bluuebunny/crossref_metadata_2025_split huggingface dataset:
Role of Surgeons in Clinical Trials for Thyroid Cancer
Authors: You Y. Nancy , Wells Samuel A. 
Published: April 2007

AbstractProperly performed clinical trials provide a foundation for evidence‐based medical practice. The surgeon plays a central role in the management of patients with malignant solid tumors, including thyroid cancer, because operative extirpation of the malignancy is the essential first step in effective therapy. This article discusses the role of the surgeon in the clinical research of thyroid cancer and also reviews the important clinical trials that have influenced the treatment of patients with thyroid cancer. Recent discoveries defining the genetic mutations underlying the various types of thyroid cancers have led to the development of targeted therapies. These chemical compounds, which are now being evaluated in clinical trials, hold great promise for the treatment of patients with locally advanced and distant metastatic disease. The surgical investigator also plays an important role in procuring tumor tissue from patients in clinical trials. The molecular analysis of these tissues is of critical importance in selecting specific therapies and predicting patient response and prognosis.
Transient Liver Dysfunction after Laparoscopic Gastrectomy for Gastric Cancer Patients
Authors: Etoh Tsuyoshi , Shiraishi Norio , Tajima Masaaki , Shiromizu Akio , Yasuda Kazuhiro , Inomata Masafumi , Kitano Seigo 
Published: April 2007

AbstractIntroductionThe effect of laparoscopic surgery under CO2 pneumoperitoneum on liver function is not clear. The aim of this study was to clarify whether laparoscopy‐assisted distal gastrectomy (LADG) is associated with changes in liver function compared with open distal gastrectomy (ODG).MethodsA total of 205 patients who underwent LADG (n = 147) or ODG (n = 58) between January 1994 and April 2004 were included in this study. Liver function tests—aspartate aminotransferase (AST), alanine aminotransferase (ALT), albumin, total bilirubin—were examined before surgery and at 1, 3, and 7 days after surgery. The postoperative clinical course was compared between the two groups.ResultsAST levels on day 1 and ALT levels on days 1 and 3 were significantly higher in the LADG group. Albumin levels showed a marked decrease after operation in both groups, but the level recovered more rapidly in the LADG group than in the ODG group, showing significant differences on days 3 and 7. The total bilirubin levels remained unchanged from baseline. The postoperative complication rate was similar in the two groups, although 3 LADG patients among the 27 patients with liver disease suffered severe enteritis.ConclusionsTransient liver dysfunction was documented in patients after laparoscopic gastrectomy under CO2 pneumoperitoneum.
A Single Surgical Unit’s Experience with Abdominal Tuberculosis in the HIV/AIDS Era
Authors: Clarke D.L. , Thomson S.R. , Bissetty T. , Madiba T.E. , Buccimazza I. , Anderson F. 
Published: April 2007

AbstractIntroductionHuman immunodeficiency virus/acquired immunodeficiency syndrome (HIV/AIDS) has resulted in a resurgence of abdominal tuberculosis in South Africa, and these patients often present to general surgeons. We describe a single‐hospital experience in a region of high HIV prevalence.MethodsA prospective database of all patients with suspected abdominal tuberculosis was maintained from January 2003 until July 2005.ResultsThere were 67 patients (20 men, 47 women) with an average age of 32 years (range 27–61 years). The erythrocyte sedimentation rate was universally elevated (105 ± 23). Altogether, 23 patients were HIV‐positive and 7 were HIV‐negative. The status was unknown in the remainder. Chest radiographs demonstrated an abnormality in 17 patients (22%). Abdominal ultrasonography was performed in 59 patients and computed tomography in 12. Twelve laparotomies were performed, seven as emergencies. None in the elective laparotomy group died, whereas the mortality rate in the emergency group was 60%. Laparoscopy was insufficient for a variety of reasons. Two patients underwent appendectomy and two excision of a perianal fistula. Two patients underwent biopsy of a palpable subcutaneous node, which confirmed the diagnosis in both cases. A definitive diagnosis was achieved in all 12 patients subjected to laparotomy and at colonoscopic biopsy in 2, lymph node biopsy in 2, appendectomy in 2, perianal fistulectomy in 2, and percutaneous drainage in 2. In the remaining 47 patients the diagnosis was made on the basis of the clinical presentation and radiologic imaging. The patients were commenced on antituberculous therapy. The in‐hospital mortality in this group was 10%. Therapy was continued at a centralized tuberculosis facility independent of the hospital. Surgical follow‐up was poor, with only five (7%) patients completing the 6‐month review at a surgical clinic.ConclusionsA resurgence in tuberculosis during the HIV era produces a new spectrum of presentations for the surgeon. Emergency surgery is associated with high mortality. Bacterial and histologic evidence of infection are difficult to obtain, and indirect clinical and imaging evidence are used to commence a trial of therapy. A short‐term clinical response is regarded as proof of disease. Lack of follow‐up means that the efficacy of this strategy is unproven. Health policy changes are needed to enable appropriate surgical follow‐up to determine the most effective management algorithm.
Prevalence of markers of heart failure in patients with atrial fibrillation and the effects of ximelagatran compared to warfarin on the incidence of morbid and fatal events: A report from the SPORTIF III and V trials
Authors: Cleland John G.F. , Shelton Rhiddian , Nikitin Nikolay , Ford Sarah , Frison Lars , Grind Margaretha 
Published: April 2007

AbstractBackground:Patients with atrial fibrillation (AF) who also have heart failure have a worse outcome but the diagnosis of heart failure is often missed.Aim:To compare the effects of warfarin and ximelagatran on morbidity and mortality in patients with AF with and without markers of heart failure.Methods and results:Data for 7329 patients from two randomised controlled trials were merged. Treatment with loop diuretics or the presence of left ventricular dysfunction, were used as markers of possible heart failure. The 3555 (49%) patients with markers of heart failure had higher composite event rates on warfarin (10.81% per year [py] [95% CI 9.59 to 12.13]) compared to the 3774 (51%) patients without markers of heart failure (4.18% py [95% CI 3.44 to 5.01]). The composite event rate was lower on ximelagatran overall (6.18% py [95% CI 5.51 to 6.89] versus 7.34% py [95% CI 6.63 to 8.10] on warfarin; P=0.0219 for the difference) with similar effects in each trial and in patients with and without markers of heart failure, mainly due to fewer heart‐failure events (hazard ratio 0.69 [95% CI 0.54 to 0.87]; P<0.001).Conclusions:Patients with markers of heart failure, even if the diagnosis is not well established, are at increased risk of thromboembolic events and might be targeted for more effective antithrombotic therapy. This might include patients in sinus rhythm as well as AF.
Effect of supplementation of women in high-risk pregnancies with long-chain polyunsaturated fatty acids on pregnancy outcomes and growth measures at birth: a meta-analysis of randomized controlled trials
Authors: Horvath Andrea , Koletzko Berthold , Szajewska Hania 
Published: April 2007

It is hypothesized that the intake of long-chain PUFA (LC-PUFA) throughout pregnancy could protect against pre-eclampsia, pregnancy-induced hypertension or intra-uterine growth retardation, and is essential for optimal neural development. The objective of the present study was to systematically evaluate the effect of LC-PUFA supplementation of high-risk pregnant women's diets on pregnancy outcomes and growth measures at birth. We searched MEDLINE, EMBASE, CINAHL and the Cochrane Library through March 2006 and references in reviewed articles for randomized controlled trials (RCT) comparing LC-PUFA supplementation with placebo or no supplementation in women with high-risk pregnancies. We found no evidence that supplementation influenced the duration of pregnancy or the percentage of preterm deliveries < 37 weeks of gestation. However, compared with controls, supplementation was associated with a significantly lower rate of early preterm delivery ( < 34 weeks of gestation) (two RCT; n 291; relative risk 0·39 (95 % CI 0·18, 0·84)). There was no significant difference in the infant birth weight, the rate of low birth weight ( < 2500 g or < 10th percentile) and the recurrence of intra-uterine growth retardation. Other pregnancy outcomes (for example, the rate of pregnancy-induced hypertension, the rate of pre-eclampsia and the rate of Caesarean section) were also similar in both groups. In conclusion, the present data suggest that supplementation with n-3 LC-PUFA in women with high-risk pregnancies reduced the risk of early preterm delivery in the fatty acid-supplemented group compared with the placebo group, while no other effects on pregnancy outcomes were detected.
Choosing a paediatric tracheostomy tube: an update on current practice
Authors: Tweedie D J , Skilbeck C J , Cochrane L A , Cooke J , Wyatt M E 
Published: April 2007

AbstractObjectives:A variety of paediatric tracheostomy tubes are available. This article reviews those in current use at Great Ormond Street Hospital.Methods:We outline our preferences and the particular indications for the different tubes, speaking valves and other attachments.Results:Practice has changed significantly in recent years. One product has been re-sized by its manufacturer; others are no longer commonly used. An updated sizing chart is included for reference purposes, together with manufacturers' contact details.Conclusions:The choice of paediatric tracheostomy tube is driven by clinical requirements. A small range of tubes are suitable for the majority of children, but some will require other varieties in specific circumstances.
Spherical splitting of 3-orbifolds
Authors: PETRONIO CARLO 
Published: April 2007

AbstractThe famous Haken–Kneser–Milnor theorem states that every 3-manifold can be expressed in a unique way as a connected sum of prime 3-manifolds. The analogous statement for 3-orbifolds has been part of the folklore for several years, and it was commonly believed that slight variations on the argument used for manifolds would be sufficient to establish it. We demonstrate in this paper that this is not the case, proving that the apparently natural notion of “essential” system of spherical 2-orbifolds is not adequate in this context. We also show that the statement itself of the theorem must be given in a substantially different way. We then prove the theorem in full detail, using a certain notion of “efficient splitting system.”
Kummer theory for big Galois representations
Authors: DELBOURGO DANIEL , SMITH PAUL 
Published: April 2007

AbstractIn their 1990 paper, Bloch and Kato described the image of the Kummer map on an abelian variety over a local field, as the group of 1-cocycles which trivialise after tensoring by Fontaine's mysterious ring BdR. We prove the analogue of this statement for the universal nearly-ordinary Galois representation. The proof uses a generalisation of the Tate local pairing to representations over affinoid K-algebras.
The abelianization of the congruence IA-automorphism group of a free group
Authors: SATOH TAKAO 
Published: April 2007

AbstractWe consider the abelianizations of some normal subgroups of the automorphism group of a finitely generated free group. Let Fn be a free group of rank n. For d ≥ 2, we consider a group consisting the automorphisms of Fn which act trivially on the first homology group of Fn with ${\mathbf Z}$/d${\mathbf Z}$-coefficients. We call it the congruence IA-automorphism group of level d and denote it by IAn,d. Let IOn,d be the quotient group of the congruence IA-automorphism group of level d by the inner automorphism group of a free group. We determine the abelianization of IAn,d and IOn,d for n ≥ 2 and d ≥ 2. Furthermore, for n=2 and odd prime p, we compute the integral homology groups of IA2,p for any dimension.
Antileukoproteinase protects against hepatic inflammation, but not apoptosis in the response of D‐galactosamine‐sensitized mice to lipopolysaccharide
Authors: Eipel C , Kidess E , Abshagen K , LeMinh K , Menger M D , Burkhardt H , Vollmar B 
Published: April 2007

Background and purpose:There is major evidence for the strong bi‐directional interrelation of parenchymal cell apoptosis and leukocyte accumulation and inflammation in acute liver injury. Therefore, the aim of this in vivo study was to investigate the anti‐apoptotic and anti‐inflammatory potential of antileukoproteinase (ALP) in a murine model of acute liver failure.Experimental approach:C57BL/6J mice were given galactosamine (D‐GalN) and E. coli lipopolysaccharide (LPS) followed by administration of saline or ALP. Besides survival rate, hepatic tissue damage and inflammatory response were analyzed by intravital fluorescence microscopy 6 hours after treatment. In addition, immunohistochemical analysis of NFκB‐p65 and hepatocellular apoptosis, plasma levels of AST/ALT, TNF‐α and IL‐10 were determined.Key results:Administration of D‐GalN/LPS provoked hepatic damage, including marked leukocyte recruitment and microvascular perfusion failure, as well as hepatocellular apoptosis and enzyme release. NFκB‐p65 became increasingly detectable in hepatocellular nuclei, accompanied by a rise of TNF‐α and IL‐10 plasma levels. ALP markedly reduced intrahepatic leukocyte accumulation, nuclear translocation of NFκB and plasma levels of TNF‐α and IL‐10. Moreover, liver enzyme levels indicated the absence of necrotic parenchymal cell death. In contrast, ALP failed to block both apoptosis and caspase‐3 levels and the mortality rate of ALP‐treated animals was comparable to that of saline‐treated mice.Conclusions and implications:ALP could effectively prevent D‐GalN/LPS‐associated intrahepatic inflammatory responses by inhibition of NFκB activity, but not apoptosis‐driven mortality. Thus, a protease‐inactivating approach such as application of ALP seems to be inadequate in damaged liver where apoptosis represents the predominant mode of cell death.British Journal of Pharmacology (2007) 151, 406–413; doi:10.1038/sj.bjp.0707230
Differential effects of selective oestrogen receptor modulators (SERMs) tamoxifen, ospemifene and raloxifene on human osteoclasts in vitro
Authors: Michael H , Härkönen P L , Kangas L , Väänänen H K , Hentunen T A 
Published: April 2007

Background and purpose:Several selective oestrogen receptor modulators (SERMs) with oestrogen agonist effects in bone cells and without increased risk of breast and endometrial cancer have been developed. Here, we have investigated the effects of different types of SERMs on osteoclast differentiation, bone resorption and apoptosis in vitro.Experimental approach:Human peripheral blood‐derived CD14+ monocytes were cultured on bovine bone slices in the presence of RANKL, M‐CSF, TNF‐α and dexamethasone for seven days. Also, CD14+ monocytes were co‐cultured either with human SaOS‐2 or MG‐63 osteosarcoma cells, in the presence of parathyroid hormone. Osteoclast cultures were treated with different SERMs. TRACP+ multinucleated cells and C‐terminal telopeptide of type I collagen were used as markers for osteoclast formation and bone resorption, respectively.Key Results:In CD14+ monocyte cultures, tamoxifen directly inhibited human osteoclast formation and bone resorption, while raloxifene and ospemifene had no inhibitory effect. In the co‐cultures either with SaOS‐2 or MG‐63 cells, ospemifene and raloxifene as well as tamoxifen inhibited osteoclast formation in a concentration‐dependent manner. The inhibitory effect was associated with an increased production of osteoprotegerin. The anti‐oestrogen ICI 182 780 completely reversed the effects of these SERMs.Conclusion and Implications:Tamoxifen had an oestrogen receptor dependent, direct, inhibitory effect on human osteoclast differentiation and bone resorption, whereas ospemifene and raloxifene required osteoblastic cells to achieve a similar inhibition. The effects of ospemifene and raloxifene were mediated by oestrogen receptors by a mechanism involving paracrine induction of osteoprotegerin in cultures with osteoblast derived osteosarcoma cells.British Journal of Pharmacology (2007) 151, 384–395; doi:10.1038/sj.bjp.0707232
Monoterpenoid agonists of TRPV3
Authors: Vogt‐Eisele A K , Weber K , Sherkheli M A , Vielhaber G , Panten J , Gisselmann G , Hatt H 
Published: April 2007

Background and purpose:Transient receptor potential (TRP) V3 is a thermosensitive ion channel expressed predominantly in the skin and neural tissues. It is activated by warmth and the monoterpene camphor and has been hypothesized to be involved in skin sensitization. A selection of monoterpenoid compounds was tested for TRPV3 activation to establish a structure‐function relationship. The related channel TRPM8 is activated by cool temperatures and a number of chemicals, among them the monoterpene (‐)‐menthol. The overlap of the receptor pharmacology between the two channels was investigated.Experimental approach:Transfected HEK293 cells were superfused with the test substances. Evoked currents were measured in whole cell patch clamp measurements. Dose‐response curves for the most potent agonists were obtained in Xenopus laevis oocytes.Key results:Six monoterpenes significantly more potent than camphor were identified: 6‐tert‐butyl‐m‐cresol, carvacrol, dihydrocarveol, thymol, carveol and (+)‐borneol. Their EC50 is up to 16 times lower than that of camphor. All of these compounds carry a ring‐located hydroxyl group and neither activates TRPM8 to a major extent.Conclusions and implications:Terpenoids have long been recognized as medically and pharmacologically active compounds, although their molecular targets have only partially been identified. TRPV3 activation may be responsible for several of the described effects of terpenoids. We show here that TRPV3 is activated by a number of monoterpenes and that a secondary hydroxyl‐group is a structural requirement.British Journal of Pharmacology (2007) 151, 530–540; doi:10.1038/sj.bjp.0707245
Probe diagnostics of argon-oxygen-tetramethyltin capacitively coupled plasmas for the deposition of tin oxide thin films
Authors: Pulpytel J. , Morscheidt W. , Arefi-Khonsari F. 
Published: April 2007

Langmuir probe measurements in nondepositing and depositing rf capacitively coupled (CCP) plasmas are briefly reviewed and compared to the results obtained in our rf system used for the deposition of tin oxide (SnO2) thin films from argon-oxygen-tetamethyltin [Sn(CH3)4] plasmas. Typically in our experimental conditions for tin oxide deposition, values of kTeff= 1.2−1.5 eV and ne=3−5×109 cm−3 were measured. These values are consistent with those generally reported in other depositing discharges. The shape of the electron energy probability function (EEPF), obtained from the Druyvesteyn procedure, was discussed too. As a consequence of the two electron heating mechanisms in capacitively coupled discharges, that is, ohmic and stochastic heating, the electrons have a bi-Maxwellian EEPF at low pressure (in the range of 10−100 mTorr). Moreover, a deep “hole” appears in the EEPF at the energy which could correspond to the resonant peak of the vibrational excitation cross section of some molecules which can be present in the discharge, such as N2, CH4, or CO.
Randomized exposure‐controlled trials; impact of randomization and analysis strategies
Authors: Karlsson Kristin E. , Grahnén Anders , Karlsson Mats O. , Jonsson E. Niclas 
Published: April 2007

What is already known about this subject • When characterizing an exposure–response relationship it has been suggested that the randomized concentration‐controlled trial (RCCT) is potentially a more informative design than a randomized dose‐controlled trial design (RDCT).• Traditionally, these trials have been analysed by group‐wise comparison or similar statistics.• The aim of this study was to compare different randomization schemes when a model‐based analysis has been performed. What this study adds • Alternative randomization schemes may not have the proposed advantages if a model‐based analysis is employed.AimsIn the literature, five potential benefits of randomizing clinical trials on concentration levels, rather than dose, have been proposed: (i) statistical study power will increase; (ii) study power will be less sensitive to high variability in the pharmacokinetics (PK); (iii) the power of establishing an exposure–response relationship will be robust to correlations between PK and pharmacodynamics (PD); (iv) estimates of the exposure–response relationship are likely to be less biased; and (v) studies will provide a better control of exposure in situations with toxicity issues. The main aim of this study was to investigate if these five statements are valid when the trial results are evaluated using a model‐based analysis.MethodsQuantitative relationships between drug dose, concentration, biomarker and clinical end‐point were defined using pharmacometric models. Three randomization schemes for exposure‐controlled trials, dose‐controlled (RDCT), concentration‐controlled (RCCT) and biomarker‐controlled (RBCT), were simulated and analysed according to the models.Results(i) The RCCT and RBCT had lower statistical power than RDCT in a model‐based analysis; (ii) with a model‐based analysis the power for an RDCT increased with increasing PK variability; (iii) the statistical power in a model‐based analysis was robust to correlations between CL and EC50 or Emax; (iv) under all conditions the bias was negligible (<3%); and (v) for studies with equal power RCCT could produce either more or fewer adverse events compared with an RDCT.ConclusionAlternative randomization schemes may not have the proposed advantages if a model‐based analysis is employed.
A randomized comparison of the effect of two prelinguistic communication interventions on the acquisition of spoken communication in preschoolers with ASD
Authors: Temple Kathryn 
Published: April 2007

.

Yoder, P. &
Stone, W. P.
(
2006
)

,
49
,
698
–
711
.
Purpose  This randomized group experiment compared the efficacy of two communication interventions [Responsive Education and Prelinguistic Milieu Teaching (RPMT) and the Picture Exchange Communication System (PECS)] on spoken communication in 36 pre‐schoolers with autism spectrum disorders (ASD).Method  Each treatment was delivered to children for a maximum total of 24 h over a 6‐month period. Spoken communication was assessed in a rigorous test of generalization at pretreatment, post‐treatment and 6‐month follow‐up periods.Results  Picture Exchange Communication System was more successful than RPMT in increasing the number of non‐imitative spoken communication acts and the number of different non‐imitative words used at the post‐treatment period. Considering growth over all three measurement periods, an exploratory analysis showed that growth rate of the number of different non‐imitative words was faster in the PECS group than in the RPMT group for children who began treatment with relatively high object exploration. In contrast, analogous slopeswere steeper in the RPMT group than in the PECS group for children who began treatment with relatively low object exploration.