bluuebunny/crossref_metadata_2025_split huggingface dataset:
Invisible Barriers to Clinical Trials: The Impact of Structural, Infrastructural, and Procedural Barriers to Opening Oncology Clinical Trials
Authors: Dilts David M. , Sandler Alan B. 
Published: September 2006

Purpose To investigate the administrative barriers that impact the opening of clinical trials at the Vanderbilt-Ingram Cancer Center (VICC) and at VICC Affiliate Network (VICCAN) sites. Methods VICC, a National Cancer Institute–designated comprehensive cancer center, and three VICCAN community practice sites were studied. Methodology used was identification and mapping of existing processes and analysis of historical timing data. Results At course granularity, the process steps required at VICC and VICCAN main office plus local sites are 20 v 17 to 30 steps, respectively; this gap widens with finer granularity, with more than 110 v less than 60 steps, respectively. Approximately 50% of the steps are nonvalue added. For example, in the institutional review board (IRB) process, less than one third of the steps add value to the final protocol. The numbers of groups involved in the approval processes are 27 (VICC) and 6 to 14 (VICCAN home office and local sites). The median times to open a trial are 171 days (95% CI, 158 to 182 days) for VICC and 191 days (95% CI, 119 to 269 days) for the VICCAN sites. Contrary to expectations, the time for IRB review and approval (median, 47 days) is the fastest process compared with the scientific review committee review and approval (median, 70 days) and contracts and grants review (median, 78.5 days). Opening a cooperative group clinical trial is significantly (P = .05) more rapid because they require fewer review steps. Conclusion There are numerous opportunities to remove nonvalue-added steps and save time in opening clinical trials. With increasing numbers of new agents, fewer domestic principal investigators, and more companies off-shoring clinical trials, overcoming such barriers is of critical importance for maintenance of core oncology research capabilities in the United States.
Catheter-Related Deep Venous Thrombosis and Other Catheter Complications in Children With Cancer
Authors: Journeycake Janna M. , Buchanan George R. 
Published: September 2006

Purpose Asymptomatic deep vein thrombosis (DVT) is a complication of central venous catheter (CVC) use in children with cancer, but its clinical significance is not well defined. Children with CVCs commonly experience two other CVC-related complications: occlusion and infection. The aim of this study was to determine the frequency of these two complications and their association with DVT. Patients and Methods We conducted a retrospective cohort study of patients who were diagnosed with cancer. Data collected included number and type of catheter insertions, duration of use, reason for removal, associated catheter complications, and demographic information. Results Catheters were placed in 287 patients for a total of 128,403 days (mean, 290 ± 269 days/catheter). Of 21 patients (7%) diagnosed with CVC-related DVT, only five had specific signs or symptoms. Nineteen (90%) of these 21 children had prior history of catheter occlusion, and 10 of the 19 also experienced infection. Ten children (48%) were not identified as having DVT until they had had multiple catheters with recurrent complications. Odds of having DVT were higher in patients who had a single catheter complicated by repeated occlusions (odds ratio [OR], 3.7; P = .001) or infection (OR, 2.2; P = .016). Patients experiencing both infection and occlusion were at 6.4 times (P < .0001) higher risk of developing DVT. Conclusion Children with CVC-related DVT frequently have recurrent catheter complications. Unrecognized thrombosis may therefore be clinically important. Prospective studies are needed to determine if identification and treatment of occult DVT will prevent additional CVC-related complications and prolong the duration of catheter use.
The HOXB13:IL17BR Expression Index Is a Prognostic Factor in Early-Stage Breast Cancer
Authors: Ma Xiao-Jun , Hilsenbeck Susan G. , Wang Wilson , Ding Li , Sgroi Dennis C. , Bender Richard A. , Osborne C. Kent , Allred D. Craig , Erlander Mark G. 
Published: September 2006

Purpose We previously identified three genes, HOXB13, IL17BR and CHDH, and the HOXB13:IL17BR ratio index in particular, that strongly predicted clinical outcome in breast cancer patients receiving tamoxifen monotherapy. Confirmation in larger independent patient cohorts was needed to fully validate their clinical utility. Patients and Methods Expression of HOXB13, IL17BR, CHDH, estrogen receptor (ER) and progesterone receptor (PR) were quantified by real-time polymerase chain reaction in 852 formalin-fixed, paraffin-embedded primary breast cancers from 566 untreated and 286 tamoxifen-treated breast cancer patients. Gene expression and clinical variables were analyzed for association with relapse-free survival (RFS) by Cox proportional hazards regression models. Results ER and PR mRNA measurements were in close agreement with immunohistochemistry. In the entire cohort, expression of HOXB13 was associated with shorter RFS (P = .008), and expression of IL17BR and CHDH was associated with longer RFS (P < .0001 for IL17BR and P = .0002 for CHDH). In ER+ patients, the HOXB13:IL17BR index predicted clinical outcome independently of treatment, but more strongly in node-negative patients. In multivariate analysis of the ER+ node-negative subgroup including age, PR status, tumor size, S phase fraction, and tamoxifen treatment, the two-gene index remained a significant predictor of RFS (hazard ratio = 3.9; 95% CI, 1.5 to 10.3; P = .007). Conclusion This tumor bank study demonstrated HOXB13:IL17BR index is a strong independent prognostic factor for ER+ node-negative patients irrespective of tamoxifen therapy.
Processes to Activate Phase III Clinical Trials in a Cooperative Oncology Group: The Case of Cancer and Leukemia Group B
Authors: Dilts David M. , Sandler Alan B. , Baker Matthew , Cheng Steven K. , George Stephen L. , Karas Kathleen S. , McGuire Stephen , Menon Gourija S. , Reusch Jason , Sawyer Debbie , Scoggins Maren , Wu Amy , Zhou Kai , Schilsky Richard L. 
Published: September 2006

Purpose National Cancer Institute–sponsored cooperative oncology groups are major sponsors of phase III clinical trials, yet the time and steps required to design and activate such studies has not been well studied. We examine the processes and document the calendar time required to activate such studies opened by the Cancer and Leukemia Group B (CALGB). Methods Setup steps were documented by (1) interviewing CALGB headquarters and statistical center staff and committee chairs to discover the steps required to transit from concept development to final study activation, (2) reviewing procedure manuals, and (3) inspecting all study records, documents, and e-mails to identify any additional steps. Calendar time was collected for each major process. Results Thirteen phase III studies were activated by CALGB during the study period of May 2002 to May 2005. More than 370 distinct processes were required for study activation: 317 work steps, 42 decision points, and 29 processing loops. Sixty-three percent of the decision points were outside CALGB. The complete process map measures 243.5” × 41” in 8-point font. Median calendar days to activate a phase III study at CALGB was 580 days (range, 295 to 1,248 days) from concept approval and 784 days (range, 537 to 1,130 days) from initial conception of the study. Conclusion Setup of a phase III study at a major cooperative oncology group is a complex and lengthy process, with the majority of decision points external to the cooperative group. To improve the activation process, research should to be directed toward both internal and external groups and processes.
Changing concepts of sinusitis
Authors: Putney F. Johnson 
Published: September 2006

AbstractRealization of the importance of proper nasal and sinus physiology alters the approach to the problem of sinusitis, while the antibiotic and chemotherapeutic agents afford valuable weapons in treatment. Restoration rather than destruction of diseased tissue is the cardinal aim. When the pathologic change in the membrane is irreversible surgery is required, conservative operations being preferred. In longstanding suppurative sinusitis the membrane becomes fibrotic and little benefit results from the sulfonamides or penicillin. Sinusitis is classified as follows: 1. allergic, 2. mechanical, 3. bacterial. In general, allergic cases require primary attention to the allergic diathesis, those due to mechanical blockage are relieved by simple surgical procedures, and early bacterial sinusitis responds to penicillin. Penicillin is equally valuable in treating the complications of orbital cellulitis and osteomyelitis of the skull. When given early surgery can often be avoided, but in chronic osteomyelitis surgical drainage is usually needed in addition.
The progression of impaired hearing for high tones during childhood
Authors: Guild Stacy R. 
Published: September 2006

AbstractSUMMARY. The “abrupt” type of high‐tone loss is discussed from the standpoint, primarily, of remote or true causes of the lesion of the basal turn of the cochlea usually regarded as the immediate cause of the functional impairmentFour cases are reported, in considerable detail, of children who while under observation either developed an “abrupt” type of high‐tone loss or had a marked degree of progression of an already existing impairment of this type. In all four instances, the impairments progressed graduallyThe cause of the impairments, had the last examinations of these children been their first, would have been regarded by most otologists as either an exposure to acoustic trauma of the blast type or a congenital cochlear lesion. The reported observations show that neither diagnosis would be correct for any of these four casesOther hypothetical, or even plausible, causes are discussed in the light of the evidence from the reported cases. All are ruled out of consideration, more or less completely, and the conclusion is reached that the remote or true cause of many instances of “abrupt” type high‐tone loss is as yet unknown, or unrecognizedThe suggestion is made that a follow‐up study of a large number of persons from childhood until they reach mid‐adult age would provide basic information about the most common type of impaired hearing that occurs in man, and that such a study would also furnish a better basis than now exists for clinical prognosis and advice
On the chemical composition of the human perilymph and endolymph
Authors: Waltner Jules G. , Raymond Samuel 
Published: September 2006

AbstractSUMMARY. 1. Five specimens of perilymph were obtained from the lateral semicircular canal of humans while performing Day operations for Ménière's disease2. One specimen of endolymph was collected from a patient with Ménière's disease during a Portmann operation3. Measurements of the ultraviolet absorption and total nitrogen were made on these fluids4. The protein content of the inner ear fluids as indicated by the above measurements was more than twice that of the cerebrospinal fluid of the same patients5. These figures corroborate the existence of a barrier between perilymph and spinal fluid, probably of semipermeable nature.
Aureomycin in treatment of otitic and ophthalmic herpes zoster
Authors: Gans Edward W. 
Published: September 2006

AbstractSUMMARY. I have given a short resumé of the treatments of herpes zoster and considered the probable etiology of the disease. The gravity of this disease when affecting areas about the head and face is not to be denied. Any drug, therefore, that shortens the duration, relieves the pain and decreases complications is an important therapeutic addition. Six cases treated with aureomycin in the department of Ophthalmology and Otolaryngology of Permanente Foundation Hospital are presented. In all six cases there was rapid control of pain, early healing of lesions and a minimum of complications; only one case showing any residuum when last seenIt is concluded, therefore, from these cases and others presented in the literature that aureomycin has a specific effect on herpes zoster infection
Granulomatous complications of oval window fat grafts
Authors: Harris Irwin , Weiss Leo 
Published: September 2006

AbstractIn a series of 119 surgical cases of total stapedectomy utilizing adipose tissue, six cases of granulomatous complication occurred. In five of the six cases the hearing was impaired to below the preoperative level, and in four of the six cases the discrimination score was markedly impaired by the complication.A satisfactory explanation for this development has been noted in only two of the six cases.
A Comparison of Costs in Providing Dental Care for Special Needs Patients under Sedation or General Anaesthesia in the North East of England
Authors: Prabhu Neeta T , Nunn June H , Evans David J 
Published: September 2006

Objective To compare the costs of providing dental treatment under general anaesthesia or sedation for special needs patients. Methods After a Delphi exercise, a questionnaire was designed, piloted and then sent to nine NHS Trust dental service managers, within the Salaried Dental Services in the North East of England, to obtain information on the costs incurred during the treatment of special needs patients using sedation or general anaesthesia. The questionnaire related to the average number of such patients treated per session, staff costs, depreciation cost for buildings and equipment, and overhead costs including consumables and drugs. Results All nine dental service managers returned completed questionnaires. The all-inclusive cost for treatment per patient under general anaesthesia ranged from £203.65–£479.50 (mean cost: £285.79) and for sedation from £57.60–£153.50 (mean cost: £90.81). On average three special needs patients were treated per session. The greatest variation in the costs for general anaesthesia was due to staffing costs, which ranged from £1064.10 to £350.00 per session across the Trusts. Conclusions In the small number of centres sampled, the cost of delivering dental care under sedation or general anaesthesia was shown to vary widely. Overall, the mean cost of sedation was one-third that of general anaesthesia. However, the cost of both was substantial and cognisance needs to be taken of the costs of such services.
Effect of Prolonged Thermal Cycling on Microleakage around Class V Cavities Restored with Glass-Ceramic Inserts with Different Coefficients of Thermal Expansion. An In Vitro Study
Authors: Santini Ario , Ivanovic Vladimir , Tan Chuei Luan , Ibbetson Richard 
Published: September 2006

Purpose The purpose of this in vitro study was to evaluate microleakage around Class V glass-ceramic restorations of different coefficients of thermal expansion after prolonged thermal cycling. Materials and Methods One hundred and twenty non-carious extracted human premolars (patient age range 12–20 years) were randomly assigned to three groups. Standard Class V preparations were cut in the buccal surface using customised Cerana burs, size no. 3. Glass-ceramic inserts from two manufacturers (Cerana, Nordiska Dental AB, Helsingborg, Sweden; Beta-Quartz, Hager & Werken GmbH, Duisburg, Germany) were used to restore the cavities and were luted with a hybrid, high-viscous composite (Tetric Ceram, Ivoclar Vivadent, Schaan, Liechtenstein) and a bonding agent (Excite, Ivoclar Vivadent, Schaan, Liechtenstein). A control group, without inserts, was bulk-filled with the same composite used as the luting agent. In accordance with American Dental Association guidelines, half of the preparation was in enamel, half in dentine/cementum and had a mesio-distal width of 3 mm, an occluso-gingival height of 3 mm, and a depth of 2 mm. All margins had butt joints. Sixty teeth, selected at random, were not thermal cycled; the remaining 60 teeth were thermal cycled 4000 times between water baths held at 5°C and 55°C and the specimens prepared and examined for microleakage using 2.0% Procion Red® (ICI, Slough, UK) dye, buffered at pH7, as a marker. The results were analysed using the Kruskal-Wallis test (ANOVA) at a 95% significance level. Results At the occlusal margins there was no significant difference in microleakage between the three groups (P>0.5) without thermal cycling. After thermal cycling, microleakage at the occlusal margins was significantly less around cavities restored with Cerana glass-ceramic inserts versus Beta-Quartz and Tetric Ceram (P<0.05 in both cases). At the gingival margins, there was no significant difference in microleakge between the groups before thermal cycling (P>0.5). After thermal cycling, there was significantly less microleakage between Cerana inserts and Tetric Ceram (P<0.05). Comparisons between non-thermal cycled and thermal cycled groups showed there was no significant difference with the Cerana inserts (P=0.5590). Clinical Implications The results indicate that, after thermal cycling, restorations restored with Cerana glass-ceramic inserts, which have a coefficient of thermal expansion approximating to that of enamel, show a decrease in marginal microleakage, compared with Beta-Quartz glass-ceramic inserts and Tetric Ceram resin-based composite material. Restorative materials, which have a coefficient of thermal expansion approximating to that of enamel, would seem to be the materials of choice in reducing the problem of marginal microleakege.
Coho Salmon Smolt Production from Constructed and Natural Floodplain Habitats
Authors: Roni Phil , Morley Sarah A. , Garcia Patsy , Detrick Chris , King Dave , Beamer Eric 
Published: September 2006

AbstractWe examined existing smolt trapping data from 30 constructed and natural floodplain habitats to determine whether the number (production), density, and length of coho salmon Oncorhynchus kisutch smolts varied by project type and area. At 13 of the 30 sites we conducted detailed physical surveys to examine how morphology (shoreline irregularity), depth, and cover influenced smolt density and length. Mean smolt production for all sites averaged 2,492, density 0.37 smolts/m2, and length 98.9 mm. We found no significant difference in smolt production or density between natural and constructed sites or among project types. Smolt length differed by project type and morphology, excavated ponds (gravel pits and mill ponds) producing significantly larger smolts than constructed groundwater or natural channels. Smolt production was positively correlated with wetted area. Smolt length was negatively correlated with density and distance from salt water, suggesting that sites further inland with cooler water temperatures had higher densities and smaller fish. Site perimeter, shoreline irregularity, depth, and percent cover were not significantly different among habitat types at intensively sampled sites, nor were they correlated with smolt production or smolt density. However, multiple regression analysis indicated that shoreline irregularity and percent cover explained 70% of the variation in smolt length.
Size‐Related Variation in the Diet of Juvenile Tautogs from Long Island Sound
Authors: Clark Paul E. , Pereira Jose J. , Auker Linda A. , Parkins Christopher J. , Vinokur Lauren M. 
Published: September 2006

AbstractJuvenile tautogs Tautoga onitis were collected from shallow‐water nursery areas along the Connecticut coast of Long Island Sound from June through September of 2000, 2001, and 2003. A total of 164 juveniles (8.9–165 mm standard length) were collected using several different methods. The digestive tracts of 152 (92.68%) juveniles each contained at least one identifiable prey item; 12 (7.32%) stomachs were empty. The number of different identifiable prey taxa in the digestive tracts ranged from one to four. Juvenile tautogs from the study area consumed 21 mutually exclusive prey taxa. Over all size‐classes, crustacean prey constituted a major component of the diet. Gammarid amphipods (present in 45.39% of the fish with food in their digestive tracts) and calanoid copepods (16.45%) were the predominant prey. Less commonly consumed prey included hermit crabs Pagurus spp., lady crabs Ovalipes ocellatus, mud crabs (Xanthidae), Asian shore crabs Hemigrapsus sanguineus, eggs of horseshoe crabs Limulus polyphemus, sevenspine bay shrimp Crangon septemspinosa, shore shrimp Palaemonetes spp., polychaete worms (Polychaeta), milky ribbon worms Cerebratulus lacteus, common Atlantic slipper shells Crepidula fornicata, eastern oysters Crassostrea virginica, and blue mussels Mytilus edulis. Hierarchical cluster analysis of prey consumed by young tautogs revealed three distinct size‐related feeding groups: (1) small fish (9–30 mm) that consumed calanoid copepods and gammarid amphipods, (2) midsized fish (31–70 mm) that were generalist feeders, concentrating on polychaete worms and crustaceans, and (3) large fish (81–165 mm) that preyed on mollusks, shrimps, and crabs.
Mr. Hobbs's Extraordinary Approach to Teaching Reading
Authors: Brassell Danny 
Published: September 2006

Author Danny Brassell's seventh‐grade reading teacher, Will Hobbs, positively affected his reading attitude with a simple, straightforward approach that motivated students to want to read for pleasure. The teacher
Provided a huge variety of high‐interest books in his classroom
Led book discussions that encouraged students to talk about what they were reading
Allowed students to choose books to read on their own while he read
Discouraged book reports in favor of student oral reviews
Developed a point system to reward students for the number of books they read
Encouraged students to always try to read more by posting the names of the five top readers on the chalkboard
This reading teacher went on to become a best‐selling children's book author whose stories inspire countless reluctant readers to pick up books for fun. The author credits this former reading teacher for providing him with the motivational approach he uses to get his students to read today.
Prisons and Health Reforms in England and Wales
Authors: Hayton Paul , Boyington John 
Published: September 2006

Prison health in England and Wales has seen rapid reform and modernization. Previously it was characterized by over-medicalization, difficulties in staff recruitment, and a lack of professional development for staff. The Department of Health assumed responsibility from Her Majesty’s Prison Service for health policymaking in 2000, and full budgetary and health care administration control were transferred by April 2006. As a result of this reorganization, funding has improved and services now relate more to assessed health need. There is early but limited evidence that some standards of care and patient outcomes have improved. The reforms address a human rights issue: that prisoners have a right to expect their health needs to be met by services that are broadly equivalent to services available to the community at large. We consider learning points for other countries which may be contemplating prison health reform, particularly those with a universal health care system.