nils-herrmann/clean_scirepeval huggingface dataset:
Antioxidant Activity of Heracleum persicum Fruit Extract: Evidence from a Randomized Controlled Trial.

Oxidative stress is a unifying feature of several cardiometabolic risk factors, and has been suggested to be implicated in atherogenesis. This study aimed to investigate the efficacy of supplementation with Heracleum persicum fruit-a common dietary spice-in modulating systemic biomarkers of oxidative stress in subjects undergoing coronary angiography. Twenty-seven subjects with minimal coronary artery disease (CAD; defined as < 50% obstruction in the coronary arteries) were selected for this trial and were randomly allocated to Heracleum persicum hydroalcoholic fruit extract (n = 15; 300 mg/day) or placebo (n = 12) for a period of six months. Patients were visited monthly and asked to report the adverse events during the treatment period. Serum levels of malondialdehyde (MDA), reduced glutathione (GSH) and total antioxidant capacity (TAC), and enzymatic activities of glutathione peroxidase (GPx), superoxide dismutase (SOD), and catalase (CAT) were determined at baseline and at the end of trial. Comparison of changes in the evaluated biomarkers of oxidative stress indicated a significantly greater effect of H. persicum extract versus placebo in reducing serum MDA (p = .001), and elevating GSH (p = .001), and TAC (p = .001) concentrations, as well as activities of GPx (p = .001) and CAT (p = .001). The groups were comparable with respect to changes in serum SOD activities during the course of trial (p = .255). The findings of the present randomized double-blind placebo-controlled trial clearly support the efficacy of H. persicum fruit extract as a safe antioxidant supplement in subjects with minimal CAD.
Prognostic factors of radiographic progression in early rheumatoid arthritis: a two year prospective study after a structured therapeutic strategy using DMARDs and very low doses of glucocorticoids

The objective of the study was to analyze the prognostic factors of radiographic progression in a series of patients with early rheumatoid arthritis (RA) after 2 years of therapy with a structured algorithm using disease-modifying antirheumatic drugs (DMARDs) and very low doses of oral glucocorticoids. One hundred and five patients (81% female) with early RA (disease duration <2 years) treated with the same therapeutic protocol using gold salts and methotrexate in a step-up strategy, together with methylprednisolone (4 mg/day), were followed up for 2 years. The outcome variable was radiographic progression after 2 years of DMARD therapy using the modified Larsen method. Clinical, biological, immunogenetic, and radiographic data were analyzed at study entry and after 1 and 2 years of follow-up. Radiographic progression (increase of four or more units in the Larsen score) was observed in 32% of patients after 2 years of follow-up. The percentage of erosive disease increased from 18.3% at baseline to 28.9% at 12 months and 44.6% at 24 months, in spite of a significant improvement in disease activity. New erosions appeared in 33% of patients after 2 years. Several baseline parameters were associated with radiographic progression in the univariate analysis: shared epitope (SE) homozygozity, HLA-DRB*04 alleles, female gender, hemoglobin, erythrocyte sedimentation rate, and anticyclic citrullinated peptide antibodies (anti-CCP). In the multivariate analysis, female gender [odds ratio (OR) 5.5, 95% confidence interval (CI): 1.1–28.2, p = 0.04], DRB1*04 alleles (OR 3.1, 95% CI 1.1–9, p = 0.03) and, marginally, anti-CCP antibodies (OR 3.6, 95% CI 0.9–14.5, p = 0.06), were associated with progression. Female patients with both DRB1*04 alleles and anti-CCP antibodies showed the highest scores in radiographic progression. The presence, but not the titer, of anti-CCP antibodies predicted progression. The positive predictive value of the multivariate model for progression was only 53.9% whereas the negative predictive value was 80.3%. In a series of early RA patients treated with a structured algorithm using DMARDs and very low doses of glucocorticoids, radiographic progression was observed in one third of patients after 2 years. Female gender, DRB1*04 alleles (rather than the SE), and the presence of anti-CCP antibodies at baseline (independently of the titer) were the most important predictors of progression. The utility of these parameters in clinical practice is limited by their relatively low positive predictive value.
Preserving cognition, quality of life, physical health and functional ability in Alzheimer's disease: the effect of physical exercise (ADEX trial): rationale and design.

Exercise is hypothesized to improve cognition, physical performance, functional ability and quality of life, but evidence is scarce. Previous studies were of short duration, often underpowered and involving home-based light exercise programs in patients with undefined dementia. The aim of the ADEX ('Preserving Cognition, Quality of Life, Physical Health and Functional Ability in Alzheimer's Disease: the Effect of Physical Exercise') trial is to establish whether aerobic exercise is effective in improving cognition as well as in reducing the prevalence of psychiatric symptoms among patients with Alzheimer's disease (AD).



The ADEX study is a multicenter, single-blind, randomized trial with two arms: an intervention group attending 16 weeks of continuously supervised moderate-to-high intensity aerobic exercise and a control group receiving usual care. We plan to recruit 192 patients with mild AD. The primary outcome measure is change from baseline in cognitive performance at 16 weeks (as measured by the Symbol Digit Modalities test).



To our knowledge this is the first large-scale controlled study to investigate the effects of supervised moderate aerobic exercise on cognition in patients with AD. Recruitment began in January 2012 and results are expected to be available in 2014. We summarize the methodological challenges we and other studies have faced in this type of complex multicenter intervention with unique challenges to study design.
C-peptide improves adenosine-induced myocardial vasodilation in type 1 diabetes patients.

Patients with type 1 (insulin-dependent) diabetes show reduced skeletal muscle blood flow and coronary vasodilatory function despite intensive insulin therapy and good metabolic control. Administration of proinsulin C-peptide increases skeletal muscle blood flow in these patients, but a possible influence of C-peptide on myocardial vasodilatory function in type 1 diabetes has not been investigated. Ten otherwise healthy young male type 1 diabetic patients (Hb A1c 6.6%, range 5.7-7.9%) were studied on two consecutive days during normoinsulinemia and euglycemia in a double-blind, randomized, crossover design, receiving intravenous infusion of C-peptide (5 pmol.kg-1.min-1) for 120 min on one day and saline infusion on the other day. Myocardial blood flow (MBF) was measured at rest and during adenosine administration (140 microg.kg-1.min-1) both before and during the C-peptide or saline infusions by use of positron emission tomography and [15O]H2O administration. Basal MBF was not significantly different in the patients compared with an age-matched control group, but adenosine-induced myocardial vasodilation was 30% lower (P < 0.05) in the patients. During C-peptide administration, adenosine-stimulated MBF increased on average 35% more than during saline infusion (P < 0.02) and reached values similar to those for the healthy controls. Moreover, as evaluated from transthoracal echocardiographic measurements, C-peptide infusion resulted in significant increases in both left ventricular ejection fraction (+5%, P < 0.05) and stroke volume (+7%, P < 0.05). It is concluded that short-term C-peptide infusion in physiological amounts increases the hyperemic MBF and left-ventricular function in type 1 diabetic patients.
Prior Fundoplication Does not Improve Safety or Efficacy Outcomes of Radiofrequency Ablation: Results from the U.S. RFA Registry

Ongoing gastroesophageal reflux may impair healing and re-epithelialization after radiofrequency ablation (RFA) of Barrett’s esophagus (BE). Because prior fundoplication may improve reflux control, our aim was to assess the relationship between prior fundoplication and the safety/efficacy of RFA. We assessed the U.S. RFA Registry, a nationwide registry of BE patients receiving RFA at 148 institutions, to compare the safety and efficacy of ablation between those with prior fundoplication and those with medical management (proton pump inhibition). Among 5,537 patients receiving RFA, 301 (5.4 %) had prior fundoplication. Of fundoplication subjects, 1.0 % developed stricture and 1.0 % were hospitalized after RFA. Rates of stricture, bleeding, and hospitalization were not statistically different (p = ns) between patients with and without prior fundoplication. Complete eradication of intestinal metaplasia and complete eradication of dysplasia were achieved in 71 % and 87 % of fundoplication patients, and 73 % and 87 % of patients without fundoplication, respectively (p = ns for both). Patients with prior fundoplication needed similar numbers of RFA sessions for eradication compared with those without fundoplication. Radiofrequency ablation, with or without prior fundoplication, is safe and effective in eradicating BE. Prior fundoplication was associated with similar adverse event and efficacy rates when compared with medical management.
Methylphenidate (‘Ritalin’) can Ameliorate Abnormal Risk-Taking Behavior in the Frontal Variant of Frontotemporal Dementia

The frontal variant of frontotemporal dementia is a significant neurological condition worldwide. There exist few treatments available for the cognitive and behavioural sequelae of fvFTD. Previous research has shown that these patients display risky decision-making, and numerous studies have now demonstrated pathology affecting the orbitofrontal cortex. The present study uses a within-subjects, double-blind, placebo-controlled procedure to investigate the effects of a single dose of methylphenidate (40 mg) upon a range of different cognitive processes including those assessing prefrontal cortex integrity. Methylphenidate was effective in ‘normalizing’ the decision-making behavior of patients, such that they became less risk taking on medication, although there were no significant effects on other aspects of cognitive function, including working memory, attentional set shifting, and reversal learning. Moreover, there was an absence of the normal subjective and autonomic responses to methylphenidate seen in elderly subjects. The results are discussed in terms of the ‘somatic marker’ hypothesis of impaired decision-making following orbitofrontal dysfunction.
Effect on smoking quit rate of telling smokers their health risk appraisal in terms of health age: a randomized control trial.

We evaluated whether providing health risk appraisal for Koreans (KHRA) in terms of 'health age' during smoking cessation program would effectively help smokers quit smoking or not.



A total of 332 male smokers aged between 30-65 years old, registered for a smoking cessation program in a public health center in a city, were recruited and underwent a baseline survey from January 2010 to February 2011. They were then prospectively randomized to a conventional counseling group (n=165) or a KHRA group (n=167), and received conventional counseling or KHRA-based counseling for six months. Abstinence rates were identified through carbon monoxide measurement (at the 4th and 24th weeks) or urinary cotinine level (at the 12th week).



The abstinence rate confirmed by exhaled carbon monoxide was significantly higher in the KHRA group (61.1%) than the control group (49.1%) at the 4th week (absolute difference 12.0%, 95% CI: 1.4%-22.6%). However, there was no difference in abstinence rates between the two groups at the 12th and 24th weeks. The predicting factors of 24 week's smoking cessation success were age, older than 50 years old (OR 2.02, 95% CI: 1.16-3.52), lower Fagerstrom Test for Nicotine Dependence score less than 4 (OR 1.84, 95% CI: 1.03-3.29), and higher Self Efficacy/Temptation score (OR 1.79, 95% CI: 1.05-3.06).



Smoking cessation counseling with KHRA could be effective compared to conventional counseling in the short period of smoking cessation. Further study is needed to evaluate the long-term efficacy of KHRA in tobacco dependence treatment and to establish the indication and target population of this tool.
The effect of rhythmic musical training on healthy older adults' gait and cognitive function.

Older adults' gait is disturbed when a demanding secondary cognitive task is added. Gait training has been shown to improve older adults' walking performance, but it is not clear how training affects their cognitive performance. This study examined the impact on gait, in terms of cost or benefit to cognitive performance, of training healthy older adults to walk to a rhythmic musical beat.



In a mixed model design, 45 healthy older adults aged more than 65 years (M = 71.7 years) were randomly assigned to 3 groups. One group received a rhythmic musical training and their dual-task (DT) walking and cognitive performances were compared with a group who had music playing in the background but no training, and a third group who heard no music and received no training. Outcomes in single-task (ST) and DT conditions were step-time variability and velocity for gait and correct cognitive responses for the cognitive task.



The Musical Training group's step-time variability improved in both the ST (p < .05) and the DT (p < .05) after training, without adversely affecting their cognitive performance. No change was seen in the control groups.



Rhythmic musical training can improve gait steadiness in healthy older adults with no negative impact on concurrent cognitive functioning. This could potentially enhance "postural reserve" and reduce fall risk.
Does acute stress disorder predict post-traumatic stress disorder in traffic accident victims? Analysis of a self-report inventory.

The objective of this study was to account for acute stress disorder (ASD) and post-traumatic stress disorder (PTSD) morbidity in a self-report survey of traffic accident victims and to evaluate the relationship between ASD and PTSD in this sample, and furthermore, to find both a model of independent variables accounting for variance in ASD and PTSD symptom level. Ninety patients, treated at an emergency ward after traffic accidents, participated in this longitudinal self-report survey. ASD was assessed using the Acute Stress Disorder Scale (ASDS) and PTSD was assessed at 6-8 months follow-up using the Posttraumatic Diagnostic Scale (PDS). Twenty-five patients (28%) met the cutoff scores for ASDS. Fifteen patients (17%) fulfilled criteria for PTSD according to the PDS. ASD was only able to predict 50% of patients who later developed high levels of PTSD symptomatology. A model of three variables explained 35% of the variance in ASD symptom level. Two variables explained 40% of the variance in PTSD symptom level. In both regression models, dissatisfaction with social support was associated with a higher symptom level. The results from this study reflect already voiced problems with the ASD diagnosis. The lack of precision in predicting who will develop PTSD is pronounced in this study. The acute traumatic symptom level explains a large part of the variance in PTSD symptom level. However, other variables also seem to play an important role.
Survival following non surgical treatments for oral cancer: a single institutional result.

To report the results of radiotherapy with or without chemotherapy in the patients with oral cancer.



Over the 2003-2009 periods, a total number of 69 patients with squamous cell carcinoma of the oral cavity that refused surgery or had unresectable tumor were enrolled in this study. A total dose of 60 to 70 Gy (2 Gy per day) was given to the primary tumor and clinically positive nodes. In the patients with locoregionally advanced disease (57 patients with T3, T4 lesions and/ or N+) induction chemotherapy following by concomitant chemoradiation was used. Induction chemotherapy consisted of 3 cycles of Cisplatin and 5-Flourouracil with or without Docetaxel. Weekly cisplatin was used in concomitant protocol. Kaplan-Meier method was used to calculate overall survival. Log-rank test and Cox regression model were used for comparison purposes.



Median follow-up was 32 months. The mean age of the patients was 59.2 years. The overall response rate after induction chemotherapy was 68.4%. Actuarial overall survival rates after 2 and 3 years were 38% and 26%, respectively. Clinical stage emerged as the only independent predictor of survival.



Outcome of the patients with oral cancer is poor. Presenting with an advanced stage lesion contributed to this result. The role of chemotherapy in advanced cases remains to be defined.
Epidemiological African day for evaluation of patients at risk of venous thrombosis in acute hospital care settings

This study aimed to identify patients at risk for venous thromboembolism (VTE) among all patients hospitalised, and to determine the proportion of at-risk hospital patients who received effective types of VTE prophylaxis in sub-Saharan Africa (SSA).



A multinational, observational, cross-sectional survey was carried out on 1 583 at-risk patients throughout five SSA countries.



The prevalence of VTE risk was 50.4% overall, 62.3% in medical and 43.8% in surgical patients. The proportion of at-risk patients receiving prophylaxis was 51.5% overall, 36.2% in medical and 64% in surgical patients. Low-molecular weight heparin was the most frequently used prophylactic method in 40.2% overall, 23.1% in medical and 49.9% in surgical patients.



This study showed a high prevalence of VTE risk among hospitalised patients and that less than half of all at-risk patients received an American College of Clinical Pharmacy-recommended method of prophylaxis.



Recommended VTE prophylaxis is underused in SSA.
Supplementary feeding with either ready-to-use fortified spread or corn-soy blend in wasted adults starting antiretroviral therapy in Malawi: randomised, investigator blinded, controlled trial

To investigate the effect of two different food supplements on body mass index (BMI) in wasted Malawian adults with HIV who were starting antiretroviral therapy.



Randomised, investigator blinded, controlled trial.



Large, public clinic associated with a referral hospital in Blantyre, Malawi.



491 adults with BMI <18.5.



Ready-to-use fortified spread (n=245) or corn-soy blend (n=246).



changes in BMI and fat-free body mass after 3.5 months.



survival, CD4 count, HIV viral load, quality of life, and adherence to antiretroviral therapy.



The mean BMI at enrolment was 16.5. After 14 weeks, patients receiving fortified spread had a greater increase in BMI and fat-free body mass than those receiving corn-soy blend: 2.2 (SD 1.9) v 1.7 (SD 1.6) (difference 0.5, 95% confidence interval 0.2 to 0.8), and 2.9 (SD 3.2) v 2.2 (SD 3.0) kg (difference 0.7 kg, 0.2 to 1.2 kg), respectively. The mortality rate was 27% for those receiving fortified spread and 26% for those receiving corn-soy blend. No significant differences in the CD4 count, HIV viral load, assessment of quality of life, or adherence to antiretroviral therapy were noted between the two groups.



Supplementary feeding with fortified spread resulted in a greater increase in BMI and lean body mass than feeding with corn-soy blend.
What are patients' priorities for palliative care research? -- a questionnaire study.

This paper describes the questionnaire component of a two-stage study to examine the research priorities of palliative care patients. In the first stage focus groups were conducted to determine a list of priorities for future research: a questionnaire created from these themes was then used in five hospices across East Anglia. Patients thought that the focus group priorities were important and scored research into emergency care, pain control and helping doctors to understand what patients were saying as most important. Differences in priority were associated with gender, age and in-patient versus day therapy patients.
CHOP versus MACOP-B in aggressive lymphoma--a Nordic Lymphoma Group randomised trial.

The long-term survival of patients with advanced stage aggressive lymphoma has not improved significantly during the last twenty years. In a randomised trial, the efficacy of MACOP-B, a six-drug weekly chemotherapy regimen, was compared to CHOP, the current standard regimen, in terms of overall and failure-free survival, toxicity and health related quality of life.



Four hundred five patients with aggressive lymphoma, stage II-IV, age 18-67, were randomised to receive either 12 weeks of MACOP-B or 8 courses of CHOP over 24 weeks. Special emphasis was put in the definition of Ann Arbor stage in extranodal disease. A subset of 95 patients also entered a quality of life study, based on the EORTC QLQ-C30.



Thirty-one patients were ineligible. Among the remaining 374 patients, the median age was 52 years. According to the age-adjusted International Prognostic Index, 37% were 'high-intermediate' or 'high-risk' patients. No difference could be demonstrated, either in overall survival (60% at five years in the MACOP-B group and 59% in the CHOP group) or in failure-free survival (47% at five years with MACOP-B and 44% with CHOP). In terms of quality of life, physical function and global quality of life were more impaired in patients receiving MACOP-B, who also exhibited more non-haematological toxicity.



No superiority of MACOP-B compared to CHOP could be demonstrated. CHOP remains the treatment of choice in low-risk patients. At present, intensified or experimental treatment should be reserved for high-risk disease.
Phase I trial of piroxicam in 62 dogs bearing naturally occurring tumors

Piroxicam, a nonsteroidal antiinflammatory drug, was given to 62 dogs bearing naturally occurring tumors in a phase I clinical trial. Dose escalation was performed, with oral doses ranging from 0.5 mg/kg every 48 h (q48h) to 1.5 mg/kg q48h being tested. Dose-limiting gastromestinal irritation/ulceration occurred in all four animals that received 1.5 mg/kg q48h. The maximum tolerated dose was 1 mg/kg q48h. Subclinical renal papillary necrosis occurred in two dogs (initial dosages, 1 and 1.5 mg/kg q48h, respectively). Following dose escalation, an additional group of dogs was treated with 0.3 mg/kg piroxicam q24h per os, the accepted canine dosage prior to this trial. Inclusion of this treatment group enabled evaluation of the toxicity of and tumor response to a daily dosage regimen. No complete remissions occurred in this trial. Partial remission was documented in three of ten dogs exhibiting transitional-cell carcinoma, in three of five animals bearing squamous-cell carcinoma, in one of three dogs displaying mammary adenocarcinoma, and in the one dog that exhibited a transmissible venereal tumor. The results of this study support the additional evaluation of piroxicam in a phase II clinical trial in dogs bearing naturally occurring tumors.