nils-herrmann/clean_scirepeval huggingface dataset:
Safety of long-term large doses of aspartame.

Safety of long-term administration of 75 mg/kg of aspartame per day was evaluated with the use of a randomized, double-blind, placebo-controlled, parallel-group design in 108 male and female volunteers aged 18 to 62 years. Subjects received either aspartame or placebo in capsule form three times daily for 24 weeks. No persistent changes over time were noted in either group in vital signs; body weight; results of standard laboratory tests; fasting blood levels of aspartame's constituent amino acids (aspartic acid and phenylalanine), other amino acids, and methanol; or blood formate levels and 24-hour urinary excretion of formate. There also were no statistically significant differences between groups in the number of subjects experiencing symptoms or in the number of symptoms per subject. These results further document the safety of the long-term consumption of aspartame at doses equivalent to the amount of aspartame in approximately 10 L of beverage per day.
Effect of potassium citrate supplementation or increased fruit and vegetable intake on bone metabolism in healthy postmenopausal women: a randomized controlled trial.

Alkali provision may explain why fruit and vegetables benefit bone health.



We aimed to determine the effects of alkali-providing potassium citrate (double-blind) and fruit and vegetable intake (single-blind) on bone turnover over 2 y.



We conducted a randomized placebo-controlled trial in 276 postmenopausal women (aged 55-65 y). Women were randomly assigned to 4 groups: high-dose potassium citrate (55.5 mEq/d), low-dose potassium citrate (18.5 mEq/d), placebo, and 300 g additional fruit and vegetables/d (equivalent of 18.5 mEq alkali). Serum and fasted urine for bone markers were collected at baseline and at 3, 6, 12, 18, and 24 mo. An additional urine sample was collected at 4-6 wk. Bone mineral density (BMD) was measured at baseline and 2 y.



Repeated-measures ANOVA showed no difference between groups for urinary free deoxypyridinoline cross-links relative to creatinine (fDPD/Cr), serum N-terminal propeptide of type 1 collagen, or beta C-terminal telopeptide, although, at 4-6 wk, fDPD/Cr was lower in the high-dose potassium citrate group (P = 0.04). Mean +/- SD spine BMD loss in the placebo group (1.8 +/- 3.9%) did not differ significantly from that in the treatment groups (2.1 +/- 3.2%; P = 0.88). Hip BMD loss in the placebo and low-dose potassium citrate groups was 1.3 +/- 2.3% and 2.2 +/- 2.3%, respectively (P = 0.14).



Two-year potassium citrate supplementation does not reduce bone turnover or increase BMD in healthy postmenopausal women, which suggests that alkali provision does not explain any long-term benefit of fruit and vegetable intake on bone.
Reuse of explanted permanent pacemakers donated by funeral homes.

Poor patients in developing countries may not receive permanent pacemakers (PPMs) even as lifesaving measures because of their high cost. In this report we examined whether PPMs that were explanted and donated by funeral homes in the United States could be safely and effectively reused in indigent patients in India. With permission from the deceased patients' families, 121 PPMs were explanted and donated by funeral homes for reuse. These PPMs were sterilized and sent for implantation in needy and indigent patients at a charity hospital in Mumbai, India. From the pool of donated 121 PPMs, 53 (88%, 11 single-chamber PPMs, 21%, and 42 dual-chamber PPMs, 79%) were acceptable for reuse and implanted (37 new implants, 70%, and 16 for battery/generator replacement, 30%) in 53 patients (mean ± SD 64 ± 10 years old, 28 women, 53%). Indications for PPM implantation were complete heart block (n = 27, 51%) and sick sinus syndrome (n = 26, 49%). All patients were alive and well postoperatively. No significant complications including infections or device failures occurred over 19 to 1,827 days (mean 661) of follow-up. Of 40 patients (75%) who were followed locally, 4 (10%) died because of nonpacemaker-related causes; time to death was 121 to 750 days (mean 430) after PPM implantation. All except 2 patients (5%) reported marked improvement in their symptoms. There were only 4 patients (8%) who were previously employed, and all were able to resume their manual labor work. Also, of the women, 27 patients (96%) reported improvement in symptoms enabling them to resume regular household chores as housewives after PPM implantation. In conclusion, with proper device sterilization and handling protocols, reuse of explanted PPMs in poor patients in developing countries is safe and effective. Implantation of donated PPMs can not only save lives but also improve quality of life of needy poor patients.
What factors do cancer patients believe contribute to the development of their cancer? (New South Wales, Australia)

To analyze Australian cancer patients’ beliefs about factors contributing to the development of their cancer. As part of a case–control study (The Cancer Council NSW Cancer, Lifestyle and Evaluation of Risk Study), a total of 2,857 cancer patients (open to all types of cancer) were surveyed and via an open-ended question, were asked to specify factors they think contributed to the development of their cancer. Qualitative analysis and categorical techniques were used to analyze the data. About half, 53%, of patients specified at least one contributing factor. The odds of a person specifying a contributing factor increased with time period since diagnosis (p = 0.0006). Patients most frequently specified, respectively: “Stress” (15.4%), “Genetics/hereditary” (10.9%) and “Smoking” (6.2%). Among factors specified the largest proportion (24.1%) was perceived to be “Non-modifiable.” Cancer patients specified a broad range of factors and agents to which their disease may be attributed. Some of these were poorly correlated with epidemiological rankings of attributable risk factors. The role of psychosocial and genetic factors was overstated. Misconceptions regarding the causes of cancer are a key consideration of health professionals when devising communication strategies around cancer prevention.
Safety and efficacy of lobaplatin combined with 5-fluorouracil as first-line induction chemotherapy followed by lobaplatin-radiotherapy in locally advanced nasopharyngeal carcinoma: preliminary results of a prospective phase II trial

Due to improvements in imaging and radiological techniques as well as the use of chemotherapy, distant metastasis has become the predominant mode of treatment failure in patients with locally advanced nasopharyngeal carcinoma (LA-NPC). Platinum-based systemic chemotherapy has shown survival benefits and is now the standard strategy for systemic therapy in patients with LA-NPC. Notably, the third-generation platinum reagent lobaplatin has shown anti-tumor effects in several solid tumors with lower incidences of gastrointestinal, hepatic and renal toxicity relative to other platinum drugs. However, the safety and efficacy of lobaplatin as a first-line regimen in patients with LA-NPC are undetermined. Patients with stage III–IVa-b NPC received lobaplatin at a dose of 30 mg/m2 on days 1 and 22 combined with a continuous 120-h intravenous injection of 5-fluorouracil at a dose of 4 g/m2 followed by lobaplatin at a dose of 50 mg/m2 on days 43 and 64 concomitant with intensity-modulated radiation therapy. Objective response rates and acute toxicity were assessed based on RECIST (1.1) and CTCAE v.3.0, respectively. Kaplan-Meier analysis was used to calculate survival rates. Fifty-nine patients were enrolled, and 44 patients (74.6%) received allocated cycles of chemotherapy. The objective response rates were 88.1% (95% confidence interval [CI], 0.77 to 0.95) and 100% after induction chemotherapy (ICT) and concurrent chemoradiotherapy (CRT), respectively. With a median follow-up period of 44 months, the 3-year estimated progression-free survival and overall survival were 86.4% (95% CI, 69.8 to 98.8) and 94.9% (95% CI, 89.5 to 100), respectively. The most common grade 3–4 toxicities were neutropenia (8.5%) and thrombocytopenia (40.7%) after ICT and CRT, respectively. Lobaplatin combined with 5-fluorouracil followed by lobaplatin-RT treatment showed encouraging anti-tumor effects with tolerable toxicities in patients with LA-NPC. Randomized controlled trials of lobaplatin in patients with LA-NPC are warranted.
Enhancement of the efficacy of weekly low-dose taxotere by the long acting anti-prolactinemic drug cabergoline in pretreated metastatic breast cancer.

In view of its potential action as a growth factor, the evidence of abnormally high blood levels of prolactin (PRL) is associated with a poor prognosis in metastatic breast cancer. Moreover, metastatic breast cancer-related hyperprolactinemia has proven to counteract the efficacy of cancer chemotherapy. The negative influence of high blood levels of PRL on the efficacy of chemotherapy in metastatic breast cancer has been confirmed by previous preliminary studies, showing that the concomitant administration of the anti-prolactinemic dopaminergic agent bromocriptine may enhance the therapeutic effect of chemotherapy. However, the clinical use of bromocriptine is limited by its short duration and gastrointestinal toxicity. Therefore, new anti-prolactinemic drugs, characterized by less toxicity and a longer duration of activity, such as Cabergoline (CBG), could be more appropriated to control PRL secretion in breast cancer. On this basis, a study was planned to evaluate the efficacy and tolerability of a concomitant administration of CBG with weekly low-dose Taxotere (TXT) in pretreated metastatic breast cancer under chemotherapy. The study group comprised 70 metastatic breast cancer patients (females), pretreated with at least one previous chemotherapeutic line containing anthracyclines, who were randomized to be treated with TXT alone or TXT plus CBG. TXT 25 mg/m2 was given i.v. at weekly intervals for at least 9 consecutive cycles. CBG was given orally at 0.5 mg once per week. Abnormally high pre-treatment levels of PRL were seen in 24/70 (34%) patients, 11 of whom were treated with TXT plus CBG, whereas the other 13 received TXT alone. CBG induced a complete normalization of the PRL levels in all patients within the first two weeks of therapy, whereas no normalization of PRL occurred spontaneously in patients treated with chemotherapy alone. The objective tumor regression rate was significantly higher in patients concomitantly treated with CBG than in those who received chemotherapy alone (31/34 vs 13/36, p < 0.05), and this difference was particularly evident in patients with high PRL levels prior to therapy (6/11 vs 2/13). No CBG-related toxicity occurred. On the contrary, chemotherapy-induced asthenia was significantly lower in patients concomitantly treated with CBG (5/34 vs 11/36, p < 0.05). This study shows that the chemoneuroendocrine therapy of weekly low-dose TXT plus the anti-prolactinemic drug CBG is a new, effective and well-tolerated therapy for metastatic breast cancer. It may also be recommended in heavily pretreated patients or in those with poor clinical status.
Population densities in relation to bladder cancer mortality rates in America from 1950 to 1994

Previous studies have reported that bladder cancer risks are elevated in industrial and urban areas. The cause is believed to be the result of occupational exposure from industries located in urban areas. Recent studies suggest that traffic air pollution may also increase bladder cancer risks. The study purpose is to investigate the relationship between bladder cancer mortality and population density of counties in America. Another objective is to explore traffic air pollution and industrial exposures as risk factors. Bladder cancer mortality rates for white men and women from 1950 to 1994 and population densities (population per 10 square miles) of 2,248 counties were the basis of the study. A linear regression analysis was performed to evaluate the relationship between bladder cancer mortality rates and population densities after log transforming the population density data set. In addition, the counties were divided into quartiles based on bladder cancer mortality rates. Mean population density values with 95% confidence intervals for the quartiles were computed. Correlation coefficients (R) between bladder cancer mortality rates and the population densities were R = .37, P < .001 for men and R = .28, P < .001 for women. In addition, population densities increased with increasing bladder cancer mortality rates across all quartiles. The mean population density of the highest quartile was more than ten times higher than the lowest. In this study, we found a strong association between bladder cancer mortality and population density. Traffic air pollution is a potential cause.
Vancomycin clearance during continuous venovenous haemofiltration in critically ill patients

To study the pharmacokinetics of vancoymcin in critically ill patients with acute renal failure treated with continuous venovenous haemofiltration  Open-label study.¶Setting: Hospital pharmacy centre and medical intensive care unit of the University Medical Centre Utrecht.¶Materials and methods: In a laboratory setting, the sieving coefficient (s) of vancomycin by polyacrilonitrile (PAN) haemofilters of different surface areas was studied. In one patient, the pharmacokinetics of vancomycin were studied following a single dose of vancomycin. Another patient was treated with a vancomycin dosing regimen based on data from the literature, but high trough concentrations made dose reduction necessary after 24 h of withholding therapy. After two doses of 250 mg, serum and ultrafiltrate samples were collected for pharmacokinetic evaluation.¶Intervention: CVVHF with the following operational characteristics: blood flow 200 ml/min, ultrafiltrate flow 25 ml/min, postdilution, PAN 06 hollow fibre haemofilter.¶Measurements and results: The average sieving coefficient in vitro was 0.73 ± 0.06, 0.86 ± 0.11, and 0.80 ± 0.06 for the PAN 03, 06, and 10 haemofilters, respectively. Changes in the sieving coefficient by increasing the ultrafiltration rate were not clinically significant. The first patient was given a single dose of vancomycin, 1000 mg by intravenous infusion. The following pharmacokinetic data were obtained: apparent volume of distribution (Vd) 55.8 l, terminal half-life time (t1/2 term) 15.4 h, total clearance (Cltot) 2.5 l/h, CVVHF clearance (CLCVVHF, form 1) 1.4 l/h, and body clearance (Clbody) 1.1 l/h. The average sieving coefficient during the study period was 0.89 ± 0.03. In the second patient, the pharmacokinetics of vancomycin were studied following dose reduction: Vd 41.7 l, ¶t1/2 term 20.3 h, Cltot 1.4 l/h, ClCVVHF, form 1 1.4 l/h, and Clbody < 0.1 l/h. The average sieving coefficient during the study period was 0.88 ± 0.03. The cumulative amount of vancomycin removed by means of CVVHF during the 12-h study period was 245 mg in patient 1 and 228 mg in patient 2.¶Conclusion: CVVHF with a PAN 06 haemofilter effectively removed vancomycin in two critically ill patients. The amount of vancomycin removed with CVVHF was about 250 mg per 12 h. A clear difference in body clearance in the two patients was observed. Our dosage recommendation for vancomycin in critically ill patients receiving CVVHF is a loading dose of 15–20 mg/kg followed after 24 h by 250 to 500 mg twice daily with close monitoring of the serum and ultrafiltrate vancomycin concentration.
Effectiveness of a colour coded HbA1c graphical record in improving diabetes control in people with type 2 diabetes: a randomized control trial.

We conducted a six-month randomized-controlled-trial to evaluate the effectiveness of a colour-coded HbA1c-graphical record in improving HbA1c level among type 2 diabetes patients. There was an improvement in the mean HbA1c knowledge score but the usage of the colour-coded HbA1c-graphical record did not produce reduction in the HbA1c level.
Motherhood after traumatic spinal cord injury

The present study includes all women with a traumatic spinal cord injury in Sweden who became pregnant and delivered live infants during 1980-1991. This group comprises six tetraplegic and 20 paraplegic patients, all confined to a wheelchair. During the above mentioned period the patients had delivered a total of 47 children. The study evaluated parental ability and quality of family life as regards interpersonal relationships, family relationships, social integration, recreational interests and demand for external assistance. An individual standardised interview was performed with all patients. In addition a standardised questionnaire was sent to all spouses (n = 20) and to all children above 10 years of age (n = 10). All 26 patients participated, 18 spouses completed and returned the questionnaires and all children took part in the study. We found an overall favourable outcome as regards the parameters evaluated. The families seem to live a rich and complete family life with very little demand for external help. They report a well functioning social network and seem socially integrated both as individuals and as families. To conclude, the study indicates that there is no reason to question females with an SCI in their roles as parents. The spinal cord injury per se, in females, thus does not preclude the possibility of having a family and caring for children adequately.
Serial determinations of absolute plasma volume with indocyanine green during hemodialysis.

Hemodynamic stability during hemodialysis depends largely on plasma volume (PV) preservation during ultrafiltration (UF). Current estimates of blood volume (BV) are indirect or involve the use of radioactive tracers, which does not allow repeated measurements during hemodialysis. Indocyanine green was used to measure PV during hemodialysis. After an initial pilot phase (phase I), PV values were determined before dialysis, repeatedly during isovolemic hemodialysis (phase II), and during stepwise UF (phase III). Absolute BV values were calculated from PV and hematocrit values. Patients were monitored for extracellular fluid volume (bioimpedance monitoring) and relative BV changes (ultrasonic monitoring). Phase I demonstrated dye stability in plasma, peak absorbance at 805 nm, and a short half-life (4.53 +/- 1.5 min). Ten milligrams of dye (2.5 mg/ml) were injected for each PV measurement. Eight plasma samples were obtained beginning 3 min after injection, at 1-min intervals, for assessment of decay characteristics. The isovolemic hemodialysis PV measurements demonstrated excellent reproducibility (r(2) = 0.98; method SD, 356 ml; mean coefficient of variation, 4.07%) and a difference of only 149 +/- 341 ml (mean +/- SD), compared with predialysis PV values (Bland-Altman method). PV values at the beginning of dialysis were significantly correlated with body surface area (r(2) = 0.82, P < 0.001) and extracellular fluid estimates (r(2) = 0.73, P < 0.001). BV prediction formulae significantly underestimated absolute BV at the start of dialysis (P < 0.0001). The findings demonstrate that this method can be used for repeated PV determinations during hemodialysis, with excellent reproducibility. It is a potential tool for further research on hemodynamic stability during UF.
ect of omeprazole 20 mg twice daily on duodenogastric and gastro-oesophageal bile reflux in Barrett ’ s oesophagus

Both acid and duodenal contents are thought to be responsible for the mucosal damage in Barrett’s oesophagus, a condition often treated medically. However, little is known about the eVect of omeprazole on duodenogastric reflux (DGR) and duodenogastro-oesophageal reflux (DGOR). To study the eVect of omeprazole 20 mg twice daily on DGR and DGOR, using the technique of ambulatory bilirubin monitoring. Twenty three patients with Barrett’s oesophagus underwent manometry followed by 24 hour oesophageal and gastric pH monitoring. In conjunction with pH monitoring, 11 patients (group 1) underwent oesophageal bilirubin monitoring and 12 patients (group 2) underwent gastric bilirubin monitoring, both before and during treatment with omeprazole 20 mg twice daily. In both groups there was a significant reduction in oesophageal acid (pH<4) reflux (p<0.005) and a significant increase in the time gastric pH was above 4 (p<0.005). In group 1, median total oesophageal bilirubin exposure was significantly reduced from 28.9% to 2.4% (p<0.005). In group 2, median total gastric bilirubin exposure was significantly reduced from 24.9% to 7.2% (p<0.005). Treatment of Barrett’s oesophagus with omeprazole 20 mg twice daily results in a notable reduction in the exposure of the oesophagus to both acid and duodenal contents. In addition, delivery of duodenal contents to the upper gastric body is reduced.
Comparison of inflammatory cell counts in asthma: induced sputum vs bronchoalveolar lavage and bronchial biopsies.

Induced sputum potentially allows monitoring of airway inflammation in patients with asthma in a non-invasive way. However, the relationship between the cellular content in sputum and airway tissue has not been fully clarified.



We compared the cellular compositions of hypertonic saline-induced sputum, bronchoalveolar lavage fluid (BAL) and bronchial biopsies in 18 clinically stable patients with mild to moderate atopic asthma (baseline FEV1: range 61-114%pred, PC20 methacholine: 0.04-4.7 mg/mL). They were treated with inhaled short-acting bronchodilators on demand, with (n = 8) or without (n = 10) regular inhaled steroids.



Each patient underwent sputum induction and fiberoptic bronchoscopy on separate days in random order. Differential cell counts of induced sputum, bronchoalveolar lavage and bronchial wash were determined on May-Grünwald-Giemsa stained cytospins. Flow cytometry was performed on sputum and BAL samples. Immunohistochemical techniques were used to stain inflammatory cells in 6 microm cryostat sections of bronchial biopsies.



Sputum cell differentials were not different between the patients with and without inhaled steroids, and showed a median value of 19.4% squamous cells, with 1.0% eosinophils, 3.3% lymphocytes, 28.7% neutrophils, 49.4% macrophages and 6.9% cylindric epithelial cells (in percentage non-squamous cells). The percentage eosinophils in sputum was significantly correlated with their percentage in bronchial wash (Rs = 0.52, P = 0.03) and in BAL (Rs = 0.55, P= 0.02), whilst there was a trend towards such a correlation between the number of eosinophils/mL sputum and the number of EG2+ eosinophils/mm2 lamina propria in bronchial biopsies (Rs = 0.44, P = 0.07). In addition, the percentage of CD4+ lymphocytes correlated between sputum and BAL (Rs = 0.55, P = 0.03).



We conclude that the eosinophil counts in hypertonic saline-induced sputum from patients with asthma are related to those in bronchial wash and BAL and, to a lesser extent, with the counts in bronchial biopsies. This suggests that induced sputum can be used to monitor the presence and severity of airway inflammation in asthma.