nils-herrmann/clean_scirepeval huggingface dataset:
Fixation of the tibial component in knee arthroplasty after six weeks

The fixation of cemented and uncemented PCA modular cruciform-stemmed tibial components was examined 6 weeks after operation using roentgenstereophotogrammetric analysis in 26 randomly selected patients. Physiological external forces were applied in external/internal rotation and eccentric posterior loading generated by squatting. All cases showed inducible displacement, but there were no statistically significant differences between the 2 groups in inducible displacement or in the initial migration, except for subsidence between the lying and standing position. In some, the greatest movement was found when changing from resting to standing, or during rotational stress; in others, the greatest movement was found during squatting. There was a statistical difference in subsidence on squatting which was greater in the uncemented group. The design of the cruciform stem and the use of an internally cooled saw may explain this small differences between the 2 groups. La fixation de prothèses du genou PCA Modular à tige tibiale cruciforme, cimentée ou non, a été étudiée par analyse stéréophotométrique, 6 semaines après l'intervention, chez 26 patients randomisés. Des contraintes externes physiologiques ont été appliquées en rotation externe et interne et l'accroupissement a simulé la mise en charge excentrique postérieure. Dans tous les cas un déplacement provoqué a pu être constaté. Une différence statistiquement significative, entre les deux groupes, n'a pu être mise en évidence ni pour le déplacement provoqué, ni pour la migration initiale, à l'exception de l'abaissement constaté entre les positions couché sur le ventre et debout (0,0 pour le groupe cimenté contre 0,2 mm pour le non-cimenté, p<0.05). Dans certains cas le déplacement le plus important a été noté durant le passage de la position de repos à la position debout ou lors des contraintes en rotation interne-externe, alors que dans d'autres cas le déplacement le plus grand a été observé lors de l'accroupissement. Une différence statistiquement significative de l'abaissement de la prothèse dans cette position a été constatée, puisqu'il est nul pour les pièces cimentées et de 0,2 mm pour les non-cimentées (p<0,05). La forme de la prothèse avec une queue cruciforme ainsi que l'utilisation d'une lame de scie à refroidissement interne peuvent expliquer que la différence ne soit que minime entre les deux groupes, cimenté et non-cimenté.
Bioequivalence of two tablet formulations of capecitabine and exploration of age, gender, body surface area, and creatinine clearance as factors influencing systemic exposure in cancer patients

The objective of the study was to assess the bioequivalence of two tablet formulations of capecitabine and to explore the effect of age, gender, body surface area and creatinine clearance on the systemic exposure to capecitabine and its metabolites.  The study was designed as an open, randomized two-way crossover trial. A single oral dose of 2000 mg capecitabine was administered on two separate days to 25 patients with solid tumors. On one day, the patients received four 500-mg tablets of formulation B (test formulation) and on the other day, four 500-mg tablets of formulation A (reference formulation). The washout period between the two administrations was between 2 and 8 days. After each administration, serial blood and urine samples were collected for up to 12 and 24 h, respectively. Unchanged capecitabine and its metabolites were determined in plasma using LC/MS-MS and in urine by NMRS.  Based on the primary pharmacokinetic parameter, AUC0–∞ of 5′-DFUR, equivalence was concluded for the two formulations, since the 90% confidence interval of the estimate of formulation B relative to formulation A of 97% to 107% was within the acceptance region 80% to 125%. There was no clinically significant difference between the tmax for the two formulations (median 2.1 versus 2.0 h). The estimate for Cmax was 111% for formulation B compared to formulation A and the 90% confidence interval of 95% to 136% was within the reference region 70% to 143%. Overall, these results suggest no relevant difference between the two formulations regarding the extent to which 5′-DFUR reached the systemic circulation and the rate at which 5′-DFUR appeared in the systemic circulation. The overall urinary excretions were 86.0% and 86.5% of the dose, respectively, and the proportion recovered as each metabolite was similar for the two formulations. The majority of the dose was excreted as FBAL (61.5% and 60.3%), all other chemical species making a minor contribution. Univariate and multivariate regression analysis to explore the influence of age, gender, body surface area and creatinine clearance on the log-transformed pharmacokinetic parameters AUC0–∞ and Cmax of capecitabine and its metabolites revealed no clinically significant effects. The only statistically significant results were obtained for AUC0–∞ and Cmax of intact drug and for Cmax of FBAL, which were higher in females than in males.  The bioavailability of 5′-DFUR in the systemic circulation was practically identical after administration of the two tablet formulations. Therefore, the two formulations can be regarded as bioequivalent. The variables investigated (age, gender, body surface area, and creatinine clearance) had no clinically significant effect on the pharmacokinetics of capecitabine or its metabolites.
Prevalence and determinants of recent HIV testing among sexually active men who have sex with men in the St. Louis metropolitan area, Missouri, 2008.

New human immunodeficiency virus (HIV) diagnoses in the St. Louis metropolitan area, MO, occur predominantly among men who have sex with men (MSM). The Centers for Disease Control and Prevention recommends HIV testing at least annually for sexually active MSM. We examined prevalence and factors associated with recent HIV testing among MSM in the St. Louis area.



The 2008 National HIV Behavioral Surveillance system recruited men in 21 US metropolitan areas through venue-based, time-space sampling. Men were interviewed for behavioral risks and testing history. The analysis included men in St. Louis who had engaged in male-male sex during the previous year and excluded men who had tested HIV-positive >12 months before the interviews. Factors associated with testing during the previous 12 months were identified using log-binomial regression.



Among 339 MSM, 198 (58%) had been tested during the previous 12 months. MSM were more likely to have been tested if they were black (adjusted prevalence ratio [APR]: 1.6; 95% confidence interval [CI]: 1.0-2.5); had visited a health care provider during the previous 12 months (APR: 1.6; 95% CI: 1.3-2.1); or had ever disclosed same-sex attractions or male-male sex to health care providers (APR: 1.6; 95% CI: 1.2-2.0). Of the 141 men who were untested within 12 months, 89 (63%) attributed not testing to perceived low risk.



Nearly half of sexually active MSM in this analysis had not been tested for HIV during the previous year. Annual visits to health care providers during which sexual risk is discussed are likely to promote testing among MSM.
Effect of Renal and Hepatic Impairment on the Pharmacokinetics of Cabozantinib.

Cabozantinib is a tyrosine kinase inhibitor approved for the treatment of patients with progressive, metastatic medullary thyroid cancer. Two clinical pharmacology studies were conducted to characterize single-dose pharmacokinetics (PK) of cabozantinib in renally or hepatically impaired subjects. Study 1 enrolled 10 subjects, each with mild or moderate impairment of renal function; 12 healthy subjects were matched to the moderate group for age, sex, and body mass index (BMI). Study 2 enrolled 8 males each with mild or moderate hepatic impairment; 10 healthy males were matched to the moderate group for age, BMI, and ethnicity. All subjects received one 60 mg cabozantinib oral capsule dose followed by PK sampling over 21 days. Plasma concentration and protein binding were determined by liquid chromatography tandem mass spectrometry and equilibrium dialysis, respectively. PK parameters were computed using noncompartmental methods. Geometric least squared mean (LSM) ratios for plasma cabozantinib AUC0-∞ for impaired to normal organ function cohorts were (1) approximately 30% and 6% higher in subjects with mild and moderate renal impairment, respectively, and (2) approximately 81% and 63% higher in subjects with mild and moderate hepatic impairment, respectively. The percentage of unbound drug was slightly higher in both moderately impaired cohorts. No deaths or discontinuations due to adverse events occurred in either study. Cabozantinib should be used with caution in subjects with mild or moderate renal impairment. Subjects with mild or moderate hepatic impairment administered cabozantinib should be monitored closely for potential treatment-emergent drug toxicity that may necessitate a dose hold or reduction.
The response of right ventricular size, function, and pressure to supine exercise: A comparison of patients with chronic obstructive lung disease and normal subjects

The response of right ventricular ejection fraction (RVEF) and right ventricular end-diastolic volume (RVEDV) to exercise was studied in 11 patients with severe (FEF25%–75%=0.32±0.13, mean ±SD) chronic obstructive pulmonary disease (COPD). Using gated radionuclide cardiac blood pool imaging techniques, the response of the patients with COPD was compared with that of 15 control subjects. Arterial blood gases, pulmonary arterial pressures, wedge pressure, and right ventricular pressures also were monitored in patients with COPD. The resting R VEF was lower and the resting RVEDV was higher in patients with COPD than in normals (both,P<0.01). Two of the 11 COPD patients had a RVEF during rest that was below lower limits, while 10 of 11 patients had RV dilation. Right ventricular end-diastolic pressure, measured during rest in patients with COPD, was normal (6.1±2.1 mm Hg) and cardiac index was within normal limits (3.55±0.82 l/min/m2). With exercise this cardiac index rose to 5.52±1.7/min/m2 (P<0.01) due to the increase in heart rate (83±18 to 125±25 beats/min;P<0.01) while stroke volume did not significantly change. During exercise, normal subjects showed and increase in RVEF while RVEDV did not change; in patients with COPD, the RVEF fell and the RVEDV increased. In the patients with COPD, mild resting arterial hypoxemia and hypercapnia were both exaggerated during exercise; and mild resting pulmonary arterial hypertension (PAm=24.3±7.6 mm Hg) also worsened with exercise (PAm=41±19 mm Hg,P<0.01). Correlation between change in RVEF and PAm was-0.58, and between change in RVEDV and PAm was 0.63. We conclude that patients with severe COPD often have right ventricular dilation at rest and commonly respond to supine exercise with a fall in LV ejection fraction and further dilation of the right ventricle.
Does oral supplementation of a fermented papaya preparation correct respiratory burst function of innate immune cells in type 2 diabetes mellitus patients?

Fermented papaya preparation (FPP) is a nutritional supplement reported to act as an antioxidant by scavenging reactive oxygen species (ROS) and removing "bad ROS," while inducing "respiratory burst" production of necessary "good ROS." We sought to investigate the safety of oral administration of FPP (9 g/day, 6 weeks) to T2D patients with regard to its effect on the hyperglycemia status of these patients. Peripheral blood was collected during a baseline visit, followed by subsequent collections both during and after supplementation. Induced "respiratory burst" ROS production was measured at each visit in addition to fasting blood glucose, lipid profile, glycated hemoglobin (HbA1c), and lipid/protein peroxidation. Oral FPP supplementation induced "respiratory burst" in peripheral blood mononuclear cells while not influencing other blood parameters studied. When human monocytic THP-1 cells were supplemented with sugar-based FPP, cellular ATP and NADPH concentrations were increased while matched glucose alone did not produce similar effects, suggesting a glucose-independent component of FPP to be responsible for increasing cellular energetics. THP-1 cells supplemented with FPP also exhibited higher mitochondrial membrane potential (Δψm) and oxygen consumption as compared with cells treated with glucose alone. Taken together, our observations lead to the hypothesis that FPP corrects inducible "respiratory burst" function in type 2 diabetes patients.
Meal replacement based on Human Ration modulates metabolic risk factors during body weight loss: a randomized controlled trial.

A meal replacement may be an effective strategy in the management of obesity to increase antioxidant intake, attenuating oxidative stress and inflammation. In the present study, we investigated the efficacy of a new nutritional supplement to reduce metabolic risk parameters in obese women.



In a randomized controlled crossover study (2 × 2), 22 women (percentage body fat 40.52 ± 3.75%; body mass index-BMI 28.72 ± 2.87 kg/m²; 35.04 ± 5.6 years old) were allocated into two treatments: hypocaloric diet and drink containing "Human Ration" (HR) consumption (CRHR), and hypocaloric diet and control drink consumption (CR). The study consisted of 2 periods of 5 weeks with 1 week of washout in two orders (CR → CRHR and CRHR → CR). Caloric restriction was 15%, based on estimated energy requirement. Anthropometric, clinical and metabolic risk parameters were assessed at baseline and at the end of each period.



Some metabolic risk factors were favorably modulated in both interventions: reduction in body weight (CR -0.74 ± 1.27 kg; p = 0.01; CRHR -0.77 ± 1.3 kg; p = 0.02), body mass index (BMI) (CR -0.27 ± 0.51 kg/m²; p = 0.02; CRHR -0.30 ± 0.52 kg/m²; p = 0.01) and HOMA-IR (CR -0.35 ± 0.82; p = 0.02, CRHR -0.41 ± 0.83; p = 0.03). However, CRHR reduced waist circumference (-2.54 ± 2.74 cm; p < 0.01) and gynoid fat (-0.264 ± 0.28 g; p < 0.01), and increased HDL-c levels (0.08 ± 0.15 mmol/l; p = 0.04).



Associated with hypocaloric diet, the intake of a nutritional supplement rich in phytochemicals as a breakfast substitute for 5 weeks had no additional effect on weight reduction than caloric restriction alone, but increased central lipolysis and improved the lipoprotein profile.
Reducing glucocorticoid dosage improves serum osteocalcin in patients with rheumatoid arthritis—results from the TOMORROW study

Decreasing the daily dose of glucocorticoids improved bone metabolic marker levels in patients with rheumatoid arthritis. However, changes in disease activity did not influence bone metabolism. Bone metabolism might thus remain uncontrolled even if disease activity is under good control. Decreasing glucocorticoid dosage appears important for improving bone metabolism. Patients with rheumatoid arthritis (RA) develop osteoporosis more frequently than healthy individuals. Bone resorption is increased and bone formation is inhibited in patients with RA, and glucocorticoid negatively affects bone metabolism. We aimed to investigate factors influencing bone metabolic markers in patients with RA. We started the 10-year prospective cohort Total Management of Risk Factors in Rheumatoid Arthritis Patients to Lower Morbidity and Mortality (TOMORROW) study in 2010. We compared changes in urinary cross-linked N-telopeptide of type I collagen (uNTx) and serum osteocalcin (OC), as markers of bone resorption and formation, respectively, in 202 RA patients and age- and sex-matched volunteers between 2010 and 2011. We also investigated factors influencing ΔuNTx and ΔOC in the RA group using multivariate analysis. Values of ΔuNTx were significantly lower in patients with RA than in healthy controls (−0.51 vs. 7.41 nmol bone collagen equivalents (BCE)/mmol creatinine (Cr); p = 0.0013), whereas ΔOC values were significantly higher in RA patients (0.94 vs. 0.37 ng/ml; p = 0.0065). Changes in prednisolone dosage correlated negatively with ΔOC (β = −0.229, p = 0.001), whereas changes in disease activity score, bisphosphonate therapy, and period of biologics therapy did not correlate significantly with ΔOC. No significant correlation was seen between ΔuNTx and change in prednisolone dosage. Decreased glucocorticoid dosage improved bone metabolic markers in RA, but disease activity, bisphosphonate therapy, and period of biologics therapy did not influence levels of bone metabolic markers. Decreasing glucocorticoid dosage appears important for improving bone metabolic marker profiles in patients with RA.
Use of a Non-Fluoroscopic Catheter Navigation System for Pulmonary Vein Isolation

Pulmonary vein (PV) isolation is commonly performed by using separate mapping and ablating catheters. Steering the ablation catheter to the target electrodes on the mapping catheter can be difficult and time consuming under fluoroscopic guidance. We investigated the use of a non-fluoroscopic catheter navigation system to facilitate radiofrequency pulmonary vein isolation.  The LocaLisa non-fluoroscopic catheter navigation system was used during PV isolation in 21 patients. Eleven control patients underwent the procedure under fluoroscopic guidance alone. PV isolation was performed by mapping the veins with a 10 or 20 pole circular mapping catheter and ablating at targeted mapping bipoles with a separate ablation catheter.  The electrodes of both catheters were visualized in 3 dimensional virtual space by LocaLisa. There were no clinical differences between the LocaLisa and control patients. During mapping, electrical artifacts were produced on specific mapping electrodes by contact with the ablation catheter. A blinded observer using LocaLisa correctly identified the mapping electrodes being contacted by the ablation catheter in 368 of 398 (92%) of cases. Total fluoroscopic time was reduced in the LocaLisa group (72 ± 29 minutes) compared to the control group (102 ± 37 minutes, p = 0.02). There were no differences between the groups in total procedure times, number of lesions given, complications or long term procedural success (all p > 0.45).  The LocaLisa catheter navigation system accurately identifies the position of an ablation catheter relative to the target electrodes on a circular mapping catheter. The system also significantly reduces total fluoroscopic time for PV isolation.
Do genetic and individual risk factors moderate the efficacy of motivational enhancement therapy? Drinking outcomes with an emerging adult sample.

Research indicates that motivational enhancement therapy (MET) helps catalyze reductions in problem drinking among emerging adults. However, moderators of this intervention remain relatively unknown. Therefore, the objectives of this study were: (1) to test whether a single session of MET increased motivation to reduce drinking and drinking outcomes; and (2) to examine whether genetic dopamine D(4) receptor L (DRD4 L) and individual personality risk factors (impulsivity and novelty seeking) moderated the effects of the MET. These hypotheses were evaluated by randomly assigning a sample of emerging adult problem drinkers (n = 67) to receive a single session of MET or alcohol education. Follow-up data indicated that only individuals who were low in impulsivity, novelty seeking and/or who had the short DRD4 variable number of tandem repeats genotype evidenced differentially increased behavior change (taking steps toward reducing drinking) following the MET.
Low prevalence of HBV DNA in the liver allograft from anti-HBc-positive donors: a single-center experience.

Allografts from donors positive for antibody to hepatitis B core antigen (anti-HBc(+)) can transmit hepatitis B virus (HBV) to the recipients. We aimed to study the prevalence of HBV DNA in liver allografts from anti-HBc(+) donors. Between January 2003 and December 2008, this retrospective study identified 18 patients who received a liver from an anti-HBc(+) donor. Pre- and post-transplantation HBV serology and serum HBV DNA level of the study subjects were reviewed. DNA extracted from liver biopsy tissue was used for PCR assay. Immunohistochemistry was also performed to determine viral protein expression. We observed a low prevalence of HBV DNA in allografts from anti-HBc(+) donors even among patients who did not receive prophylaxis. Only one of 18 patients had detectable HBV DNA in the liver allograft. This recipient was seronegative for HBV before transplantation and did not receive prophylaxis after transplantation, and developed de novo hepatitis B. Of the five patients who were positive for both antibody to hepatitis B surface antigen and anti-HBc before transplantation and did not receive prophylaxis after transplantation, none developed HBV infection. Prophylaxis for HBV is important for seronegative recipients receiving a liver from an anti-HBc(+) donor. Such prophylaxis may not be necessary for recipients who do not have detectable HBV DNA in the liver allograft.
Speed-dependent treadmill training in ambulatory hemiparetic stroke patients: a randomized controlled trial.

A new gait training strategy for patients with stroke seeks to increase walking speed through treadmill training. This study compares the effects of structured speed-dependent treadmill training (STT) (with the use of an interval paradigm to increase the treadmill speed stepwise according to principles of sport physiology) with limited progressive treadmill training (LTT) and conventional gait training (CGT) on clinical outcome measures for patients with hemiparesis.



Sixty ambulatory poststroke patients were each randomly selected to receive 1 of the 3 different gait therapies: 20 subjects were treated with STT, 20 subjects were trained to walk on a treadmill with a 20% increase of belt speed over the treatment period (LTT), and 20 subjects were treated with CGT. Treatment outcomes were assessed on the basis of overground walking speed, cadence, stride length, and Functional Ambulation Category scores.



After a 4-week training period, the STT group scored significantly higher than the LTT and CGT groups for overground walking speed (STT versus LTT, P<0.001; STT versus CGT, P<0.001), cadence (STT versus LTT, P=0.007; STT versus CGT, P<0.001), stride length (STT versus LTT, P<0.001; STT versus CGT, P<0.001), and Functional Ambulation Category scores (STT versus LTT, P=0.007; STT versus CGT, P<0.001).



Structured STT in poststroke patients resulted in better walking abilities than LTT or CGT. This gait training strategy provides a dynamic and integrative approach for the treatment of gait dysfunction after stroke.
Action des gènes de nanisme (dw) et de cou nu (Na) sur la croissance du poussin et le métabolisme lipidique

Au cours de deux expériences, des poussins sont associés en couples de vraies soeurs, l'une naine (dw), l'autre normale (Dw), élevées dans des cages individuelles voisines jusqu'à l'âge de cinq semaines. Les poussins porteurs du gène recessif dw lié au sexe sont identifiés grâce au gène étroitement associé k qui détermine un emplumement rapide remarquable dès l'éclosion. Dans un couple sur deux environ, les poussins appariés ont le cou nu et sont donc porteurs du gène auto-somal dominant Na. La présence du gène dw provoque une réduction du gain de poids d'environ 30 p. 100, elle abaisse la température corporelle, augmente l'engraissement et la radioactivité des lipides de réserve néoformés dans les heures qui suivent l'injection de "C-acétate. Cette dernière influence est expliquée en invoquant, ou un accroissement de la lipogénèse, ou une diminution de la dépense énergétique, ou plus probablement encore les deux à la fois. La présence du gène Na semble déterminer une augmentation de la lipogenèse. Dans un local insuffisamment chauffé, le poussin à cou nu a une dépense énergétique accrue; il paraît jouir d'une aptitude particulière pour modifier sa thermorégulation selon les conditions externes. Une interaction entre les gènes dw et Na apparaît lorsque le milieu environnant est relative-ment froid. Le gène dm pourrait empêcher le fonctionnement du système de thermorégulation propre aux animaux à cou nu; il interviendrait en inhibant la dégradation des lipides.