nils-herrmann/clean_scirepeval huggingface dataset:
Outcomes in women receiving low-molecular-weight heparin during pregnancy.

To assess the rate and type of maternal and infant complications among pregnant women receiving low-molecular-weight heparin (LMWH). Retrospective study of pregnant women on LMWH referred to two university hematology clinics from January 2001 to December 2010. We recorded the number of pregnancies, indication, dose and dose adjustments for LMWH, pregnancy outcomes (live births, maternal and infant complications) and side effects of LMWH. There were 89 pregnancies in 76 women. The most common indication for LMWH was a history of adverse outcome of pregnancy associated with thrombophilia. LMWH was adjusted in 75 and 45% of pregnancies in women on therapeutic and prophylactic doses, respectively. Live birth rate was 97%. There were 25 maternal and 11 infant complications. Side effects were minimal and included decreased bone mineral density and bleeding. LMWH use among pregnant women is associated with successful pregnancy outcomes. Although side effects were minimal, maternal and infant complications occurred in 28 and 12% of cases, respectively.
Priority Setting and Influential Factors on Acceptance of Pharmaceutical Recommendations in Collaborative Medication Reviews in an Ambulatory Care Setting – Analysis of a Cluster Randomized Controlled Trial (WestGem-Study)

Medication reviews are recognized services to increase quality of therapy and reduce medication risks. The selection of eligible patients with potential to receive a major benefit is based on assumptions rather than on factual data. Acceptance of interprofessional collaboration is crucial to increase the quality of medication therapy.



The research question was to identify and prioritize eligible patients for a medication review and to provide evidence-based criteria for patient selection. Acceptance of the prescribing general practitioner to implement pharmaceutical recommendations was measured and factors influencing physicians' acceptance were explored to obtain an impression on the extent of collaboration in medication review in an ambulatory care setting.



Based on data of a cluster-randomized controlled study (WestGem-study), the correlation between patient parameters and the individual performance in a medication review was calculated in a multiple logistic regression model. Physician's acceptance of the suggested intervention was assessed using feedback forms. Influential factors were analyzed.



The number of drugs in use (p = 0.001), discrepancies between prescribed and used medicines (p = 0.014), the baseline Medication Appropriateness Index score (p<0.001) and the duration of the intervention (p = 0.006) could be identified as influential factors for a major benefit from a medication review, whereas morbidity (p>0.05) and a low kidney function (p>0.05) do not predetermine the outcome. Longitudinal patient care with repeated reviews showed higher interprofessional acceptance and superior patient benefit. A total of 54.9% of the recommendations in a medication review on drug therapy were accepted for implementation.



The number of drugs in use and medication reconciliation could be a first rational step in patient selection for a medication review. Most elderly, multimorbid patients with polymedication experience a similar chance of receiving a benefit from a medication review. Longitudinal patient care should be preferred over confined medication reviews. The acceptance of medication reviews by physicians supports further implementation into health care systems.
Ureteroscopic holmium laser lithotripsy in patients with renal impairment

In this study, we try to evaluate the efficacy and safety of holmium lasers for treatment of ureteric stones in patients with renal impairment or obstructive anuria. Twenty-six patients were included in this study, of which 20 patients presented with elevated blood urea and serum creatinine (2.1–7.6 mg%), and six patients presented with calcular anuria (mean serum creatinine 22 mg%). None of the patients had a ureteric stent or nephrostomy tube before the ureteroscopy. All patients were treated with holmium laser. A stone basket or grasper was used to remove significant stone fragments at the end of the procedure in seven patients. In these seven patients, ureteric stents were placed at the end of the procedure. All patients were free of any stone fragments at 1 week and at 3 months postoperatively. In all patients, including the six with obstructive anuria, the renal impairment resolved or improved as evidenced by normalization or fall in blood urea and creatinine. Thus, in this small group of uremic patients, the success rate for treatment of ureteral stone was 100%. A holmium laser is a safe and effective modality of ureteroscopic lithotripsy in patients with significant renal impairment or even obstructive anuria. The use of holmium laser with ureteroscopy may be considered in this group of patients as long as the general condition of the patient permits the safe administration of anesthesia.
A randomised controlled trial of ibuprofen, paracetamol or a combination tablet of ibuprofen/paracetamol in community-derived people with knee pain.

To compare the efficacy and safety of single versus combination non-prescription oral analgesics in community-derived people aged 40 years and older with chronic knee pain.



A randomised, double-blind, four-arm, parallel-group, active controlled trial investigating short-term (day 10) and long-term (week 13) benefits and side-effects of four regimens, each taken three times a day: ibuprofen (400 mg); paracetamol (1000 mg); one fixed-dose combination tablet (ibuprofen 200 mg/paracetamol 500 mg); two fixed-dose combination tablets (ibuprofen 400 mg/paracetamol 1000 mg).



There were 892 participants (mean age 60.6, range 40-84 years); 63% had radiographic knee osteoarthritis and 85% fulfilled American College of Rheumatology criteria for osteoarthritis. At day 10, two combination tablets were superior to paracetamol (p<0.01) for pain relief (determined by mean change from baseline in WOMAC pain; n=786). At 13 weeks, significantly more participants taking one or two combination tablets rated their treatment as excellent/good compared with paracetamol (p=0.015, p=0.0002, respectively; n=615). The frequency of adverse events was comparable between groups. However, by 13 weeks, decreases in haemoglobin (≥1 g/dl) were observed in some participants in all groups. Twice as many participants taking two combination tablets had this decrease compared with those on monotherapy (p<0.001; paracetamol, 20.3%; ibuprofen, 19.6%; one or two combination tablets, 24.1%, 38.4%, respectively).



Ibuprofen/paracetamol combination analgesia, at non-prescription doses, confers modest short-term benefits for knee pain/osteoarthritis. However, in this population, paracetamol 3 g/day may cause similar degrees of blood loss as ibuprofen 1200 mg/day, and the combination of the two appears to be additive. Study no ISRCTN77199439.
Prehabilitation for men undergoing radical prostatectomy: a multi-centre, pilot randomized controlled trial

An emerging field of research describes the role of preoperative health behaviours, known as prehabilitation. The preoperative period may be a more physically and emotionally salient time to introduce and foster chronic adherence to health behaviours, such as exercise, in patients compared to post-treatment during recovery. Moreover, physical and psychosocial improvements during the preoperative period may translate into an enhanced recovery trajectory with reduced operative complications and postoperative adverse effects. No studies have assessed prehabilitation for men with prostate cancer undergoing radical prostatectomy.



This is a multi-centre, pilot randomized control trial conducted at two Canadian urban teaching hospitals. 100 men undergoing radical prostatectomy for prostate cancer with no contraindications to exercise will be recruited and randomized to the prehabiliation program or usual care. Prehabilitation participants will engage in a preoperative, individualized exercise program including pelvic floor muscle strengthening instructions and a healthy lifestyle guide for men with prostate cancer. These participants will be asked to engage in 60 minutes of home-based, unsupervised, moderate-intensity exercise on 3-4 days per week. Usual care participants will receive the same pelvic floor muscle strengthening instructions and healthy lifestyle guide only. We will assess the feasibility of conducting an adequately powered trial of the same design via recruitment rate, programmatic adherence/contamination, attrition, and safety. Estimates of intervention efficacy will be captured through measurements at baseline (4-8 weeks preoperatively), within 1 week prior to surgery, and postoperatively at 4, 12, and 26 weeks. Efficacy outcomes include: fatigue, quality of life, urinary incontinence, physical fitness, body composition, aerobic fitness, pain, and physical activity volume.



The primary outcome of this study is to determine the feasibility of conducting a full-scale, randomized controlled trial of prehabilitation versus usual care and to estimate effect sizes that will inform sample size determinations for subsequent trials in this field. To our knowledge, this is the first study to examine a structured presurgical exercise program for men undergoing radical prostatectomy for prostate cancer. This trial will advance our understanding of strategies to efficiently and effectively use the preoperative period to optimize postoperative recovery.
Inattention and impulsivity associated with prenatal alcohol exposure in a prospective cohort study with 11-years-old Brazilian children

This paper aimed to examine prenatal alcohol exposure and neuropsychological parameters and its relationship to impulsivity and inattention. Longitudinal prospective case–control cohort study starting with the risk drinking assessment of 449 third-trimester pregnant women, and a follow-up phase with 56 mother–child pairs (28 alcohol-exposed versus 28 non-exposed), with 11–12 years old children. The cohort study was followed up for 11 years. Quantity-frequency structured questions as well as AUDIT and T-ACE questionnaires were used to assess maternal alcohol consumption. A comprehensive set of neuropsychological testing instruments was used, including d2 Test, RCFT, RAVLT, WISC-III, among others. To control low IQ effects and intellectual disability diagnoses, as well differences in school skills biasing the neuropsychological comparison assessment, children with IQ <70 or learning disabilities were excluded of the sample. The two groups showed to be very comparable regarding sex, age, schooling, global IQ, laterality and maternal and social risk factors. Significant statistical differences were found for higher speed processing, total errors, and number of omission errors in the d2 Test. Likewise, there were differences found on RCFT test (lower scores for copy, immediate and delayed recall), and on semantic verbal fluency tests with a lower score. Prenatal alcohol-exposed children seems to be more inattentive and impulsive; they have poorer skills in verbal fluency, visuospatial working memory, and executive processing when compared to non-exposed children who were part of the same cohort sample.
Health Facility Utilisation Changes during the Introduction of Community Case Management of Malaria in South Western Uganda: An Interrupted Time Series Approach

Malaria endemic countries have scaled-up community health worker (CHW) interventions, to diagnose and treat malaria in communities with limited access to public health systems. The evaluations of these programmes have centred on CHW's compliance to guidelines, but the broader changes at public health centres including utilisation and diagnoses made, has received limited attention.



This analysis was conducted during a CHW-intervention for malaria in Rukungiri District, Western Uganda. Outpatient department (OPD) visit data were collected for children under-5 attending three health centres one year before the CHW-intervention started (pre-intervention period) and for 20 months during the intervention (intervention-period). An interrupted time series analysis with segmented regression models was used to compare the trends in malaria, non-malaria and overall OPD visits during the pre-intervention and intervention-period.



The introduction of a CHW-intervention suggested the frequency of diagnoses of diarrhoeal diseases, pneumonia and helminths increased, whilst the frequency of malaria diagnoses declined at health centres. In May 2010 when the intervention began, overall health centre utilisation decreased by 63% compared to the pre-intervention period and the health centres saw 32 fewer overall visits per month compared to the pre-intervention period (p<0.001). Malaria visits also declined shortly after the intervention began and there were 27 fewer visits per month during the intervention-period compared with the pre-intervention period (p<0.05). The declines in overall and malaria visits were sustained for the entire intervention-period. In contrast, there were no observable changes in trends of non-malarial visits between the pre-intervention and intervention-period.



This analysis suggests introducing a CHW-intervention can reduce the number of child malaria visits and change the profile of cases presenting at health centres. The reduction in workload of health workers may allow them to spend more time with patients or undertake additional curative or preventative roles.
Antifungal prophylaxis with posaconazole in patients with acute myeloid leukemia: dose intensification coupled with avoidance of proton pump inhibitors is beneficial in shortening time to effective concentrations.

This study aimed to assess the influence of dose frequency and the presence or absence of cotreatment with proton pump inhibitors (PPIs) on the time to a target trough concentration (Cmin) of >700 ng/ml with posaconazole in the first 8 days of antifungal prophylaxis in hematological patients. This was a retrospective, observational study performed with 42 adult patients with acute myeloid leukemia who underwent posaconazole prophylaxis with 200 mg every 8 h (q8h) or 200 mg q6h after receiving induction chemotherapy and who had at least three subsequent therapeutic drug monitoring assessments during the first 8 days of treatment. The cohort was split into four groups (group 1, 200 mg q8h without PPI; group 2, 200 mg q8h with PPI; group 3, 200 mg q6h without PPI; group 4, 200 mg q6h with PPI). Rapid attainment of the target Cmin was obtained only in group 3 (P < 0.01) (median Cmin on day 4 of 935.5 ng/ml [interquartile range, 760.0 to 1,270.0 ng/ml] in group 3, versus 567.0 ng/ml [346 to 906 ng/ml] in group 1, 420.0 ng/ml [326.2 to 527.2 ng/ml] in group 2, and 514.0 ng/ml [403.7 to 564.7 ng/ml] in group 4). A linear accumulation of posaconazole over time was observed among patients in groups 1 and 3, regardless of the total daily dosage, differently from what occurred among those receiving PPI cotreatment (groups 2 and 4). Dose intensification (200 mg q6h) coupled with avoidance of PPI coadministration may represent a very powerful strategy to rapidly achieve effective concentrations with posaconazole in neutropenic hematological patients.
HeapMD: identifying heap-based bugs using anomaly detection

We present the design, implementation, and evaluation of HeapMD, a dynamic analysis tool that finds heap-based bugs using anomaly detection. HeapMD is based upon the observation that, in spite of the evolving nature of the heap, several of its properties remain stable. HeapMD uses this observation in a novel way: periodically, during the execution of the program, it computes a suite of metrics which are sensitive to the state of the heap. These metrics track heap behavior, and the stability of the heap reflects quantitatively in the values of these metrics. The "normal" ranges of stable metrics, obtained by running a program on multiple inputs, are then treated as indicators of correct behaviour, and are used in conjunction with an anomaly detector to find heap-based bugs. Using HeapMD, we were able to find 40 heap-based bugs, 31 of them previously unknown, in 5 large, commercial applications.
The Fear of Positive Evaluation Scale: psychometric properties in a clinical sample.

Cognitive models of social anxiety suggest that fear of negative evaluation (FNE) is the central cognitive dimension underlying the disorder. The Fear of Positive Evaluation Scale (FPES; Weeks, Heimberg, & Rodebaugh, 2008) was recently developed to assess an additional cognitive dimension purported to underlie social anxiety disorder (SAD), but its psychometric properties have yet to be examined in clinical populations. The present study, with 133 treatment-seeking patients, examined the applicability of the FPES with a clinical sample. Results indicated that the FPES was factorially distinct from a measure assessing FNE, and patients with SAD (n=51) had higher mean scores on the FPES than patients with other anxiety disorders (n=82). The FPES also showed adequate reliability (internal consistency), good convergent and discriminant validity, acceptable criterion-related validity in predicting social interaction anxiety symptoms, and appropriate sensitivity to treatment. The FPES appears to have good psychometric properties and is a promising new assessment tool for better understanding SAD.
Acute caffeine administration effect on brain activation patterns in mild cognitive impairment.

Previous studies showed that acute caffeine administration enhances task-related brain activation in elderly individuals with preserved cognition. To explore the effects of this widely used agent on cognition and brain activation in early phases of cognitive decline, we performed a double-blinded, placebo-controlled functional magnetic resonance imaging (fMRI) study during an n-back working memory task in 17 individuals with mild cognitive impairment (MCI) compared to 17 age-matched healthy controls (HC). All individuals were regular caffeine consumers with an overnight abstinence and given 200 mg caffeine versus placebo tablets 30 minutes before testing. Analyses included assessment of task-related activation (general linear model), functional connectivity (tensorial-independent component analysis, TICA), baseline perfusion (arterial spin labeling, ASL), grey matter density (voxel-based morphometry, VBM), and white matter microstructure (tract-based spatial statistics, TBSS). Acute caffeine administration induced a focal activation of the prefrontal areas in HC with a more diffuse and posteromedial activation pattern in MCI individuals. In MCI, TICA documented a significant caffeine-related enhancement in the prefrontal cortex, supplementary motor area, ventral premotor and parietal cortex as well as the basal ganglia and cerebellum. The absence of significant group differences in baseline ASL perfusion patterns supports a neuronal rather than a purely vascular origin of these differences. The VBM and TBSS analyses excluded potentially confounding differences in grey matter density and white matter microstructure between MCI and HC. The present findings suggest a posterior displacement of working memory-related brain activation patterns after caffeine administration in MCI that may represent a compensatory mechanism to counterbalance a frontal lobe dysfunction.
Invasive infections caused by Trichosporon species and Geotrichum capitatum in patients with hematological malignancies: a retrospective multicenter study from Italy and review of the literature.

Trichosporonosis is an uncommon but frequently fatal mycosis in immunocompromised patients. A multicenter retrospective study was conducted to characterize cases of proven or probable invasive trichosporonosis diagnosed over the past 20 years in Italian patients with hematological diseases. Of the 52 cases identified, 17 were classified as Trichosporon sp. infections and 35 were attributed to Geotrichum capitatum. Acute myeloid leukemia accounted for 65.4% of the cases. The incidence rates of Trichosporon sp. and G. capitatum infections in acute leukemia patients were 0.4 and 0.5%, respectively. Overall, 76.9% of cases had positive blood cultures. Pulmonary involvement was documented in 26.9% of cases. Death was reported for 57.1% of G. capitatum infections and for 64.7% of Trichosporon sp. infections. A literature review on trichosporonosis in patients with any underlying disease or condition reveals G. capitatum as a predominantly European pathogen, particularly in certain Mediterranean areas, while Trichosporon sp. infections are seen with similar frequencies on all continents. The majority of published Trichosporon sp. and G. capitatum infections occurred in patients with hematological diseases (62.8 and 91.7%, respectively). Well over half of these were suffering from acute leukemia (68 and 84% of patients with Trichosporon sp. and G. capitatum infections, respectively). Crude mortality rates were 77% for Trichosporon spp. and 55.7% for G. capitatum. The optimal therapy for trichosporonosis has yet to be identified; however, in vitro experiences are providing encouraging evidence of the potential role of the new triazoles, in particular, voriconazole.
FDA approval: ceritinib for the treatment of metastatic anaplastic lymphoma kinase-positive non-small cell lung cancer.

On April 29, 2014, the FDA granted accelerated approval to ceritinib (ZYKADIA; Novartis Pharmaceuticals Corporation), a breakthrough therapy-designated drug, for the treatment of patients with anaplastic lymphoma kinase (ALK)-positive, metastatic non-small cell lung cancer (NSCLC) who have progressed on or are intolerant to crizotinib. The approval was based on a single-arm multicenter trial enrolling 163 patients with metastatic ALK-positive NSCLC who had disease progression on (91%) or intolerance to crizotinib. Patients received ceritinib at a starting dose of 750 mg orally once daily. The objective response rate (ORR) by a blinded independent review committee was 44% (95% CI, 36-52), and the median duration of response (DOR) was 7.1 months. The ORR by investigator assessment was similar. Safety was evaluated in 255 patients. The most common adverse reactions and laboratory abnormalities included diarrhea (86%), nausea (80%), increased alanine transaminase (80%), increased aspartate transaminase (75%), vomiting (60%), increased glucose (49%), and increased lipase (28%). Although 74% of patients required at least one dose reduction or interruption due to adverse reactions, the discontinuation rate due to adverse reactions was low (10%). With this safety profile, the benefit-risk analysis was considered favorable because of the clinically meaningful ORR and DOR.