nils-herrmann/clean_scirepeval huggingface dataset:
The metabolic syndrome and its components in patients with prostate cancer on androgen deprivation therapy.

Androgen deprivation therapy may promote the development of the metabolic syndrome in patients with prostate cancer. We assessed the prevalence of the full metabolic syndrome and its components during the first year of androgen deprivation therapy.



This observational, multicenter, prospective study included 539 patients with prostate cancer scheduled to receive 3-month depot luteinizing hormone-releasing hormone analogs for more than 12 months. Waist circumference, body mass index, lipid profile, blood pressure and fasting glucose were evaluated at baseline and after 6 and 12 months. The metabolic syndrome was assessed according to NCEP ATP III criteria (2001) and 4 other definitions 
At 6 and 12 months after the initiation of androgen deprivation therapy, significant increases were observed in waist circumference, body mass index, fasting glucose, triglycerides, total cholesterol, and high-density and low-density lipoprotein cholesterol. No significant changes in blood pressure 130/85 or greater were detected. A nonsignificant increase of 3.9% in the prevalence of the full metabolic syndrome (ATP III) was observed (22.9% at baseline vs 25.5% and 26.8% at 6 and 12 months, respectively). The prevalence of the metabolic syndrome at baseline varied according to the definition used, ranging from 9.4% (WHO) to 50% (IDF). At 12 months significant increases in prevalence were observed with the WHO (4.1%) and AHA/NHLBI (8.1%) definitions.



Androgen deprivation therapy produces significant early effects on waist circumference, body mass index, fasting glucose, triglycerides and cholesterol. The prevalence of and increase in the metabolic syndrome depend on the defining criteria. Counseling patients on the prevention, early detection and treatment of specific metabolic alterations is recommended.
Exercise training increases oxygen uptake efficiency slope in chronic heart failure.

The oxygen uptake efficiency slope (OUES) is a novel measure of cardiopulmonary reserve. OUES is measured during an exercise test, but it is independent of the maximally achieved exercise intensity. It has a higher prognostic value in chronic heart failure (CHF) than other exercise test-derived variables such as(Equation is included in full-text article.)or(Equation is included in full-text article.)slope. Exercise training improves(Equation is included in full-text article.)and(Equation is included in full-text article.)in CHF patients. We hypothesized that exercise training also improves OUES.



We studied 34 New York Heart Association (NYHA) class II-III CHF patients who constituted an exercise training group T (N=20; 19 men/1 woman; age 60+/-9 years; left ventricular ejection fraction 34+/-5%) and a control group C (N=14; 13 men/one woman; age 63+/-10 years; left ventricular ejection fraction 34+/-7%). A symptom-limited exercise test was performed at baseline and repeated after 4 weeks (C) or after completion of the training program (T). Exercise training increased NYHA class from 2.6 to 2.0 (P<0.05),(Equation is included in full-text article.)by 14% [P(TvsC)<0.01], and OUES by 19% [P(TvsC)<0.01]. Exercise training decreased(Equation is included in full-text article.)by 14% [P(TvsC)<0.05].



Exercise training improved NYHA class,(Equation is included in full-text article.)and also OUES. This finding is of great potential interest as OUES is insensitive for peak load. Follow-up studies are needed to demonstrate whether OUES improvements induced by exercise training are associated with improved prognosis.
A randomized controlled trial of brief interventions for problem gambling in substance abuse treatment patients.

This study evaluated the efficacy of brief gambling treatments in patients attending substance abuse treatment clinics.



Substance abuse treatment patients with gambling problems (N = 217) were randomly assigned to a 10- to 15-min brief psychoeducation gambling intervention; a 10- to 15-min brief advice intervention addressing gambling norms, risk factors, and methods to prevent additional problems; or 4 50-min sessions of motivational enhancement therapy plus cognitive behavior therapy for reducing gambling (MET + CBT). Gambling and related problems were assessed at baseline and throughout 24 months.



In the sample as a whole, days and dollars wagered and gambling problems decreased markedly from baseline through Month 5; thereafter, reductions in dollars wagered and gambling problems continued to decrease modestly but significantly, and days gambled remained constant. Brief advice significantly reduced days gambled between baseline and Month 5 relative to brief psychoeducation. The MET + CBT condition engendered no benefit beyond brief advice in terms of days gambled but did lead to more precipitous reductions in dollars gambled and problems experienced in the initial 5 months, and greater clinically significant improvements in gambling in both the short and long term. MET + CBT also resulted in initial decreases in self-reported alcohol use and problems but did not differentially impact self-reported illicit drug use or submission of positive samples.



Gambling problems tend to dissipate over time regardless of the intervention applied, but offering MET + CBT was more efficacious in decreasing gambling than providing a brief single session intervention.
Effects of an oral nutritional supplement containing eicosapentaenoic acid on nutritional and clinical outcomes in patients with advanced non-small cell lung cancer: randomised trial.

Nutritional interventions have shown increased energy intake but not improvement in health-related quality of life (HRQL) or prognosis in non small cell lung cancer (NSCLC) patients. Eicosapentaenoic acid has been proposed to have anti-inflammatory, anticachectic and antitumoural effects.



To compare the effect of an oral EPA enriched supplement with an isocaloric diet on nutritional, clinical and inflammatory parameters and HRQL in advanced NSCLC patients.



Patients with advanced NSCLC were randomized to receive diet plus oral nutritional supplement containing EPA (ONS-EPA) or only isocaloric diet (C). All patients received paclitaxel and cisplatin/carboplatin treatment. Weight, body composition, dietary intake, inflammatory parameters and HRQL were assessed at baseline and after the first and second cycles of chemotherapy. Response to chemotherapy and survival were evaluated.



Ninety two patients were analysed (46 ONS-EPA,46 C). ONS-EPA group had significantly greater energy (p < 0.001) and protein (p < 0.001) intake compared with control. Compared with baseline, patients receiving the ONS-EPA gained 1.6 ± 5 kg of lean body mass (LBM) compared with a loss of -2.0 ± 6 kg in the control (p = 0.01). Fatigue, loss of appetite and neuropathy decreased in the ONS-EPA group (p ≤ 0.05). There was no difference in response rate or overall survival between groups.



Patients with NSCLC receiving ONS-EPA significantly improves energy and protein intake, body composition. and decreased fatigue, loss of appetite and neuropathy. Registered with ClinicalTrials.gov (NCT01048970).
Validation of endoscopic activity scores in patients with Crohn's disease based on a post hoc analysis of data from SONIC.

Mucosal healing might alter midterm and long-term outcomes of patients with Crohn's disease (CD) and has become an important end point in clinical trials. However, the minimal degree of mucosal improvement (endoscopic response) required to alter midterm outcomes is not known. We aimed to determine the best definition of endoscopic response by evaluating data on the Simple Endoscopic Score for Crohn's Disease (SES-CD) and the Crohn's Disease Endoscopic Index of Severity (CDEIS) from the Study of Biologic and Immunomodulator Naive Patients in Crohn's Disease (SONIC trial).



We analyzed data from 172 patients who participated in the SONIC trial, were found to have endoscopic lesions at baseline, and underwent a second endoscopic examination at week 26 of treatment with infliximab, azathioprine, or both. Mucosal healing was defined as absence of ulcers. A central reader calculated SES-CD and CDEIS results. Different cutoff values were set for endoscopic response based on the SES-CD or CDEIS. The diagnostic ability of these different cutoff values was evaluated using receiver operating characteristic (ROC) curves, positive likelihood ratios (PLR), and negative likelihood ratios (NLR). Corticosteroid-free clinical remission (CFREM) at week 50 was used as a binary classifier.



Based on analyses of ROC curves, PLR, and NLR, endoscopic response was defined as a decrease from baseline in SES-CD of at least 50%. At week 26, mucosal healing and endoscopic response were achieved in 48% and 65% of patients, respectively. Mucosal healing at week 26 was associated with CFREM at week 50, with 56% sensitivity, 65% specificity, a PLR of 1.60, and an NLR of 0.67. Endoscopic response at week 26 was associated with CFREM at week 50, with 74% sensitivity, 48% specificity, a PLR of 1.42, and an NLR of 0.54. Endoscopic response, defined as a decrease from baseline in CDEIS of at least 50%, yielded similar results.



In patients with CD, mucosal healing and endoscopic response (defined as a decrease from baseline in SES-CD or CDEIS of at least 50%) at week 26 of treatment identified those most likely to be in CFREM at week 50. The ability of the proposed endoscopic response cutoff value to predict midterm CFREM should be validated in an independent, prospective cohort. Its correlation with changes in long-term disease progression still needs to be demonstration.
Pregnancy Outcomes after Treatment for Cervical Cancer Precursor Lesions: An Observational Study

To examine whether surgical procedures involving the uterine cervix were associated with pregnancy outcomes, including preterm birth, low birth weight, cesarean delivery and pregnancy loss.



Population-based observational study nested in retrospective matched cohort.



Kaiser Permanente Northwest integrated health plan in Oregon/Washington, U.S.A.



Female health plan members age 14-53 years with documented pregnancies from 1998-2009. Women with prior excisional and ablative cervical surgical procedures (N = 322) were compared to women unexposed to cervical procedures (N = 4,307) and, separately, to those having undergone only diagnostic/biopsy procedures (N = 847).



Using log-linear regression models, we examined risk of adverse pregnancy outcomes in relation to prior excisional or ablative cervical surgical procedures. We stratified excisional procedures by excision thickness. We evaluated for confounding by age, body mass index, race, smoking history, previous preterm birth, and parity.



We found a positive association between excisional treatment > = 1.0 cm and the outcomes preterm birth and low birth weight (preterm birth unadjusted risk ratio [RR] = 2.15, 95% confidence interval [CI] 1.16-3.98 for excisions ≥1.0 cm compared to unexposed women), particularly in women who delivered within one year of surgery (RR = 3.26, 95% CI 1.41-7.53). There was no clear association between excisional treatment and cesarean delivery, and treated women did not have a substantially higher risk of dysfunctional labor. Ablative treatment was not associated with low birth weight, preterm birth, or cesarean delivery but was associated with pregnancy loss (RR = 1.43, 95% CI 1.05-1.93 vs. unexposed women). Analyses using the diagnostic procedures comparison group produced similar results.



Women with > = 1.0 cm excisional treatment had elevated risk of preterm birth and low birth weight when compared to unexposed women and women with cervical diagnostic procedures. This suggests that increased risk derives from the treatment itself, not from other characteristics. The observed association between pregnancy loss and ablative surgical treatment requires further investigation.
Theta and gamma oscillations during encoding predict subsequent recall.

Electrophysiological and hemodynamic measures of human brain activity have been shown to distinguish between episodes of encoding items that are later recalled versus those that are not recalled (Paller and Wagner, 2002). Using intracranial recordings from 793 widespread cortical and subcortical sites in 10 epileptic patients undergoing invasive monitoring, we compared oscillatory power at frequencies ranging from 2 to 64 Hz as participants studied lists of common nouns. Significant increases in oscillatory power during encoding predicted subsequent recall, with this effect predominantly in the 4-8 Hz (theta) and 28-64 Hz (gamma) frequency bands. Sites exhibiting increased theta activity during successful encoding were clustered in right temporal and frontal cortex, whereas those exhibiting increased gamma activity appeared bilaterally at widespread cortical locations. These findings implicate theta and gamma oscillatory activity, across a widespread network of cortical regions, in the formation of new episodic memories.
Mammaglobin-A cDNA vaccination of breast cancer patients induces antigen-specific cytotoxic CD4+ICOShi T cells

Mammaglobin-A (Mam-A) is a 10 kDa secretory protein that is overexpressed in 80 % of primary and metastatic human breast cancers. Previous studies from our laboratory demonstrated that Mam-A cDNA vaccine can induce Mam-A-specific CD8 T cell responses and mediate regression of human breast cancer xenografts in NOD/SCID mice. In this article, we present our results on a phase I clinical trial of a Mam-A cDNA vaccination in breast cancer patients with stage-IV metastatic disease, including the impact of vaccination on the expression of the inducible co-stimulator molecule (ICOS) on CD4 T cells. Specimens from seven patients with stage-IV metastatic cancer were available for these analyses. Patients were vaccinated with a Mam-A cDNA vaccine on days 0, 28, and 56, and immune responses were assessed at serial time points following vaccination. At 6 months following the first vaccination, flow cytometric analysis demonstrated a significant increase in the frequency of CD4+ICOShi T cells from 5 ± 2 % pre-vaccination to 23 ± 4 % (p < 0.001), with a concomitant decrease in the frequency of CD4+FoxP3+ T cells (regulatory T cells [Treg]) from 19 ± 6 to 10 ± 5 % (p < 0.05). ELISpot analysis of CD4+ICOShi sorted T cells demonstrated that following vaccination the cytokines produced by Mam-A-specific T cells switched from IL-10 (78 ± 21 spm pre-vaccination to 32 ± 14 spm 5 months post-vaccine p < 0.001) to IFN-γ (12 ± 6 spm pre-vaccination to 124 ± 31 spm 5 months post-vaccine p < 0.001). The ratio of CD4+ICOShi T cells to CD4+FoxP3+ T cells increased from 0.37 ± 0.12 before vaccination to 2.3 ± 0.72 (p = 0.021) following vaccination. Further, these activated CD4+ICOShi T cells induced preferential lysis of human breast cancer cells expressing Mam-A protein. We conclude that Mam-A cDNA vaccination is associated with specific expansion and activation of CD4+ICOShi T cells, with a concomitant decrease in Treg frequency. These encouraging results strongly suggest that Mam-A cDNA vaccination can induce antitumor immunity in breast cancer patients.
Validation of the palliative prognostic index and palliative prognostic score in a palliative care consultation team setting for patients with advanced cancers in an acute care hospital in Japan.

This study aims to clarify the predictive value of two prognostic prediction tools, the palliative prognostic index (PPI) and the palliative prognostic score (PaPS), in a setting of general hospital palliative care team for patients with advanced cancers in an acute care hospital in Japan. The retrospective observational study includes 247 patients for the PPI analysis and 187 patients for the PaPS analysis, all patients are older than 18 years, hospitalized with an advanced cancer, and referred to the palliative care team in an acute care hospital in Japan. The study successfully show that both the PPI and PaPS have an ability to divide patients into three groups, each with significantly different survival length (p<0.001). However, there are discrepancies in the results for predicting the length of survival between the study and the original studies conducted in hospice settings. The results suggest that although PPI and PaPS successfully divide patients into three groups with significantly different survival times, discrepancies exist in predicting the actual length of survival.
The effect of antidepressant treatment on HIV and depression outcomes: results from a randomized trial.

Depression is a major barrier to HIV treatment outcomes.



To test whether antidepressant management decision support integrated into HIV care improves antiretroviral adherence and depression morbidity.



Pseudo-cluster randomized trial.



Four US infectious diseases clinics.



HIV-infected adults with major depressive disorder.



Measurement-based care (MBC) - depression care managers used systematic metrics to give HIV primary-care clinicians standardized antidepressant treatment recommendations.



Primary - antiretroviral medication adherence (monthly unannounced telephone-based pill counts for 12 months). Primary time-point - 6 months. Secondary - depressive severity, depression remission, depression-free days, measured quarterly for 12 months.



From 2010 to 2013, 149 participants were randomized to intervention and 155 to usual care. Participants were mostly men, Black, non-Hispanic, unemployed, and virally suppressed with high baseline self-reported antiretroviral adherence and depressive severity. Over follow-up, no differences between arms in antiretroviral adherence or other HIV outcomes were apparent. At 6 months, depressive severity was lower among intervention participants than usual care [mean difference -3.7, 95% confidence interval (CI) -5.6, -1.7], probability of depression remission was higher [risk difference 13%, 95% CI 1%, 25%), and suicidal ideation was lower (risk difference -18%, 95% CI -30%, -6%). By 12 months, the arms had comparable mental health outcomes. Intervention arm participants experienced an average of 29 (95% CI: 1-57) more depression-free days over 12 months.



In the largest trial of its kind among HIV-infected adults, MBC did not improve HIV outcomes, possibly because of high baseline adherence, but achieved clinically significant depression improvements and increased depression-free days. MBC may be an effective, resource-efficient approach to reducing depression morbidity among HIV patients.
Diagnosing Lassa virus infection by tracking the antiviral response

Lassa fever is an acute viral hemorrhagic fever caused by the Lassa virus. It infects 300,000 to 500,000 West Africans every year, with a mortality rate among hospitalized patients of 15%. It is difficult to diagnose because its early symptoms (fever, sore throat, general malaise) often go unnoticed, or are confused with those of the common flu, malaria, or other febrile diseases. For this reason, there is considerable interest in developing tests that can detect the presence of the virus at the earliest stages of infection, when treatment is most effective. Methods such as the enzyme-linked immunosorbent assay (ELISA) or the
Frailty Index and Incident Mortality, Hospitalization, and Institutionalization in Alzheimer's Disease: Data From the ICTUS Study.

The identification of an objective evaluation of frailty capable of predicting adverse outcomes in Alzheimer's disease is increasingly discussed. The purpose of this study was to investigate whether the Frailty Index (FI) predicts hospitalization, institutionalization, and mortality in Alzheimer's disease patients.



A prospective multicenter cohort study (follow-up = 2 years) that included 1,191 participants with Alzheimer's disease was carried out. The outcomes of interest were incident hospitalization, institutionalization, and mortality. The FI was calculated as the ratio of actual to thirty potential deficits, that is, deficits presented by the participant divided by 30. Severity of dementia was assessed using the Clinical Dementia Rating score. Cox proportional hazard models were performed.



Mean age of the study sample was 76.2 (SD = 7.6) years. A quadratic relationship of the FI with age was reported at baseline (R (2) = .045, p < .001). The FI showed a statistically significant association with mortality (age- and gender-adjusted hazard ratio [HR] = 1.019, 95% confidence interval [CI] = 1.002-1.037, p = .031) and hospitalization (age- and gender-adjusted HR = 1.017, 95% CI = 1.006-1.029, p = .004) and a borderline significance with institutionalization. When the Clinical Dementia Rating score was simultaneously included in the age- and gender-adjusted models, the FI confirmed its predictive capacity for hospitalization (HR = 1.019, 95% CI = 1.006-1.032, p = .004), whereas the Clinical Dementia Rating score was the strongest predictor for mortality (HR = 1.922, 95% CI = 1.256-2.941, p = .003) and institutionalization (HR = 1.955, 95%CI = 1.427-2.679, p < .001).



The FI is a robust predictor of adverse outcomes even after the stage of the underlying dementia is considered. Future work should evaluate the clinical implementation of the FI in the assessment of demented individuals in order to improve the personalization of care.
Results of consecutive trials for children newly diagnosed with acute myeloid leukemia from the Australian and New Zealand Children's Cancer Study Group.

Despite improvements in the treatment of acute myeloid leukemia (AML), approximately 50% of children die of the disease. Clinical trials in adult patients with AML indicate that idarubicin may have superior efficacy when compared to daunorubicin in the remission-induction phases of chemotherapy. We conducted consecutive clinical trials in children with newly diagnosed AML in which daunorubicin (group 1, n = 102) or idarubicin (group 2, n = 160) was used during the remission-induction (RI) and the early consolidation phases of chemotherapy. Idarubicin was given at a dose of either 10 mg/m(2) (group 2A, n = 106) or 12 mg/m(2) (group 2B, n = 53). A high rate of RI was achieved for all groups (95% group 1, 90% group 2A, 94% group 2B). There were no significant differences in 5-year event-free survival (EFS) or in overall survival (OS) when the 3 groups were compared (group 1: EFS 50%, OS 56%; group 2A: EFS 50%, OS 60%; group 2B: EFS 34%, OS 50%). RI deaths resulting from treatment toxicity were low-2% for group 1 and 5% for group 2. More gastrointestinal, pulmonary, and renal toxicity but fewer infections were observed in patients receiving idarubicin (P <.001, P =.04, P =.03, respectively). Following RI chemotherapy, all patients received 3 to 4 more courses of identical chemotherapy and then underwent either autologous (n = 156) or an allogeneic bone marrow transplantation (BMT) (n = 35). OS was higher in allogeneic BMT patients than in autologous BMT patients (79% vs 63%; P =.23). We conclude that daunorubicin is as effective as idarubicin for remission-induction therapy for childhood AML and has reduced toxicity.