nils-herrmann/clean_scirepeval huggingface dataset:
Precision of Ci-navigated extension and flexion gap balancing in total knee arthroplasty and analysis of potential predictive variables

The aim of this study was to evaluate the accuracy of final limb alignment and flexion–extension and medial–lateral gap balancing in computer navigated total knee arthroplasty and to analyze various possible predictive variables that may affect the gaps in computer navigated knee arthroplasty. The DePuy Ci system, a nonimage-based passive optical computer navigation system, was used in 225 patients with knee osteoarthritis to assist for the total knee arthroplasty. From the raw data the Ci-verified pre- and postoperative leg axis in extension, angle of tibia and femur resection, the flexion and extension angle, the medial and lateral extension and flexion gaps were extracted; and differences in gaps were calculated and subjected to statistical analysis. Leg alignment and implant position were determined only by the navigation system. Preoperative variables were evaluated for their impact on the final flexion/extension and medial/lateral gaps achieved. Though the preoperative femoro-tibial coronal alignment had a large variance, postoperatively 98.22% of the knee was found to be between −3° and +3° in the coronal limb alignment axis. The Ci-verified femoral and tibial cuts in the coronal plane showed a good accuracy. The sagittal alignment of the femoral cut ranged from 8.20° flexion to 3.20° of extension. Rectangular extension and flexion gaps were achieved with ≤3 mm of difference in gaps on medial and lateral sides in 98 and 93% of knees, respectively. Difference between extension and flexion gaps on the medial side was ≤3 mm in 83% and on the lateral side in 84% of the knees. Of all the possible predictive variables analyzed, Pearson correlation and multiple regression analysis showed significant correlation only between the medial–lateral gap difference in extension and the Ci-verified femoral cut, tibial cut and limb axis, all in the coronal plane. Computer-assisted navigated total knee replacement allows for accurate gap balancing that is not dependent on the various pre- and intraoperative factors mentioned, including age, sex, Range of motion preoperative deformity and grade of osteoarthritis. The Ci-calculated and verified tibial, and femoral cuts are the only possible factors affecting the extension gap.
Effects of hormone therapy on soluble cell adhesion molecules in postmenopausal women with coronary artery disease.

Although observational studies showed an apparent lower ischemic coronary disease risk in postmenopausal women receiving hormone therapy (HT), randomized clinical trials in postmenopausal women showed an increase in ischemic cardiovascular events. Soluble cell adhesion molecules have been associated with cardiovascular risk factors and events. HT reduces circulating levels of soluble cell adhesion molecules in healthy postmenopausal women, but its effects in postmenopausal women with coronary artery disease are less clear. We assessed the effect of HT on soluble cell adhesion molecules in the Estrogen Replacement and Atherosclerosis trial.



The Estrogen Replacement and Atherosclerosis trial was a double-blind, placebo-controlled study that randomized 309 postmenopausal women (mean age, 65.8 y) to daily unopposed estrogen (conjugated estrogens 0.625 mg), estrogen plus 2.5 mg of medroxyprogesterone acetate, or placebo, with a mean follow-up period of 3.2 years. Soluble intercellular adhesion molecule-1, vascular cell adhesion molecule-1, and E-selectin were measured in serum obtained from participants at baseline and after 12 months of follow-up.



Of the 265 women with complete data, 87 women were assigned to unopposed estrogen, 88 women to estrogen plus medroxyprogesterone acetate, and 90 women to placebo. Compared with placebo, 12 months of HT (n = 175) was associated with reductions in soluble intercellular adhesion molecule-1 (25.6 +/- 4.7 vs 10.6 +/- 6.4 ng/mL, P = 0.06), soluble vascular cell adhesion molecule-1 (80.2+/- 10.6 vs 28.8 +/- 14.7 ng/mL, P = 0.005), and E-selectin (8.8 +/- 0.9 vs -1.1 +/- 1.2 ng/mL, P < 0.001).



Twelve months of HT in postmenopausal women with established coronary artery disease was associated with reductions in serum markers of endothelial cell activation/injury such as soluble intercellular adhesion molecule-1, vascular cell adhesion molecule-1, and E-selectin.
Fixed-dose rate gemcitabine plus docetaxel as second-line therapy for metastatic uterine leiomyosarcoma: a Gynecologic Oncology Group phase II study.

Doxorubicin-based treatment is standard therapy for metastatic uterine leiomyosarcoma. There is no standard second-line therapy. We determined activity of fixed-dose rate gemcitabine plus docetaxel as second-line treatment for metastatic uterine leiomyosarcoma.



Eligible women with unresectable uterine leiomyosarcoma progressing after prior cytotoxic therapy were treated with gemcitabine 900 mg/m(2) days one and eight over 90 min, plus docetaxel 100 mg/m(2) on day 8 of a 21-day cycle with granulocyte growth factor. Patients with prior pelvic radiation received lower doses. 
Forty-eight of 51 women were evaluable for response (one wrong histology, two never treated). Prior therapy was doxorubicin-based in 90%, and ifosfamide-based in 6%. The overall objective response rate is 27%, with complete response in 6.3% (3/48), and partial response in 20.8% (10/48). An additional 50% (24/48) had stable disease (median duration 5.4 months). The median number of cycles per patient was 5.5 (range 1-22); 73% of patients remained progression-free at 12 weeks and 52% at 24 weeks. The predominant toxicity was uncomplicated myelosuppression: thrombocytopenia grade 3 (29%), grade 4 (10.4%); neutropenia grade 3 (12.5%), grade 4 (8.3%) anemia grade 3 (20.8%), grade 4 (4.2%). While pulmonary toxicity was reported, no patient had drug-related pneumonitis/hypoxia-type toxicity. Median progression-free survival (PFS) was 5.6+ months (range 0.7-27+ months). The median duration of objective response was 9+ months (range 3.9-24.5+ months).



Fixed-dose rate gemcitabine plus docetaxel is active second-line therapy for uterine leiomyosarcoma.
Adjuvant chemotherapy with folinic acid and 5-fluorouracil in patients with locally advanced rectal cancer previously treated by preoperative radiochemotherapy and curative tumor resection

The role of postoperative adjuvant chemotherapy in patients with rectal cancer pretreated by preoperative radiochemotherapy (RCT) and curative surgery is still poorly investigated. We pooled data from both arms of a phase III trial in which patients with locally advanced (T3/4) rectal cancer were randomized to preoperative RCT alone or combined with pelvic radio-frequency hyperthermia. After surgery, R0-resected patients were scheduled to adjuvant chemotherapy with four monthly courses of 50 mg folinic acid (FA) and gradually escalated 5-fluorouracil (5-FU, 350–500 mg/m2, days 1–5). Reasons preventing initiation of chemotherapy and treatment-related toxicities were evaluated. Patients’ characteristics and survival parameters were compared between the treated and untreated patient groups. Out of 93 patients, 73 (79%) started adjuvant chemotherapy, whereas 19 (21%) did not, mostly due to perioperative complications and refusal. Chemotherapy-related toxicities were mild to moderate in most cases, but—together with protracted postoperative complications—prevented the intended dose escalation of 5-FU in 71% of patients. Distant-failure-free (p=0.03) and overall survival (p=0.03) were improved in the chemotherapy group, although there was a negative selection of patients with unfavourable characteristics into the untreated patient group. Adjuvant chemotherapy using FA and 5-FU can be safely applied to the majority of patients with rectal cancer pretreated by RCT and surgery. Survival data are not suitable to allow far-reaching conclusions, but are in line with suggestions of a favourable effect of adjuvant chemotherapy in these patients.
Impact of laughter on air trapping in severe chronic obstructive lung disease

Static and dynamic hyperinflation is an important factor of exertional dyspnea in patients with severe COPD. This proof-of-concept intervention trial sought to study whether laughter can reduce hyperinflation through repetitive expiratory efforts in patients with severe COPD. For small groups of patients with severe COPD (n = 19) and healthy controls (n = 10) Pello the clown performed a humor intervention triggering regular laughter. Plethysmography was done before and up to 24 hours after intervention. Laughing and smiling were quantified with video-analysis. Real-time breathing pattern was assessed with the LifeShirt, and the psychological impact of the intervention was monitored with self-administered questionnaires. The intervention led to a reduction of TLC in COPD (p = 0.04), but not in controls (p = 0.9). TLC reduction was due to a decline of the residual volume. Four (22 [CI 95% 7 to 46] %) patients were > or = 10% responders. The frequency of smiling and TLC at baseline were independent predictors of TLC response. The humor intervention improved cheerfulness, but not seriousness nor bad mood. In conclusion, smiling induced by a humor intervention was able to reduce hyperinflation in patients with severe COPD. A smiling-derived breathing technique might complement pursed-lips breathing in patients with symptomatic obstruction.
A Randomized Controlled Trial of an HIV Prevention Intervention for Street-Based Female Sex Workers in Yerevan, Armenia: Preliminary Evidence of Efficacy

This study evaluated the efficacy of an HIV intervention among female sex workers (FSWs) randomized to an intervention or wait-list control. FSWs (N = 120) completed baseline, 3- and 6-month assessments. A health educator implemented 2-hour intervention emphasized gender-empowerment, self-efficacy to persuade clients to use condoms, condom application skills, and eroticizing safer sex. Over the 6-month follow-up, FSWs in the intervention reported more consistent condom use with clients (P = .004) and were more likely to apply condoms on clients (P = .0001). Intervention effects were observed for other psychosocial mediators of safer sex. Brief, gender and culturally congruent interventions can enhance HIV-preventive behaviors among FSWs.
Child, parent, and peer predictors of early-onset substance use: a multisite longitudinal study.

The purpose of this study was to identify kindergarten-age predictors of early-onset substance use from demographic, environmental, parenting, child psychological, behavioral, and social functioning domains. Data from a longitudinal study of 295 children were gathered using multiple-assessment methods and multiple informants in kindergarten and 1st grade. Annual assessments at ages 10, 11, and 12 reflected that 21% of children reported having initiated substance use by age 12. Results from longitudinal logistic regression models indicated that risk factors at kindergarten include being male, having a parent who abused substances, lower levels of parental verbal reasoning, higher levels of overactivity, more thought problems, and more social problem solving skills deficits. Children with no risk factors had less than a 10% chance of initiating substance use by age 12, whereas children with 2 or more risk factors had greater than a 50% chance of initiating substance use. Implications for typology, etiology, and prevention are discussed.
The importance of sputum cytology in the diagnosis of lung cancer: a cost-effectiveness analysis.

To assess the potential health and cost effects of initial testing with sputum cytology to diagnose lung cancer.



Cost-effectiveness analysis.



Surveillance Epidemiology and End Results (SEER) program; cost data from Northern California Kaiser Permanente Hospitals and Universities of Stanford and Iowa; National Center for Health Statistics; and a MEDLINE search.



The use of sputum cytologies preceding other tests (ie, fine-needle aspiration, bronchoscopy, thoracoscopy) in patients with suspected lung cancer.



Mortality associated with testing and initial surgical treatment (eg, performance of thoracoscopy to remove a local-stage, centrally located cancer), cost of testing and initial treatment, life expectancy, lifetime cost of medical care, and cost-effectiveness.



In central lesions, sputum cytology as the first test was the dominant strategy because it both lowers medical-care costs ($2,516 per patient) and lowers the mortality risk (19 deaths in 100,000 patients) of the evaluation without adversely affecting long-term survival. In peripheral lesions, sputum cytology costs less then $25,000 per year of life saved if the pretest probability of cancer exceeds 50%. The estimated annual savings of adopting sputum cytology as the first test for diagnosing lung cancer in the United States is at least $30 million.



Experience in regional centers indicates that sputum cytologic testing is infrequently ordered before implementing invasive diagnostic techniques, even in patients with central lung masses. The study findings suggest that sputum cytology as the first test in suspected lung cancer is likely to be cost saving without adversely affecting patient outcomes.
Effect of Lamivudine Therapy on the Serum Covalently Closed-Circular (ccc) DNA of Chronic Hepatitis B Infection

To determine the effect of 1-yr lamivudine treatment on serum covalently closed-circular DNA (cccDNA) level.Serum total HBV DNA and cccDNA levels at baseline, week 24, and week 52 were measured in 82 lamivudine-treated patients, 17 of whom received 1-yr placebo and acted as controls.There was a significant reduction in the cccDNA levels from baseline (median 3.0 × 106 copies/ml) to week 24 (33,476 copies/ml) and week 52 (48,694 copies/ml) (p < 0.001 for both). The median reduction in cccDNA level at week 24 and 52 were 2.21 and 2.12 logs, respectively, which were significantly greater than those of controls (0.31 log, p < 0.001; 0.2 log, p < 0.001, respectively). Fifteen patients (18.3%) developed YMDD mutations by week 52. Compared to patients without YMDD mutations, patients with YMDD mutations had significantly less median reduction of total HBV DNA level (4.44 vs 3.65 logs, respectively, p = 0.02) and cccDNA level (2.27 vs 1.65 logs, respectively, p = 0.016) at week 24 and significantly less median reduction of cccDNA at week 52 (2.35 vs 0.8 logs respectively, p < 0.001).CONCLUSIONS:One-year lamivudine treatment decreased serum cccDNA level by 2 logs. The chance of YMDD mutations at week 52 was related to the magnitude of viral suppression at week 24.
Estimation of ¹²³I-IMP arterial blood activity using ¹²³I-IMP acquisition data from the lungs and brain without any blood sampling: validation of its usefulness for quantification of regional cerebral blood flow.

The conventional methods for the estimation of regional cerebral blood flow (rCBF) using ¹²³I-labeled N-isopropyl-p-iodoamphetamine (¹²³I IMP) autoradiography (ARG) require continuous or 1-point arterial blood sampling. Patients who need rCBF quantification benefit from the avoidance of arterial puncture. In this study, we attempted to develop a method without any blood sampling to estimate ¹²³I IMP activity in the arterial blood sample at 10 minutes after injection of ¹²³I IMP (Ca10) for the purpose of rCBF quantification. For the evaluation of validity of this method, the mean of rCBFs in various regions of the brain (mean CBF) calculated by ¹²³I IMP ARG method using the estimated Ca10 was compared with that calculated using the Ca10 directly measured with the actual arterial blood sample. Both groups of the mean CBF values were also compared with those measured by O-15 H₂O PET ARG method.



I-123 IMP ARG study was applied to 23 patients, and O-15 H₂O PET ARG was applied to 20 patients of them. Dynamic images of the lungs, time series of static images of the brain, and brain SPECT images were acquired after injection of ¹²³I IMP. Arterial blood sampling was done 10 minutes after injection of ¹²³I IMP. Multiple regression analysis was used to estimate Ca10 using 5 parameters from the lung washout counts, time series of brain static counts, and brain SPECT average counts as the explanatory variables and the Ca10 directly measured with the actual arterial blood sample as the objective variable, and the regression equation was calculated.



The regression equation was calculated by multiple regression analysis as follows: Estimated Ca10 = (2.09 × 10⁻² · LW3) - (2.29 × 10⁻⁴ · Cb5) - (9.87 × 10⁻³ · Cbpre-SPECT) + (1.06 · CbSPECTav) + (1.03 × 10⁻² · Cbpost-SPECT) + 165 (counts/s/g), where LW3: lung washout count at 3 minutes after injection, Cb5: brain count at 5 minutes, Cb pre-SPECT: brain count before SPECT, Cb SPECT av: average brain count during SPECT, and Cb post-SPECT: brain count after SPECT. The estimated Ca10 values closely correlated with the directly measured Ca10 values (r = 0.907, P < 0.01). The mean CBF values (mL/min/100 g) calculated by ¹²³I IMP ARG method using the estimated Ca10 also closely correlated with those calculated using the directly measured Ca10 (r = 0.818, P < 0.01). The mean CBF values calculated by the ¹²³I IMP ARG method using either the directly measured or the estimated Ca10 significantly correlated (r = 0.698 and 0.590, respectively; P < 0.01) with those measured by O-15 H₂O PET ARG method.



The ¹²³I IMP arterial blood activity can be estimated reliably without any blood sampling using the ¹²³I IMP acquisition data from the lungs and brain. This method can serve for a convenient and noninvasive rCBF quantification technique instead of the conventional methods requiring arterial blood sampling.
Effects of food on the relative bioavailability of lapatinib in cancer patients.

This study was conducted to characterize the effect of food on the relative bioavailability of lapatinib.



A single 1,500-mg, oral dose of lapatinib was administered to 27 patients with advanced solid tumors on each of three occasions that were 1 week apart, in random order: after an overnight fast, with a low-fat breakfast, and with a high-fat breakfast.



The low-fat breakfast produced mean increases in lapatinib area under the concentration-time curve (AUC) of 167% (2.67-fold) and maximum concentration (C(max)) of 142% (2.42-fold). The high-fat breakfast produced mean increases in lapatinib AUC of 325% (4.25-fold) and C(max) of 203% (3.03-fold) compared with the fasted state. Increased bioavailability in the fed state did not significantly decrease relative variability. Therefore, absolute variability in systemic exposure was increased.



These large increases in lapatinib bioavailability and absolute variability support the recommendation for dosing in the fasted state to achieve consistent therapeutic exposure. Prescribers and patients should consider the potential consequences of toxicity or diminished efficacy that might result from dosing without regard to variations in diet.
Effects of Risedronate Treatment on Bone Density and Vertebral Fracture in Patients on Corticosteroid Therapy

Men and women (n = 518) receiving moderate-to-high doses of corticosteroids were enrolled in two studies with similar protocols and randomly assigned to receive either placebo or risedronate (2.5 or 5 mg) for 1 year. All patients received daily calcium supplementation (500–1000 mg), and most also received supplemental vitamin D (400 IU). The primary endpoint was the difference between the placebo and active groups in lumbar spine bone mineral density (BMD) at 1 year; changes in BMD at other sites, biochemical markers of bone turnover, and the incidence of vertebral fractures were also assessed. In the overall population, the mean (SE) lumbar spine BMD increased 1.9 ± 0.38% from baseline in the risedronate 5 mg group (P < 0.001) and decreased 1.0 ± 0.4% in the placebo group (P= 0.005). BMD at the femoral neck, trochanter, and distal radius increased or was maintained with risedronate 5 mg treatment, but decreased in the placebo group. Midshaft radius BMD did not change significantly in either treatment group. The difference in BMD between the risedronate 5 mg and placebo groups was significant at all skeletal sites (P < 0.05) except the midshaft radius at 1 year. The 2.5 mg dose also had a positive effect on BMD, although of a lesser magnitude than that seen with risedronate 5 mg. A significant reduction of 70% in vertebral fracture risk was observed in the risedronate 5 mg group compared with the placebo group (P= 0.01). Risedronate was efficacious in both men and women, irrespective of underlying disease and duration of corticosteroid therapy, and had a favorable safety profile, with a similar incidence of upper gastrointestinal adverse events in the placebo and active treatment groups. Daily treatment with risedronate 5 mg significantly increases BMD and decreases vertebral fracture risk in patients receiving moderate-to-high doses of corticosteroid therapy.
Evaluation of the European LeukemiaNet recommendations for predicting outcomes of patients with acute myeloid leukemia treated in low- and middle-income countries (LMIC): A Brazilian experience.

Current results regarding treatment outcomes in acute myeloid leukemia (AML) point to significant differences between low- and middle-income countries (LMIC) and high-income countries (HIC). Excluding well-known socioeconomic issues, genetic markers important for prognosis have not been properly incorporated into the clinical practice so far and their usefulness outside of well-controlled clinical trials remain unknown.



Here, we assessed the clinical significance of the European LeukemiaNet (ELN) recommendations in 196 consecutive patients with AML in a real-life setting. All patients were younger than 60 years of age (49% male) and treated with conventional chemotherapy for induction and consolidation in three Brazilian Institutions that well represent Brazilian geographic and socioeconomic diversity.



Multivariable analysis showed that ELN recommendations had a slight association with complete remission achievement (odds ratio: 0.74, 95% confidence interval, CI: 0.53-1.01; P=0.06), but were independently associated with poor overall survival (OS) (hazard ratio, HR: 1.3, 95% CI: 1.1-1.54; P=0.002), disease-free survival (DFS) (HR: 1.42, 95% CI: 1.03-1.95; P=0.028) and event-free survival (EFS) (HR: 1.24, 95% CI: 1.06-1.47; P=0.007), considering initial leukocyte counts and age as confounders. ELN recommendations had no impact on cumulative incidence of relapse (P=0.09).



Our results suggest that within the context of LMIC, the prognostic markers recommended by ELN may be useful to predict patient's clinical outcomes; however, the OS, DFS and EFS were shorter than the reported in Europe and US for the respective risk groups.