nils-herrmann/clean_scirepeval huggingface dataset:
The EPIC Kids Study: a randomized family-focused YMCA-based intervention to prevent type 2 diabetes in at-risk youth

It is well established that behavioral lifestyle interventions resulting in modest weight reduction in adults can prevent or delay type 2 diabetes mellitus; however in children, successful weight management interventions are rarely found outside of controlled clinical settings. The lack of effective community-based programs is a barrier to reducing obesity prevalence and diabetes risk in children. The objective of our study is to develop and test a group-randomized family-centered community-based type 2 diabetes prevention intervention targeting at-risk children, 9- to 12-years-old.



Using participatory methods, the adult-focused YMCA Diabetes Prevention Program was adapted for families, creating a novel lifestyle behavior change program focused on healthy eating, physical activity, and a supportive home environment. The program will be tested in sixty 9- to 12-year-old children at risk of diabetes and sixty parents over 12 consecutive weeks with two intervention formats randomized by location: a face-to-face instructor-led program, or a hybrid program with alternating face-to-face and mobile technology-delivered content. Anthropometric, behavioral, psychosocial and physiological outcomes will be assessed at baseline, post-intervention (12 weeks), and follow-up (24 weeks). Secondary outcomes are participant acceptability, feasibility, and adherence. The RE-AIM framework (reach, efficacy, adoption, implementation, and maintenance) will guide intervention implementation and evaluation. Changes at 12 weeks will be assessed using a paired t-test combining both delivery formats. Exploratory models using linear regression analysis will estimate the magnitude of the difference between the face-to-face and hybrid format. The sample size of 60 children, informed by a previous YMCA intervention in which -4.3 % change in overweight (SE = 1.1) was observed over 6 months, will give us 80 % power to detect an effect size of this magnitude, assuming a one-sided test at alpha = 0.05.



The proposed study capitalizes on a partnership with the YMCA, a popular and widespread community organization, and uses mobile technologies to extend program reach while potentially reducing burden associated with weekly attendance. The long-term goal is to create a scalable, replicable, and sustainable pediatric "diabesity" prevention program that overcomes existing barriers to the translation of efficacious interventions into effective community programs.
Pre-hospital 12 lead ECG to triage ST elevation myocardial infarction and long term improvements in door to balloon times: The first 1000 patients from the MonAMI project.

Pre-hospital ECG is one strategy to improve door to balloon times (D2BT), however its long term effectiveness to sustain reductions in D2BT has not been evaluated.



From 2007 to 2011 we conducted a prospective interventional study involving 1000 patients undergoing primary PCI (PPCI) at a single tertiary referral institution to determine the long term impact of pre-hospital 12 lead ECG on D2BT.



The median D2BT of patients (n=414) who underwent PPCI following field 12-lead ECG was 54 min [IQR: 37-71 min] compared to the median time of a contemporary group (n=586) undergoing PPCI during the same period but not presenting via field triage of 100 min [74-134] (p<0.001). The proportion of patients who achieved a D2BT of ≤90 min in the pre-hospital ECG group was greater than that in the contemporary group (90% vs 42%, p<0.001). A comparison of the first 250 patients compared to subsequent 250 patient blocks showed no change in D2BT.



Introduction of pre-hospital ECG in the triage of STEMI resulted in a sustained reduction in D2BT.
Cooking of meat and fish in Europe—results from the European Prospective Investigation into Cancer and Nutrition (EPIC)

There is epidemiologic evidence that the consumption of fried, grilled or barbecued meat and fish that are well-done or browned may be associated with an increased cancer risk. These high-temperature cooking methods are thought to be surrogates for mutagens and carcinogens produced in meat and fish, eg heterocyclic amines or polycyclic hydrocarbons. Since data on food cooking methods are scarce, the aim of this study was to describe the variation in meat and fish cooking methods in different parts of Europe. Using a standardized 24 h recall from a sub-sample of the EPIC cohort (35 644 persons, 35–75 y old), mean daily intake of meat and fish prepared by different cooking methods and the relative contribution of the cooking methods to the overall cooking of meat and fish was calculated. Whereas frying was more often noted in northern Europe, roasting and stir frying were more often used in the south. Concerning high-temperature cooking methods, their frequency of application varies between 15% in the EPIC cohort of North-Italy and 49% in the cohort of The Netherlands. Average consumption of fried, grilled and barbecued meat and fish ranges from a low of 12 g/day in the centres in southern Spain to a high of 91 g/day in northern Spain. High variation in both the kind of meat/fish consumed as well as its cooking methods is observed within EPIC. In order to use this variation for the evaluation of the impact of cooking methods on cancer risk, a questionnaire on meat and fish cooking methods is being developed and could be applied in the whole EPIC cohort.
Six-year outcome of cognitive behavior therapy for prevention of recurrent depression.

A paucity of studies use nonpharmacological strategies for preventing recurrence in depression. Cognitive behavior treatment of residual symptoms was found to yield a significantly lower relapse rate than clinical management in recurrent depression at a 2-year follow-up. The objective of this investigation was to provide a 6-year follow-up of cognitive behavior treatment versus clinical management.



Forty patients with recurrent major depression who had been successfully treated with antidepressant drugs were randomly assigned to either cognitive behavior treatment of residual symptoms (supplemented by lifestyle modification and well-being therapy) or clinical management. In both groups, antidepressant drugs were tapered and discontinued. A 6-year follow-up was undertaken. During this period, no antidepressant drugs were used unless a relapse ensued.



Cognitive behavior treatment resulted in a significantly lower relapse rate (40%) at a 6-year follow-up than did clinical management (90%). When multiple recurrences were considered, the group that received cognitive behavior treatment had a significantly lower number of relapses in comparison with the clinical management group.



The results suggest that the sequential use of cognitive behavior treatment after pharmacotherapy may improve the long-term outcome in recurrent depression. A significant proportion of patients with recurrent depression might be able to withdraw from medication successfully and to stay well for at least 6 years with a focused course of psychotherapy.
Influence of neoadjuvant anastrozole (Arimidex) on intratumoral estrogen levels and proliferation markers in patients with locally advanced breast cancer.

Anastrozole (Arimidex) is a novel, selective, and potent aromatase inhibitor used for the treatment of postmenopausal breast cancer. The drug has been shown to inhibit in vivo aromatization by 96--97% and to suppress plasma estrogen levels by 84--94%. However, the effects of anastrozole on intratumoral estrogen levels have not been studied. Here we report the effects of neoadjuvant treatment with anastrozole on intratumoral levels of estrone (E(1)), estradiol (E(2)), and estrone sulfate (E(1)S), measured by a highly sensitive RIA following a multistep purification procedure involving high-pressure liquid chromatography. Tumor tissue was obtained prior to treatment and after 15 weeks on therapy with anastrozole (1 mg once daily) from 12 postmenopausal women with locally advanced breast cancer (T(3)--T(4) and/or N(2)). Pretreatment tissue levels of E(2), E(1), and E(1)S were 217.9 (69.8--679.9), 173.6 (83.9--358.9), and 80.7 (31.4--207.3) fmol/g tissue (geometric mean values with 95% confidence interval, respectively). Treatment with anastrozole suppressed tissue E(2), E(1), and E(1)S levels by 89.0% (73.2--95.5%), 83.4% (63.2--92.5%), and 72.9% (47.3--86.1%), respectively, compared with baseline levels, with no significant difference between responders and nonresponders. Plasma levels of E(2), E(1), and E(1)S were suppressed by 86.1, 83.9, and 94.2%, respectively. Anastrozole caused a decrease in the immunoexpression of the proliferation markers Ki67 and pS2 in all of the patients, with a trend for a more profound suppression in those achieving an objective response. The mean percentage of apoptotic cells was found to be decreased in responders and increased in nonresponders after 15 weeks of anastrozole therapy. Our results reveal anastrozole to cause a significant suppression of tissue estrogen levels and to influence the biology of primary estrogen receptor-positive breast cancers in postmenopausal women.
Improvement of bacterial clearance and relief of clinical signs of
Salmonella enterica serovar Typhimurium infection in pigs through
upregulation of Th 1-specific responses by administration of a combination of two silicate
minerals, biotite and bentonite

Biotite and bentonite are phyllosilicate minerals that were originally used in industrial applications. Several beneficial activities of them have recently been reported, especially regulation of the immune system and antimicrobial effects. Therefore, we investigated the immune-enhancing and bacterial clearance effects of a biotite and bentonite mixture (BBM) on experimental infection of Salmonella enterica serovar Typhimurium (S. Typhimurium) to determine whether the BBM could be used as an alternative antibiotic. We administered 1% or 2% BBM as a feed supplement. We then evaluated the bacterial clearance effects of the BBM against S. Typhimurium. We also evaluated the immune-enhancing effect of the BBM through several immunological experiments that included examination of the lysozyme activity, CD4(+)/CD8(+) T lymphocyte ratio and the T-helper type 1 (Th 1) cytokine profile. The clinical signs of S. Typhimurium and the number of viable bacteria in feces and tissues were significantly decreased in both BBM groups, especially in the 2% BBM group. The BBM also markedly enhanced the lysozyme activity, CD4(+)/CD8(+) T lymphocyte ratio and expression levels of IFN-γ and IL-12 in S. Typhimurium-challenged pigs. Therefore, the BBM could be a good candidate as an alternative antibiotic that improves Th 1-specific immune responses and the bacterial clearance effect.
Hüft- und Knietotalendoprothesenversorgung

Zur Evaluation der ambulanten Rehabilitation nach Hüft- und Knietotalendoprothesenversorgung wurden in dieser multizentrischen Studie zu Reha-Beginn (T1), am Ende (T2) sowie 3 Monate danach (T3) Assessments zu Lebensqualität, allgemeiner Gesundheit sowie subjektiver und objektiver Beeinträchtigung erhoben: SF-36, EQ-5D und WOMAC. Zu T1 und T2 wurden der Knee-Society- bzw. der Harris-Hip-Score dokumentiert. Erfasst wurden 721 Patienten [359 Hüft-, 362 Knietotalendoprothese (-TEP)]. Das mittlere Alter betrug 65 Jahre. 49 % waren Frauen. Sowohl die Ergebnisse der klinischen Scores als auch subjektiver Gesundheitsstatus und Lebensqualität zeigten zum großen Teil hoch signifikant positive Veränderungen im Rehabilitationsverlauf sowie auch Nachwirkung im weiteren Beobachtungszeitraum. Ein Wirkungsverlust mit rückläufigen Resultaten nach Rehabilitationsende war nicht festzustellen. Die Studie zeigt positive Ergebnisse nach ambulanter Rehabilitation bei Endoprothesenversorgung. For evaluation of outpatient rehabilitation after total hip and knee replacement, a multicenter study was performed to assess quality of life, general health as well as subjective and objective impairment at the beginning (T1), at the end (T2) and 3 months (T3) after rehabilitation: SF 36, EQ-5D, and WOMAC. The Knee Society and Harris Hip Score scores were documented at T1 and T2. A total of 721 patients were included (359 hips, 362 knees). The average age was 65 years, and 49 % of the patients were women. Both the results of the clinical scores and health statuses showed highly significantly positive changes in the rehabilitation course as well as sustainability in the further observation time period. An effect loss with declining results after rehabilitation was not observed. The study illustrates positive effects of outpatient rehabilitation following endoprosthetic treatment.
Impact of depression and anxiety on burden and management of episodic and chronic headaches – a cross-sectional multicentre study in eight Austrian headache centres

Recurrent and especially chronic headaches are associated with psychiatric comorbidities such as depression and anxiety. Only few studies examined the impact of depression and anxiety on episodic (EH) and chronic headache (CH), and data for Austria are missing at all. Therefore, the aim of the present study was to assess the impact of depression and anxiety on burden and management of EH and CH in patients from eight Austrian headache centres. We included 392 patients (84.1 % female, mean age 40.4 ± 14.0 years) who completed the Eurolight questionnaire. The treating physician recorded details about ever-before prophylactic medications. We used Hospital Anxiety and Depression Scale to assess depression and anxiety and compared patients with anxiety and/or depression to those without. Depression and anxiety were more common in CH than in EH (64 % vs. 41 %, p < 0.0001). Presence compared to absence of depression and anxiety increased the prevalence of poor or very poor quality of life from 0.7 % to 13.1 % in EH and from 3.6 % to 40.3 % in CH (p = 0.001; p < 0.0001). Depression and anxiety had a statistically significant impact on employment status and on variables related to the burden of headache such as reduced earnings, being less successful in career, or feeling less understood. Neither in EH nor in CH health care use and the ever-before use of prophylactic medication was correlated with anxiety and/or depression. Depression and anxiety have a significant impact on quality of life and increase the burden in patients with EH and CH. Improved multidimensional treatment approaches are necessary to decrease disability on the personal, social and occupational level in these patients.
Dose-dependent effects of the once-daily GLP-1 receptor agonist lixisenatide in patients with Type 2 diabetes inadequately controlled with metformin: a randomized, double-blind, placebo-controlled trial

To evaluate the dose-response relationship of lixisenatide (AVE0010), a glucagon-like peptide-1 (GLP-1) receptor agonist, in metformin-treated patients with Type 2 diabetes.



Randomized, double-blind, placebo-controlled, parallel-group, 13 week study of 542 patients with Type 2 diabetes inadequately controlled [glycated haemoglobin (HbA(1c)) > or = 7.0 and < 9.0% (> or = 53 and < 75 mmol/mol)] on metformin (> or = 1000 mg/day) treated with subcutaneous lixisenatide doses of 5, 10, 20 or 30 microg once daily or twice daily or placebo. The primary end-point was change in HbA(1c) from baseline to 13 weeks in the intent-to-treat population.



Lixisenatide significantly improved mean HbA(1c) from a baseline of 7.55% (59.0 mmol/mol); respective mean reductions for 5, 10, 20 and 30 microg doses were 0.47, 0.50, 0.69 and 0.76% (5.1, 5.5, 7.5 and 8.3 mmol/mol), on once-daily and 0.65, 0.78, 0.75 and 0.87% (7.1, 8.5, 8.2 and 9.5 mmol/mol) on twice-daily administrations vs. 0.18% (2.0 mmol/mol) with placebo (all P < 0.01 vs. placebo). Target HbA(1c) < 7.0% (53 mmol/mol) at study end was achieved in 68% of patients receiving 20 and 30 microg once-daily lixisenatide vs. 32% receiving placebo (P < 0.0001). Dose-dependent improvements were observed for fasting, postprandial and average self-monitored seven-point blood glucose levels. Weight changes ranged from -2.0 to -3.9 kg with lixisenatide vs. -1.9 kg with placebo. The most frequent adverse event was mild-to-moderate nausea.



Lixisenatide significantly improved glycaemic control in mildly hyperglycaemic patients with Type 2 diabetes on metformin. Dose-response relationships were seen for once- and twice-daily regimens, with similar efficacy levels, with a 20 microg once-daily dose of lixisenatide demonstrating the best efficacy-to-tolerability ratio. This new, once-daily GLP-1 receptor agonist shows promise in the management of Type 2 diabetes to be defined further by ongoing long-term studies.
Quality of life after restorative proctocolectomy for ulcerative colitis: different questionnaires lead to different interpretations.

According to some researchers, health-related quality-of-life scores for patients who undergo restorative proctocolectomy (RPC) for ulcerative colitis (UC) are comparable to those of healthy control subjects. Other studies show evidence that patients who undergo RPC experience a health-related quality of life similar to patients with mild UC or UC in remission.



The discrepancy in health-related quality-of-life scores among studies may be due to different health-related quality-of-life analyses.



Cross-sectional study.



Outpatient clinic of a tertiary care center.



In the first phase of the study, we consecutively enrolled 24 patients with UC, 24 patients with Crohn disease, and 24 healthy controls. In the second phase of the study, 40 patients who underwent RPC, 43 patients with UC, and 44 controls were consecutively enrolled.



We administered an Italian version of the Cleveland Global Quality of Life (CGQL) instrument, the Padova Inflammatory Bowel Disease Quality of Life instrument, and the Italian 36-Item Short-Form Health Survey.



We evaluated the construct validity, internal consistency, test-retest reliability, sensitivity to change, and discriminant ability of the Italian CGQL instrument. We compared its discriminative ability with that of the Padova Inflammatory Bowel Disease Quality of Life instrument.



The Italian CGQL instrument obtained good construct validity, internal consistency, test-retest reliability, and sensitivity to change. The Italian CGQL score did not distinguish patients who underwent RPC from healthy controls and those with mild UC or UC in remission, while the Padova Inflammatory Bowel Disease Quality of Life instrument reported similar scores for patients who underwent RPC and those with mild UC or UC in remission, and showed a difference vs healthy controls.



We validated an Italian version of the CGQL score. The different results obtained with the CGQL and the Padova Inflammatory Bowel Disease Quality of Life instruments can be attributed to the different discriminative ability of the 2 questionnaires.
Effect of contraindicated drugs for heart failure on hospitalization among seniors with heart failure

Little is known about the effect of nonsteroidal anti-inflammatory drugs (NSAIDs), thiazolidinediones (TZDs), nifedipine and nondihydropyridine calcium channel blockers (CCBs) usage on the risk of all-cause hospitalization among seniors with heart failure (HF). We assessed the risk of all-cause hospitalization associated with exposure to each of these drug classes, in a population of seniors with HF.Using the Quebec provincial databases, we conducted a nested case-control study in a population of individuals aged ≥65 with a first HF diagnosis between 2000 and 2009. Patients were considered users of a potentially inappropriate drug class if their date of hospital admission occurred in the interval between the date of the last drug claim and the end date of its days' supply. The risks of hospitalization were estimated using multivariate conditional logistic regression.Of the 128,853 individuals included in the study population, 101,273 (78.6%) were hospitalized. When compared to nonusers, users of NSAIDs (adjusted odds ratio: 1.16; 95% confidence interval: 1.13-1.20), TZD (1.09; 1.04-1.14), and CCBs (1.03; 1.01-1.05) had an increased risk of all-cause hospitalization, but not the users of nifedipine (1.00; 0.97-1.03).Seniors with HF exposed to a potentially inappropriate drug class are at increased risk of worse health outcomes. Treatment alternatives should be considered, as they are available.
Weight change in people with type 2 diabetes: secular trends and the impact of alternative antihyperglycaemic drugs.

This study aimed to describe the pattern of weight change in people with type 2 diabetes (T2DM) over time and when using alternative treatment regimens.



Data were from routine clinical practice in the UK. The weight trend was determined for each year from 1995 to 2010 for both prevalent and incident cases. Baseline weight was compared to absolute (mean Δ) and relative weights (% Δ) at 6, 12 and 24 months.



Mean, standardized weight in prevalent cases increased from 83.4 to 92.1 kg for males and from 73.5 to 79.9 kg for females between 1995 and 2010 (p < 0.0001). For incident cases, the respective figures were 86.7 to 93.6 kg for males and 76.0 to 80.7 kg for females (p < 0.001). Between baseline and 6, 12 and 24 months, there were significant changes in weight for the majority of the treatment regimens selected for analysis. The largest weight increase at 12 months was for the patients who were prescribed a combination therapy with insulin and a thiazolidinedione, with a median increase of 4.1 kg (95% CI -0.60 to 8.0, p < 0.001). The largest weight decrease at 12 months was for the patients who were prescribed a combination therapy of metformin and exenatide, with a median decrease of -7.0 kg (95% CI -12.0 to -2.0, p < 0.001).



There was a continual increase in body weight in people with T2DM over time, and considerable differences in the impact on weight using alternative treatment regimens. At the same time, glycaemic control remained relatively unchanged.
Mechanism-specific injury biomarkers predict nephrotoxicity early following glyphosate surfactant herbicide (GPSH) poisoning.

Acute kidney injury (AKI) is common following glyphosate surfactant herbicide (GPSH) self-poisoning. Serum creatinine (sCr) is the most widely used renal biomarker for diagnosis of AKI although a recent study in rats suggested that urinary kidney injury molecule-1 predicted AKI earlier and better after GPSH-induced nephrotoxicity. We explored the utility of a panel of biomarkers to diagnose GPSH-induced nephrotoxicity in humans. In a prospective multi-centre observational study, serial urine and blood samples were collected until discharge and at follow-up. The diagnostic performance of each biomarker at various time points was assessed. AKI was diagnosed using the Acute Kidney Injury Network (AKIN) definitions. The added value of each biomarker to sCr to diagnose AKI was assessed by the integrated discrimination improvement (IDI) metric. Of 90 symptomatic patients, 51% developed AKI and 5 patients who developed AKIN≥2 died. Increased sCr at 8 and 16h predicted moderate to severe AKI and death. None of the 10 urinary biomarkers tested increased above normal range in patients who did not develop AKI or had mild AKI (AKIN1); most of these patients also had only minor clinical toxicity. Absolute concentrations of serum and urinary cystatin C, urinary interleukin-18 (IL-18), Cytochrome C (CytoC) and NGAL increased many fold within 8h in patients who developed AKIN≥2. Maximum 8 and 16h concentrations of these biomarkers showed an excellent diagnostic performance (AUC-ROC ≥0.8) to diagnose AKIN≥2. However, of these biomarkers only uCytoC added value to sCr to diagnose AKI when assessed by IDI metrics. GPSH-induced nephrotoxicity can be diagnosed within 24h by sCr. Increases in uCytoC and uIL-18 confirm GPSH-induces apoptosis and causes mitochondrial toxicity. Use of these biomarkers may help to identify mechanism specific targeted therapies for GPSH nephrotoxicity in clinical trials.