peopling of the New World
Authors: González‐José Rolando , Neves Walter , Lahr Marta Mirazón , González Silvia , Pucciarelli Héctor , Martínez Miquel Hernández , Correal Gonzalo 
Published: July 2005

AbstractSeveral studies on craniofacial morphology showed that most Paleoindians, who were the first settlers of the New World, clearly differ from modern Amerindians and East Asians, their supposed descendants and sister group, respectively. Here we present new evidence supporting this view from the Late Pleistocene/Early Holocene horizon from Mexico, as well as from the most complete set of dated Paleoindian remains. We analyzed the phenotypic resemblance of early Mexicans with other South Paleoamerican and modern human series. Two independent approaches to the data were used. In the first case, individual specimens were tested for morphological similarity with a set of modern reference samples. In the second analysis, Mexican specimens were treated as a sample in order to compute minimum genetic distances. Results from both approaches tend to associate early Mexican skulls with Paleoindians from Brazil, an Archaic sample from Colombia, and several circum‐Pacific populations. These results give support to a model in which morphologically generalized groups of non‐Northeast Asian descent (the so‐called Paleoamericans) entered the continent first, and then dispersed from North to South America through Central America. The large geographic dispersal of Paleoamericans, and their presence in Mexico in the Early Holocene, raise new issues about the continent's settlement scenario. Am J Phys Anthropol, 2005. © 2005 Wiley‐Liss, Inc.
Strategien für die Wasserstoffspeicherung in metall‐organischen Kompositgerüsten
Authors: Rowsell Jesse L. C. , Yaghi Omar M. 
Published: July 2005

AbstractMetall‐organische Gerüste finden verstärkt Interesse als mögliche Materialien zur Wasserstoffspeicherung. Hintergrund dieser Forschungen sind die zahlreichen herausragenden Merkmale dieser Substanzen – wie hohe Porosität, reproduzierbare und einfache Synthesen, leichte Skalierbarkeit und die Möglichkeit zur gezielten chemischen Modifizierung zur Einstellung gewünschter Eigenschaften. Dieser Kurzaufsatz diskutiert Strategien zur Verbesserung der Wasserstoffaufnahme durch metall‐organische Gerüste. Die Ansätze umfassen die Optimierung der Porengröße und Adsorptionsenergien durch Modifizierung von Linkern, durch Imprägnierung und Catenierung sowie durch den Einbau von koordinativ ungesättigten Metallzentren und Leichtmetallen.