nils-herrmann/clean_scirepeval huggingface dataset:
Effectiveness and safety of vildagliptin and vildagliptin add-on to metformin in real-world settings in Egypt - results from the GUARD study.

The GUARD study evaluated the effectiveness, safety, and tolerability of vildagliptin treatment with or without metformin in patients with type 2 diabetes mellitus (T2DM) in real-life settings. Here we present the results of the GUARD study for the patient subset from Egypt.



This was a 24 ± 6 weeks, prospective, non-interventional study that enrolled adult patients with T2DM receiving vildagliptin or vildagliptin + metformin combination therapy as per local prescribing information.



The primary effectiveness endpoint was change in HbA1c levels from baseline to week 24 ± 6 endpoint. Safety was assessed by reporting of adverse events and serious adverse events (SAEs).



Of 2786 patients enrolled from Egypt, 655 received vildagliptin and 2131 received vildagliptin + metformin. Overall, at baseline, mean (± standard deviation [SD]) age was 49.5 ± 9.49 years, BMI was 31.5 ± 4.85 kg/m2, HbA1c was 8.4 ± 0.86%, and duration of T2DM was 2.3 ± 3.78 years. At week 24, significant reductions in mean (±SD) HbA1c were observed in the vildagliptin (-1.47 ± 0.79%) and vildagliptin + metformin (-1.62 ± 0.82%) groups (both p < 0.0001) from baseline HbA1c of 8.1% and 8.4%, respectively. At week 24, 67.5% patients in the vildagliptin group and 60.5% in the vildagliptin + metformin group achieved HbA1c ≤7.0%. Treatment with vildagliptin (± metformin) was well tolerated, with a low incidence of hypoglycemia in both groups (vildagliptin, 0.5%; vildagliptin + metformin, 0.6%). No SAEs or deaths were reported in the vildagliptin group; however, 0.2% of patients experienced SAEs and one death (accidental death) was reported in the vildagliptin + metformin group.



In a real-world setting, vildagliptin, with or without metformin, resulted in significant reductions in HbA1c and was well tolerated in patients with T2DM from Egypt. Limitations of the study include non-randomization and the open-label, observational nature of the study.
Interleukin-15 (IL-15) Strongly Correlates with Increasing HIV-1 Viremia and Markers of Inflammation

IL-15 has been postulated to play an important role in HIV-1 infection, yet there are conflicting reports regarding its expression levels in these patients. We sought to measure the level of IL-15 in a large, well characterised cohort of HIV-1 infected patients and correlate this with well known markers of inflammation, including CRP, D-dimer, sCD163 and sCD14.



IL-15 levels were measured in 501 people (460 patients with HIV-1 infection and 41 uninfected controls). The HIV-1 infected patients were divided into 4 groups based on viral load: <50 copies/ml, 51-10,000 copies/ml, 10,001-100,000 copies/ml and >100,000 copies/ml. The Mann Whitney test (non-parametric) was used to identify significant relationships between different patient groups.



IL-15 levels were significantly higher in patients with viral loads >100,000 copies/ml (3.02 ± 1.53 pg/ml) compared to both uninfected controls (1.69 ± 0.37 pg/ml, p<0.001) or patients with a viral load <50 copies/ml (1.59 ± 0.40 pg/ml (p<0.001). There was a significant correlation between HIV-1 viremia and IL-15 levels (Spearman r = 0.54, p<0.001) and between CD4+ T cell counts and IL-15 levels (Spearman r = -0.56, p<0.001).



IL-15 levels are significantly elevated in HIV-1 infected patients with viral loads >100,000 copies/ml compared to uninfected controls, with a significant direct correlation noted between IL-15 and HIV-1 viremia and an inverse correlation between IL-15 levels and CD4+ T cell counts. These data support a potential role for IL-15 in the pathogenesis of HIV-associated immune activation.
Effect of Extended-Release Niacin/Laropiprant Combination on Plasma Adiponectin and Insulin Resistance in Chinese Patients with Dyslipidaemia

This study examined whether the increase of adiponectin associated with extended-release (ER) niacin/laropiprant combination attenuates the adverse effect of niacin on glucose and insulin resistance in Hong Kong Chinese patients with dyslipidaemia.



Patients (N = 121) were treated with ER niacin/laropiprant 1 g/20 mg for 4 weeks and then the dose was doubled for an additional 8 weeks. Measurements of fasting lipids, glucose, insulin, and adiponectin were performed at baseline and during the study.



There were significant (P < 0.001) increases in glucose (9.4 ± 13.1%), insulin (70.2 ± 91.0%), HOMA-IR (87.8 ± 103.9%), and adiponectin (169.3 ± 111.6%). The increase in adiponectin was significantly associated with increase in glucose (r = 0.221, P < 0.05), insulin (r = 0.184, P < 0.05), and HOMA-IR (r = 0.237, P < 0.01) and the association remained significant after adjustment for changes in body weight or body fat mass.



Treatment with ER niacin/laropiprant led to a significant increase in adiponectin levels but worsening of glucose levels and insulin resistance, and the increase in adiponectin and insulin resistance were correlated suggesting the increase in adiponectin did not ameliorate the deterioration in insulin resistance.
The effect of ascorbic acid on plasma lipids and oxidisability of LDL in male smokers

The aims of this study were to investigate the effect of ascorbic acid (AA) supplementation on the oxidisability of low density lipoprotein (LDL) in vitro and on plasma lipoproteins under controlled dietary conditions.  Randomised single-blind cross-over trial.  Free living subjects.  Eight male smokers (age: 25±2.4 y, BMI: 20.7±0.5, cigarettes per day: 19.1±2.4; means±s.e.).  Dietary intake was determined and all subjects were advised to achieve an intake as close as possible to the recommended dietary intake of AA (40 mg). After two weeks on the baseline diet, subjects were asked to consume 1 g AA per day for two weeks followed by two weeks of placebo supplementation, or vice versa. In view of the carry-over effects of plasma AA, a wash-out period was incorporated between treatments. Duplicate venous blood samples were collected before and after supplementation and the plasma concentrations of AA, lipids and lipoproteins were determined. The in vitro copper-induced oxidisability of LDL was assessed by monitoring of the absorbance of 234 nm.  No changes in the plasma lipids or the oxidisability of LDL were found after AA supplementation compared to placebo. Plasma AA concentrations doubled on average after supplementation indicating that the lack of effect was not a result of poor compliance.  AA supplementation at this dose did not alter plasma lipids of LDL oxidisability in male smokers.  University of Sydney.
Associations of Organic Produce Consumption with Socioeconomic Status and the Local Food Environment: Multi-Ethnic Study of Atherosclerosis (MESA)

Neighborhood characteristics, such as healthy food availability, have been associated with consumption of healthy food. Little is known about the influence of the local food environment on other dietary choices, such as the decision to consume organic food. We analyzed the associations between organic produce consumption and demographic, socioeconomic and neighborhood characteristics in 4,064 participants aged 53-94 in the Multi-Ethnic Study of Atherosclerosis using log-binomial regression models. Participants were classified as consuming organic produce if they reported eating organic fruits and vegetables either "sometimes" or "often or always". Women were 21% more likely to consume organic produce than men (confidence interval [CI]: 1.12-1.30), and the likelihood of organic produce consumption was 13% less with each additional 10 years of age (CI: 0.84-0.91). Participants with higher education were significantly more likely to consume organic produce (prevalence ratios [PR] were 1.05 with a high school education, 1.39 with a bachelor's degree and 1.68 with a graduate degree, with less than high school as the reference group [1.00]). Per capita household income was marginally associated with produce consumption (p = 0.06), with the highest income category more likely to consume organic produce. After adjustment for these individual factors, organic produce consumption was significantly associated with self-reported assessment of neighborhood produce availability (PR: 1.07, CI: 1.02-1.11), with an aggregated measure of community perception of the local food environment (PR: 1.08, CI: 1.00-1.17), and, to a lesser degree, with supermarket density (PR: 1.02: CI: 0.99-1.05). This research suggests that both individual-level characteristics and qualities of the local food environment are associated with having a diet that includes organic food.
Thrombolysis with intravenous rtPA in a series of 100 cases of acute carotid territory stroke: determination of etiological, topographic, and radiological outcome factors.

Although new, large, double-blind, randomized studies are needed to establish the efficiency of intravenous thrombolysis, open trials of sufficient size may also provide novel data concerning specific outcomes after thrombolysis.



An open study of intravenous rtPA in 100 patients with internal carotid artery (ICA) territory strokes between 20 and 81 years of age, with a baseline Scandinavian Stroke Scale (SSS) score of <48 at entry was conducted. Inclusion time was within 7 hours after stroke onset. rtPA (0.8 mg/kg) was infused for 90 minutes, with an initial 10% bolus. Heparin was given according to 3 consecutive protocols. The SSS evaluation was done on days 0, 1, 7, 30, and 90. CT scan was performed before treatment, on days 1 and 7. Etiological investigations included echocardiography and carotid Doppler sonography and/or angiography. Outcome at 1 year was documented by SSS score, the modified Rankin Scale (mRS) score, and a 10-point invalidity scale. Multivariate logistic regression was used to identify predictors of poor versus good outcome.



At day 90, 45 patients (45%) had a good result, defined as complete regression or slight neurological sequelae (mRS score of 0-1), 18 patients had a moderate outcome (mRS 2-3), and 31 patients had serious neurological sequelae (mRS 4-5). Six patients died, 2 with intracerebral hematoma after immediate heparin. Five of 11 patients (45.5%) treated between 6 and 7 hours had a good result. The overall intracerebral hematoma rate was 7%. Higher values of fibrin degradation products at 2 hours were observed in the subgroup with intracerebral hematomas. Significant predictors of poor outcome on multivariate logistic regression analysis were baseline SSS score of <15 (odds ratio [OR], 3.38; 95% confidence interval [CI], 1.07 to 10. 74; P=0.04), indistinction between white and gray matter on CT scan (OR, 6.59; 95% CI, 2.19 to 19.79; P=0.0008), and proximal internal carotid thrombosis (OR, 3.29; 95% CI, 0.99 to 10.95; P=0.05).



Our study confirms the safety of intravenous rtPA at a dose of 0.8 mg/kg and suggests efficacy for this drug even within 7 hours. Outcome and hematoma rates were at least as favorable as for trials of therapy with a 3-hour time window. Subgroups with a poor prognosis include low baseline neurological score, baseline CT changes, and proximal ICA thrombosis. However, approximately 30% of patients with each of these characteristics show a good outcome, so their inclusion in future routine rtPA protocols is still justified.
The effect of exercise and antioxidant enzyme levels in syndrome X and coronary slow flow phenomenon: an observational study.

In this study the antioxidant enzyme [catalase (CAT), superoxide dismutase (SOD), and glutathione peroxidase (GPx) ] levels at rest in patients with syndrome X and coronary slow flow are measured. Then it has been investigated whether there is any enzymatic difference between the normal controls and syndrome X patients or patients with coronary slow flow and ascertain if exercise has any effects on the antioxidant enzyme levels.



Fifty-five patients were included in this prospective observational controlled study. Patients were divided into 3 groups: Group 1- normal controls (n=20); Group 2-patients with coronary slow flow (n=20); and Group 3-patients diagnosed with syndrome X (n=15). In all patients, blood samples were collected at rest and after maximal exercise. The antioxidant enzymes (SOD, CAT, Gpx) in the erythrocytes were studied for these three groups of blood sample. Statistical analysis was performed using Student t-test, Mann-Whitney U and Chi-square tests, Kruskal-Wallis variance analysis and ANOVA.



Under basal conditions the lowest SOD and GPx levels were measured in the 2nd Group, whereas significant differences in paired comparisons were observed only between the 2nd and 3rd Groups (p=0.024 vs. p<0.01, respectively) during paired comparisons. The post-exercise SOD levels were decreased significantly in the 3rd Groups when compared with the basal concentrations (p=0.014), however no significant pre- and post-exercise differences were observed in the CAT and GPx concentrations (p>0.05).



The post-exercise SOD level when compared with basal SOD levels were decreased significantly in the syndrome X group, however no differences were observed between the other groups. This can be interpreted as the reduction in the exercise related symptoms and ischemic findings are resulting from the decrease of SOD activity.
Patterns of management of atrial fibrillation complicating coronary artery bypass grafting: Results from the PRoject of Ex-vivo Vein graft ENgineering via Transfection IV (PREVENT-IV) Trial.

Current practice related to the management of atrial fibrillation (AF) complicating coronary artery bypass grafting (CABG) is uncertain.



We examined management of post-CABG AF in the PREVENT-IV trial, and we explored patterns of use of postoperative rhythm versus rate control and anticoagulation for AF by geographic region and type of site. We also compared outcomes of patients who developed post-CABG AF (663) with those who did not (2,131).



The incidence of AF was 24%. Post-CABG AF was treated with a rhythm control strategy in 81% of patients and with warfarin in 23% of patients. Although there were significant variations across sites in the management of post-CABG AF, patterns of use of postoperative rhythm versus rate control and anticoagulation did not differ by geographic region or by whether or not the enrolling site was an academic institution. Mortality was higher in patients with post-CABG AF than patients without AF at 30 days (1.5% vs 0.7%, P = .01) but not at 3 years (6.9% vs 4.9%, P = .41). There was a trend toward a higher risk of mortality or stroke at 30 days in patients with AF (2.4% vs 1.9%, P = .08).



Although a rhythm control strategy was used in most of the patients in this trial and the overall rate of use of warfarin was low, the significance of these findings is uncertain because of the lack of data from randomized clinical trials. The substantial variations in the management of post-CABG AF across sites are likely because of definitive data on the most effective therapies, highlighting the need for clinical trials on rate versus rhythm control and on anticoagulation for AF in this setting.
Drug-free remission, functioning and radiographic damage after 4 years of response-driven treatment in patients with recent-onset rheumatoid arthritis.

To compare the occurrence of drug-free remission, functional ability and radiological damage after 4 years of response-driven treatment according to four different treatment strategies for rheumatoid arthritis (RA).



Patients with recent-onset, active RA (n = 508) were randomly assigned to four different treatment strategies: (1) sequential monotherapy; (2) step-up combination therapy; (3) initial combination therapy with prednisone and (4) initial combination therapy with infliximab. Treatment was adjusted based on 3-monthly disease activity score (DAS) assessments, aiming at a DAS < or =2.4. From the third year, patients with a sustained DAS <1.6 discontinued treatment.



In total, 43% of patients were in remission (DAS <1.6) at 4 years and 13% were in drug-free remission: 14%, 12%, 8% and 18% of patients in groups 1-4, respectively. The absence of anti-cyclic citrullinated peptide antibodies, male gender and short symptom duration were independently associated with drug-free remission. Functional ability and remission were maintained in all four groups with the continuation of DAS-driven treatment, without significant differences between the groups. Significant progression of joint damage was observed in 38% and 31% of patients in groups 3 and 4 versus 51% and 54% of patients in groups 1 and 2 (p<0.05, group 4 versus groups 1 and 2, group 3 versus group 2).



In patients with recent-onset active RA, drug-free remission was achieved in up to 18% of patients. DAS-driven treatment maintained clinical and functional improvement, independent of the treatment strategy. Joint damage progression remained significantly lower after initial combination therapy compared with initial monotherapy.
Monitoring of neoadjuvant chemotherapy using multiparametric, 23Na sodium MR, and multimodality (PET/CT/MRI) imaging in locally advanced breast cancer

We prospectively investigated using advanced magnetic resonance imaging (MRI) and positron emission tomography/computed tomography (PET/CT) to identify radiological biomarkers for treatment response in patients receiving preoperative systemic therapy (PST) for locally advanced breast cancer. Patients with a stage II or III breast cancer receiving PST were selected and underwent positron emission tomography (PET), magnetic resonance imaging (MRI), and breast biopsies at baseline and after the first cycle of PST (days 7–8) during the full course of treatment. PET/CT was acquired after injection of 2-deoxy-2-[18F]-fluoro-d-glucose (18FDG, 0.22 mCi/kg) and quantified with standardized uptake value assessment (SUV). Diagnostic breast MRI and sodium (23Na) was acquired at 1.5 T. Total tissue sodium concentration (TSC), response criteria in solid tumors (RECIST), and volumes were quantified. Treatment response was determined by pathological assessment at surgery. Immunohistochemistry values of the proliferative index (Ki-67) were performed on biopsy specimens. Six of nineteen eligible women (43 ± 11 years) who received PST underwent radiological imaging of 18FDG-PET/CT and MRI for at least two cycles of treatment. Five patients had a pathological partial response (pPR) and one had pathological non-response (pNR). TSC decreased 21% in responders with increases in the non-responder (P = 0.03). Greater reduction in SUV was observed in responders (38%) compared to the non-responder (22%; P = 0.03). MRI volumes decreased after cycle 1 by 42% (responders) and 35% (non-responder; P = 0.11). Proliferation index Ki-67 declined in responders in the first cycle (median = 47%, range = 29–20%), but increased (4%) in the non-responder. Significant decreases in TSC, SUV, and Ki-67 were observed in responders with increases in TSC and Ki-67 in non-responders. Our results demonstrate the feasibility of using multi-modality proton, 23Na MRI, and PET/CT metrics as radiological biomarkers for monitoring response to PST in patients with operable breast cancer.
The impact of diabetes on the outcomes of surgical and nonsurgical treatment of patients in the spine patient outcomes research trial.

A secondary analysis comparing diabetic patients with nondiabetic patients enrolled in the Spine Patient Outcomes Research Trial (SPORT).



To compare surgical outcomes and complications between diabetic and nondiabetic spine patients.



Patients with diabetes are predisposed to comorbidities that may confound the diagnosis and treatment of patients with spinal disorders.



Baseline characteristics and outcomes of 199 patients with diabetes were compared with those of the nondiabetic population in a total of 2405 patients enrolled in the Spine Patient Outcomes Research Trial for the diagnoses of intervertebral disc herniation (IDH), spinal stenosis (SpS), and degenerative spondylolisthesis (DS). Primary outcome measures include the 36-Item Short Form Health Survey (SF-36) Health Status questionnaire and the Oswestry Disability Index.



Patients with diabetes were significantly older and had a higher body mass index than nondiabetic patients. Comorbidities, including hypertension, stroke, cardiovascular disease, and joint disease, were significantly more frequent in diabetic patients than in nondiabetic patients. Patients with diabetes and IDH did not make significant gains in pain and function with surgical intervention relative to diabetic patients who underwent nonoperative treatment. Diabetic patients with SpS and DS experienced significantly greater improvements in pain and function with surgical intervention when compared with nonoperative treatment. Among those who had surgery, nondiabetic patients with SpS achieved marginally significantly greater gains in function than their diabetic counterparts (SF-36 physical function, P = 0.062). Among patients who had surgery for DS, diabetic patients did not have as much improvement in pain or function as did the nondiabetic population (SF-36 bodily pain, P = 0.003; physical function, P = 0.002). Postoperative complications were more prevalent in patients with diabetes than in nondiabetic patients with SpS (P = 0.002). There was an increase in postoperative (P = 0.028) and intraoperative (P = 0.029) blood replacement in DS patients with diabetes.



Diabetic patients with SpS and DS benefited from surgery, though older SpS patients with diabetes have more postoperative complications. IDH patients with diabetes did not benefit from surgical intervention.
Effects of a Combination of Berberis aristata, Silybum marianum and Monacolin on Lipid Profile in Subjects at Low Cardiovascular Risk; A Double-Blind, Randomized, Placebo-Controlled Trial

The aim of this study was to evaluate the efficacy and safety of an anti-hypercholesterolemic agent containing Berberis aristata, Silybum marianum and monacolin K and KA in a sample of Caucasian patients at low cardiovascular risk according to Framingham score. The primary outcome was to evaluate the effects of this nutraceutical combination on lipid profile; the secondary outcome was to evaluate the effect on some inflammatory markers, in particular high sensitivity C-reactive protein and tumor necrosis factor-α interleukin-6. One hundred and forty-three patients were randomized to placebo or Berberol® K, once a day, during the dinner, for 3 months, in a randomized, double-blind, placebo-controlled trial. We recorded a significant reduction of fasting plasma glucose with Berberol® K compared to placebo (-12.2%, p < 0.05). Moreover, we recorded an increase of fasting plasma insulin with Berberol® K both compared to baseline and to placebo (+9.9%, p < 0.05). Accordingly, the homeostasis model assessment (HOMA) index obtained after treatment with Berberol® K was lower than the one in the placebo group (-2.8%, p < 0.05). No variations of lipid profile were observed with placebo, while there was a significant decrease of total cholesterol (-20.5%, p < 0.05), triglycerides (-17.7%, p < 0.05), and low density lipoprotein (LDL) cholestero (-27.8%, p < 0.05) with Berberol® K, compared to placebo. There was a decrease of high sensitivity C-reactive protein (-30.8%, p < 0.05), and interleukin-6 (-25.0%, p < 0.05), with Berberol® K compared to placebo. In conclusion, combining different hypocholesterolemic nutraceutical agents such as Berberis aristata, Silybum marianum and monacolin K and KA could be effective and safe to obtain a reduction of lipid profile and an improvement of inflammatory parameters.