nils-herrmann/clean_scirepeval huggingface dataset:
3 year simvastatin treatment and lens nuclear back scattering.

To determine if 3 year treatment of hypercholesterolaemia with simvastatin causes an increase of lens nuclear back scattering.



160 patients with hypercholesterolaemia in the Scandinavian Simvastatin Survival Study (4S) were followed for 3 years. Half (80) of the patients took simvastatin and half (80) received placebo. The lens was photographed with a Topcon SL-45 slit lamp camera at the beginning and at 1 year intervals. A common lens nuclear area was used for measuring lens nuclear back scattering.



Nuclear back scattering increased with age and there was more pronounced scattering in women than in men. Lens nuclear back scattering did not differ significantly between the simvastatin and placebo groups, but the power was low (0.2). Lens nuclear back scattering increased during the study period independently of baseline back scattering, age, and sex for both groups.



Although no significant difference was found between the simvastatin and placebo groups, the currently available data are insufficient for exclusion of the possibility that taking simvastatin during a 3 year period increases nuclear back scattering. However, a possible minor increase of nuclear back scattering is clinically irrelevant considering known beneficial effects of simvastatin on coronary heart disease.
Enhancing Project-Based Learning: Variations on Mentoring

Project-based learning is an essential part of a software engineer's education. The learning achieved through projects can be improved through structured interaction between more experienced students and those students encountering their rst software engineering project. In this paper, we report on our experience over three years with trials of several forms of interaction between undergraduate students at the third-and fourth-year levels. This mentoring involved full year project subjects at both year levels. We discuss the problems encountered during these trials, and describe how the interaction was varied in response. We examine the beneets achieved through this interaction and provide details of student feedback. Such beneets include broadening the experience of the fourth-year students, providing a form of mentoring for less experienced students, and improving both the project process and the quality of the project product.
Assessment of Remote Heart Rhythm Sampling Using the AliveCor Heart Monitor to Screen for Atrial Fibrillation: The REHEARSE-AF Study.

Asymptomatic atrial fibrillation (AF) is increasingly common in the aging population and implicated in many ischemic strokes. Earlier identification of AF with appropriate anticoagulation may decrease stroke morbidity and mortality.



We conducted a randomized controlled trial of AF screening using an AliveCor Kardia monitor attached to a WiFi-enabled iPod to obtain ECGs (iECGs) in ambulatory patients. Patients ≥65 years of age with a CHADS-VASc score ≥2 free from AF were randomized to the iECG arm or routine care (RC). iECG participants acquired iECGs twice weekly over 12 months (plus additional iECGs if symptomatic) onto a secure study server with overread by an automated AF detection algorithm and by a cardiac physiologist and/or consultant cardiologist. Time to diagnosis of AF was the primary outcome measure. The overall cost of the devices, ECG interpretation, and patient management were captured and used to generate the cost per AF diagnosis in iECG patients. Clinical events and patient attitudes/experience were also evaluated.



We studied 1001 patients (500 iECG, 501 RC) who were 72.6±5.4 years of age; 534 were female. Mean CHADS-VASc score was 3.0 (heart failure, 1.4%; hypertension, 54%; diabetes mellitus, 30%; prior stroke/transient ischemic attack, 6.5%; arterial disease, 15.9%; all CHADS-VASc risk factors were evenly distributed between groups). Nineteen patients in the iECG group were diagnosed with AF over the 12-month study period versus 5 in the RC arm (hazard ratio, 3.9; 95% confidence interval=1.4-10.4; P=0.007) at a cost per AF diagnosis of $10 780 (£8255). There was a similar number of stroke/transient ischemic attack/systemic embolic events (6 versus 10, iECG versus RC; hazard ratio=0.61; 95% confidence interval=0.22-1.69; P=0.34). The majority of iECG patients were satisfied with the device, finding it easy to use without restricting activities or causing anxiety.



Screening with twice-weekly single-lead iECG with remote interpretation in ambulatory patients ≥65 years of age at increased risk of stroke is significantly more likely to identify incident AF than RC over a 12-month period. This approach is also highly acceptable to this group of patients, supporting further evaluation in an appropriately powered, event-driven clinical trial.
A Gene Signature for Predicting Outcome in Patients with Basal-like Breast Cancer

Basal-like breast cancer is a molecular subtype of breast cancer with a poor prognosis. Follow-up studies of long-term outcome in these patients, demonstrates they can be separated into two clinical groups: those who succumb to their disease within the first 5 years and those expected to show excellent long term survival. Currently available clinical/histopathological variables as well as molecular signatures show little capacity to identify basal breast cancer patients with either a high or low risk of disease relapse. Using data derived from 85 basal-like breast cancer patients, we identified a 14-gene signature, which we subsequently validated on an additional 49 basal breast cancer patient set. The ability to distinguish between these two sub-groups of basal breast cancer patients at the time of initial diagnosis would permit tailoring aggressive therapeutic regimens to those patients with a poor prognosis and conversely avoid such therapy in low risk patients.
Humoral, mucosal, and cell-mediated immunity against vaccine and nonvaccine genotypes after administration of quadrivalent human papillomavirus vaccine to HIV-infected children.

To characterize the immunogenicity of a quadrivalent human papillomavirus vaccine (QHPV) in human immunodeficiency virus (HIV)-infected children, we studied their immune responses to 3 or 4 doses.



HIV-infected children aged 7-12 years with a CD4 cell percentage of ≥15% of lymphocytes, received 3 doses of QHPV with or without a fourth dose after 72 weeks. Type-specific and cross-reactive antibodies and cell-mediated immunity were measured.



Type-specific antibodies to HPV6, 11, and 16 were detected in 100% and ≥94% of children at 4 and 72 weeks, respectively, after the third QHPV dose. Corresponding numbers for HPV18 were 97% and 76%, respectively. A fourth QHPV dose increased seropositivity to ≥96% for all vaccine genotypes. Four weeks after the third QHPV dose, 67% of vaccinees seroconverted to HPV31, an HPV16-related genotype not in the vaccine; 69% and 39% of vaccinees developed mucosal HPV16 and 18 immunoglobulin G antibodies, respectively; and 60% and 52% of vaccinees developed cytotoxic T lymphocytes (CTLs) for HPV16 and 31, respectively.



Three QHPV doses generated robust and persistent antibodies to HPV6, 11, and 16 but comparatively weaker responses to HPV18. A fourth dose increased antibodies against all vaccine genotypes in an anamnestic fashion. CTLs and mucosal antibodies against vaccine genotypes, as well as cross-reactive antibodies and CTL against nonvaccine genotypes, were detected.
Breast Cancer and Nonsteroidal Anti-Inflammatory Drugs : Prospective Results from the Women ’ s Health Initiative 1

We analyzed data from the prospective Women’s Health Initiative (WHI) Observational Study to examine the effects of regular use of aspirin, ibuprofen, and other nonsteroidal anti-inflammatory drugs (NSAIDs) on breast cancer risk. We studied a population of 80,741 postmenopausal women between 50 and 79 years of age who reported no history of breast cancer or other cancers (excluding nonmelanoma skin cancer), and we completed a personal baseline interview that elicited comprehensive health information including data on breast cancer risk factors and NSAID use. All of the cases were adjudicated by WHI physicians using pathology reports. Our analysis was based on 1392 confirmed cases of breast cancer. Relative risks (RRs) with 95% confidence intervals (CIs) were estimated with adjustment for age and other breast cancer risk factors. Regular NSAID use (two or more tablets/week) for 5–9 years produced a 21% reduction in the incidence of breast cancer (RR, 0.79; 95% CI, 0.60–1.04); regular NSAID use for 10 or more years produced a 28% reduction (RR, 0.72; CI, 0.56–0.91), and there was a statistically significant inverse linear trend of breast cancer incidence with the duration of NSAID use (P < 0.01). The estimated risk reduction for long-term use of ibuprofen (RR, 0.51; CI, 0.28–0.96) was greater than for aspirin (RR, 0.79; CI, 0.60–1.03). Subgroup analysis by breast cancer risk factors did not result in effect modification. Regular use of acetaminophen (an analgesic agent with little or no anti-inflammatory activity) or lowdose aspirin (<100 mg) was unrelated to the incidence of breast cancer. Our results indicate that the regular use of aspirin, ibuprofen, or other NSAIDs may have a significant chemopreventive effect against the development of breast cancer and underscore the need for clinical trials to confirm this effect.
Autonomic status and pain profile in patients of chronic low back pain and following electro acupuncture therapy: a randomized control trial.

Pain is a syndrome characterized by several neurophysiological changes including that of the autonomic nervous system. Chronic low back pain (LBP) is a major health problem and is a frequent reason for using unconventional therapies especially acupuncture. This study was conducted to evaluate the autonomic status and pain profile in chronic LBP patients and to observe the effect of electro acupuncture therapy. Chronic LBP patients (n=60) were recruited from the Department of Orthopaedics, GTB Hospital, Delhi. Age and sex matched healthy volunteers were selected as controls (n=30). Following a written consent, LBP patients were randomly allocated into two study groups - Group A received 10 sittings of electro acupuncture, on alternate days, at GB and UB points selected for back pain, while the Group B received a conventional drug therapy in the form of oral Valdecoxib together with supervised physiotherapy. Controls were assessed once while the patients were assessed twice, before and after completion of the treatment program (3 weeks). The autonomic status was studied with non-invasive cardiovascular autonomic function tests which included E: I ratio, 30:15 ratio, postural challenge test and sustained handgrip test. Pain intensity was measured with the visual analogue scale (VAS) and the global perceived effect (GPE). Statistical analysis was performed using repeated measure's ANOVA with Tukey's test. Pain patients showed a significantly reduced vagal tone and increased sympathetic activity as compared to the controls (P<0.05 to P<0.001 in different variables). Following treatment, both the study groups showed a reduction in vagal tone together with a decrease in the sympathetic activity. There was also a considerable relief of pain in both groups, however, the acupuncture group showed a better response (P<0.01). We conclude that there is autonomic dysfunction in chronic LBP patients. Acupuncture effectively relieves the pain and improves the autonomic status and hence can be used as an alternative/additive treatment modality in these cases.
Clinical history of patients with peritoneal carcinomatosis exluded from cytoreductive surgery & HIPEC.

The aim of this study was to explore the natural course of peritoneal carcinomatosis (PC) in patients who are not fit to undergo cytoreductive (CRS) surgery and hyperthermic intraperitoneal chemotherapy (HIPEC).



Over an 8-year period (2006-2013) 320 patients were excluded from CRS and HIPEC at our center. Exclusion criteria were: (a) age >75 years; (b) ASA score ≥ 3; (c) extraperitoneal disease; (d) massive disease involvement of the small bowel; (e) disease involvement of the hepatic pedicle or the pancreas; (f) invasion of retroperitoneal space; (g) more than two stenoses of the small bowel. Another 130 patients underwent CRS and HIPEC.



In the HIPEC group (N=130), the mean overall survival was 26.2±11.7 months, while from the non- HIPEC group (N=320), 200 patients underwent palliative surgery, with a mean overall survival of 11.7±8.3 months. Only 120 patients received palliative chemotherapy with a mean overall survival of 7.2±4.3 months.



Our study suggests that, in patients unfit to undergo CRS & HIPEC, an exploratory laparotomy and palliative surgery should be performed, offering a survival benefit and improved quality of life.
Complications associated with enteral nutrition using catheter jejunostomy after esophagectomy

The present study was conducted on 78 patients, encountered over a 7-year period, who had a catheter-feeding jejunostomy placed at the time of thoracoabdominal esophagectomy for esophageal cancer. A broad-based attachment of the jejunal wall to the peritoneum at the place of entry of the catheter was used. Enteral nutrition was begun an average of 10 days after the operation, the caloric content was increased gradually, and the mean duration was 69 days. There were three patients who suffered from local skin erosion at the site of catheter entry, and seven who developed diarrhea and/or a feeling of abdominal fullness, but none of the patients showed any signs of peritonitis or ileus. The morbidity rates related to enteral nutrients and placement of the catheter jejunostomy were 8.9% and 3.8%, respectively. These findings demonstrate that a broad-based attachment of the jejunal wall to the peritoneum at the place of entry of the catheter is useful for preventing leakage or twisting of the jejunum, and for reducing the incidence and severity of the complications of catheter jejunostomy feeding.
Risedronate Increases Bone Density and Reduces Vertebral Fracture Risk Within One Year in Men on Corticosteroid Therapy

Limited information is available on the effect of bisphosphonates in men receiving corticosteroid therapy. We studied 184 men among the patients enrolled in two, double-blind, placebo-controlled, 1-year studies with similar protocols. The studies evaluated the effects of risedronate in patients beginning corticosteroid treatment at a dose of at least 7.5 mg per day of prednisone or equivalent (prevention study) or continuing long-term treatment of corticosteroid at that dose (treatment study). The men received either placebo or risedronate (2.5 mg or 5 mg) daily, along with calcium supplementation (500-1000 mg). Endpoints included differences in bone mineral density (BMD) at the lumbar spine, femoral neck, and femoral trochanter, assessment of vertebral fractures, changes in biochemical markers of bone turnover, and overall safety. In the treatment study, risedronate 5 mg significantly (P < 0.01) increased lumbar spine BMD by 4.8% at the lumbar spine, 2.1% at the femoral neck, and 2.6% at the femoral trochanter compared with baseline values. In the prevention study, bone loss was prevented with risedronate 5 mg; in the placebo group, BMD decreased significantly (P < 0.01) by 3.4%, 3.3%, and 3.4% in the lumbar spine, femoral neck, and trochanter, respectively, at 1 year. The differences between risedronate 5 mg and placebo groups were significant at all skeletal sites in the prevention study (P < 0.01) and at the lumbar spine in the treatment study (P < 0.001). The 2.5 mg dose also had a positive effect on BMD, although of a lesser magnitude than the 5 mg dose. When the data from the two studies were combined, the incidence of vertebral fractures decreased 82.4% (95% confidence interval, 36.6%-95.1%) in the pooled risedronate groups compared with placebo (P = 0.008). Risedronate was well tolerated in men, with a similar incidence of upper gastrointestinal adverse events in the placebo and treatment groups. Daily treatment with risedronate increases bone density and decreases vertebral fracture risk within 1 year in men receiving corticosteroid therapy.
Uncontrolled persistent allergic asthma in practice: eXpeRience registry baseline characteristics.

Medical registries can be used to assess and monitor the effectiveness and safety of approved therapy, and provide insights into how quality of care can be optimized.



The post-marketing, non-interventional, observational registry (eXpeRience) aims to collect data on the treatment effectiveness and safety of omalizumab in 'real-world' practice. The baseline characteristics of patients with uncontrolled allergic asthma receiving omalizumab therapy and included in the first interim analysis of this observational registry are reported.



A total of 294 patients were included in the first interim analysis. Of these patients, 271 (92.2%) were active in the registry at the time of reporting. At baseline, the mean duration of allergic asthma was approximately 19 years, with over 87% of patients testing positive for a perennial allergen. Mean % predicted FEV(1) and serum total IgE levels were 62.4% and 316.7 IU/mL, respectively. Asthma was uncontrolled for approximately 62% of patients, while around 23% were partly controlled. The majority of patients were being treated with multiple asthma controller medications, including inhaled-corticosteroids, long-acting β(2)-agonists and leukotriene receptor antagonists, and 28% of patients were also receiving maintenance oral corticosteroids. Concomitant diseases were present in many patients, the most common being perennial allergic rhinitis (42.5%).



Demographic and disease characteristics highlight the unmet clinical need in patients with uncontrolled allergic asthma. Future analyses from this study will further determine the real-life effectiveness and safety of omalizumab.
The chronic kidney disease outcomes and practice patterns study Brazil (CKDopps-Brazil): design, data and methodology.

The chronic kidney disease outcomes and practice patterns study (CKDopps) is an international observational, prospective, cohort study involving patients with chronic kidney disease (CKD) stages 3-5 [estimated glomerular filtration rate (eGFR) < 60 ml/min/1.73 m2, with a major focus upon care during the advanced CKD period (eGFR < 30 ml/min/1.73 m2)]. During a 1-year enrollment period, each one of the 22 selected clinics will enroll up to 60 advanced CKD patients (eGFR < 30 ml/min/1.73 m2 and not dialysis-dependent) and 20 earlier stage CKD patients (eGFR between 30-59 ml/min/1.73 m2).



age < 18 years old, patients on chronic dialysis or prior kidney transplant. The study timeline include up to one year for enrollment of patients at each clinic starting in the end of 2013, followed by up to 2-3 years of patient follow-up with collection of detailed longitudinal patient-level data, annual clinic practice-level surveys, and patient surveys. Analyses will apply regression models to evaluate the contribution of patient-level and clinic practice-level factors to study outcomes, and utilize instrumental variable-type techniques when appropriate.



Launching in 2013, CKDopps Brazil will study advanced CKD care in a random selection of nephrology clinics across Brazil to gain understanding of variation in care across the country, and as part of a multinational study to identify optimal treatment practices to slow kidney disease progression and improve outcomes during the transition period to end-stage kidney disease.
Association between statin use and lipid status in quality improvement initiatives: statin use, a potential surrogate?

To test the association between statin use and low-density-lipoprotein (LDL)-cholesterol control in outpatient community practices undergoing quality improvement efforts in diabetes care.



A retrospective observational study of primary care practices that underwent efforts at improving the quality of diabetes care. Each practice provided an electronic registry-based monthly report of the percentage of patients with LDL <130 mg/dl (3.4 mmol/l), LDL <100 mg/dl (2.6 mmol/l) and statin use.



Primary care practices in Pennsylvania focused on improving diabetes care by implementing the Chronic Care Model in urban, suburban and rural regions.



Consisted of 109 primary care practices, academic practices and federal health centres. Practices typically saw patients from a mix of government-funded and commercial health plan carriers.



There was a positive linear association between documented statin use and the percentage of patients with LDL <130 mg/dl (3.4 mmol/l) and LDL <100 mg/dl (2.6 mmol/l = goal for patients with diabetes). The correlation between statin use and LDL <130 was 0.50 (95% CI 0.41-0.64), and between statin use and the percentage of patients with LDL <100 was 0.47 (95% CI 0.29-0.58). Practices with 5% larger statin use had an expected 1.9% larger percentage of patients with LDL <130 (95% CI 1.4 -2.9%) and an expected 1.7% larger percentage of patients with LDL <100 (95% CI 0.9- 2.3%).



An association exists between statin use and LDL control in the real world of primary care practices undergoing quality improvement. Additional studies are necessary to ultimately test the validity of statin use as a process measure and/or surrogate for LDL-cholesterol control.