nils-herrmann/clean_scirepeval huggingface dataset:
Lipoprotein Changes in Relation to Body Mass Index in Native American Adolescents

In view of their known high incidence of noninsulin dependent diabetes(NIDDM), we sought to determine whether Native American (Plains Indian) children and adolescents show evidence of risk factors for both NIDDM and cardiovascular disease. Children and adolescents between the ages of 4 and 19 y were recruited, and field days were organized for data collection, which included height, weight [to compute body mass index (BMI)], waist and hip circumference, family histories, quantum of Native American ancestry, and blood sampling for fasting lipids, apolipoproteins, insulin, and glucose. BMI increased with age in boys and girls and tended to be higher than in Caucasian children. The difference was significant in 5-9-y-old (p < 0.05) and 10-14-y-old (p < 0.05) boys and 10-14-y-old girls(p < 0.001). Ten- to 14-y-old girls in the highest quartile for BMI had higher triglyceride levels (p < 0.05) and lower HDL cholesterol (p < 0.001) when compared with those in the lower quartiles. In contrast, 15-19 y olds in the highest quartile for BMI had higher cholesterol, LDL cholesterol, and apolipoprotein B (p < 0.001). The mean fasting insulin levels were not related to BMI. The data suggest that, within this Plains Indian population, obesity associated with elevated lipid levels tends to begin at an early age in Native American children. Insulin levels do not appear to be related to BMI, a putative index of adiposity, in this population of children known to be prone to NIDDM in adult life.
Effects of administration of hormone therapy or raloxifene on the immune system and on biochemical markers of bone remodeling.

Over the last few years, conclusive evidence of the involvement of the immune system in the regulation of bone metabolism has been identified. Consequently, one question that should be formulated concerns the possible effects of antiresorptive therapies on the immune system. Therefore, the purpose of the present work was to evaluate both the functionality of the immune system and bone turnover in women receiving antiresorptive therapies, such as hormone therapy (HT; n = 33) and raloxifene (RLX; n = 66), acting through estrogen receptors.



To that end, this study analyzed bone turnover markers in a population of postmenopausal women before and after beginning therapy and compared these with data of women not treated (NT; n = 102). In a subgroup of participants (NT = 33, RLX = 24, and HT = 26), we analyzed the effects of treatments on immune system parameters such as serum levels of interleukin (IL)-6, tumor necrosis factor α, and IL-1β; lymphocyte subpopulations; cell proliferation by peripheral blood mononuclear cells (PBMCs); in vitro production of IL-1β by PBMCs; and the expression of receptor activator of nuclear factor-κB ligand, transforming growth factor β, and IL-4 genes by PBMCs.



The results showed that bone resorption was inhibited strongly in women in the RLX and HT groups when compared with women in the NT group. Interestingly, the administration of RLX inhibited the production of the Wnt/β-catenin signaling pathway inhibitor Dickkopf Homolog-1 (P < 0.05) and tended to increase the levels of the osteoclastogenesis inhibitor osteoprotegerin at month 6 (P = 0.059). With regard to the immune system, the different treatments did not markedly perturb the parameters analyzed, with the exception of the increase in serum IL-1β detected in the HT group at month 6 (P < 0.05).



The main conclusions of the present work were that HT or RLX do not disturb the immune system and that both treatments have a similar antiresorptive power.
Effect of neoadjuvant cetuximab, capecitabine, and radiotherapy for locally advanced rectal cancer: results of a phase II study

The aim of this study was to investigate the efficacy and safety of neoadjuvant cetuximab, capecitabine, and radiotherapy for patients with locally advanced rectal cancer. Sixty-three eligible patients were selectively enrolled in this study. Neoadjuvant treatment consisted of cetuximab and capecitabine for 6 weeks and radiotherapy for 5 weeks. Surgical resection was performed 6–8 weeks after the completion of neoadjuvant treatment. KRAS mutation statuses were analyzed retrospectively after the cetuximab treatment. All the patients underwent a standardized postoperative follow-up for at least 3 years. A pathological complete response (pCR) was achieved in eight patients (12.7 %). Overall down-staging was found in 49 patients (77.8 %). The 3-year disease-free survival (DFS) rate and overall survival (OS) rate was 76.2 % and 81.0 %, respectively. The most common adverse events during neoadjuvant treatment were acneiform skin rash (82.5 %), radiodermatitis (46.0 %), and diarrhea (36.5 %). KRAS mutations were detected in 19 of 63 (31.2 %) tumors. The down-staging rate in patients with KRAS wild-type (WT) was significantly higher than patients with KRAS mutation (P = 0.020). There was no significant difference in the pCR rate, 3-year DFS rate or 3-year OS rate between KRAS WT patients and KRAS-mutated patients. Neoadjuvant treatment with cetuximab and capecitabine-based chemoradiotherapy is safe and well tolerated. The pCR rate, 3-year DFS rate and OS rate are not superior to the rate of neoadjuvant chemoradiotherapy using two or more cytotoxic agents. The KRAS WT is highly associated with tumor down-staging to cetuximab plus capecitabine-based CRT in patients with LARC.
The role of parent depressive symptoms in positive and negative parenting in a preventive intervention.

This study examined the role of parent depressive symptoms as a mediator of change in behaviorally observed positive and negative parenting in a preventive intervention program. The purpose of the program was to prevent child problem behaviors in families with a parent who has current or a history of major depressive disorder. One hundred eighty parents and one of their 9- to 15-year-old children served as participants and were randomly assigned to a family group cognitive-behavioral (FGCB) intervention or a written information (WI) comparison condition. At two months after baseline, parents in the FGCB condition had fewer depressive symptoms than those in the WI condition, and these symptoms served as a mediator for changes in negative, but not positive, parenting at 6 months after baseline. The findings indicate that parent depressive symptoms are important to consider in family interventions with a parent who has current or a history of depression.
Laparoscopic Pancreatoduodenectomy in 50 Consecutive Patients with No Mortality: A Single-Center Experience.

Laparoscopic pancreatic surgery has gradually expanded to include pancreatoduodenectomy (PD). This study presents data regarding the efficacy of laparoscopic PD in a single center.



This was a single-cohort, prospective observational study. From March 2012 to September 2015, 50 consecutive patients underwent laparoscopic PD using a five-trocar technique. Reconstruction of the digestive tract was performed with double jejunal loop technique whenever feasible. Patients with radiological signs of portal vein invasion were operated by open approach.



Twenty-seven women and 23 men with a median age of 63 years (range 23-76) underwent laparoscopic PD. Five patients underwent total pancreatectomy. All, but 1 patient (previous bariatric operation), underwent pylorus-preserving resection. Reconstruction was performed with double jejunal loop in all cases except in 5 cases of total pancreatectomy. Conversion was required in 3 patients (6%) as a result of difficult dissection (two cases) and unsuspected portal vein invasion (1 patient). Median operative time was 420 minutes (range 360-660), and the 90-day mortality was nil. Pancreatic fistula occurred in 13 patients (26%). There was one grade C (reoperated), one grade B (percutaneous drainage), and all remaining were grade A (conservative treatment). Other complications included port site bleeding (n = 1), biliary fistula (n = 2), and delayed gastric emptying (n = 2). Mean hospital stay was 8.4 days (range 5-31).



Laparoscopic PD is feasible and safe, but is technically demanding and may be reserved to highly skilled laparoscopic surgeons with proper training in high-volume centers. Isolated pancreatic anastomosis may be useful to decrease the severity of postoperative pancreatic fistulas. Therefore, it could be a good option in patients with a high risk for developing postoperative pancreatic, as well as by less-experienced surgeons.
Angiotensin-(1-7)-induced renal vasodilation in hypertensive humans is attenuated by low sodium intake and angiotensin II co-infusion.

Current evidence suggests that angiotensin-(1-7) plays an important role in the regulation of tissue blood flow. This evidence, however, is restricted to studies in animals and human forearm. Therefore, we studied the effects of intrarenal angiotensin-(1-7) infusion on renal blood flow in hypertensive humans. To assess the influence of renin-angiotensin system activity, sodium intake was varied and co-infusion with angiotensin II was performed in a subgroup. In 57 hypertensive patients who were scheduled for renal angiography, renal blood flow was measured ((133)Xenon washout method) before and during intrarenal infusion of angiotensin-(1-7) (3 incremental doses: 0.27, 0.9, and 2.7 ng/kg per minute). Patients were randomized into low or high sodium intake. These 2 groups of patients received angiotensin-(1-7), with or without intrarenal co-infusion of angiotensin II (0.3 ng/kg per minute). Angiotensin-(1-7) infusion resulted in intrarenal vasodilation in patients adhering to a sodium-rich diet. This vasodilatory effect of angiotensin-(1-7) was clearly attenuated by low sodium intake, angiotensin II co-infusion, or both. Regression analyses showed that the prevailing renin concentration was the only independent predictor of angiotensin-(1-7)-induced renal vasodilation. In conclusion, angiotensin-(1-7) induces renal vasodilation in hypertensive humans, but the effect of angiotensin-(1-7) is clearly attenuated by low sodium intake and co-infusion of angiotensin II. This supports the hypothesis that angiotensin-(1-7) induced renal vasodilation depends on the degree of renin-angiotensin-system activation.
Therapeutic effects of the long-term use of PAN membrane dialyzer in hemodialysis patients: efficacy in old dialysis patients with mild PAD.

AN69 dialyzer, a plate type dialyzer with a polyacrylonitrile membrane (PAN membrane) is reported to reduce symptoms in hemodialysis (HD) patients with complications such as poor nutritional status and peripheral arterial disease (PAD). Yet very few studies have investigated the long-term use of the PAN membrane or compared the solute-removal properties of the PAN membrane with those of the Type IV polysulfone membrane (PS membrane), the dialysis membrane most widely used. In the present study we compared the contaminant-removal properties of the AN69 membrane dialyzer with those of a Type IV PS membrane dialyzer and investigated the clinical effects of the long-term use of the former for elderly hemodialysis patients with mild PAD.



Cross-over trials with 2 week intervals for solute were conducted in 6 patients to compare the performance of the membranes in removing small molecular weight substances, β2 microglobulin (β2MG), amino acid (AA), and serum albumin (Alb). Next, the AN69 membrane was used for dialysis over a period of 72 weeks in 8 patients. The time course changes of Alb, the geriatric nutritional risk index (GNRI), the % creatinine generation rate (%CGR), the normalized protein catabolic rate (nPCR) and the dry weight (DW) were observed to evaluate the nutritional status. The time course changes of β2MG, C-reactive proteins (CRP), LDL cholesterol (LDL), fibrinogens (Fib), nitrogen oxide (NOx), hemoglobin (Hb), ferritins, transferrin saturation (TSAT), dose of erythropoiesis-stimulating agents (ESA), and dose of iron were observed to evaluate the therapeutic effects of long-term use. Skin perfusion pressure (SPP) was measured at two points: once at the switchover to the AN69 membrane and once 72 weeks later.



In cross-over trials, the AN69 membrane showed basically the same dialysis efficiency as the PS membrane in removing small molecular weight substances, but it removed significantly lower amounts of β2MG. The AN69 membrane also showed significantly lower rates of AA removal rate and Alb leakage. The nutritional status was stably maintained during long-term use after the switchover to the AN69 membrane, and no significant increase of β2MG was observed. Fib and NOx were both reduced, the latter to a significant degree. The Hb values showed a good time course, with relatively high TSAT levels and low ferritin levels overall. SPP remained generally stable for 72 weeks.



The cross-over trial show the AN69 membrane eliminates less AA and Alb compared with the PS membrane. Judging from the therapeutic effects of the long-term use of the AN69 membrane, the membrane is effective for dialysis and has good biocompatibility in the treatment of elderly HD patients with mild PAD.
Relationship between plasma risperidone and 9-hydroxyrisperidone concentrations and clinical response in patients with schizophrenia

Evaluation of relationships between serum antipsychotic drug concentrations and clinical response may provide valuable information for rational dosage adjustments. For risperidone, this relationship has been little investigated to date.  To assess the relationship between plasma concentrations of risperidone and its active 9-hydroxy-metabolite (9-OH-risperidone) and clinical response in schizophrenic patients who experienced an acute exacerbation of the disorder.  Forty-two patients (30 males, 12 females, age 24–60 years) were given risperidone at dosages ranging from 4 to 9 mg/day for 6 weeks. The design of the study was open and risperidone dosage could be adjusted individually according to clinical response. Steady-state plasma concentrations of risperidone and its 9-hydroxy-metabolite were measured after 4 and 6 weeks using a specific HPLC assay. Psychopathological state was assessed at baseline and at weeks 2, 4, and 6 by means of the positive and negative syndrome scale (PANSS), and patients were considered responders if they showed a greater than 20% reduction in total PANSS score at final evaluation compared with baseline.  Mean plasma concentrations of risperidone, 9-OH-risperidone, and active moiety (sum of risperidone and 9-OH-risperidone concentrations) did not differ between responders (n=28) and non-responders (n=14). No correlation between plasma levels and percent decrease in total PANSS score was found for risperidone (rs=–0.187, NS), 9-OH-risperidone (rs=0.246, NS), and active moiety (rs=0.249, NS). Active moiety concentrations in plasma were higher (P<0.001) in patients developing clinically significant parkinsonian symptoms (n=7) than in those with minimal (n=7) or no drug-induced parkinsonism (n=28).  In chronic schizophrenic patients experiencing an acute exacerbation of the disorder, plasma levels of risperidone and its active metabolite correlate with the occurrence of parkinsonian side effects, whereas no significant correlation appears to exist with the degree of clinical improvement.
Antipsychotic drug and body weight set-point

Antipsychotic (AP) drugs frequently induce weight gain. The present study aimed at exploring a potential association between antipsychotic-induced weight gain and delayed negative alliesthesia for sweet stimuli.



The study aimed at recruiting patients undergoing AP treatment, half of them with stable weight and the other half with documented weight gain. Negative alliesthesia to sweet stimuli was assessed through a specific procedure.



A multivariate regression of the data obtained from the entire sample was performed to establish the relationship between alliesthesia dependent variables and weight gain as a predictor. The overall F statistic shows that there was a significant association between delayed negative alliesthesia for sweet stimuli and weight gain.



Atypical antipsychotic drug-induced weight gain seems to result from a raised body weight set-point.
Prognostic value of osteoprotegerin in chronic heart failure: The GISSI-HF trial.

Circulating levels of osteoprotegerin (OPG), a member of the tumor necrosis factor receptor superfamily, is predictive of death and hospitalization for heart failure after acute coronary syndrome. The association between OPG and outcome in patients with chronic heart failure (CHF) is unknown.



Plasma OPG levels at baseline were assessed in 1,229 patients with CHF recruited from 51 clinical centers and included in the Gruppo Italiano per lo Studio della Sopravvivenza nell'Infarto Miocardico-Heart Failure (GISSI-HF) trial. Patients were randomized to n-3 polyunsaturated fatty acids (1 g/d) or rosuvastatin (10 mg/d) versus placebo. Osteoprotegerin was analyzed by enzyme-linked immunosorbent assay. The association between OPG and outcome was assessed by Cox proportional hazards regression models.



During a median follow-up time of 3.9 years, 332 patients died; and 791 patients died or were hospitalized because of cardiovascular causes. By univariate analysis, baseline OPG levels were strongly associated with the incidence of death (hazard ratio {HR} [95% CI] 1.53 [1.40-1.67] per 1-SD increase in log OPG). After adjustment for conventional risk markers, OPG remained a significant predictor of death (HR [95% CI] 1.20 [1.06-1.35], P < .001). Similar findings were observed for the composite end point (HR [95% CI] 1.34 [1.07-1.69], P = .012).



In patients with CHF, OPG is associated with the incidence of death independently of conventional cardiovascular risk factors.
Asymptomatic worsening of airway inflammation during low-dose allergen exposure in asthma: protection by inhaled steroids.

Asthma is a chronic inflammatory disease that persists even during adequate therapy and asymptomatic episodes. We questioned whether "silent" chronic allergen exposure can induce and maintain airway inflammation and whether this still occurs during regular treatment with inhaled steroids. Twenty-six patients with house dust mite allergy and mild asthma (dual responders) participated in a parallel, double-blind study. All patients inhaled a low-dose of allergen on 10 subsequent working days (Days 1-5, 8-12). They were treated with 400 micro g budesonide once daily (n = 13) or placebo (n = 13) from Days -3 to 19. At baseline (Day -6) and on Days 5, 12, and 19 we measured the provocative concentration of methacholine causing a 20% fall in FEV(1) (PC(20)), and percent eosinophils, interleukin (IL)-5/interferon-gamma messenger RNA ratio (in sputum cells by real-time reverse transcription-polymerase chain reaction [RT-PCR]), and eosinophilic cationic protein (ECP) in induced sputum. Symptoms, peak expiratory flow (PEF), FEV(1), and exhaled nitric oxide (NO) were recorded repeatedly during the study. In the placebo group, repeated low-dose allergen exposure resulted in a significant increase in sputum eosinophils (p = 0.043), ECP (p = 0.011), IL-5/IFN-gamma messenger RNA ratio (p = 0.04), and in exhaled NO (p = 0.001), without worsening of symptoms, PEF, or baseline FEV(1) (p > 0.07). In the budesonide group, the changes in PC(20), sputum ECP, and exhaled NO were significantly different as compared with the placebo group (p < 0.03). We conclude that repeated low-dose allergen exposure in asthma can lead to airway inflammation without worsening of symptoms, which can be prevented by inhaled steroid treatment. This suggests that antiinflammatory therapy is beneficial during allergen exposure, even during asymptomatic episodes.
Treatment of acute leukemia with idarubicin, etoposide and cytarabine (IDEA). A randomized study of etoposide schedule

The differences in toxicity of etoposide following continuous or bolus infusion are unknown. We studied the schedule-dependent toxicity of high-dose etoposide when combined with high-dose cytarabine and idarubicin (IDEA) in 138 patients with acute leukemia. Four groups of patients were studied: group I, relapse; group II, secondary acute myeloid leukemia (AML); group III, de novo AML, age >60 years; and group IV, induction failure or blast crisis of myeloproliferative syndrome. Treatment for groups I–III was idarubicin 8 mg/m2 per day days 1–3, cytarabine 2000 mg/m2 once a day days 1–6, and etoposide 1600 mg/m2 total dose. Group IV treatment differed by cytarabine given twice daily days 1–6. Patients were randomized to etoposide as a continuous infusion days 1–6 or as a bolus infusion over 10 h on day 7. Continuous infusion etoposide produced significantly more oral mucositis than bolus etoposide. In groups I–III, comparing continuous and bolus etoposide, there was a median of 3 vs 0 days of grade 2 or more oral mucositis (P<0.0001) and 13.5 vs 0 days of total parenteral nutrition (TPN) (P=0.0003). Group IV patients had a median 7 vs 0 days of grade 2 or more oral mucositis (P<0.01) and 21 vs 7 days of TPN (P<0.003), respectively. There were no differences in hematologic recovery, length of hospital stay, complete remission rate or overall survival between the two etoposide schedules. Of groups I–III patients, 51% achieved complete remission, and 11% died from treatment-related complications. The toxicity profile of high-dose etoposide is schedule-dependent with prolonged exposure producing significantly more non-hematologic toxicity.
Comparative physiologic effects of noninvasive assist-control and pressure support ventilation in acute hypercapnic respiratory failure.

To compare the effects of noninvasive assist-control ventilation (ACV) and pressure support ventilation (PSV) by nasal mask on respiratory physiologic parameters and comfort in acute hypercapnic respiratory failure (AHRF).



A prospective randomized study.



A medical ICU.



Fifteen patients with COPD and AHRF were consecutively and randomly assigned to two noninvasive ventilation (NIV) sequences with ACV and PSV mode, spontaneous breathing (SB) via nasal mask being used as control. ACV and PSV settings were always subsequently adjusted according to patient's tolerance and air leaks. Fraction of inspired oxygen did not change between the sequences.



ACV and PSV mode strongly decreased the inspiratory effort in comparison with SB. The total inspiratory work of breathing (WOBinsp) expressed as WOBinsp/tidal volume (VT) and WOBinsp/respiratory rate (RR), the pressure time product (PTP), and esophageal pressure variations (deltaPes) were the most discriminant parameters (p<0.001). ACV most reduced WOBinsp/VT (p<0.05), deltaPes (p<0.05), and PTP (0.01) compared with PSV mode. The surface diaphragmatic electromyogram activity was also decreased >32% as compared with control values (p<0.01), with no difference between the two modes. Simultaneously, NIV significantly improved breathing pattern (p<0.01) with no difference between ACV and PSV for VT, RR, minute ventilation, and total cycle duration. As compared to SB, respiratory acidosis was similarly improved by both modes. The respiratory comfort assessed by visual analog scale was less with ACV (57.23+/-30.12 mm) than with SB (75.15+/-18.25 mm) (p<0.05) and PSV mode (81.62+/-25.2 mm) (p<0.01) in our patients.



During NIV for AHRF using settings adapted to patient's clinical tolerance and mask air leaks, both ACV and PSV mode provide respiratory muscle rest and similarly improve breathing pattern and gas exchange. However, these physiologic effects are achieved with a lower inspiratory workload but at the expense of a higher respiratory discomfort with ACV than with PSV mode.