nils-herrmann/clean_scirepeval huggingface dataset:
Sirolimus-eluting stent for the treatment of in-stent restenosis: a quantitative coronary angiography and three-dimensional intravascular ultrasound study.

We have previously reported the safety and effectiveness of sirolimus-eluting stents for the treatment of de novo coronary lesions. The present investigation explored the potential of this technology to treat in-stent restenosis.



Twenty-five patients with in-stent restenosis were successfully treated with the implantation of 1 or 2 sirolimus-eluting Bx VELOCITY stents in São Paulo, Brazil. Nine patients received 2 stents (1.4 stents per lesion). Angiographic and volumetric intravascular ultrasound (IVUS) images were obtained after the procedure and at 4 and 12 months. All vessels were patent at the time of 12-month angiography. Angiographic late loss averaged 0.07+/-0.2 mm in-stent and -0.05+/-0.3 mm in-lesion at 4 months, and 0.36+/-0.46 mm in-stent and 0.16+/-0.42 mm in-lesion after 12 months. No patient had in-stent or stent margin restenosis at 4 months, and only one patient developed in-stent restenosis at 1-year follow-up. Intimal hyperplasia by 3-dimensional IVUS was 0.92+/-1.9 mm(3) at 4 months and 2.55+/-4.9 mm(3) after 1 year. Percent volume obstruction was 0.81+/-1.7% and 1.76+/-3.4% at the 4- and 12-month follow-up, respectively. There was no evidence of stent malapposition either acutely or in the follow-up IVUS images, and there were no deaths, stent thromboses, or repeat revascularizations.



This study demonstrates the safety and the potential utility of sirolimus-eluting Bx VELOCITY stents for the treatment of in-stent restenosis.
Lifestyle counseling in hypertension-related visits – analysis of video-taped general practice visits

The general practitioner (GP) can play an important role in promoting a healthy lifestyle, which is especially relevant in people with an elevated risk of cardiovascular diseases due to hypertension. Therefore, the aim of this study was to determine the frequency and content of lifestyle counseling about weight loss, nutrition, physical activity, and smoking by GPs in hypertension-related visits. A distinction was made between the assessment of lifestyle (gathering information or measuring weight or waist circumference) and giving lifestyle advice (giving a specific advice to change the patient's behavior or referring the patient to other sources of information or other health professionals).



For this study, we observed 212 video recordings of hypertension-related visits collected within the Second Dutch National Survey of General Practice in 2000/2001.



The mean duration of visits was 9.8 minutes (range 2.5 to 30 minutes). In 40% of the visits lifestyle was discussed (n = 84), but in 81% of these visits this discussion lasted shorter than a quarter of the visit. An assessment of lifestyle was made in 77 visits (36%), most commonly regarding body weight and nutrition. In most cases the patient initiated the discussion about nutrition and physical activity, whereas the assessment of weight and smoking status was mostly initiated by the GP. In 35 visits (17%) the GP gave lifestyle advice, but in only one fifth of these visits the patient's motivation or perceived barriers for changing behavior were assessed. Supporting factors were not discussed at all.



In 40% of the hypertension-related visits lifestyle topics were discussed. However, both the frequency and quality of lifestyle advice can be improved.
The Cell: A Molecular Approach

The Biology of Death: Origins of Mortality. By Andre Klarsfeld, Frederic Revah, and Lydia Brady (Translator). Ithaca, New York: Cornell University Press; 2003, 211 pp. $29.95. Written by two accomplished French neurobiologists and translated by an experienced scientific and technical translator, this book explores various ideas concerning death in living organisms. The book focuses on the reasons an organism stops living and takes a scientific approach toward understanding the causes of death. The book describes in detail the varying lifespans of different organisms and even discusses statistical analyses regarding the probability that an organism will reach a certain age. The simple fact that certain organisms age at seemingly different rates is a key issue in this book. The authors point out examples of organisms with life spans ranging from minutes for some insects to millenniums for certain types of trees such as sequoias. A key concept addressed in this book is the idea that death is something that occurs inevitably in all living organisms whether by being killed by another organism or by natural aging. They also touch on current research on aging in yeast (Saccharomyces cerevisiae) and examine the possible links between death and sexual reproduction. The authors do an excellent job in looking at death from all aspects of nature whether in yeast or mammals, which is why this book will have something for everyone. Anyone who has studied science will find this book an easy read. The translation of this book was done relatively well, but there were some grammatical errors found in the book that could have been easily located if edited more thoroughly. All in all, this book takes the sometimes morbid subject of death and does a good job of analyzing it from an objective scientific viewpoint.
A double-blind, randomized controlled trial to compare the effect of biannual peripheral magnetic resonance imaging, radiography and standard of care disease progression monitoring on pharmacotherapeutic escalation in rheumatoid and undifferentiated inflammatory arthritis: study protocol for a rando

Permanent joint damage is a major consequence of rheumatoid arthritis (RA), the most common and destructive form of inflammatory arthritis. In aggressive disease, joint damage can occur within 6 months from symptom onset. Early, intensive treatment with conventional and biologic disease-modifying anti-rheumatic drugs (DMARDs) can delay the onset and progression of joint damage. The primary objective of the study is to investigate the value of magnetic resonance imaging (MRI) or radiography (X-ray) over standard of care as tools to guide DMARD treatment decision-making by rheumatologists for the care of RA.



A double-blind, randomized controlled trial has been designed. Rheumatoid and undifferentiated inflammatory arthritis patients will undergo an MRI and X-ray assessment every 6 months. Baseline adaptive randomization will be used to allocate participants to MRI, X-ray, or sham-intervention groups on a background of standard of care. Prognostic markers, treating physician, and baseline DMARD therapy will be used as intervention allocation parameters. The outcome measures in rheumatology RA MRI score and the van der Heijde-modified Sharp score will be used to evaluate the MRI and X-ray images, respectively. Radiologists will score anonymized images for all patients regardless of intervention allocation. Disease progression will be determined based on the study-specific, inter-rater smallest detectable difference. Allocation-dependent, intervention-concealed reports of positive or negative disease progression will be reported to the treating rheumatologist. Negative reports will be delivered for the sham-intervention group. Study-based radiology clinical reports will be provided to the treating rheumatologists for extra-study X-ray requisitions to limit patient radiation exposure as part of diagnostic imaging standard of care. DMARD treatment dose escalation and therapy changes will be measured to evaluate the primary objective. A sample size of 186 (62 per group) patients will be required to determine a 36% difference in pharmacological treatment escalation between the three groups with intermediate dispersion of data with 90% power at a 5% level of significance.



This study will determine if monitoring RA and undifferentiated inflammatory arthritis patients using MRI and X-ray every 6 months over 2 years provides incremental evidence over standard of care to influence pharmacotherapeutic decision-making and ultimately hinder disease progression.
Randomized, multicenter study: on-demand versus continuous maintenance treatment with esomeprazole in patients with non-erosive gastroesophageal reflux disease

Most patients with gastroesophageal reflux disease experience symptomatic relapse after stopping acid-suppressive medication. The aim of this study was to compare willingness to continue treatment with esomeprazole on-demand versus continuous maintenance therapy for symptom control in patients with non-erosive reflux disease (NERD) after 6 months.



This multicenter, open-label, randomized, parallel-group study enrolled adults with NERD who were heartburn-free after 4 weeks' treatment with esomeprazole 20 mg daily. Patients received esomeprazole 20 mg daily continuously or on-demand for 6 months. The primary variable was discontinuation due to unsatisfactory treatment. On-demand treatment was considered non-inferior if the upper limit of the one-sided 95 % confidence interval (CI) for the difference between treatments was <10 %.



Of 877 patients enrolled, 598 were randomized to maintenance treatment (continuous: n = 297; on-demand: n = 301). Discontinuation due to unsatisfactory treatment was 6.3 % for on-demand and 9.8 % for continuous treatment (difference -3.5 % [90 % CI: -7.1 %, 0.2 %]). In total, 82.1 and 86.2 % of patients taking on-demand and continuous therapy, respectively, were satisfied with the treatment of heartburn and regurgitation symptoms, a secondary variable (P = NS). Mean study drug consumption was 0.41 and 0.91 tablets/day, respectively. Overall, 5 % of the on-demand group developed reflux esophagitis versus none in the continuous group (P < 0.0001). The Gastrointestinal Symptom Rating Scale Reflux dimension was also improved for continuous versus on-demand treatment. Esomeprazole was well tolerated.



In terms of willingness to continue treatment, on-demand treatment with esomeprazole 20 mg was non-inferior to continuous maintenance treatment and reduced medication usage in patients with NERD who had achieved symptom control with initial esomeprazole treatment.
Treatment of elderly patients with isolated systolic hypertension with isosorbide dinitrate in an asymmetric dosing schedule

Nitrates decrease pulse pressure more than mean arterial pressure (MAP) and are advocated for the treatment of isolated systolic hypertension (ISH). Nitrates show drug tolerance during chronic treatment so an asymmetric dosing regimen may prevent loss of effect of nitrates. This study investigates the anti-hypertensive effect of isosorbide dinitrate (ISDN) given in a twice daily asymmetric dosing regimen in elderly patients with ISH.After a 6-week placebo run-in period, patients entered the double-blind study. Ten patients received placebo and 11 patients ISDN 20 mg b.i.d. for 8 weeks. This dose could be doubled once. Office systolic and diastolic blood pressures (SBP/DBP) and ambulatory BP were measured. Pulse pressure was calculated as SBP–DBP.Office pulse pressure was more reduced during ISDN (17.9%) than with placebo (5%; P < 0.05). sbp and map decreased compared to baseline, but the changes were not statistically significant between the two groups. dbp tended to increase with isdn compared to placebo. mean 24-h, mean daytime and mean night-time pulse pressure decreased after treatment with isdn (10.7%, 12.1%, 7.9%, respectively). pulse pressure tended to decrease more during the day than during the night with isdn. no changes could be demonstrated with placebo.In conclusion, pulse pressure decreased with ISDN, resulting in a lower SBP without a decrease in DBP. The latter may preserve coronary perfusion in ISH. With the asymmetric dosing regimen the decrease in pulse pressure was not clear at night. Whether a decrease in nocturnal BP, in addition to the spontaneous decrease, is advisable in ISH remains a matter of debate.
Omalizumab in the management of oral corticosteroid-dependent IGE-mediated asthma patients.

Several studies have demonstrated the beneficial effects of omalizumab in asthma patients. Here we describe the drug's tolerance and oral corticosteroid sparing capacity in a long-term observational study.



Thirty-two patients aged ≥18 years with obstructive airway disease and FEV(1) reversibility ≥12% and 200  mL, with an oral steroid requirement ≥7.5  mg per day of prednisolone during a period of ≥1 year, a positive prick test or in vitro reactivity (RAST) to at least one perennial aeroallergen and a baseline immunoglobulin E level ranking between 30-700  IU/mL were prospectively followed for 17.2  ±  8.5 months. Patients were visited once or twice a month, depending on their schedule for omalizumab administration.



blood analysis every six months; spirometry and nitric oxide measurement at every visit.



One patient who dropped out early was excluded. Follow-up period: the treatment benefited 83.9% (26/31) of the cohort; oral corticosteroids were reduced from 7.19 ± 11.1 to 3.29 ± 11.03  mg (p < 0.002) and withdrawn in 74.2% of patients. FEV(1) (percent predicted) was 64.4 ± 22.7 at the beginning and 62.9 ± 24.3 at the end. IgE at entry was 322.2 ± 334.2  IU/mL and increased 2.34-fold. Respiratory function and NO did not present statistically significant changes. We identified three groups of patients: the first (n = 17) receiving oral steroid at entry in whom the accumulated dose of oral steroids progressively decreased; another (n = 10) including patients who had quit oral steroids before starting omalizumab although they had not been instructed to do so and whose oral steroid dose at the end of follow-up was zero; and a third group (n = 4) that did not benefit from omalizumab treatment. The only relevant side effect was a flu-like syndrome which required discontinuation of treatment in one patient.



In our series, a substantial, safe decrease in oral corticosteroid requirements was observed due, at least to some extent, to omalizumab therapy. Oral corticosteroids were withdrawn in three-quarters of the patients. We were unable to identify a factor able to predict which patients would benefit most from omalizumab treatment.
Liraglutide vs insulin glargine and placebo in combination with metformin and sulfonylurea therapy in type 2 diabetes mellitus (LEAD-5 met+SU): a randomised controlled trial

The aim of the study was to compare the efficacy and safety of liraglutide in type 2 diabetes mellitus vs placebo and insulin glargine (A21Gly,B31Arg,B32Arg human insulin), all in combination with metformin and glimepiride. This randomised (using a telephone or web-based randomisation system), parallel-group, controlled 26 week trial of 581 patients with type 2 diabetes mellitus on prior monotherapy (HbA1c 7.5–10%) and combination therapy (7.0–10%) was conducted in 107 centres in 17 countries. The primary endpoint was HbA1c. Patients were randomised (2:1:2) to liraglutide 1.8 mg once daily (n = 232), liraglutide placebo (n = 115) and open-label insulin glargine (n = 234), all in combination with metformin (1 g twice daily) and glimepiride (4 mg once daily). Investigators, participants and study monitors were blinded to the treatment status of the liraglutide and placebo groups at all times. The number of patients analysed as intention to treat were: liraglutide n = 230, placebo n = 114, insulin glargine n = 232. Liraglutide reduced HbA1c significantly vs glargine (1.33% vs 1.09%; −0.24% difference, 95% CI 0.08, 0.39; p = 0.0015) and placebo (−1.09% difference, 95% CI 0.90, 1.28; p < 0.0001). There was greater weight loss with liraglutide vs placebo (treatment difference –1.39 kg, 95% CI 2.10, 0.69; p = 0.0001), and vs glargine (treatment difference −3.43 kg, 95% CI 4.00, 2.86; p < 0.0001). Liraglutide reduced systolic BP (−4.0 mmHg) vs glargine (+0.5 mmHg; −4.5 mmHg difference, 95% CI 6.8, −2.2; p = 0.0001) but not vs placebo (p = 0.0791). Rates of hypoglycaemic episodes (major, minor and symptoms only, respectively) were 0.06, 1.2 and 1.0 events/patient/year, respectively, in the liraglutide group (vs 0, 1.3, 1.8 and 0, 1.0, 0.5 with glargine and placebo, respectively). A slightly higher number of adverse events (including nausea at 14%) were reported with liraglutide, but only 9.8% of participants in the group receiving liraglutide developed anti-liraglutide antibodies. Liraglutide added to metformin and sulfonylurea produced significant improvement in glycaemic control and bodyweight compared with placebo and insulin glargine. The difference vs insulin glargine in HbA1c was within the predefined non-inferiority margin.
Long-term efficacy and tolerability of add-on pioglitazone therapy to failing monotherapy compared with addition of gliclazide or metformin in patients with type 2 diabetes

The aim of this analysis was to examine the long-term effects of pioglitazone or gliclazide addition to failing metformin monotherapy and pioglitazone or metformin addition to failing sulphonylurea monotherapy in patients with type 2 diabetes. Two 2-year, randomised, multicentre trials were performed in patients with inadequately controlled type 2 diabetes (HbA1c 7.5–11% inclusive), who were receiving either metformin or a sulphonylurea at ≥50% of the maximum recommended dose or at the maximum tolerated dose. In the first study, patients on metformin received add-on therapy with pioglitazone (15–45 mg/day, n=317) or gliclazide (80–320 mg/day, n=313). In the second study, patients on sulphonylurea therapy were randomised to receive add-on therapy with either pioglitazone (15–45 mg/day, n=319) or metformin (850–2,550 mg/day, n=320). HbA1c, fasting plasma glucose, insulin and lipids were investigated. At week 104, the mean reduction from baseline in HbA1c was 0.89% for pioglitazone and 0.77% for gliclazide addition to metformin (p=0.200). There was a statistically significant between-group difference for the change in mean fasting plasma glucose at week 104 (−1.8 mmol/l for pioglitazone vs −1.1 mmol/l for gliclazide, p<0.001). There were no significant differences in changes from baseline in glycaemic parameters for pioglitazone compared with metformin addition to sulphonylurea therapy. Whether added to metformin or sulphonylurea, pioglitazone caused significantly greater decreases in triglycerides and significantly greater increases in HDL cholesterol than the comparator regimens (p≤0.001). There were decreases in LDL cholesterol in the comparator groups and these were significantly different from the small changes observed with pioglitazone (p<0.001). All treatment regimens were well tolerated. There were weight increases of 2.5 kg and 3.7 kg in the pioglitazone and 1.2 kg in the gliclazide add-on groups, and there was a mean decrease of 1.7 kg in the metformin add-on group. As add-on therapy to existing sulphonylurea or metformin therapy, pioglitazone improved glycaemic control and this improvement was sustained over 2 years. Furthermore, there were potential benefits in terms of improvements in specific lipid abnormalities. This could offer an advantage over the addition of other oral agents in the long-term treatment of diabetes.
The impact of team processes on psychiatric case management.

This paper is a report of a study to identify the structures and interactions within community mental health teams that facilitate or impede effective teamwork and psychiatric case management.



Effective case management requires close collaboration between case managers or care co-ordinators and other members of the multidisciplinary mental health team, yet there has been little research into this relationship.



A multiple case study of seven United Kingdom community mental health teams was conducted between 1999 and 2001, using qualitative methods of participant observation, semi-structured interviews and document review.



Factors were identified that impacted on the ability of care co-ordinators to act effectively: 'structure and procedures'; 'disrespect and withdrawal'; 'humour and undermining'; 'safety and disclosure'. Care co-ordination was enhanced when team structures and policies were in place and where team interactions were respectful. Where members felt disrespected or undermined, communication, information sharing and collaboration were impaired, with a negative impact on the care provided to service users.



Teams require clear operating procedures alongside interprofessional trust and respect to ensure that there is open, safe and reflective participation. Further research is required to identify how best to bring about collaborative, effective teamwork in mental healthcare.
Discordance in neonatal risk factors and early childhood outcomes of very low birth weight (<1.5 kg) twins

To examine the rates of discordance in neonatal risk factors and neurodevelopmental outcomes within very low birth weight twin pairs and the factors associated with discordant outcomes.Rates of neonatal risk factors and neurodevelopmental outcomes, and discordance in outcomes were examined for 88 very low birth weight twin pairs born between 1990 and 2005 and followed through 20 months’ corrected age.Discordance rates ranged from 17 to 42% for neonatal risk factors and from 18 to 31% for neurodevelopmental outcomes. In regression analysis, affected co-twins were significantly more likely to have had an abnormal cerebral ultrasound than their unaffected co-twins in pairs discordant for cerebral palsy (odds ratio (OR): 13.00, 95% confidence interval (CI): 2.22 to 76.03)) and in pairs discordant for neurodevelopmental impairment (OR: 4.00, 95% CI: 1.13 to 14.18). Outcomes and discordance in outcomes were similar for monochorionic and dichorionic pairs.Despite shared genetics and risk factors, twins may have discordant outcomes. Information on discordant neonatal and neurodevelopmental outcomes is important for counseling families of twins.
Effect of selenium supplementation on CD4+ T-cell recovery, viral suppression and morbidity of HIV-infected patients in Rwanda: a randomized controlled trial

To examine the effect of selenium supplementation on CD4 T-cell counts, viral suppression, and time to antiretroviral therapy (ART) initiation in ART-naive HIV-infected patients in Rwanda.



A multicenter, double-blinded, placebo-controlled, randomized clinical trial was conducted. Eligible patients were HIV-infected adults (≥21 years) who had a CD4 cell count between 400 and 650 cells/μl (ART eligibility was ≤350 cells/μl throughout the trial), and were willing to practice barrier methods of birth control. Patients were randomized to receive once-daily 200 μg selenium tablets or identical placebo. They were followed for 24 months with assessments every 6 months. Declines in CD4 cell counts were modeled using linear regressions with generalized estimating equations and effect modification, and the composite outcome (ART eligible or ART initiation) using Cox proportional-hazards regression, both conducted with intention to treat.



Of the 300 participants, 149 received selenium, 202 (67%) were women, and median age was 33.5 years. The rate of CD4 depletion was reduced by 43.8% [95% confidence interval (CI) 7.8-79.8% decrease] in the treatment arm - from mean 3.97 cells/μl per month to mean 2.23 cells/μl per month. We observed 96 composite outcome events - 45 (47%) in the treatment arm. We found no treatment effect for the composite outcome (hazard ratio 1.00, 95% CI 0.66-1.54) or viral suppression (odds ratio 1.18, 95% CI 0.71-1.94). The trial was underpowered for the composite outcome due to a lower-than-anticipated event rate. Adverse events were comparable throughout.



This randomized clinical trial demonstrated that 24-month selenium supplementation significantly reduces the rate of CD4 cell count decline among ART-naive patients.