nils-herrmann/clean_scirepeval huggingface dataset:
A phase II randomized study comparing navelbine and capecitabine (Navcap) followed either by Navcap or by weekly docetaxel in the first-line treatment of HER-2/neu negative metastatic breast cancer.

Following the proven efficacy and tolerability of Navcap and Navcap followed by docetaxel in the treatment of MBC, a phase II randomized study was initiated to assess the ORR of both arms in the first-line setting of MBC. Patients with no prior chemotherapy for MBC and HER-2/neu negative were eligible. All patients received Navcap (V 25 mg/m2 on d1 and d8 and C 825 mg/m2 bid D1-14 q3w) for a total of 4 cycles. Patients progressing under Navcap were withdrawn and received docetaxel as second-line treatment. Patients responding or stable were randomized to 2 arms: 4 cycles of Navcap (A) or 12 weekly docetaxel (25 mg/m²/week) (B). From July 2004 to July 2008, a total of 106 patients were enrolled. Ninety-four patients were evaluable before randomization, with a clinical benefit of 58%. Twenty-one patients (22%) had disease progression and were therefore not randomized. Forty-one patients were randomized to arm A and 29 patients to arm B. ORRs were 56 and 71% in arms A and B, respectively. The median time to progression and overall survival were 10 and 35 months in arm A and 12 and 37 months in arm B. Adverse events were mild. Arm A: grade 3-4 neutropenia (10%), grade 3 anemia (5%). Arm B: grade 3 neutropenia (6%), grade 3 anemia (6.2%), and grade 2 alopecia (12%).



Both Navcap and Navcap followed by Docetaxel regimens were tolerated with manageable toxicity, offering consistent activities in terms of response rate for metastatic breast cancer patients.
Bispectral index-guided sedation in transfemoral transcatheter aortic valve implantation: a retrospective control study

Transcatheter aortic valve implantation (TAVI) is a minimally invasive therapy for elderly patients with severe aortic valve stenosis who were refused surgical aortic valve replacement because of the high perioperative risk. Traditionally, this procedure has been done under general anesthesia, but more recently local anesthesia and sedation have become popular. This research assessed the effectiveness of transfemoral TAVI under bispectral index (BIS)-guided sedation. In this single-center retrospective control analysis, clinical data, including demographic characteristics, echocardiography, periprocedural data, and main complications, were collected and assessed in 113 patients undergoing TAVI through the femoral artery under general anesthesia (GA group, n=36) and under BIS-guided sedation (SED group, n=77). The demographic characteristics and echocardiographic parameters between the two groups were similar (P>0.05). Two (2.6%) of patients were moved from BIS-guided sedation to general anesthesia for surgical reasons. Procedures were significantly shorter in the SED group than in the GA group ((127.10±44.43) min vs. (165.90±71.62) min, P=0.004). Patients in the SED group lost less blood and received significantly fewer red blood cells and catecholamines than those in the GA group (5.19% vs. 22.22%, P=0.017 and 67.53% vs. 97.22%, P<0.001). The length of hospital stay was significantly shorter and there were fewer pulmonary complications in the SED group than in the GA group. Thirty-day mortality was similar between the two groups. BIS-guided sedation is a feasible and safe approach for transfemoral TAVI. The anesthesiologist should choose the best anesthetic method according to the team’s experience. 脑电双频谱指数导向的镇静在股动脉入路经导管主动脉瓣植入术中的应用 探讨脑电双频谱指数(BIS)导向的镇静在股动 脉入路经导管主动脉瓣植入术(TAVI)中的可行 性和有效性。 由于TAVI 患者高龄、心功能差、合并症多,加 上导管室布局不利于麻醉操作,实施镇静难度很 大。我们利用目前常用的镇静监测手段BIS 来实 施导向镇静,有效地实现了深度可控的镇静,减 少了并发症。 回顾了本中心所有经股动脉入路的113 名TAVI 患者(图1)。将患者分为两组,其中36 名患者 进行了全身麻醉,77 名患者施行了BIS 导向的镇 静。两组患者的术前一般情况的差别不显著 (表1)。术中资料显示,BIS 导向的镇静组较全身 麻醉组手术时间更短、失血更少、输血制品和血 管活性药使用更少(表2)。术后的资料显示,两 组的30 天死亡率差异不显著,而BIS 导向的镇静 组有更短的住院时间和更少的肺部并发症(表3)。 BIS 导向的镇静在股动脉入路TAVI 是安全可行 的。各个临床中心可根据自身经验选择最合适的 麻醉方法。
Five-year outcome of surgical decompression of the lumbar spine without fusion

As the average life expectancy of the population increases, surgical decompression of the lumbar spine is being performed with increasing frequency. It now constitutes the most common type of lumbar spinal surgery in older patients. The present prospective study examined the 5-year outcome of lumbar decompression surgery without fusion. The group comprised 159 patients undergoing decompression for degenerative spinal disorders who had been participants in a randomised controlled trial of post-operative rehabilitation that had shown no between-group differences at 2 years. Leg pain and back pain intensity (0–10 graphic rating scale), self-rated disability (Roland Morris), global outcome of surgery (5-point Likert scale) and re-operation rates were assessed 5 years post-operatively. Ten patients had died before the 5-year follow-up. Of the remaining 149 patients, 143 returned a 5-year follow-up (FU) questionnaire (effective return rate excluding deaths, 96%). Their mean age was 64 (SD 11) years and 92/143 (64%) were men. In the 5-year follow-up period, 34/143 patients (24%) underwent re-operation (17 further decompressions, 17 fusions and 1 intradural drainage/debridement). In patients who were not re-operated, leg pain decreased significantly (p < 0.05) from before surgery to 2 months FU, after which there was no significant change up to 5 years. Low back pain also decreased significantly by 2 months FU, but then showed a slight, but significant (p < 0.05), gradual increase of <1 point by 5-year FU. Disability decreased significantly from pre-operative to 2 months FU and showed a further significant decrease at 5 months FU. Thereafter, it remained stable up to the 5-year FU. Pain and disability scores recorded after 5 years showed a significant correlation with those at earlier follow-ups (r = 0.53–0.82; p < 0.05). Patients who were re-operated at some stage over the 5-year period showed significantly worse final outcomes for leg pain and disability (p < 0.05). In conclusion, pain and disability showed minimal change in the 5-year period after surgery, but the re-operation rate was relatively high. Re-operation resulted in worse final outcomes in terms of leg pain and disability. At the 5-year follow-up, the “average” patient experienced frequent, but relatively low levels of, pain and moderate disability. This knowledge on the long-term outcome should be incorporated into the pre-operative patient information process.
Impairment of insulin secretion in man by nifedipine

The effect of nifedipine, a calcium antagonist, on carbohydrate metabolism and insulin secretion was evaluated in patients who required treatment with this drug. 20 subjects underwent two oral glucose tolerance tests (100 g), one under basal conditions, and the other after ten days of treatment with nifedipine 30 mg/day by mouth, in three divided doses. 10 subjects had normal glucose tolerance; in them nifedipine administration reduced the insulin response to oral glucose in the first 60 min, but improved glucose tolerance. The other 10 subjects had impaired glucose tolerance and nifedipine treatment resulted in a further reduction both of insulin secretion and glucose tolerance. No such effects were seen in the placebo (weight- and disease-matched) group. The mechanism by which nifedipine influences carbohydrate metabolism and insulin secretion is discussed.
Dialysis therapy for children with acute renal failure: survey results

We surveyed 123 pediatric nephrologists to investigate the current dialytic management of acute renal failure (ARF) in children. Data collected from 92 responding physicians revealed that hemodialysis (HD), peritoneal dialysis (PD), and continuous renal replacement therapy (CRRT) are currently used as the primary means of acute renal replacement therapy in a nearly equal percentage of centers. The preferential use of CRRT appears to be increasing, while PD usage is decreasing except for the youngest infants and those patients likely to develop end-stage renal disease (ESRD). Additional data correlating patient outcome to dialytic modality should be collected to compare the efficacy of the three techniques.
Microcirculatory mechanisms in postnatal hypotension affecting premature infants

Hypotension remains a common complication in preterm infants and is associated with high neonatal morbidity and mortality. The underlying mechanisms are still not fully understood. We studied the microcirculation in extremely low birth weight infants to understand the relationship between blood pressure and skin perfusion.In 21 patients (gestational age <30 wk, birth weight <1,225 g), functional vessel density (FVD) and diameter distribution were obtained prospectively by side stream dark-field imaging at the right arm in the first 48 h after birth. Infants with blood pressure below gestational age and receiving catecholamines were defined as hypotensive as compared with the remaining normotensive control group.In the first 6 h after birth, FVD was significantly higher in the hypotensive group than in the control group. After 12 h, there were no significant differences in either blood pressure or FVD between the two groups. FVD did not change significantly during the observation period in either group.Hypotensive infants have a higher FVD, possibly due to loss of microvascular tone leading to vasodilation and flow redistribution. However, the link between blood pressure and perfusion remains unclear, and no definitive correlation could be found.
Evaluation of the Simplify D-dimer assay as a screening test for the diagnosis of deep vein thrombosis in an emergency department.

To evaluate the use in an emergency department of a new D-dimer assay (Simplify D-dimer) as a screening test for deep vein thrombosis (DVT).



187 outpatients with clinical features suspicious of acute DVT were entered into this study. A Simplify D-dimer test was performed in the emergency department on all patients. A SimpliRED D-dimer test and a semi-automated latex agglutination assay (Auto-D-dimer 700 on a Thromboscreen 400C analyser) were performed in the haematology laboratory. All patients were investigated with contrast venography to confirm or exclude the diagnosis of DVT.



The Simplify test had a sensitivity of 94.1% and a negative predictive value (NPV) of 94.8%. These results compared favourably with the SimpliRED test (sensitivity 74.5%, NPV 89.7%) and the latex agglutination assay (sensitivity 90.2%, NPV 92.2%). This increased sensitivity was at the cost of a lower specificity, the specificity of the three d-dimer tests being Simplify 40.4%, SimpliRED 83.1%, and latex agglutination 43.4%.



Simplify proved to be a rapid and easy to use test and may be useful for use in the emergency department as part of a diagnostic algorithm for deep vein thrombosis. Further larger scale studies are needed.
The standardised mistletoe extract PS76A2 improves QoL in patients with breast cancer receiving adjuvant CMF chemotherapy: a randomised, placebo-controlled, double-blind, multicentre clinical trial.

Patients with breast cancer receiving adjuvant chemotherapy frequently suffer from a restricted quality of life (QoL) due to the side-effects of chemotherapy and the consequences of coping with the diagnosis. Therefore, the objective of this clinical study was to investigate the impact of PS76A2, an aqueous mistletoe extract standardised to the galactoside-specific mistletoe lectin, on QoL by performing a placebo-controlled trial. Overall, 272 patients with breast cancer receiving adjuvant CMF chemotherapy (cyclophosphamide-methotrexate-fluorouracil) were enrolled and randomised to groups receiving placebo or PS76A2 at concentrations of 10, 30 or 70 ng mistletoe lectin (ML) per ml. The patients received 0.5 ml study medication twice weekly subcutaneously for 15 consecutive weeks (4 CMF cycles). Primary variables were the self-assessment QoL scores GLQ-8 (Global Life Quality) and Spitzer's uniscale. As a result, statistically significant effects on QoL were obtained with the medium dose (15 ng ML/0.5 ml). The treatment difference between the medium dose and placebo with regard to the GLQ-8 sum was 60.8 mm (95% confidence interval: 19.3 to 102.0 mm). The treatment effect for Spitzer's uniscale between the medium dose and placebo was 16.4 mm (95% confidence interval: 6.3 to 26.6 mm). The results on QoL were supported by an increase of T helper lymphocytes (CD4+) and the CD4+/CD8+ ratio (p<0.05). Overall, PS76A2 was well tolerated. Local reactions at the injection sites occurred dose-dependently, but were mild at the low and medium dose levels.
Predictors of relapse in a prospective study of fluoxetine treatment of major depression.

Loss of response to a previously effective antidepressant is a common clinical problem. Retrospective analyses have shown that the pattern of response during antidepressant treatment (late onset and persistent versus other patterns) can be used to predict relapse during continuation and maintenance treatment and possibly to identify placebo responses to treatment. This study was designed to test the predictive value of response pattern prospectively and to examine the data for other predictors of relapse.



Five hundred seventy persons with major depressive disorder were treated with fluoxetine for 12 weeks and their pattern of response was determined. Those who responded (N=292) underwent random assignment, under double-blind conditions, to continue taking fluoxetine or to switch to placebo for 52 weeks or until relapse. Survival analysis was used to examine the effect of covariates on relapse.



Although fluoxetine was significantly more effective than placebo during maintenance treatment, this chronically ill group had a high rate of relapse. Contrary to previous findings, a pattern of acute response was not predictive of relapse. Chronicity, symptom severity, a neurovegetative symptom pattern, and female gender were all associated with a significantly greater risk of relapse, with no difference observed between fluoxetine and placebo.



The pattern of response to acute treatment appears to be inconsistently predictive of relapse. There is a high rate of relapse with both active medication and placebo in patients with chronic depression. Illness characteristics predict loss of response both to fluoxetine and to placebo. No variable examined was predictive of differential relapse rates between fluoxetine and placebo.
Characteristics of hemophagocytic lymphohistiocytosis in neonates: a nationwide survey in Japan.

To assess the etiology, prognosis, and appropriate treatment of hemophagocytic lymphohistiocytosis (HLH) in neonates.



We collected information on neonates in whom HLH was diagnosed between 1997 and 2007 from participating members of the Japanese Society of Pediatric Hematology.



HLH was diagnosed in 20 patients within 4 weeks after birth. Of the diagnostic criteria for HLH-2004, the incidence of fever was quite low in preterm infants, and hypertriglyceridemia and neutropenia were uncommon. Familial HLH (n = 6) or severe combined immunodeficiency-associated HLH (n = 1) was diagnosed in 7 patients, and 2 of them have survived. Herpes simplex virus-associated HLH was diagnosed in 6 patients, and 2 of them have survived. The overall survival rate for the 20 patients was 40%.



HLH is rare in neonates and has a poor prognosis. Early diagnosis and immediate treatment are required when considering the possibility of herpes simplex virus-associated or familial HLH.
The Effect of India's Total Sanitation Campaign on Defecation Behaviors and Child Health in Rural Madhya Pradesh: A Cluster Randomized Controlled Trial

Poor sanitation is thought to be a major cause of enteric infections among young children. However, there are no previously published randomized trials to measure the health impacts of large-scale sanitation programs. India's Total Sanitation Campaign (TSC) is one such program that seeks to end the practice of open defecation by changing social norms and behaviors, and providing technical support and financial subsidies. The objective of this study was to measure the effect of the TSC implemented with capacity building support from the World Bank's Water and Sanitation Program in Madhya Pradesh on availability of individual household latrines (IHLs), defecation behaviors, and child health (diarrhea, highly credible gastrointestinal illness [HCGI], parasitic infections, anemia, growth).



We conducted a cluster-randomized, controlled trial in 80 rural villages. Field staff collected baseline measures of sanitation conditions, behaviors, and child health (May-July 2009), and revisited households 21 months later (February-April 2011) after the program was delivered. The study enrolled a random sample of 5,209 children <5 years old from 3,039 households that had at least one child <24 months at the beginning of the study. A random subsample of 1,150 children <24 months at enrollment were tested for soil transmitted helminth and protozoan infections in stool. The randomization successfully balanced intervention and control groups, and we estimated differences between groups in an intention to treat analysis. The intervention increased percentage of households in a village with improved sanitation facilities as defined by the WHO/UNICEF Joint Monitoring Programme by an average of 19% (95% CI for difference: 12%-26%; group means: 22% control versus 41% intervention), decreased open defecation among adults by an average of 10% (95% CI for difference: 4%-15%; group means: 73% intervention versus 84% control). However, the intervention did not improve child health measured in terms of multiple health outcomes (diarrhea, HCGI, helminth infections, anemia, growth). Limitations of the study included a relatively short follow-up period following implementation, evidence for contamination in ten of the 40 control villages, and bias possible in self-reported outcomes for diarrhea, HCGI, and open defecation behaviors.



The intervention led to modest increases in availability of IHLs and even more modest reductions in open defecation. These improvements were insufficient to improve child health outcomes (diarrhea, HCGI, parasite infection, anemia, growth). The results underscore the difficulty of achieving adequately large improvements in sanitation levels to deliver expected health benefits within large-scale rural sanitation programs.


 Please see later in the article for the Editors' Summary.
Characteristics of clear cell ovarian cancer arising from endometriosis: a two center cohort study.

Endometrioid and clear cell ovarian tumors have been referred to as "endometriosis associated ovarian cancers". However, very few studies have compared clinical and prognostic features of endometriosis-associated cancers or cancers not associated with endometriosis according to specific histotypes. We have investigated clinical and histological features of the largest published series of clear cell ovarian cancers arising in endometriosis using a retrospective database.



Seventy three patients with a primary diagnosis of either pure clear cell ovarian cancer and mixed endometrioid-clear cell ovarian cancer have been divided into two groups according to the detection of cancer strictly arising from ovarian endometriosis or not (n=27 and n=46, respectively). Clinical and pathological data have been compared.



Patients with clear cell carcinomas arising from endometriosis tend to be significantly younger (51.4±10.0 and 58.4±11.2years, p=0.02). FIGO stage, laterality, prevalence of pure versus mixed histology, and presence of synchronous endometrial carcinoma were not significantly different between the two groups. Unilateral ovarian involvement was more frequent in cases arising in endometriosis (85% vs 63%, p=0.04). Ascites was not found in any of the endometriosis-associated cancer cases vs 19.5% in patients without endometriosis. The presence of endometriosis did not affect 5-year overall survival rates.



Endometriosis per se does not appear to be associated with a lower stage tumor or to predict prognosis in ovarian clear cell cancers. Unilateral involvement and reduced presence of ascites may be linked to the cystic nature of endometriosis which frequently presents as monolateral and in which associated tumors are more likely to be longer confined to the ovary before spreading.
No-glucose strategy influences posterior cranial fossa tumors' postoperative course: introducing the Glycemic Stress Index

In a selected patient population, we evaluated the glycemic response to different infusional policies in the management of posterior cranial fossa tumor (PFT) removal. We analyzed the perioperative course, prospectically collected, of 137 children undergoing 150 surgical procedures. Patients were divided in two groups according to different intraoperative fluids (group A, 2.5% glucose; group B, crystalloids). In group B glycemia remained below 125 mg dl−1, while group A showed persistently supranormal glycemic plasma values, reaching statistical significance at the end of surgery (P < 0.018). As no perioperative mortality occurred and no differences were found between groups regarding PICU respiratory or infectious complications, PICU length of stay (LOS) was assumed as the main outcome indicator. LOS was not influenced by group A or B inclusion, while a new indicator, namely the Glycemic Stress Index (GSI), representing both glycemic intraoperative change and procedure length, showed significantly different results in the study groups (P = 0.004). Our clinical experience suggests that both intraoperative glucose-free solutions are safe, and GSI can be a useful tool to identify prolonged PICU stay patients.
Measures of cumulative exposure from a standardized sun exposure history questionnaire: a comparison with histologic assessment of solar skin damage.

Ultraviolet radiation exposure is the dominant environmental determinant of all major forms of skin cancer; however, the nature of the association is incompletely understood. Existing instruments to capture sun exposure history tend to yield reproducible results, but the validity of these responses is unknown. To address this question, the authors examined the relation between responses to a standardized sun exposure instrument and histologic evidence of actinic damage in a population-based study of keratinocyte cancers from New Hampshire diagnosed from July 1, 1997, through March 31, 2000. A single study dermatopathologist histologically reviewed the adjacent skin of 925 skin cancer biopsies for the presence of solar keratoses and the extent of solar elastosis. The authors compared these measures with responses to a personal interview on history of sunburns, sunbathing, and time spent outdoors. Focusing on site-specific exposure, they found variables that estimated cumulative exposure related to histologic evidence of actinic damage. In contrast, measures of acute/intermittent exposure were generally unrelated to solar damage histologically. Findings suggest that cumulative, but not intermittent, measures of sun exposure derived from a personal interview appear to reflect a person's exposure history based on histologic evidence.