nils-herrmann/clean_scirepeval huggingface dataset:
Influence of Phenol-Enriched Olive Oils on Human Intestinal Immune Function.

Olive oil (OO) phenolic compounds (PC) are able to influence gut microbial populations and metabolic output. Our aim was to investigate whether these compounds and changes affect the mucosal immune system. In a randomized, controlled, double blind cross-over human trial, for three weeks, preceded by two-week washout periods, 10 hypercholesterolemic participants ingested 25 mL/day of three raw virgin OO differing in their PC concentration and origin: (1) an OO containing 80 mg PC/kg (VOO); (2) a PC-enriched OO containing 500 mg PC/kg from OO (FVOO); and (3) a PC-enriched OO containing a mixture of 500 mg PC/kg from OO and thyme (1:1, FVOOT). Intestinal immunity (fecal immunoglobulin A (IgA) and IgA-coated bacteria) and inflammation markers (C-reactive protein (CRP) and fecal interleukin 6 (IL-6), tumor necrosis factor α (TNFα) and calprotectin) was analyzed. The ingestion of high amounts of OO PC, as contained in FVOO, tended to increase the proportions of IgA-coated bacteria and increased plasma levels of CRP. However, lower amounts of OO PC (VOO) and the combination of two PC sources (FVOOT) did not show significant effects on the variables investigated. Results indicate a potential stimulation of the immune system with very high doses of OO PC, which should be further investigated.
Clinical profile, level of affection and therapeutic management of patients with osteoarthritis in primary care: The Spanish multicenter study EVALÚA.

To determine the clinical profile, degree of involvement and management in patients with knee, hip or hand osteoarthritis.



Observational study (health centers from 14 autonomous regions, n=363 primary care physicians), involving patients with clinical and/or radiological criteria for osteoarthritis from the American College of Rheumatology, consecutively selected (n=1,258). Sociodemographic variables, clinical and radiological findings, comorbidity and therapeutic management were analyzed.



Mean age was 68.0±9.5 years old; 77.8% were women and 47.6% obese. Distribution by location was: 84.3% knee, 23.4% hip, 14.7% hands. All patients reported pain. The most frequent radiographic Kellgren-Lawrence grade was stage 3 for knee and hip (42.9% and 51.9%, respectively), and 3 (37.2%) and 2 (34.5%) for hip. Time since onset of osteoarthritis symptoms was 9.4±7.5 years, with a mean age at onset of around 60 years old and a family history of osteoarthritis in 66.0%. The most frequent comorbidities were: hypertension (55.1%), depression/anxiety (24.7%) and gastroduodenal diseases (22.9%). A total of 97.6% of the patients received pharmacological treatment, with oral analgesics (paracetamol) (70.5%) and oral NSAIDs (67.9%) being the most frequent drugs. Bilateral osteoarthritis was present in 76.9% of patients with knee osteoarthritis, 59.3% in hip and 94.7% in hands. Female gender and time since onset were associated with bilateral knee and hip osteoarthritis.



The profile of the osteoarthritis patient is female, >65 years old, overweight/obese, with comorbidity, frequent symptoms and moderate radiologic involvement. Most of patients had bilateral osteoarthritis, associated with female gender and time since onset of disease. Paracetamol was the most common pharmacological treatment.
Improving secondary prevention in coronary bypass patients: closing the audit loop.

To complete the audit loop assessing secondary preventative care of patients who had had coronary artery bypass graft (CABG) surgery.



Two separate surveys of 1000 patients who had had CABG at the regional centre between 1988 and 1997, selected in 1998 and 2001. A single page questionnaire was sent to the patient's general practitioner.



A list was sent to each general practice in Lothian, Scotland, of their patients on the CABG database and the results of the original survey. Lothian Health organised a project to contact and recall patients with cardiac disease in each practice. Sixty five (of 128) practices participated.



Blood pressure, smoking status, serum cholesterol concentrations, and prescription of lipid lowering drugs and aspirin.



918 questionnaires (92%) in the second survey were returned describing 875 patients: 151 (17%) patients smoked and 752 patients (86%) took aspirin. Mean (SD) systolic blood pressure was lower in the second survey (142.5 (19.2) mm Hg in the first survey v 139.4 (19.1) mm Hg, p < 0.005). In our first survey 34% of patients had cholesterol concentrations less than target (5.2 mmol/l). This increased from 12% of patients operated on in 1988 to 50% of patients operated on in 1997 (Spearman rank correlation 0.77, p < 0.01). In the second survey this proportion had risen to 65% and the correlation with year of operation was abolished.



By closing the audit loop, substantial improvements were shown in the management of risk factors in patients who have had coronary artery surgery in Lothian.
Elevated Plasma Long Pentraxin-3 Levels and Primary Graft Dysfunction After Lung Transplantation for Idiopathic Pulmonary Fibrosis

J. M. Diamonda,*, D. J. Lederere, S. M. Kawuta,b,c, J. Leea, V. N. Ahyaa, S. Bellamya, S. M. Palmerg, V. N. Lamah, S. Bhoradei, M. Crespoj, E. Demissiea,b, J. Sonettf, K. Willek, J. Orensl, P. D. Shahm, A. Weinackern, D. Weilln, B. A. Kohld, C. C. Deutschmand, S. Arcasoye, A. S. Shaho, J. A. Belperiop, D. Wilkesq, J. M. Reynoldsq, L. B. Warem,† and J. D. Christiea,b,†; for the Lung Transplant Outcomes Group
Total and regional bone mineral content and fracture rate in postmenopausal osteoporosis treated with salmon calcitonin: A prospective study

Seventy-two postmenopausal osteoporotic women having more than one nontraumatic vertebral crush fracture were studied. Thirty-six of them, aged 68.8±1.2 years (18±4 YSM-years since menopause), were treated with 100 IU/day of salmon calcitonin i.m. plus 500 mg of elemental calcium for 10 days each month. The remaining 36 patients, aged 69.6±1.4 years (19±3 YSM), were given only 500 mg of elemental calcium for 10 days each month. All patients underwent clinical and analytical evaluation every 3 months. Radiological evaluation, assessment of vertebral deformities, and metacarpal radiogrammetry were done every 6 months. Densitometric measurements of total and regional bone mass were made every 12 months. At 24 months, the calcitonin group showed a 60% reduction in the number of new fractures and the group receiving only calcium had a 45% increase (P<0.001). The incidence of vertebral fractures was 0.07 per patient-year in the group treated with calcitonin and 0.45 per patient-year in the group treated with calcium (P<0.001). At 2 years, the calcitonin group showed a 12% increase in cortical bone mass on metacarpal radiogrammetry, a 16% increase in the axial skeleton on trunk densitometry, a 3.5% increase in total body bone mineral content, a 30.7% increase in pelvic bone mineral content, and a 6.2% increase in arm bone mineral content (all P<0.001). In the group treated with calcium alone there was a loss of bone mass in every region. These findings suggest that salmon calcitonin is effective in the treatment of osteoporosis and show that it acts on cortical and trabecular bone.
CYP2D6 is a major determinant of metoprolol disposition and effects in hospitalized Russian patients treated for acute myocardial infarction

To investigate individual metabolism-related determinants of metoprolol disposition and effects in patients receiving the drug as standard treatment for acute myocardial infarction (AMI). We recruited 187 AMI patients receiving metoprolol on clinical grounds and genotyped them for CYP2D6 *3, *4, *10, and gene duplication. Heart rates (HR) at admission and discharge were registered. Clinical details were derived from the case histories. Metoprolol and α-hydroxy-metoprolol were analyzed by HPLC in plasma before and after 2, 6 and 12 h post dose in the first 115 patients. HR at rest was registered after each sampling. Ventricular rhythm disturbance (VRD) association with CYP2D6 activity, found accidentally, was studied in a newly formed subgroup (n = 23). Metoprolol represented 85% of all beta-blocker prescriptions. CYP2D6 genotype distribution was comparable with other Caucasian populations. Genotypically poor metabolizers (PM, n = 2) exhibited the most pronounced bradycardia at discharge, while in the ultrarapid metabolizers (UM, n = 7) therapeutic effect was not achieved. Metoprolol and α-hydroxy-metoprolol plasma concentration AUCs differed significantly between the genotypes corresponding to predicted metabolic activity (P < 0.005). Correspondingly, the mean HRs were lower in PMs and increased with increasing number of active CYP2D6 genes (P < 0.05). Trough metoprolol concentrations were only quantifiable in patients with at least one mutated allele. Neither decreased cardiac ejection fraction nor age and gender influenced metoprolol disposition. Higher mean number of active CYP2D6 genes was found in patients with VRDs (2.2 vs. 1.7), which could not be clearly explained by metoprolol concentrations. CYP2D6 gene duplication was overrepresented in this group (22 vs. 2%, P = 0.0002). Metoprolol disposition and effects are mainly controlled by CYP2D6 genotype. Patients with gene duplication are at high risk of not benefiting from treatment due to lower metoprolol concentrations. Higher CYP2D6 activity seems to be associated with VRDs complicating AMI, being a negative prognostic factor for patients’ survival.
Cardiff cardiac ablation patient-reported outcome measure (C-CAP): validation of a new questionnaire set for patients undergoing catheter ablation for cardiac arrhythmias in the UK

To formally test and validate a patient-reported outcome measure (PROM) for patients with cardiac arrhythmias undergoing catheter ablation procedures in the UK [Cardiff Cardiac Ablation PROM (C-CAP)]. A multicentre, prospective, observational cohort study with consecutive patient enrolment from three UK sites was conducted. Patients were sent C-CAP questionnaires before and after an ablation procedure. Pre-ablation C-CAP1 (17 items) comprised four domains: patient expectations; condition and symptoms; restricted activity and healthcare visits; medication and general health. Post-ablation C-CAP2 (19 items) comprised five domains including change in symptoms and procedural complications. Both questionnaires also included the generic EQ-5D-5L tool (EuroQol). Reliability, validity, and responsiveness measures were calculated. A total of 517 valid pre-ablation and 434 post-ablation responses were received; questionnaires showed good feasibility and item acceptability. Internal consistency was good (Cronbach’s alpha >0.7) and test–retest reliability was acceptable for all scales. C-CAP scales showed high responsiveness (effect size >0.8). Patients improved significantly (p < 0.001) following ablation across all disease-specific and global scales. Minimal clinically important difference was calculated. Improvement beyond the smallest detectable change of 9 points (symptom severity scale), 3 points (frequency and duration of symptoms scale), and 8 points (impact on life scale) indicates an important change. Amendments to the C-CAP questionnaires were identified through the validation process and made to produce the final tools. The final C-CAP questionnaires are valid, reliable, and responsive tools for measuring symptom change, impact, and expectations in patients undergoing ablation for cardiac arrhythmias. C-CAP questionnaires provide a tool with disease-specific and generic domains to explore how cardiac ablation procedures in the UK impact upon patients’ lives.
Pregnancy in spinal cord-injured women, a cohort study of 37 pregnancies in 25 women

A retrospective observational study.To describe specificities of pregnancy in a traumatic spinal cord-injured (SCI) population managed by a coordinated medical care team involving physical medicine and rehabilitation (PMR) physicians, urologists, infectious diseases' physicians, obstetricians and anaesthesiologists.NeuroUrology Department in a University Hospital, France.All consecutive SCI pregnant women managed between 2001 and 2014 were included. A preconceptional consultation was proposed whenever possible. Obstetrical and urological outcomes, delivery mode and complications were reported.Overall, thirty-seven pregnancies in 25 women, of a mean age of 32±4 years, were included. Thirty-five children were born alive (three miscarriages, a twin pregnancy) without complications except for a case of neonatal respiratory distress in premature twins born at 33 weeks. The mean birth weight was 2979±599 g. Twenty-one (57%) pregnancies benefited from preconceptional care. A weekly oral cyclic antibiotic programme was prescribed in 28 (75%) pregnancies. The main complications during pregnancy included pyelonephritis (30%), lower urinary tract infections (UTI) (32%), pressure sores (8.8%) and prematurity (12% deliveries before 37 weeks, with only one delivery before 36 weeks). Two patients suffered from autonomic dysreflexia, one with serious complication (brain haematoma). Caesarean sections were performed for 68% of deliveries (23/34) to prevent syringomyelia deterioration (n=10), stress urinary incontinence aggravation (n=3) or for obstetrical reasons (n=7).Conclusions:Mothers’ and infants’ outcomes were satisfying after pregnancy in SCI women, but required many adjustments. Pregnancy must be prepared by a preconceptional consultation, and managed by a multidisciplinary team involving specialists of neurological disability and pregnancy.
A prospective comparison of the two main indications of efavirenz in 2001 highly active antiretroviral therapy (HAART) regimens: first-line versus salvage use.

To determine the efficacy of efavirenz introduction in first-line HAART compared with salvage multidrug regimens.



Prospective 15 month comparison of 107 consecutive HIV-infected patients starting efavirenz, according to laboratory and clinical outcome of first-line versus rescue drug use, therapeutic history and association of selected antimicrobial agents: naive patients were compared with nucleoside reverse transcriptase inhibitor (NRTI)-experienced patients in the first group, and patients in the second group who had one or more NRTI changed when starting a rescue treatment containing one or more novel protease inhibitors (PIs) were compared with those who did not.



Efavirenz was administered with one or more novel NRTIs to 55 patients (27 antiretroviral-naive and 28 patients experienced with NRTIs only), compared with 52 patients who needed a multidrug salvage regimen after two or more failures of a 15-40 month PI-containing regimen. In an intention-to-treat analysis, con-sidering early interruption or an unsatisfactory virological course as a failure, only one patient on salvage therapy completed a favourable 15 month follow-up, compared with 31 patients experiencing first-line efavirenz-based HAART (P < 0.0001). The immunological response was less affected in both intensity and duration in patients undergoing rescue therapy. While no significant outcome difference was detected in the first group between naive and NRTI-experienced patients, among the salvage subjects the change of one or more NRTIs seemed to significantly improve virological and immunological outcome. Viral genotyping detected at least the K103N mutation in 41% of the 78 evaluable patients, despite lack of exposure to efavirenz and related compounds. Salvage patients had a significantly greater frequency of non-nucleoside RTI (NNRTI) resistance compared with the first-line group (P < 0.0001), in proportion to the extent of mutations affecting other drug classes (P < 0.0001).



An efavirenz-based initial triple drug HAART proved significantly more effective than efavirenz adjunct to a rescue treatment performed after repeated failures of PI-based regimens. The unsatisfactory response of the salvage group was probably due to diffuse cross-resistance descending from previous therapy, even when NNRTIs were never administered.
When to use broader internalising and externalising subscales instead of the hypothesised five subscales on the Strengths and Difficulties Questionnaire (SDQ): data from British parents, teachers and children.

The Strengths and Difficulties Questionnaire (SDQ) is a widely used child mental health questionnaire with five hypothesised subscales. There is theoretical and preliminary empirical support for combining the SDQ's hypothesised emotional and peer subscales into an 'internalizing' subscale and the hypothesised behavioral and hyperactivity subscales into an 'externalizing' subscale (alongside the fifth prosocial subscale). We examine this using parent, teacher and youth SDQ data from a representative sample of 5-16 year olds in Britain (N = 18,222). Factor analyses generally supported second-order internalizing and externalizing factors, and the internalizing and externalizing subscales showed good convergent and discriminant validity across informants and with respect to clinical disorder. By contrast, discriminant validity was poorer between the emotional and peer subscales and between the behavioral, hyperactivity and prosocial subscales. This applied particularly to children with low scores on those subscales. We conclude that there are advantages to using the broader internalizing and externalizing SDQ subscales for analyses in low-risk samples, while retaining all five subscales when screening for disorder.
The Primary Prevention of PTSD in Firefighters: Preliminary Results of an RCT with 12-Month Follow-Up

To develop and evaluate an evidence-based and theory driven program for the primary prevention of Post-traumatic Stress Disorder (PTSD).



A pre-intervention / post-intervention / follow up control group design with clustered random allocation of participants to groups was used. The "control" group received "Training as Usual" (TAU).



Participants were 45 career recruits within the recruit school at the Department of Fire and Emergency Services (DFES) in Western Australia. The intervention group received a four-hour resilience training intervention (Mental Agility and Psychological Strength training) as part of their recruit training school curriculum. Data was collected at baseline and at 6- and 12-months post intervention.



We found no evidence that the intervention was effective in the primary prevention of mental health issues, nor did we find any significant impact of MAPS training on social support or coping strategies. A significant difference across conditions in trauma knowledge is indicative of some impact of the MAPS program.



While the key hypotheses were not supported, this study is the first randomised control trial investigating the primary prevention of PTSD. Practical barriers around the implementation of this program, including constraints within the recruit school, may inform the design and implementation of similar programs in the future.
A randomized, double-blind, placebo-controlled, parallel-group, enriched-design study of nabiximols* (Sativex(®) ), as add-on therapy, in subjects with refractory spasticity caused by multiple sclerosis.

Spasticity is a disabling complication of multiple sclerosis, affecting many patients with the condition. We report the first Phase 3 placebo-controlled study of an oral antispasticity agent to use an enriched study design.


A 19-week follow-up, multicentre, double-blind, randomized, placebo-controlled, parallel-group study in subjects with multiple sclerosis spasticity not fully relieved with current antispasticity therapy. Subjects were treated with nabiximols, as add-on therapy, in a single-blind manner for 4weeks, after which those achieving an improvement in spasticity of ≥20% progressed to a 12-week randomized, placebo-controlled phase.


Of the 572 subjects enrolled, 272 achieved a ≥20% improvement after 4weeks of single-blind treatment, and 241 were randomized. The primary end-point was the difference between treatments in the mean spasticity Numeric Rating Scale (NRS) in the randomized, controlled phase of the study. Intention-to-treat (ITT) analysis showed a highly significant difference in favour of nabiximols (P=0.0002). Secondary end-points of responder analysis, Spasm Frequency Score, Sleep Disturbance NRS Patient, Carer and Clinician Global Impression of Change were all significant in favour of nabiximols.


The enriched study design provides a method of determining the efficacy and safety of nabiximols in a way that more closely reflects proposed clinical practice, by limiting exposure to those patients who are likely to benefit from it. Hence, the difference between active and placebo should be a reflection of efficacy and safety in the population intended for treatment.
Health-related quality of life of patients with advanced breast cancer treated with everolimus plus exemestane versus placebo plus exemestane in the phase 3, randomized, controlled, BOLERO-2 trial.

The randomized, controlled BOLERO-2 (Breast Cancer Trials of Oral Everolimus) trial demonstrated significantly improved progression-free survival with the use of everolimus plus exemestane (EVE + EXE) versus placebo plus exemestane (PBO + EXE) in patients with advanced breast cancer who developed disease progression after treatment with nonsteroidal aromatase inhibitors. This analysis investigated the treatment effects on health-related quality of life (HRQOL).



Using the European Organisation for Research and Treatment of Cancer Quality of Life Questionnaire-Core 30 (EORTC QLQ-C30) questionnaire, HRQOL was assessed at baseline and every 6 weeks thereafter until disease progression and/or treatment discontinuation. The 30 items in 15 subscales of the QLQ-C30 include global health status wherein higher scores (range, 0-100) indicate better HRQOL. This analysis included a protocol-specified time to definitive deterioration (TDD) analysis at a 5% decrease in HRQOL versus baseline, with no subsequent increase above this threshold. The authors report additional sensitivity analyses using 10-point minimal important difference decreases in the global health status score versus baseline. Treatment arms were compared using the stratified log-rank test and Cox proportional hazards model adjusted for trial stratum (visceral metastases, previous hormone sensitivity), age, sex, race, baseline global health status score and Eastern Cooperative Oncology Group performance status, prognostic risk factors, and treatment history.



Baseline global health status scores were found to be similar between treatment groups (64.7 vs 65.3). The median TDD in HRQOL was 8.3 months with EVE + EXE versus 5.8 months with PBO + EXE (hazard ratio, 0.74; P = .0084). At the 10-point minimal important difference, the median TDD with EVE + EXE was 11.7 months versus 8.4 months with PBO + EXE (hazard ratio, 0.80; P = .1017).



In patients with advanced breast cancer who develop disease progression after treatment with nonsteroidal aromatase inhibitors, EVE + EXE was associated with a longer TDD in global HRQOL versus PBO + EXE.