bluuebunny/crossref_metadata_2025_split huggingface dataset:
Comparison of two recombinant erythropoietin formulations in patients with anemia due to end-stage renal disease on hemodialysis: A parallel, randomized, double blind study
Authors: Pérez-Oliva Jorge F , Casanova-González Martha , García-García Idrian , Porrero-Martín Pedro J , Valenzuela-Silva Carmen M , Hernández-Montero Tairí , Lagarde-Ampudia Marcia , Casanova-Kutsareva Yuri , Ávila-Albuerne Yisel , Vargas-Batista Alicia , Bobillo-López Hailen , Herrera-Valdés Raúl , López-Saura Pedro A ,   the Bioequivalence Study of Erythropoietin Group
Published: May 2005

Abstract
Background
Recombinant human erythropoietin (EPO) is used for the treatment of last stage renal anemia. A new EPO preparation was obtained in Cuba in order to make this treatment fully nationally available. The aim of this study was to compare the pharmacokinetic, pharmacodynamic and safety properties of two recombinant EPO formulations in patients with anemia due to end-stage renal disease on hemodialysis.

Methods
A parallel, randomized, double blind study was performed. A single 100 IU/Kg EPO dose was administered subcutaneously. Heberitro (Heber Biotec, Havana, formulation A), a newly developed product and Eprex (CILAG AG, Switzerland, formulation B), as reference treatment were compared. Thirty-four patients with anemia due to end-stage renal disease on hemodialysis were included. Patients had not received EPO previously. Serum EPO level was measured by enzyme immunoassay (EIA) during 120 hours after administration. Clinical and laboratory variables were determined as pharmacodynamic and safety criteria until 216 hours.

Results
Both groups of patients were similar regarding all demographic and baseline characteristics. EPO kinetics profiles were similar for both formulations; the pharmacokinetic parameters were very close (i.e., AUC: 4667 vs. 4918 mIU.h/mL; Cmax: 119.1 vs. 119.7 mIU/mL; Tmax: 13.9 vs. 18.1 h; half-life, 20.0 vs. 22.5 h for formulations A and B, respectively). The 90% confidence intervals for the ratio between both products regarding these metrics were close to the 0.8 – 1.25 range, considered necessary for bioequivalence. Differences did not reach 20% in any case and were not determined by a formulation effect, but probably by a patients' variability effect. Concerning pharmacodynamic features, a high similitude in reticulocyte counts increments until 216 hours and the percentage decrease in serum iron until 120 hours was observed. There were no differences between formulations regarding the adverse events and their intensity. The more frequent events were pain at injection site (35.3%) and hypertension (29%). Additionally, further treatment of the patients with the study product yielded satisfactory increases in hemoglobin and hematocrit values.

Conclusion
The formulations are comparable. The newly developed product should be acceptable for long-term application.
Adenovirus-mediated interleukin-12 gene transfer combined with cytosine deaminase followed by 5-fluorocytosine treatment exerts potent antitumor activity in Renca tumor-bearing mice
Authors: Hwang Kyung-Sun , Cho Won-Kyung , Yoo Jinsang , Yun Hwan-Jung , Kim Samyong , Im Dong-Soo 
Published: May 2005

Abstract
Background
Therapeutic gene transfer affords a clinically feasible and safe approach to cancer treatment but a more effective modality is needed to improve clinical outcomes. Combined transfer of therapeutic genes with different modes of actions may be a means to this end. Interleukin-12 (IL-12), a heterodimeric immunoregulatory cytokine composed of covalently linked p35 and p40 subunits, has antitumor activity in animal models. The enzyme/prodrug strategy using cytosine deaminase (CD) and 5-fluorocytosine (5-FC) has been used for cancer gene therapy. We have evaluated the antitumor effect of combining IL-12 with CD gene transfer in mice bearing renal cell carcinoma (Renca) tumors.

Methods
Adenoviral vectors were constructed encoding one or both subunits of murine IL-12 (Ad.p35, Ad.p40 and Ad.IL-12) or cytosine deaminase (Ad.CD). The functionality of the IL-12 or CD gene products expressed from these vectors was validated by splenic interferon (IFN)-γ production or viability assays in cultured cells. Ad.p35 plus Ad.p40, or Ad.IL-12, with or without Ad.CD, were administered (single-dose) intratumorally to Renca tumor-bearing mice. The animals injected with Ad.CD also received 5-FC intraperitoneally. The antitumor effects were then evaluated by measuring tumor regression, mean animal survival time, splenic natural killer (NK) cell activity and IFN-γ production.

Results
The inhibition of tumor growth in mice treated with Ad.p35 plus Ad.p40 and Ad.CD, followed by injection of 5-FC, was significantly greater than that in mice treated with Ad.CD/5-FC, a mixture of Ad.p35 plus Ad.p40, or Ad.GFP (control). The combined gene transfer increased splenic NK cell activity and IFN-γ production by splenocytes. Ad.CD/5-FC treatment significantly increased the antitumor effect of Ad.IL-12 in terms of tumor growth inhibition and mean animal survival time.

Conclusion
The results suggest that adenovirus-mediated IL-12 gene transfer combined with Ad.CD followed by 5-FC treatment may be useful for treating cancers.
Colon cancer in Luxembourg: a national population-based data report, 1988–1998
Authors: Scheiden René , Pescatore Paul , Wagener Yolande , Kieffer Nelly , Capesius Catherine 
Published: May 2005

Abstract
Background
Over the last two decades time trends in incidence rates of colorectal cancer, changes in the proportions of stage at diagnosis and changes in the anatomic sub-site distribution of colon cancers have been reported in some European countries. In order to determine a strategy for early detection of colon cancer in the Grand-Duchy of Luxembourg, all consecutive colon adenocarcinomas diagnosed during the period 1988–1998 at a nation-wide level were reviewed.

Methods
The population-based data of the national Morphologic Tumour Registry report all new high-grade adenomas (i.e. high-grade intraepithelial adenomatous neoplasias) and all consecutive new invasive adenocarcinomas of the colon diagnosed in the central department of pathology. Attention has been focused on variations in incidence, stage, anatomical site distribution and survival rates. Rectal cancers were excluded.

Results
Over the study period, 254 new colonic high-grade adenomas and 1379 new invasive adenocarcinomas were found; the crude incidence rates of colon adenocarcinomas grew steadily by 30%. Comparing the two 5-year periods 1988–1992 and 1994–1998, the crude incidence rates of high-grade adenomas (stage 0) rose by 190%, that of stage I cases by 14.3%, stage II cases 12.9% and stage III cases 38.5%, whereas the crude incidence rates of stage IV cases decreased by 11.8%. The high-grade adenoma/adenocarcinoma ratio increased. The right-sided colonic adenocarcinomas in elderly patients (>69 years) increased by 76%. The observed survival rates correlated with tumour stages. The overall observed 5-year survival rate (stage I-IV) was 51 ± 3% (95% confidence interval).

Conclusion
The increasing incidence rates of colon adenocarcinomas, the persistence of advanced tumour stages (stage III), the mortality rates which remain stable, and the changing trends in the age- and sub-site distribution underline the need for preventive measures at the age of 50 in asymptomatic patients to reduce mortality from colo(rectal) cancer.
Efficacy of Wnt-1 monoclonal antibody in sarcoma cells
Authors: Mikami Iwao , You Liang , He Biao , Xu Zhidong , Batra Sonny , Lee Amie Y , Mazieres Julien , Reguart Noemi , Uematsu Kazutsugu , Koizumi Kiyoshi , Jablons David M 
Published: May 2005

Abstract
Background
Sarcomas are one of the most refractory diseases among malignant tumors. More effective therapies based on an increased understanding of the molecular biology of sarcomas are needed as current forms of therapy remain inadequate. Recently, it has been reported that Wnt-1/β-catenin signaling inhibits apoptosis in several cancers. In this study, we investigated the efficacy of a monoclonal anti-Wnt-1 antibody in sarcoma cells.

Methods
We treated cell lines A-204, SJSA-1, and fresh primary cultures of lung metastasis of sarcoma with a monoclonal anti-Wnt-1 antibody. Wnt-1 siRNA treatment was carried out in A-204. We assessed cell death using Crystal Violet staining. Apoptosis induction was estimated by flow cytometry analysis (Annexin V and PI staining). Cell signaling changes were determined by western blotting analysis.

Results
We detected Wnt-1 expression in all tissue samples and cell lines. Significant apoptosis induction was found in monoclonal anti-Wnt-1 antibody treated cells compared to control monoclonal antibody treated cells (p < 0.02). Similarly, we observed increased apoptosis in Wnt-1 siRNA treated cells. Blockade of Wnt-1 signaling in both experiments was confirmed by analyzing intracellular levels of Dishevelled-3 and of cytosolic β-catenin. Furthermore, the monoclonal anti-Wnt-1 antibody also induced cell death in fresh primary cultures of metastatic sarcoma in which Wnt-1 signaling was active.

Conclusion
Our results indicate that Wnt-1 blockade by either monoclonal antibody or siRNA induces cell death in sarcoma cells. These data suggest that Wnt-1 may be a novel therapeutic target for the treatment of a subset of sarcoma cells in which Wnt-1/β-catenin signaling is active.
Bupivacaine versus lidocaine analgesia for neonatal circumcision
Authors: Stolik-Dollberg Orit C , Dollberg Shaul 
Published: May 2005

Abstract
Background
Analgesia for neonatal circumcision was recently advocated for every male infant, and its use is considered essential by the American Academy of Pediatrics. We compared the post-operative analgesic quality of bupivacaine to that of lidocaine for achieving dorsal penile nerve block (DPNB) when performing neonatal circumcision.

Methods
Data were obtained from 38 neonates following neonatal circumcision. The infants had received DPNB analgesia with either lidocaine or bupivacaine. The outcome variable was the administration by the parents of acetaminophen during the ensuing 24 hours.

Results
Seventeen infants received lidocaine and 19 received bupivacaine DPNB. Ten infants in the lidocaine group (59%) were given acetaminophen following circumcision compared to only 3 (16%) in the bupivacaine group (P < 0.01). Regression analysis showed that the only significant variable associated with the need for acetaminophen was the use of lidocaine (R2 = 20.6; P = 0.006).

Conclusion
DPNB with bupivacaine for neonatal circumcision apparently confers better analgesia than lidocaine as judged by the requirement of acetaminophen over the ensuing 24-hour period.
Optimal fetal growth for the Caucasian singleton and assessment of appropriateness of fetal growth: an analysis of a total population perinatal database
Authors: Blair Eve M , Liu Yingxin , de Klerk Nicholas H , Lawrence David M 
Published: May 2005

Abstract
Background
The appropriateness of an individual's intra uterine growth is now considered an important determinant of both short and long term outcomes, yet currently used measures have several shortcomings. This study demonstrates a method of assessing appropriateness of intrauterine growth based on the estimation of each individual's optimal newborn dimensions from routinely available perinatal data. Appropriateness of growth can then be inferred from the ratio of the value of the observed dimension to that of the optimal dimension.

Methods
Fractional polynomial regression models including terms for non-pathological determinants of fetal size (gestational duration, fetal gender and maternal height, age and parity) were used to predict birth weight, birth length and head circumference from a population without any major risk factors for sub-optimal intra-uterine growth. This population was selected from a total population of all singleton, Caucasian births in Western Australia 1998–2002. Births were excluded if the pregnancy was exposed to factors known to influence fetal growth pathologically. The values predicted by these models were treated as the optimal values, given infant gender, gestational age, maternal height, parity, and age.

Results
The selected sample (N = 62,746) comprised 60.5% of the total Caucasian singleton birth cohort. Equations are presented that predict optimal birth weight, birth length and head circumference given gestational duration, fetal gender, maternal height, age and parity. The best fitting models explained 40.5% of variance for birth weight, 32.2% for birth length, and 25.2% for head circumference at birth.

Conclusion
Proportion of optimal birth weight (length or head circumference) provides a method of assessing appropriateness of intrauterine growth that is less dependent on the health of the reference population or the quality of their morphometric data than is percentile position on a birth weight distribution.
Pretreatment Beck Depression Inventory score is an important predictor for Post-treatment score in infertile patients: a before-after study
Authors: Khademi Afsaneh , Alleyassin Ashraf , Aghahosseini Marzieh , Ramezanzadeh Fatemeh , Abhari Ali Ahmadi 
Published: May 2005

Abstract
Background
The experience of infertility can be extremely stressful. Some of the risk factors for depression in infertility are being female, repeated unsuccessful treatment cycles or a 2 to 3 year history of infertility, low socioeconomic status, foreign nationality, lack of partner support, life events and previous depression. In this study, we analyzed the Beck Depression Inventory score at the beginning and the end of infertility treatment, to determine which factors may influence the BDI score after treatment of infertility.

Methods
In a before-after study, in a university-affiliated teaching hospital, 251 women who had been visited for assisted reproductive technology infertility treatment participated in the study. BDI score was assessed before and after treatment of infertility.

Results
The mean BDI score rose after unsuccessful treatment and dropped after successful treatment. Those with lower education levels had a higher BDI score before treatment. BDI score after treatment was positively correlated with pretreatment BDI scoreand duration of infertility.

Conclusion
BDI score after treatment was strongly connected to the BDI score before treatment, the result of therapy and to the duration of infertility. The influence of duration of infertility on BDI score after treatment of infertility is weak. So a simple method to screen patients at risk of depression after infertility treatment is determining pretreatment BDI score and predicting the result of infertility treatment by other risk factors.
Are non-responders in a quitline evaluation more likely to be smokers?
Authors: Tomson Tanja , Björnström Catrine , Gilljam Hans , Helgason Asgeir 
Published: May 2005

Abstract

Background
In evaluation of smoking cessation programs including surveys and clinical trials the tradition has been to treat non-responders as smokers. The aim of this paper is to assess smoking behaviour of non-responders in an evaluation of the Swedish national tobacco cessation quitline a nation-wide, free of charge service.

Methods
A telephone interview survey with a sample of people not participating in the original follow-up. The study population comprised callers to the Swedish quitline who had consented to participate in a 12 month follow-up but had failed to respond. A sample of 84 (18% of all non-responders) was included. The main outcome measures were self-reported smoking behaviour at the time of the interview and at the time of the routine follow-up. Also, reasons for not responding to the original follow-up questionnaire were assessed. For statistical comparison between groups we used Fischer's exact test, odds ratios (OR) and 95% confidence intervals (CI) on proportions and OR.

Results
Thirty-nine percent reported to have been smoke-free at the time they received the original questionnaire compared with 31% of responders in the original study population. The two most common reasons stated for not having returned the original questionnaire was claiming that they had returned it (35%) and that they had not received the questionnaire (20%). Non-responders were somewhat younger and were to a higher degree smoke-free when they first called the quitline.

Conclusion
Treating non-responders as smokers in smoking cessation research may underestimate the true effect of cessation treatment.
New chemolysis for urological calcium phosphate calculi – a study in vitro
Authors: Xiang-bo Zhang , Zhi-ping Wang , Jian-min Duan , Jian-zhong Lu , Bao-liang Ma 
Published: May 2005

Abstract
Background
Advances in techniques have left very few indications for open surgical extraction of urinary stones currently. These advances notwithstanding, the search continues for medical approaches to urinary stone management. In this study, we perform an in vitro study analyzing the efficiency and prospect of two new complex solutions in urological calcium phosphate calculi dissolution.

Methods
Eighteen stones composed mainly of calcium phosphates were taken from patients who underwent kidney stone surgery. These stones were large enough (weight range 0.514–0.928 g) to be fragmented and matched equally into six groups. Chemolysis of phosphate stones was done with six different solvents and was repeated 3 times with 6 stones for each solution. At 24, 48 and 72 h, reduction in weight, percentage weight change, and dissolution rate; the dissolution rates at pH 5.0, 7.0 and 8.5 for each solution, using different cations (Na+, K+ or Ca2+), according to different dilutions (1:1, 1:2, 1:3, 1:4) of S1 and S2 were simultaneously determined.

Results
Calcium phosphate calculi were poorly dissolved by Phys and Art, and they had a low dissolution rate in pH 8.5 EDTA. The most effective solutions were S1, S2 and R, with 72 h mean dissolution rates: 5.75 ± 0.44 mg/hr (S1), 5.2 ± 0.63 mg/hr (S2), 4.55 ± 0.46 mg/hr (R) ("Equation missing" ± s, p < 0.01 R, S1 and S2 vs Phys, Art and EDTA; p < 0.05, S1 vs R, LSD-test). The mean percentage weight loss at 72 h was: 52.1 ± 15.75 % (S1), 44.4 ± 7.37 % (S2) and 40.5 ± 3.67 % (R) ("Equation missing" ± s, p < 0.01 R, S1 and S2 vs Phys, Art and EDTA, LSD-test). Diluted twice, S1 and S2 had even better effectiveness than their initial solution. The additive of Na+, K+ or Ca2+ greatly reduced the dissolution rates of S1, S2.

Conclusion
Our data indicate that test solutions S1 and S2 are effective solvents in the chemolysis of calcium phosphate stones. At twice dilutions, these solutions are even more useful in the treatment of stone disease.
Simultaneous imaging of GFP, CFP and collagen in tumors in vivousing multiphoton microscopy
Authors: Sahai Erik , Wyckoff Jeffrey , Philippar Ulrike , Segall Jeffrey E , Gertler Frank , Condeelis John 
Published: May 2005

Abstract

Background
The development of multiphoton laser scanning microscopy has greatly facilitated the imaging of living tissues. However, the use of genetically encoded fluorescent proteins to distinguish different cell types in living animals has not been described at single cell resolution using multiphoton microscopy.

Results
Here we describe a method for the simultaneous imaging, by multiphoton microscopy, of Green Fluorescent Protein, Cyan Fluorescent Protein and collagen in vivo in living tumors. This novel method enables: 1) the simultaneous visualization of overall cell shape and sub-cellular structures such as the plasma membrane or proteins of interest in cells inside living animals, 2) direct comparison of the behavior of single cells from different cell lines in the same microenvironment in vivo.

Conclusion
Using this multi-fluor, multiphoton technique, we demonstrate that motility and metastatic differences between carcinoma cells of differing metastatic potential can be imaged in the same animal simultaneously at sub-cellular resolution.
A centralised public information resource for randomised trials: a scoping study to explore desirability and feasibility
Authors: Langston Anne L , Campbell Marion K , Entwistle Vikki A , Skea Zoë 
Published: May 2005

Abstract

Background
There are currently several concerns about the ways in which people are recruited to participate in randomised controlled trials, the low acceptance rates among people invited to participate, and the experiences of trial participants. An information resource about on-going clinical trials designed for potential and current participants could help overcome some of these problems.

Methods
We carried out a scoping exercise to explore the desirability and feasibility of establishing such a resource. We sought the views of a range of people including people who were considering taking part in a trial, current trial participants, people who had been asked but refused to participate in a trial, consumer group representatives and researchers who design and conduct trials.

Results
There was broad-based support for the concept of a centralised information resource for members of the public about on-going and recently completed clinical trials. Such an information resource could be based on a database containing standardised information for each trial relating to the purpose of the trial; the interventions being compared; the implications of participation for participants; and features indicative of scientific quality and ethical probity. The usefulness of the database could be enhanced if its search facility could allow people to enter criteria such as a disease and geographic area and be presented with all the trials relevant to them, and if optional display formats could allow them to view information in varying levels of detail. Access via the Internet was considered desirable, with complementary supported access via health information services. The development of such a resource is technically feasible, but the collation of the required information would take a significant investment of resources.

Conclusion
A centralised participant oriented information resource about clinical trials could serve several purposes. A more detailed investigation of its feasibility and exploration of its potential impacts are required.