nils-herrmann/clean_scirepeval huggingface dataset:
Peripheral blood stem cell collection in children with acute leukemia: effectiveness of the ‘DIAVE’ mobilizing regimen

Few experiences of peripheral blood (PB) hematopoietic stem cell mobilization for autologous transplantation have been reported to date in children with acute leukemia (AL). The five-drug-chemotherapy ‘DIAVE’ (dexamethazone, idarubicine, cytosine-arabinoside, vincristine, etoposide), followed by G-CSF, previously reported as consolidation, was adopted as a mobilization regimen in 29 children (median age: 8 years, range: 3–21; median weight: 34 kg, range: 15–73) with ALL in second remission (CR2: 21), in CR3 (2) or ANLL in CR1 (6). A median peak of 94 × 106 CD34+cells/l (range: 10–604) was reached at a median time of 12 days (range: 10–18) after the beginning of the mobilizing regimen, which was well tolerated. A median of 10.9 × 106 CD34+cells/kg (range: 2.4–56.6) were collected in 25 patients (86%), approaching 40 × 106/l CD34+ cells in the PB (ALL in CR2: 20/21, in CR3: 0/2; ANLL: 5/6) by means of one (20) or two (5) leukaphereses; a median of 2.5 blood volumes was processed. Patients with ANLL mobilized more cells than patients with ALL; moreover, the shorter the interval between remission and mobilizing therapy, the higher was the yield. The products collected underwent purification, aiming at achieving complete removal of possibly contaminating leukemic cells, in 21 cases; also, unmanipulated aliquots were stored as rescues for all but one patient. All the 23 patients undergoing transplantation engrafted (ANC >0.5 × 109/l) at a median of 12 days. In conclusion, the DIAVE regimen compares favorably with conventional mobilizing regimens, usually containing cyclophosphamide, in terms of low toxicity, collection time predictability, and efficacy, as shown by the high proportion of patients mobilizing, the large amounts of stem cell collected by means of one or two leukaphereses only, and the prompt engraftment after infusion.
Amisulpride is an “atypical” antipsychotic associated with low weight gain

It is possible that amisulpride, with its unique receptor binding profile, is not associated with significant weight gain, a serious side effect of most “atypical” antipsychotic drugs. While most “atypicals” have a high affinity for both dopamine and serotonin receptors, amisulpride has only dopamine receptor action. To analyse the weight gain associated with amisulpride. A pooled database of prospective randomised amisulpride studies was analysed. The mean weight gain after 10 weeks of treatment was estimated by regression analysis. Eleven studies with a total of 1422 patients were pooled, providing 1392 patients who were eligible for evaluation. In the main analysis of all effective doses (50–1200 mg/day) the mean weight gain associated with amisulpride at 10 weeks was 0.8 kg, 95% CI (0.48–1.18). Linear regression showed no dependence of weight gain on daily dose levels (P=0.7). When patients with mean daily doses below 400 mg/day were excluded in a sensitivity analysis, the mean weight gain at ten weeks was again 0.80 kg, 95% CI (0.47–1.16) with n=874. The mean weight gain at study endpoints in 1-year studies was 1.4 kg, 95% CI (0.85–1.90), n=548. Amisulpride is an atypical antipsychotic associated with low weight gain.
Association of job-related stress factors with psychological and somatic symptoms among Japanese hospital nurses: effect of departmental environment in acute care hospitals.

The present study examined degrees of job-related stress factors as well as mental and physical symptoms among Japanese hospital nurses in various departments, and clarified associations of departments and job-related stress factors with those symptoms. A self-administered anonymous questionnaire was distributed to 1,882 full-time nurses at four acute care hospitals in Japan. The survey included demographic factors, and the Brief Job Stress Questionnaire. Among 1,599 nurses who completed all items relevant to the present study, we analyzed data from 1,551 female nurses. The results show that working in operating rooms was associated with fatigue, that working in intensive care units (ICU) was associated with anxiety, and that working in surgery and internal medicine was associated with anxiety and depression independently of demographic factors and job-related stress factors. The physical and mental health of nurses might affect their time off, quality of nursing care and patient satisfaction in acute care hospitals. Therefore, job-related stress factors should be minimized, to improve the physical and mental health of nurses, considering unique departmental demands.
Early traumatic experiences in those at clinical high risk for psychosis.

Several lines of evidence suggest a possible association between a history of trauma in childhood and later psychosis or psychotic-like experiences. The purpose of this study was to determine the extent of childhood trauma and bullying in young people at clinical high risk (CHR) of developing psychosis.



The sample consisted of 360 individuals who were at CHR of developing psychosis and 180 age- and gender-matched healthy controls. All participants were assessed on past trauma and bullying. The CHR participants were also assessed on a range of psychopathology and functioning.



Individuals at CHR reported significantly more trauma and bullying than healthy controls. Those who had experienced past trauma and bullying were more likely to have increased levels of depression and anxiety and a poorer sense of self.



These results offer preliminary support for an association between a history of trauma and later subthreshold symptoms.
Physical activity monitoring in adolescents with juvenile fibromyalgia: findings from a clinical trial of cognitive-behavioral therapy.

Juvenile fibromyalgia (JFM) is a chronic musculoskeletal pain condition that is associated with reduced physical function. Recent research has demonstrated that cognitive-behavioral therapy (CBT) is effective in improving daily functioning among adolescents with JFM. However, it is not known whether these improvements were accompanied by increased physical activity levels. Our objective was to analyze secondary data from a randomized clinical trial of CBT to examine whether CBT was associated with improvement in objectively measured physical activity and whether actigraphy indices corresponded with self-reported functioning among adolescents with JFM.



Participants were 114 adolescents (ages 11-18 years) recruited from pediatric rheumatology clinics that met criteria for JFM and were enrolled in a clinical trial. Subjects were randomly (1:1) assigned to receive either CBT or fibromyalgia education (FE). Participants wore a hip-mounted accelerometer for 1 week as part of their baseline and posttreatment assessments.



The final sample included 68 subjects (94% female, mean age 15.2 years) for whom complete actigraphy data were obtained. Actigraphy measures were not found to correspond with self-reported improvements in functioning. While self-reported functioning improved in the CBT condition compared to FE, no significant changes were seen in either group for activity counts, sedentary, moderate, or vigorous activity. The CBT group had significantly lower peak and light activity at posttreatment.



Actigraphy monitoring provides a unique source of information about patient outcomes. CBT intervention was not associated with increased physical activity in adolescents with JFM, indicating that combining CBT with interventions to increase physical activity may enhance treatment effects.
Influence of Fuzheng Huayu Tablet on mental state and social function of patients with post-hepatitis B liver cirrhosis.

To observe the influence of Fuzheng Huayu Tablet on mental state and social activity of patients with post-hepatitis B liver cirrhosis (LC-HB).



Adopting grouped randomized double-blinded control method, 180 LC-HB patients in 3 research centers were distributed to 2 groups, the treated group and the control group, 90 in each group. Patients in the treated group were administered with FZHYT; while those in the control group treated with conventional therapy combined with placebo, the course for all patients were 6 months. Their mental state and social activity were evaluated before treatment, after 3 months' treatment and at terminal of the 6-month therapeutic course by estimating with Zung self-rating anxiety scale (SAS), self-rating depression scale (SDS) and social deficit screening scale (SDSS). Additionally, the basic demographic materials, liver function, cirrhosis index, hepatic and splenic images, blood coagulation function, etc. in the patients were tested and compared as well.



As compared with before treatment, the normal rate of SAS and SDS scores increased and the social deficit rate decreased in the treated group significantly after treatment, showing statistical significance (P<0.05 or P<0.01); while in the control group, change was only shown in the social deficit (P<0.01), inter-group comparisons after treatment showed significant differences in all the three indexes (P<0.05 or P<0.01). Additionally, after treatment, levels of liver function, cirrhosis, blood coagulation function and splenomegaly in the treated group were all improved significantly P<0.05 or P<0.01), and the improvements were better than those in the control group (P<0.01) in levels of total bilirubin (TBIL), albumin (ALB), type IV collagen (IV-C), prothrombin time (PT), prothrombin activity (PTA).



Most patients of LC-HB have mental disturbance and social activity deficit, which could definitely be improved by intervention with Chinese FZHYT.
Driving pressure and survival in the acute respiratory distress syndrome.

Mechanical-ventilation strategies that use lower end-inspiratory (plateau) airway pressures, lower tidal volumes (VT), and higher positive end-expiratory pressures (PEEPs) can improve survival in patients with the acute respiratory distress syndrome (ARDS), but the relative importance of each of these components is uncertain. Because respiratory-system compliance (CRS) is strongly related to the volume of aerated remaining functional lung during disease (termed functional lung size), we hypothesized that driving pressure (ΔP=VT/CRS), in which VT is intrinsically normalized to functional lung size (instead of predicted lung size in healthy persons), would be an index more strongly associated with survival than VT or PEEP in patients who are not actively breathing.



Using a statistical tool known as multilevel mediation analysis to analyze individual data from 3562 patients with ARDS enrolled in nine previously reported randomized trials, we examined ΔP as an independent variable associated with survival. In the mediation analysis, we estimated the isolated effects of changes in ΔP resulting from randomized ventilator settings while minimizing confounding due to the baseline severity of lung disease.



Among ventilation variables, ΔP was most strongly associated with survival. A 1-SD increment in ΔP (approximately 7 cm of water) was associated with increased mortality (relative risk, 1.41; 95% confidence interval [CI], 1.31 to 1.51; P<0.001), even in patients receiving "protective" plateau pressures and VT (relative risk, 1.36; 95% CI, 1.17 to 1.58; P<0.001). Individual changes in VT or PEEP after randomization were not independently associated with survival; they were associated only if they were among the changes that led to reductions in ΔP (mediation effects of ΔP, P=0.004 and P=0.001, respectively).



We found that ΔP was the ventilation variable that best stratified risk. Decreases in ΔP owing to changes in ventilator settings were strongly associated with increased survival.
Retreatment of High-Dose Interferon (5 MU Daily) Nonresponders with High-Dose IFN + Ribavirin

The treatment of chronic hepatitis C infection continues to evolve. Interferon (IFN) and ribavirin (RIBA) have become the mainstays of current therapy. The ideal dose and form of treatment of these two agents remains to be determined. An open label prospective trial of 5 MU of interferon daily plus ribavirin dosed according to weight was performed utilizing 40 patients, who were identified as being IFN nonresponders to 1 year or more of continuous IFN administered at a dose of 5 MU/day. Nineteen of the 40 subjects (47.5%) became HCV-RNA negative with normal serum ALT level when treated with the combination of IFN + RIBA. Thirteen of the 40 were sustained responders when reexamined after 6–12 months off active therapy. These results were achieved in a predominantly genotype 1 population (75%). This study suggests that the addition of RIBA to high-dose (5 MU daily) IFN can result in an increase in the number of cases experiencing both a short and sustained response to combination therapy.
Plasma p-Cresol Lowering Effect of Sevelamer in Peritoneal Dialysis Patients: Evidence from a Cross-Sectional Observational Study

p-Cresol is a by-product of the metabolism of aromatic aminoacid operated by resident intestinal bacteria. In patients with chronic kidney disease, the accumulation of p-cresol and of its metabolite p-cresyl-sulphate causes endothelial dysfunction and ultimately increases the cardiovascular risk of these patients. Therapeutic strategies to reduce plasma p-cresol levels are highly demanded but not available yet. Because it has been reported that the phosphate binder sevelamer sequesters p-cresol in vitro we hypothesized that it could do so also in peritoneal dialysis patients. To explore this hypothesis we measured total cresol plasma concentrations in 57 patients with end-stage renal disease on peritoneal dialysis, 29 receiving sevelamer for the treatment of hyperphosphatemia and 28 patients not assuming this drug. Among the patients not assuming sevelamer, 16 were treated with lanthanum whereas the remaining 12 received no drug because they were not hyperphosphatemic. Patients receiving sevelamer had plasma p-cresol and serum high sensitivity C-reactive protein concentrations significantly lower than those receiving lanthanum or no drug. Conversely, no difference was observed among the different groups either in residual glomerular filtration rate, total weekly dialysis dose, total clearance, urine volume, protein catabolic rate, serum albumin or serum phosphate levels. Multiple linear regression analysis showed that none of these variables predicted plasma p-cresol concentrations that, instead, negatively correlated with the use of sevelamer. These results suggest that sevelamer could be an effective strategy to lower p-cresol circulating levels in peritoneal dialysis patients in which it could also favorably affect cardiovascular risk because of its anti-inflammatory effect.
Examination of association with candidate genes for diabetic nephropathy in a Mexican American population.

Diabetic nephropathy (DN) is a multifactorial complication characterized by persistent proteinuria in susceptible individuals with type 1 and type 2 diabetes. Disease burden in people of Mexican-American descent is particularly high, but there are only a few studies that characterize genes for DN in this ethnic group. Two genes, carnosine dipeptidase 1 (CNDP1) and engulfment and cell motility 1 (ELMO1) previously showed association with DN in other ethnic groups. CNDP1 and ELMO1 were examined along with eight other genes that are less well characterized for DN in a new study of Mexican-Americans.



The target sample was patients of Mexican-American ancestry collected from three centers: 455 patients with DN and 437 controls with long-term diabetes but no incident nephropathy. Forty-two, 227, and 401 single nucleotide polymorphisms (SNPs) in CNDP1, ELMO1, and the other eight genes, respectively, were examined.



No region in CNDP1 or ELMO1 showed significant P values. Of the other eight candidate genes, an association of DN with a SNP pair, rs2146098 and rs6659783, was found in hemicentin 1 (HMCN1) (unadjusted P = 6.1 x 10(-5)). Association with a rare haplotype in this region was subsequently identified.



The associations in CNDP1 or ELMO1 were not replicable; however, an association of DN with HMCN1 was found. Additional work at this and other loci will enable refinement of the genetic hypotheses regarding DN in the Mexican-American population to find therapies for this debilitating disease.
IPP-rich milk protein hydrolysate lowers blood pressure in subjects with stage 1 hypertension, a randomized controlled trial

Milk derived peptides have been identified as potential antihypertensive agents. The primary objective was to investigate the effectiveness of IPP-rich milk protein hydrolysates (MPH) on reducing blood pressure (BP) as well as to investigate safety parameters and tolerability. The secondary objective was to confirm or falsify ACE inhibition as the mechanism underlying BP reductions by measuring plasma renin activity and angiotensin I and II.



We conducted a randomized, placebo-controlled, double blind, crossover study including 70 Caucasian subjects with prehypertension or stage 1 hypertension. Study treatments consisted of daily consumption of two capsules MPH1 (each containing 7.5 mg Isoleucine-Proline-Proline; IPP), MPH2 (each containing 6.6 mg Methionine-Alanine-Proline, 2.3 mg Leucine-Proline-Proline, 1.8 mg IPP), or placebo (containing cellulose) for 4 weeks.



In subjects with stage 1 hypertension, MPH1 lowered systolic BP by 3.8 mm Hg (P = 0.0080) and diastolic BP by 2.3 mm Hg (P = 0.0065) compared with placebo. In prehypertensive subjects, the differences in BP between MPH1 and placebo were not significant. MPH2 did not change BP significantly compared with placebo in stage I hypertensive or prehypertensive subjects. Intake of MPHs was well tolerated and safe. No treatment differences in hematology, clinical laboratory parameters or adverse effects were observed. No significant differences between MPHs and placebo were found in plasma renin activity, or angiotensin I and II.



MPH1, containing IPP and no minerals, exerts clinically relevant BP lowering effects in subjects with stage 1 hypertension. It may be included in lifestyle changes aiming to prevent or reduce high BP.
Plasma Septin9 versus Fecal Immunochemical Testing for Colorectal Cancer Screening: A Prospective Multicenter Study

Screening improves outcomes related to colorectal cancer (CRC); however, suboptimal participation for available screening tests limits the full benefits of screening. Non-invasive screening using a blood based assay may potentially help reach the unscreened population.



To compare the performance of a new Septin9 DNA methylation based blood test with a fecal immunochemical test (FIT) for CRC screening.



In this trial, fecal and blood samples were obtained from enrolled patients. To compare test sensitivity for CRC, patients with screening identified colorectal cancer (n = 102) were enrolled and provided samples prior to surgery. To compare test specificity patients were enrolled prospectively (n = 199) and provided samples prior to bowel preparation for screening colonoscopy.



Plasma and fecal samples were analyzed using the Epi proColon and OC Fit-Check tests respectively.



For all samples, sensitivity for CRC detection was 73.3% (95% CI 63.9-80.9%) and 68.0% (95% CI 58.2-76.5%) for Septin9 and FIT, respectively. Specificity of the Epi proColon test was 81.5% (95% CI 75.5-86.3%) compared with 97.4% (95% CI 94.1-98.9%) for FIT. For paired samples, the sensitivity of the Epi proColon test (72.2% -95% CI 62.5-80.1%) was shown to be statistically non-inferior to FIT (68.0%-95% CI 58.2-76.5%). When test results for Epi proColon and FIT were combined, CRC detection was 88.7% at a specificity of 78.8%.



At a sensitivity of 72%, the Epi proColon test is non- inferior to FIT for CRC detection, although at a lower specificity. With negative predictive values of 99.8%, both methods are identical in confirming the absence of CRC.
Independent Prospective Multicenter Validation of Biochemical Markers (Fibrotest–Actitest) for the Prediction of Liver Fibrosis and Activity in Patients with Chronic Hepatitis C: The Fibropaca Study

Fibrotest (FT) and Actitest (AT) are biochemical markers of fibrosis and activity for use as a non-invasive alternative to liver biopsy in patients with chronic hepatitis C virus (HCV). The aim of this study was to perform an external validation of FT and AT and to study the discordances between FT/AT and liver biopsy in patients with chronic hepatitis C.METHODS:A total of 519 consecutive patients with chronic HCV were prospectively included in five centers, with liver biopsy and biochemical markers taken at the same day. Fifteen patients were excluded because their biopsies could not be interpreted. Diagnostic accuracies were assessed by receiver operating characteristic (ROC) curve analysis.Median biopsy size was 15 mm (range: 2–58), with 9 portal tracts (1–37) and 1 fragment (1–12). 46% (230/504) were classified F2–F4 in fibrosis and 39% A2–A3 in activity. FT area under ROC curve for diagnosis of activity (A2–A3), significant fibrosis (F2–F4), and severe fibrosis (F3–F4) were 0.73 [0.69–0.77], 0.79 [0.75–0.82], and 0.80 [0.76–0.83], respectively. Among the 92 patients (18%) with 2 fibrosis stages of discordance between FT and biopsy, the discordance was attributable to FT in 5% of cases, to biopsy in 4%, and undetermined in 9%.CONCLUSIONS:This prospective independent and multicenter study confirms the diagnostic value of FT and AT found in the princeps study and suggests that FT and AT can be an alternative to biopsy in most patients with chronic HCV.
Safety profile of adenosine stress perfusion imaging: results from the Adenoscan Multicenter Trial Registry.

The purpose of this study was to determine the safety of adenosine infusion at 140 micrograms/kg per min in conjunction with radionuclide imaging in 9,256 consecutive patients.



Adenosine produces maximal myocardial hyperemia directly with a rapid onset of action. In addition, when used in conjunction with radionuclide perfusion imaging, it has proven efficacy for the diagnosis of coronary artery disease in patients unable to exercise. Because the ultrashort half-life (< 10s) allows dose titration and rapid reversal of side effects, it may be safer than other available pharmacologic agents.



Patients were prospectively entered at 21 clinical sites. Information on safety and adverse events during and immediately after adenosine infusion was maintained in the Adenoscan Multicenter Trial Registry.



The infusion protocol was completed in 80% of patients, required dose reduction in 13% and was terminated early in 7%. Interpretable imaging studies were obtained in 98.7% of patients, and 0.8% of patients received aminophylline. Minor and well tolerated side effects were reported in 81.1% of patients. There were no deaths, one myocardial infarction, seven episodes of severe bronchospasm and one episode of pulmonary edema. Transient atrioventricular (AV) node block occurred in 706 patients (first-degree in 256, second-degree in 378 and third-degree in 72) and resolved spontaneously in most patients (n = 508) without alteration in the adenosine infusion. There were no sustained episodes of AV block. Patients > 70 years of age had an increased risk of developing AV block (age < 70, 7.05% vs. > or = 70, 9.44%, p = 0.001, relative risk 1.37).



Adenosine infusion is safe. Vasodilator and negative dromotropic side effects are generally well tolerated. Serious side effects are relatively rare, and they reverse with termination of adenosine infusion. Interpretable radionuclide studies were obtained in 98.7% of patients and aminophylline reversal was seldom required.