nils-herrmann/clean_scirepeval huggingface dataset:
A randomized controlled trial to evaluate the effectiveness of a board game on patients' knowledge uptake of HIV and sexually transmitted diseases at the Infectious Diseases Institute, Kampala, Uganda.

As the number of HIV infections continues to rise, the search for effective health education strategies must intensify. A new educational board game was developed to increase HIV peoples' attention and knowledge to HIV and sexually transmitted infections (STIs) information. The object of this study was to assess the effect of this educational board game on the uptake of knowledge.



A randomized controlled trial where patients attending the Infectious Diseases Clinic, Kampala, Uganda were randomized to either play the board game (intervention arm) or to attend a health talk (standard of care arm). Participants' knowledge was assessed before and after the education sessions through a questionnaire.



One hundred eighty HIV-positive participants were enrolled, 90 for each study arm. The pretest scores were similar for each arm. There was a statistically significant increase in uptake of knowledge of HIV and STIs in both study arms. Compared with patients in the standard of care arm, participants randomized to the intervention arm had higher uptake of knowledge (4.7 points, 95% confidence interval: 3.9 to 5.4) than the controls (1.5 points, 95% confidence interval: 0.9 to 2.1) with a difference in knowledge uptake between arms of 3.2 points (P < 0.001). Additionally, both participants and facilitators preferred the board game to the health talk as education method.



The educational game significantly resulted in higher uptake of knowledge of HIV and STIs. Further evaluation of the impact of this educational game on behavioral change in the short and long term is warranted.
Clinical outcome and paravalvular leakage of the new balloon-expandable Edwards Sapien 3 valve in comparison to its predecessor model (Edwards Sapien XT) in patients undergoing transfemoral aortic valve replacement.

The aim of this study was to compare the 30-day procedural, clinical and echocardiographic outcome of the new balloon-expandable Edwards Sapien 3 (ES3) valve with the Edwards Sapien XT (ESXT).



Post-implant paravalvular leaks (PVL) after transfemoral aortic valve replacement (TAVR) resulting in residual aortic regurgitation (AR) are a major limitation for long term outcome. New TAVR-devices have to eliminate this problem.



Transfemoral TAVR was performed in 209 consecutive intermediate-high-risk surgical patients (pts) with symptomatic aortic stenosis (ESXT n = 102, ES3 n = 107). Transthoracic echocardiography (TTE) and 3-dimensional computed tomography were used for valve size selection. Primary endpoint of the study was none/trace AR derived by TTE 30-days after TAVR.



All pts underwent successfully TAVR with a combined device success of 100/102 (99%) in ESXT and 107/107 (100%) in ES3 pts. Fluoroscopy time (ESXT 11.8 ± 0.5 min vs. ES3 10.0 ± 0.5 min, P = 0.003) and contrast (ESXT 188.9 ± 5.6 mL vs. ES3 170.4 ± 4.7 mL, P = 0.04) were significantly lower in ES3 patients. 30-day clinical events did not differ. Transvalvular mean pressure gradients were significantly reduced to 7.4 ± 0.8 mmHg after ESXT and to 10.1± 0.4 mmHg after ES3 implantation. After 30 days none/trace AR was found in 34.3% (n = 35) of all ESXT pts in contrast to 89.7% (n = 96) of all ES3 patients. Moderate-to-severe AR was found rarely (ESXT 2.9% vs. ES3 0%, P = 0.073).



Although there was no significant difference in 30 day mortality, the newer ES3 valve reduced significantly residual paravalvular leakage.
Use of [11C]acetate and [15O]O2 PET for the assessment of myocardial oxygen utilization in patients with chronic myocardial infarction

Carbon-11 acetate positron emission tomography (PET) has been widely used to assess regional oxidative metabolism of the heart. However, the accuracy of [11C]acetate PET in assessing oxidative metabolism in infarcted myocardium remains controversial. Thirteen patients with stable coronary artery disease and old myocardial infarction were studied. The 15O-based PET studies yielded regional blood flow (rMBF, ml/min/g) and oxygen consumption (rMMRO2, ml/min/g), which was compared with the myocardial clearance rate constant (k mono) of [11C]acetate in segments with rMBF≥75% (group A), 50%–74% (group B) or <50% (group C) of the normal reference segment. Mean MBF was 0.96±0.08 ml/g/min in group A, 0.67±0.06 ml/g/min in group B and 0.42±0.07 ml/g/min in group C segments. The segmental rMMRO2 correlated linearly with k mono (r=0.89, P<0.001, y=0.61x+0.026). The k mono/rMMRO2 ratio was comparable in the group A and B segments (0.99±0.19 vs 1.07±0.21, P=NS). However, the ratio was significantly higher in the group C segments (1.28±0.35, P=0.037). It is concluded that k mono of [11C]acetate correlates linearly with rMMRO2 determined by [15O]O2 inhalation. However, k mono appears to yield higher rMMRO2 estimates than the [15O]O2 method in low-flow areas.
A specific and sensitive assay for blood levels of glycated CD59: a novel biomarker for diabetes.

Increasing evidence links the complement system with complications of human diabetes. The complement regulatory protein CD59, an inhibitor of formation of membrane attack complex (MAC), is inhibited by hyperglycemia-induced glycation fostering increased deposition of MAC, a major effector of complement-mediated tissue damage. CD59, an ubiquitous GPI-anchored membrane protein, is shed from cell membranes by phospholipases generating a soluble form present in blood and urine. We established an enzyme-linked immunosorbent assay (ELISA) to measure serum/plasma glycated human CD59 (hCD59) (GCD59) and evaluated its potential as a diabetes biomarker. We used a synthetic peptide strategy to generate (a) a mouse monoclonal antibody to capture hCD59, (b) a rabbit monoclonal antibody to detect GCD59, and (c) a GCD59 surrogate for assay standardization. ELISA conditions were optimized for precision, reproducibility, and clinical sensitivity. The clinical utility of the assay was initially evaluated in 24 subjects with or without diabetes and further validated in a study that included 100 subjects with and 90 subjects without a diagnosis of diabetes. GCD59 (a) was significantly higher in individuals with than in individual without diabetes, (b) was independently associated with HbA1c, and (c) identified individuals with diabetes with high specificity and sensitivity. We report the development and standardization of a novel, sensitive, and specific ELISA for measuring GCD59 in blood. The assay distinguished individuals with diabetes from those without, and showed strong correlation between GCD59 and HbA1c. Because GCD59 likely contributes to the pathogenesis of diabetes complications, measurement of blood levels of GCD59 may be useful in the diagnosis and management of diabetes.
Reduced dose and duration of peginterferon alfa-2b and weight-based ribavirin in patients with genotype 2 and 3 chronic hepatitis C.

There is increasing interest in identifying patients with chronic hepatitis C genotype 2 or 3 infection in whom it is possible to lower the burden of therapy while retaining high levels of efficacy.



Treatment-naive patients with chronic hepatitis C genotype 2/3 infection were randomized to receive peginterferon alfa-2b (1.5μg/kg/wk) for 24weeks (group A); peginterferon alfa-2b (1.0μg/kg/wk) for 24weeks (group B); or peginterferon alfa-2b (1.5μg/kg/wk) for 16weeks (group C), each in combination with weight-based ribavirin (800-1200mg/d). The study population comprised two cohorts: the Hep-Net cohort enrolled in Germany and an International cohort enrolled at study sites throughout Europe and Asia. The primary end point was sustained virological response (SVR).



The study included 682 patients; 80.2% had genotype 3 infection. In the intent-to-treat population, SVR rates were 66.5%, 64.3%, and 56.6% in groups A, B, and C, and were similar in Asian and white patients. Treatment differences (A vs. B and A vs. C) failed to reach the predefined margin for noninferiority of -10%; and thus groups B and C failed to show noninferiority relative to group A. Among patients with undetectable HCV RNA at week 4, SVR rates were 75.3%, 75.9%, and 72.4%, respectively. Relapse rates were 17.8%, 16.3%, and 29.3%, respectively. Treatment-emergent serious adverse events were highest in group A and lowest in group C, and adverse events leading to discontinuation were similar across treatment arms.



For patients with chronic hepatitis C genotype 2/3 infection, 24weeks of peginterferon alfa-2b (1.5μg/kg/wk) plus weight-based ribavirin remains a standard-of-care therapy; however, treatment for 16weeks may be considered for patients with undetectable HCV RNA at week 4 of the treatment.
Effects of lixisenatide once daily on gastric emptying in type 2 diabetes — Relationship to postprandial glycemia

To determine the effects of lixisenatide, a new once-daily (QD) glucagon-like peptide-1 receptor agonist, on postprandial glucose (PPG) and gastric emptying, and the relationship between these effects in patients with type 2 diabetes mellitus (T2DM).



Data were obtained from a randomized, double-blind, placebo-controlled, parallel-group study with treatment duration of 28 days in patients with T2DM receiving ≤2 oral antidiabetic drugs. Lixisenatide was injected subcutaneously using an ascending dose range (5-20 μg) increased every fifth day in increments of 2.5 μg. Blood glucose was determined before and after three standardized meals (breakfast, lunch, and dinner). Gastric emptying of the standardized breakfast was determined by a (13)C-octanoic acid breath test at baseline (Day-1) and at Day 28.



A total of 21 and 22 patients were randomized to lixisenatide 20 μg QD and placebo, respectively. With lixisenatide 20 μg QD, there was a reduction in PPG when compared with placebo after breakfast (p<0.0001), lunch (p<0.001) and dinner (p<0.05). Hence, lixisenatide 20 μg administered in the morning exhibited a pharmacodynamic effect on blood glucose throughout the day. Gastric emptying (50% emptying time) increased substantially from baseline with lixisenatide 20 μg QD, but not with placebo (change from baseline ± SD: -24.1 ± 133.1 min for placebo and 211.5 ± 278.5 min for lixisenatide; p<0.01). There was an inverse relationship between PPG area under the curve after breakfast and gastric emptying with lixisenatide 20 μg QD (n=17, r(2)=0.51, p<0.05), but not with placebo.



In this study, lixisenatide at a dose of 20 μg QD reduced postprandial glycemic excursions in patients with T2DM, possibly as a result of sustained slowing of gastric emptying.
Safety and efficacy of bivalirudin with glycoprotein IIb/IIIa for high-risk percutaneous coronary intervention.

The aim of the study was to assess the safety and efficacy of bivalirudin + glycoprotein (Gp) IIb/IIIa inhibitor as compared to unfractionated heparin (UFH) + Gp IIb/IIIa inhibitor in high risk patients undergoing elective percutaneous coronary intervention (PCI). The primary end point was time to sheath removal and ambulation where as peri-procedure myocardial damage, access site bleeding and major adverse cardiac events (MACE) rates were secondary end points.



One hundred and one high risk patients undergoing elective PCI were randomly assigned to either bivalirudin + GpIIb/IIIa inhibitor or UFH + Gp IIb/IIIa inhibitor. PCI was performed by standard technique and activated clotting time was monitored immediately on arrival to recovery area and every 60 min thereafter. Sheath were pulled out once ACT was below 150 seconds and patients were mobilized 6hrs after sheath were removed. Peri-procedure myocardial damage was assessed by serial Trop I levels.



Patient assigned to bivalirudin + tirofiban has significantly reduced time to sheath removal and ambulation as compared to those who received UFH + tirofiban (p < 0.0001) although peak Act did not differ in the groups. Peak Trop I levels were significantly lower in bivalirudin + tirofiban group (p = 0.023) and peri-procedure Trop I elevation occurred in significantly lower number of patients treated with bivalirudin + tirofiban (p = 0.029).



The combination of bivalirudin + tirofiban was safe and effective as compared to UFH + tirofiban in high risk patients undergoing elective PCI.
Effect of alpha-interferon on hepatitis C virus chronic infection in mixed cryoglobulinemia patients

Since a striking association between hepatitis C virus (HCV) infection and mixed cryoglobulinemia has been demonstrated, the aim of this study is to investigate the effect of alpha-interferon (α-IFN) on HCV viraemia and clinico-serological manifestations of 15 patients (ten female and five male, mean [±SD] age 53±7 years). In 14/15 patients pre-study steroid dosage remained unchanged during treatment. α-IFN was administered at a dose of 2×106 IU daily for a month, then every other day for five months. On the whole, a statistically significant improvement of purpura (p<0.001), serum transaminases (p<0.001), and cryocrit (p<0.01) was observed after α-IFN treatment. HCV viraemia was detected by polymerase chain reaction technique in 13/15 patients with mixed cryoglobulinemia and anti-GOR antibodies, expression of HCV-related autoimmunity, were present in 8/15. After α-IFN treatment, HCV RNA levels showed a clear-cut reduction in five persons and disappeared in another, while anti-HCV antibodies (Chiron ELISA and RIBA II) did not change after the six-month period of therapy. These data further support the possible etiopathogenetic role of HCV in patients with mixed cryoglobulinemia and suggest that α-IFN may be regarded as the elective treatment in this disease. Zwischen der Hepatitis C Virus-Infektion (HCV) und gemischter Kryoglobulinämie wurden bemerkenswerte Beziehungen festgestellt. Bei 15 Patienten mit gemischter Kryoglobulinämie wurde daher die Wirkung von alpha- Interferon (α-IFN) auf die HCV-Virämie und die klinischen und serologischen Parameter der Kryoglobulinämie geprüft (zehn Frauen, fünf Männer, mittleres Alter (±SD) 53±7 Jahre). α-IFN wurde während eines Monats täglich in einer Dosis von 2×106 IU und dann fünf Monate lang jeden zweiten Tag verabreicht. Die Kortikosteroiddosen blieben dabei in 14/15 Fällen unverändert. Nach der α-IFN-Therapie war eine signifikante Besserung der Purpura (p<0,001), der Serumtransaminasen (p<0,001) und des Kryokrit (p<0,01) festzustellen. Bei 13/15 Patienten wurde mittels Polymerase-Kettenreaktion (PCR) eine HCV-Virämie nachgewiesen. Bei 8/15 fanden sich anti-GOR-Antikörper, die als Zeichen der HCV-assoziierten Autoimmunreaktion zu werten sind. Die HCV-RNA-Spiegel waren nach Behandlung mit α-IFN in fünf Fällen deutlich zurückgegangen und in einem Fall verschwunden. Zu einer änderung der anti-HCV Antikörper (Chiron ELISA und RIBA II) kam es während der sechsmonatigen Behandlung mit α-IFN jedoch nicht. Die Ergebnisse unterstützen die Annahme einer ätiopathogenetischen Beziehung zwischen HCV-Infektion und gemischter Kryoglobulinämie. Möglicherweise stellt α-IFN eine gezielte Therapie bei dieser Krankheit dar.
Factors associated with compliance to lipid-lowering treatment in China.

There are an estimated 200 million people in China with dyslipidaemia. We sought to explore factors that influence compliance to treatment of dyslipidaemia, using a multi-centre sample in China.



Through review of medical notes and direct interviews at two points in time (2006 and 2007) of 2094 patients in 27 hospitals receiving lipid-lowering therapy since 2004, 1890 patients were recruited who had been on treatment for more than one year. Good compliance (GC) was defined as days taking lipid-lowering drugs/total days of follow-up ≥ 80%. Logistic regression models were used to assess factors associated with GC.



In patients with one, two and three years of treatment respectively, GC was greater in those with higher versus lower medical insurance cover - odds ratios 2.8 (95%CI 2.2-3.7), 2.0 (1.5-2.7), 4.3 (2.3-8.1); in patients in province-level versus county-level hospitals-2.0 (1.5-2.6), 2.9 (2.0-4.1), 4.6 (1.8-12.0); in patients treated by non-cardiology physicians compared to cardiologists -1.7 (1.1-2.5), 2.0 (1.3-3.0), 4.0 (1.5-10.3) and in patients using a statin versus other forms of medication for dyslipidaemia -1.7 (1.2-2.2), 1.7 (1.2-2.3), 4.4 (2.3-8.5).



Better medical insurance cover, care in a province-level hospital rather than county-level hospital, treatment by a non-cardiologist and use of a statin were associated with better compliance to lipid-lowering treatment.
Renal effects of aspirin are clearly dose-dependent and are of clinical importance from a dose of 160 mg.

High doses of aspirin counteract the beneficial effects of angiotensin-converting enzyme (ACE) inhibitors. It is not known how low-dose aspirin, with concomitant ACE-inhibitor treatment, affects renal function.



To study renal effects of different doses of aspirin in elderly healthy volunteers who had an activated renin-angiotensin system.



Sixteen subjects each received two different doses of aspirin (0 and160 mg or 80 and 320 mg) after pre-treatment with bendroflumethiazide and enalapril, in a randomised double-blind, cross-over fashion.



Least square means of the observations 30 to 180 min after dosing, showed that urine flow, GFR, excretion rates of sodium, osmolality clearance and free water clearance were significantly decreased in a dose-dependent manner. Urine flow, sodium excretion rate and free water clearance were significantly lower with 320 mg aspirin vs. 0 mg and 80 mg, and GFR was significantly lower with 320 mg vs. 80 mg. Urine flow, sodium excretion rate, free water and osmolality clearance was significantly lower with aspirin 160 mg vs. 0 mg.



The dose-dependent renal effects of aspirin are of clinical importance from a dose of 160 mg. The adverse influence of aspirin doses higher than 80 mg should be taken into consideration in patients with heart failure.
Daily administration of low molecular weight heparin increases Hepatocyte Growth Factor serum levels in gynaecological patients: pharmacokinetic parameters and clinical implications

Hepatocyte Growth Factor (HGF) enhances cytotoxicity of paclitaxel (PTX) and cisplatin (CDDP) in human ovarian cancer cells. Because of potential pitfalls of HGF exogenous administration, we investigated whether HGF serum concentration might be alternatively raised in vivo by administering low molecular weight heparin (LMWH). The main HGF pharmacokinetic parameters were evaluated following acute and chronic LMWH treatment. First, women, operated on for gynaecological tumors, were treated with a single dose of calcium nadroparin and studied for 12 hours. Next, women operated on for benign or malignant gynaecological tumors were treated daily with calcic nadroparin for one month. Subsequently, the biological activity of the measured HGF serum levels was tested in assays of ovarian cancer cell sensitization to drugs. In the short-term treated group, median HGF AUCss, Cmax and Caverage were about four-fold that of the control group, whereas Cmin was three-fold. In the patients treated chronically median HGF serum levels rose about six-fold in the first week, and decreased but remained significantly higher after one month. The pharmacokinetic of nadroparin-dependent HGF increase were similar in the two groups. The HGF concentrations measured after both acute and chronic treatment were found to be effective in sensitising ovarian cancer cells to chemotherapeutics. This study raises the possibility of using LMWH to increase HGF serum concentration and to take advantage of its biological activities. In particular, nadroparin might be used as a chemo-potentiating agent in epithelial cell ovarian carcinoma through its action on HGF serum concentration.
Effect of intravenous infusion of dobutamine hydrochloride on the development of early postoperative cognitive dysfunction in elderly patients via inhibiting the release of tumor necrosis factor-α.

To investigate the effects of dobutamine hydrochloride on early postoperative cognitive dysfunction (POCD) and plasma tumor necrosis factor (TNF)-α concentration in patients undergoing hip arthroplasty, 124 patients undergoing unilateral total hip arthroplasty, aged 70-92 years old, were randomly assigned to four groups (n=31) as follows: a control group of patients receiving only saline (intravenous infusion, i.v.); and groups receiving 2, 4, or 6μgkg(-1)min(-1) (i.v.) of dobutamine hydrochloride. Cognitive functions were assessed on the day before surgery (T1), and the 1st day (T2), 3rd day (T3), and 7th day (T4) postsurgery using the Mini Mental State Examination (MMSE). The plasma TNF-α protein level was determined 10min before anesthesia (Ta), and 10min (Tb), 30min (Tc), and 60min (Td) after anesthesia by an enzyme-linked immunosorbent assay. Cognitive disorder was observed within the first 3 days after hip arthroplastic surgery, and it had recovered 7 days after the operation in the control group of patients. Administration of 2 or 4μgkg(-1)min(-1) dobutamine hydrochloride was able to reverse the early POCD. Simultaneously, an increase of plasma TNF-α levels 30min after anesthesia was observed (41.34±9.61 vs. 27.75±5.45), which was significantly suppressed by the administration of low-dose dobutamine hydrochloride (29.23±7.32 vs. 41.34±9.61) but not by high-dose dobutamine hydrochloride (45.9±12.11 vs. 41.34±9.61). Together, our data indicated that the plasma concentration of TNFα was engaged in the effect of dobutamine hydrochloride on POCD.
Meropenem versus ceftazidime as empirical monotherapy for febrile neutropenic cancer patients

A total of 101 cancer patients with 121 febrile neutropenia episodes were randomised to receive empirical treatment with i.v. meropenem (1 g/8 h) or ceftazidime (2 g/8 h). After 3 days, 89% of patients were on unmodified therapy in the meropenem group, compared with 83% in the ceftazidime group. Of the evaluable episodes (n=106), the success rate with unmodified empirical therapy until the end of the treatment course was slightly higher with meropenem than with ceftazidime (48% vs 38%, P=0.39). Furthermore, initial success with further infections was observed in 22% of episodes treated with meropenem and in 13% of episodes treated with ceftazidime. Glycopeptides were used as first modification in 28% and 39% of meropenem and ceftazidime recipients, respectively. Both treatments were well tolerated and there were no reports of drug-related nausea/vomiting or seizures. No significant differences in response rate or in tolerability were observed when analysing only the first febrile episodes. In conclusion, meropenem seems to be as efficacious and well tolerated as ceftazidime and may be associated with a lesser requirement for the addition of glycopeptides.