nils-herrmann/clean_scirepeval huggingface dataset:
Comparison of trough effect of telmisartan vs perindopril using self blood pressure measurement: EVERESTE study

This multicentre study was aimed at comparing the trough effect of telmisartan and perindopril on diastolic blood pressure (DBP), using self blood pressure measurement (SBPM). A second objective was to compare the data obtained from SBPM with those provided by automatic office BP measurement. A total of 441 mild-to-moderate hypertensive patients were randomised to receive either telmisartan 40 mg or perindopril 4 mg for a period of 12 weeks. Patients whose clinic DBP remained higher than or equal to 90 mmHg at the end of the 6th week (W6) were given a double-dose regimen. Office BP and SBPM were performed at baseline (W0), at W6 and at week 12 (W12), both with the same automatic device. A greater diminution of trough DBP was obtained with telmisartan (−6.6±6.7 mmHg) than with perindopril (−5.1±7.0 mmHg; P=0.018). Regarding clinic BP, the same results were observed. Doubling dose was significantly less frequent with telmisartan (41%; n=85) than with perindopril (55%; n=115, P=0.005). Mean values of SBPM were lower than office BP values, with a difference of a greater importance at W0 than at W12: 6.6 vs 4.7 mmHg for systolic blood pressure (P<0.005) and 3.2 vs 1.4 mmHg for DBP (P<0.0001). At W12, isolated office hypertension was found in 9% of the patients (n=37), while there were 14% of the patients (n=55) with isolated home hypertension. In conclusion, the trough effect on DBP was statistically higher with telmisartan than with perindopril. SBPM values were lower than office BP values, with greater differences before than after treatment. About a quarter of the patients were found to be controlled with a method but not with the other one.
Predictive testing for BRCA1/2: attributes, risk perception and management in a multi-centre clinical cohort

The aim of this multi-centre UK study is to examine the attributes of a cohort offered predictive genetic testing for breast/ovarian cancer predisposition. Participants are adults unaffected with cancer from families with a known BRCA1/2 mutation. This is the first large multi-centre study of this population in the UK. The study evaluates mental health, perceived risk of developing cancer, preferred risk management options, and motivation for genetic testing. Participants were assessed when coming forward for genetic counselling prior to proceeding to genetic testing. Three hundred and twelve individuals, 76% of whom are female, from nine UK centres participated in the study. There are no gender differences in rates of psychiatric morbidity. Younger women (<50 years) are more worried about developing cancer than older women. Few women provide accurate figures for the population risk of breast (37%) or ovarian (6%) cancer but most think that they are at higher risk of developing breast (88%) and ovarian (69%) cancer than the average woman. Cancer related worry is not associated with perceived risk or uptake of risk management options except breast self-examination. The findings indicate that younger women may be particularly vulnerable at the time of the offer of a predictive genetic test.
Impact of valve surgery on 6-month mortality in adults with complicated, left-sided native valve endocarditis: a propensity analysis.

Complicated, left-sided native valve endocarditis causes significant morbidity and mortality in adults. The presumed benefits of valve surgery remain unproven due to lack of randomized controlled trials.



To determine whether valve surgery is associated with reduced mortality in adults with complicated, left-sided native valve endocarditis.



Retrospective, observational cohort study conducted from January 1990 to January 2000 at 7 Connecticut hospitals. Propensity analyses were used to control for bias in treatment assignment and prognostic imbalances.



Of the 513 adults with complicated, left-sided native valve endocarditis, 230 (45%) underwent valve surgery and 283 (55%) received medical therapy alone.



All-cause mortality at 6 months after baseline.



In the 6-month period after baseline, 131 patients (26%) died. In unadjusted analyses, valve surgery was associated with reduced mortality (16% vs 33%; hazard ratio [HR], 0.43; 95% confidence interval [CI], 0.29-0.63; P<.001). After adjustment for baseline variables associated with mortality (including hospital site, comorbidity, congestive heart failure, microbial etiology, immunocompromised state, abnormal mental status, and refractory infection), valve surgery remained associated with reduced mortality (adjusted HR, 0.35; 95% CI, 0.23-0.54; P<.02). In further analyses of 218 patients matched by propensity scores, valve surgery remained associated with reduced mortality (15% vs 28%; HR, 0.45; 95% CI, 0.23-0.86; P =.01). After additional adjustment for variables that contribute to heterogeneity and confounding within the propensity-matched group, surgical therapy remained significantly associated with a lower mortality (HR, 0.40; 95% CI, 0.18-0.91; P =.03). In this propensity-matched group, patients with moderate to severe congestive heart failure showed the greatest reduction in mortality with valve surgery (14% vs 51%; HR, 0.22; 95% CI, 0.09-0.53; P =.001).



Valve surgery for patients with complicated, left-sided native valve endocarditis was independently associated with reduced 6-month mortality after adjustment for both baseline variables associated with the propensity to undergo valve surgery and baseline variables associated with mortality. The reduced mortality was particularly evident among patients with moderate to severe congestive heart failure.
Quality of Life in Hormone Receptor–Positive HER-2+ Metastatic Breast Cancer Patients During Treatment with Letrozole Alone or in Combination with Lapatinib

A phase III trial compared lapatinib plus letrozole (L + Let) with letrozole plus placebo (Let) as first-line therapy for hormone receptor (HR)(+) metastatic breast cancer (MBC) patients. The primary endpoint of progression-free survival (PFS) in patients whose tumors were human epidermal growth factor receptor (HER)-2(+) was significantly longer for L + Let than for Let (8.2 months versus 3 months; p = .019). This analysis focuses on quality of life (QOL) in the HER-2(+) population.



QOL was assessed at screening, every 12 weeks, and at withdrawal using the Functional Assessment of Cancer Therapy-Breast (FACT-B). Changes from baseline were analyzed and the proportions of patients achieving minimally important differences in QOL scores were compared. Additional exploratory analyses evaluated how QOL changes reflected tumor progression status.



Among the 1,286 patients randomized, 219 had HER-2(+) tumors. Baseline QOL scores were comparable in the two arms. Mean changes in QOL scores were generally stable over time for patients who stayed on study. The average change from baseline on the FACT-B total score in both arms was positive at all scheduled visits through week 48. There was no significant difference between the two treatment arms in the percentage of QOL responders.



The addition of lapatinib to letrozole led to a significantly longer PFS interval while maintaining QOL during treatment, when compared with letrozole alone, thus confirming the clinical benefit of the combination therapy in the HR(+) HER-2(+) MBC patient population. This all oral regimen provides an effective option in this patient population, delaying the need for chemotherapy and its accompanying side effects.
Effective universal health coverage and improved 1-year survival after acute myocardial infarction: the Chilean experience.

In 2005, Chile implemented a universal system of health guarantees (AUGE) aimed at improving equitable access to quality medical care for priority health conditions, including acute myocardial infarction (MI).



To evaluate 1-year survival in MI patients before and after AUGE.



Retrospective cohorts of patients with MI (with and without ST segment elevation) discharged alive from six public hospitals between January 2001-June 2005 (pre-AUGE) and July 2008-March 2009 (post-AUGE). Chilean national mortality and MI Registry (hospital-based) databases were linked using a unique identification number (ICD-10 codes I00-I99 were used to identify cardiovascular deaths). One-year survival was assessed using Weibull multivariate regression.



About 1867 patients were discharged alive pre-AUGE and 534 post-AUGE; 25% were women in both periods. When comparing pre-AUGE and post-AUGE, there was an increase in the use of primary and elective angioplasty (1.7 vs 23.6% and 7.3 vs 20.0%), beta-blockers (62 vs 71%) and statins (40 vs 90%); P  <  0.001 all. One-year survival was 92% pre-AUGE (95% CI: 91-93%) and 96% post-AUGE (95% CI: 94-97%) (HR  =  0.50, 95% CI: 0.31-0.82; P  =  0.003). The post-AUGE improvement persisted after adjusting for variables associated with long-term case-fatality (HR  =  0.44, 95% CI: 0.26-0.75). Percutaneous coronary intervention (HR  =  0.31, 95% CI: 0.09-0.99) and statins use at discharge (HR  =  0.45, 95% CI: 0.31-0.66) had the highest effects associated with lower case-fatality and both treatments increased in the post-AUGE period.



The implementation of AUGE in Chile appears to have contributed to improved treatment of MI in public hospitals and increased 1-year survival, which is consistent with its aim to improve access to quality medical care and to reduce health inequities.
Efficacy and safety of the dipeptidyl peptidase-4 inhibitor sitagliptin added to ongoing metformin therapy in patients with type 2 diabetes inadequately controlled with metformin alone.

The efficacy and safety of the dipeptidyl peptidase-4 inhibitor, sitagliptin, added to ongoing metformin therapy, were assessed in patients with type 2 diabetes who had inadequate glycemic control (HbA(1c) [A1C] >or=7 and <or=10%) with metformin alone.



After a screening diet/exercise run-in period, a metformin dose titration/stabilization period, and a 2-week, single-blind, placebo run-in period, 701 patients, aged 19-78 years, with mild to moderate hyperglycemia (mean A1C 8.0%) receiving ongoing metformin (>or=1,500 mg/day) were randomly assigned to receive the addition of placebo or sitagliptin 100 mg once-daily in a 1:2 ratio for 24 weeks. Patients exceeding specific glycemic limits were provided rescue therapy (pioglitazone) until the end of the study. The efficacy analyses were based on an all-patients-treated population using an ANCOVA and excluded data obtained after glycemic rescue.



At week 24, sitagliptin treatment led to significant reductions compared with placebo in A1C (-0.65%), fasting plasma glucose, and 2-h postmeal glucose. Fasting insulin, fasting C-peptide, fasting proinsulin-to-insulin ratio, postmeal insulin and C-peptide areas under the curve (AUCs), postmeal insulin AUC-to-glucose AUC ratio, homeostasis model assessment of beta-cell function, and quantitative insulin sensitivity check index were significantly improved with sitagliptin relative to placebo. A significantly greater proportion of patients achieved an A1C <7% with sitagliptin (47.0%) than with placebo (18.3%). There was no increased risk of hypoglycemia or gastrointestinal adverse experiences with sitagliptin compared with placebo. Body weight decreased similarly with sitagliptin and placebo.



Sitagliptin 100 mg once-daily added to ongoing metformin therapy was efficacious and well tolerated in patients with type 2 diabetes who had inadequate glycemic control with metformin alone.
Regenerated oxidized cellulose reinforcement of low rectal anastomosis: do we still need diversion?

The leak rate after low anterior resection is in the region of 10% to 15%. The highest risks of anastomotic leak are in anastomoses less than 5 cm from the anal verge. We evaluated the outcome of oxidized regenerated cellulose reinforcement of low rectal anastomosis.



The study group consisted of 108 patients with rectal cancer. Patients with low rectal cancer had low anterior resection with stapled straight low colorectal or coloanal anastomosis without proximal diversion. They were prospectively randomized to either oxidized regenerated cellulose reinforcement or no reinforcement. Data collected included age, sex, hemoglobin percentage, albumin level, histopathologic type of the tumor, anastomotic leak, and stricture.



The mean age of patients was 56 years, and sex was matched in both groups. Clinical leak occurred in 6 of 38 cases (15.7%) in the group that did not undergo reinforcement versus 2 of 33 (6.1%) in the oxidized regenerated cellulose reinforcement group (P < .01). In the case of a leak, diversion was needed in 3 of 6 patients in the group that did not undergo reinforcement vs no patients in the oxidized regenerated cellulose reinforcement group (P = .05). Generalized peritonitis occurred in 3 patients in the group that did not undergo reinforcement versus no patients in the oxidized regenerated cellulose reinforcement group (P < .01). Length of stay was 4.8 days in the oxidized regenerated cellulose reinforcement group versus 5.9 days in the group that did not undergo reinforcement (P = .047), with no mortalities in either group.



Oxidized regenerated cellulose reinforcement of low rectal anastomosis significantly decreases the risk of postoperative leak in low rectal anastomosis and may reduce the requirement for proximal diversion. Potential benefits include avoidance of a stoma, lower morbidity, shorter hospital stay, and a lower cost of care.
A randomized, double-blind, placebo-controlled study to evaluate the efficacy and tolerability of Fufang Danshen (Salvia miltiorrhiza) as add-on antihypertensive therapy in Taiwanese patients with uncontrolled hypertension.

Hypertension generally requires the use of a combination therapy to achieve the satisfactory control of blood pressure. A traditional Chinese herb, Danshen (Salvia miltiorrhiza), has been shown to have cardioprotective effects in animals and humans. The study investigated the add-on effect of Fufang Danshen extract capsule in Taiwanese hypertensive patients with uncontrolled blood pressure. This was a double-blind, placebo-controlled, randomized, single-center study clinical trial. Fifty-five patients with uncontrolled mild to moderate hypertension were enrolled under current conventional antihypertensive treatment, randomized equally to receive a Fufang Danshen capsule (formula mixture) 1000 mg twice-daily or a placebo capsule for 12 weeks. Primary endpoints were the control rate and the response rate. By ITT analysis at week 12, the control rates were 25.5% in the Fufang Danshen group and 7.3% in the control group (p = 0.016). The response rates were 45.6% in the Fufang Danshen group and 38.2% in the placebo group (p = 0.946). A significant reduction of systolic blood pressure at week 12 was noted in the Fufang Danshen group compared with the placebo group (13.8 vs 4.2 mmHg, p = 0.005). A decrease of pulse rate was also noted in the Fufang Danshen group (- 3.2 vs +2.7/min, p = 0.027). Adverse events were not statistically different between the two groups. It was concluded that Fufang Danshen (Salvia miltiorrhiza) extract reduced systolic blood pressure and pulse rate, and was well tolerated in patients with hypertension.
Validated UHPLC-MS/MS method for the simultaneous determination of pramipexole and ropinirole in plasma of patients with Parkinson's disease.

A simple and validated ultra high pressure liquid chromatography-tandem mass spectrometry method was developed for the simultaneous determination of the dopaminergic agents pramipexole and ropinirole in plasma of patients with Parkinson's disease. Following liquid-liquid extraction with tert-butyl methyl ether from 250μL plasma, the separation of the analytes was achieved on a Gemini NX3 column using 10mM pH 6.0 ammonium formate and 10mM ammonium formate in methanol as binary gradient mobile phase at a flow rate of 0.3mL/min. The MS/MS ion transitions were 212.10→153.03 for pramipexole, 261.2→114.2 for ropinirole and 256.1→211 for the internal standard (lamotrigine). The lower limit of quantitation (LLOQ) for both analytes was 80pg/mL and the linearity was determined from 80 to 4000pg/mL for pramipexole and from 200 to 10000pg/mL for ropinirole. Mean recoveries were 94% for PRA and 73% for ROP. Both intra- and inter-assay precision and accuracy were ≤20% at LLOQ concentration and ≤15% at other concentrations. The proposed validated method was successfully applied to measure plasma concentrations of pramipexole and ropinirole in a series of patients with Parkinson's disease on chronic treatment. By grouping the two dopaminergic agents in the same assay, the method allows a large series of patient samples to be processed in a single analytical session.
One year treatment with salmeterol compared with beclomethasone in children with asthma. The Dutch Paediatric Asthma Study Group.

The aim of this study was to compare the effects of salmeterol and beclomethasone on lung function and symptoms in children with mild to moderate asthma. Sixty-seven children not treated with inhaled corticosteroids were randomized in a double-blind parallel study either to salmeterol 50 micrograms b.i.d. or beclomethasone 200 micrograms b.i.d. After one year, FEV1 significantly increased in the beclomethasone group, whereas in the salmeterol group there was a small reduction. Differences between groups were 14.2% predicted (p < 0.0001) and 7.0% predicted (p = 0.007) for pre- and postbronchodilator FEV1 values, respectively. PD20 methacholine decreased by 0.73 DD (p = 0.05) in the salmeterol group and increased by 2.02 DD (p < 0.0001) in the beclomethasone group. Morning and evening PEF and symptom scores improved in both groups, although more in the beclomethasone group. Asthma exacerbations, for which prednisolone was needed, were more frequent in the salmeterol group (17 versus two), as were the number of withdrawals due to exacerbations (six versus one). However, growth was significantly slower in the beclomethasone group (-0.28 SDS) compared with that in the salmeterol group (-0.03 SDS) (p = 0.001). We conclude that treatment with a moderate dose of beclomethasone is superior to salmeterol in children with mild to moderate asthma and recommend that salmeterol should not be used as monotherapy.
1 1 H-NMR-based metabolomic analysis of the effect of moderate wine consumption on subjects with cardiovascular risk factors

Moderate wine consumption is associated with health-promoting activities. An H-NMR-based metabolomic approach was used to identify urinary metabolomic differences of moderate wine intake in the setting of a prospective, randomized, crossover and controlled trial. Sixty-one male volunteers with high cardiovascular risk factors followed three dietary interventions (28 days): dealcoholized red wine (RWD) (272ml/day, polyphenol-control), alcoholized red wine (RWA) (272ml/day) and gin (GIN) (100ml/day, alcohol-control). After each period, 24h-urine samples were collected and analyzed by 1 H-NMR. According to the results of an one-way-ANOVA, significant markers were grouped in four categories: alcohol-related markers (ethanol); gin-related markers; wine-related markers; and gut microbiota markers (hippurate and 4hydroxphenylacetic acid). Wine metabolites were classified into two groups; first, metabolites of food metabolome: tartrate (RWA and RWD), ethanol and mannitol (RWA); and second, biomarkers which relates to endogenous modifications after wine consumption, comprising branched-chain amino acid (BCAA) metabolite (3-methyl-oxovalerate). Additionally, a possible interaction between alcohol and gut-related biomarkers has been identified. To our knowledge, this is the first time that this approach has been applied in a nutritional intervention with red wine. The results show the capacity of this approach to obtain a comprehensive metabolome picture including food metabolome and endogenous biomarkers of moderate wine intake.  BCAA, brached-chain amino acids; BAS, Basal; RWD, dealcoholized red wine; RWA, red wine alcoholized; δ, chemical shift; s, singlet; d,doublet; t, triplet; q, quadruplet; m, multiplet;
Comparison of tiotropium once daily, formoterol twice daily and both combined once daily in patients with COPD.

This study compared the bronchodilator effects of tiotropium, formoterol and both combined in chronic obstructive pulmonary disease (COPD). A total of 71 COPD patients (mean forced expiratory volume in one second (FEV1) 37% predicted) participated in a randomised, double-blind, three-way, crossover study and received tiotropium 18 microg q.d., formoterol 12 microg b.i.d. or both combined q.d. for three 6-week periods. The end-points were 24-h spirometry (FEV1, forced vital capacity (FVC)) at the end of each treatment, rescue salbutamol and safety. Compared with baseline (FEV1 prior to the first dose in the first period), tiotropium produced a significantly greater improvement in average daytime FEV1 (0-12 h) than formoterol (127 versus 86 mL), while average night-time FEV1 (12-24 h) was not different (tiotropium 43 mL, formoterol 38 mL). The most pronounced effects were provided by combination therapy (daytime 234 mL, night-time 86 mL); both differed significantly from single-agent therapies. Changes in FVC mirrored the FEV1 results. Compared with both single agents, daytime salbutamol use was significantly lower during combination therapy (tiotropium plus formoterol 1.81 puffs.day(-1), tiotropium 2.41 puffs x day(-1), formoterol 2.37 puffs x day(-1)). All treatments were well tolerated. In conclusion, in chronic obstructive pulmonary disease patients, tiotropium q.d. achieved a greater improvement in daytime and comparable improvement in night-time lung function compared with formoterol b.i.d. A combination of both drugs q.d. was most effective and provided an additive effect throughout the 24-h dosing interval.
OPUS study: suicidal behaviour, suicidal ideation and hopelessness among patients with first-episode psychosis. One-year follow-up of a randomised controlled trial.

Patients with first-episode psychosis comprise a high-risk group in terms of suicide.



To identify predictive factors for suicidal behaviour and to examine the effect of integrated treatment on suicidal behaviour and hopelessness.



A total of 341 patients with a first-episode schizophrenia-spectrum disorder were randomised to integrated treatment or treatment as usual.



During the 1-year follow-up period, 11% attempted suicide. This was associated with female gender, hopelessness, hallucinations and suicide attempt reported at baseline, with the two latter variables being the only significant ones in the final multivariate model. The integrated treatment reduced hopelessness.



Hallucinations and suicide attempt before inclusion in the study were the most significant predictors of suicide attempt in the follow-up period.