nils-herrmann/clean_scirepeval huggingface dataset:
Diagnostic Performance of Fused Diffusion-Weighted Imaging Using Unenhanced or Postcontrast T1-Weighted MR Imaging in Patients With Breast Cancer

To evaluate the diagnostic performance of fused diffusion-weighted imaging (DWI) using either unenhanced (UFMR) or early postcontrast T1-weighted imaging (PCFMR) to detect and characterize breast lesions in patients with breast cancer.This retrospective observational study was approved by institutional review board in our hospital and informed consents were waived. We retrospectively selected 87 consecutive patients who underwent preoperative breast magnetic resonance imaging, including DWI and definitive surgery. Both UFMR and PCFMR were reviewed by 5 radiologists for detection, lesion size, Breast Imaging Reporting and Data System final assessment, the probability of malignancy, lesion conspicuity, and apparent diffusion coefficients.A total of 129 lesions were identified by at least 2 readers on UFMR or PCFMR. Of 645 potentially detected lesions, there were 528 (82%) with UFMR and 554 (86%) with PCFMR. Malignant lesions or index cancers showed significantly higher detection rates than benign or additional lesions on both UFMR and PCFMR (P < 0.05). Area under the characteristic curves (AUCs) for predicting malignancy ranged 0.927 to 0.986 for UFMR, and 0.936 to 0.993 for PCFMR, which was not significantly different. Lesion conspicuity was significantly higher on PCFMR than UFMR (8.59 ± 1.67 vs 9.19 ± 1.36, respectively; P < 0.05) across 5 readers. Mean intraclass correlation coefficients for lesion size on UFMR and PCFMR were 0.89 and 0.92, respectively.Detection rates of index malignant lesions were similar for UFMR and PCFMR. Interobserver agreement for final assessments was reliable across 5 readers. Diagnostic accuracy for predicting malignancy with UFMR versus PCFMR was similar, although lesion conspicuity was significantly greater with the latter.
The use of β2-agonist therapy before hospital attendance for severe asthma exacerbations: a post-hoc analysis

Patterns of inhaled β2-agonist therapy use during severe asthma exacerbations before hospital attendance are poorly understood.To assess β2-agonist use prior to hospital attendance.We undertook an exploratory post hoc analysis of data from a 6-month clinical trial of 303 patients randomised to combination budesonide/formoterol inhaler according to a Single combination inhaler as Maintenance And Reliever Therapy regimen (‘SMART’) or fixed-dose budesonide/formoterol with salbutamol as reliever (‘Standard’). Patterns of β2-agonist use for 14 days before hospital attendance with a severe asthma exacerbation were determined by electronic monitoring of inhaler use.There were 22 hospital attendances in 16 patients during the study. Seven and nine hospital attendances were eligible for analysis in the SMART and Standard groups, respectively. In both regimens, β2-agonist use increased before hospital attendance, with a median (range) maximum daily number of actuations of 14 (9 to 63) budesonide/formoterol in SMART and 46 (6 to 95) salbutamol in Standard with 4 (0 to 10) budesonide/formoterol actuations on the day of maximal salbutamol use. There was delay in obtaining medical review despite high β2-agonist use, in 9/16 patients. Different patterns of use were observed, including repeated days of no inhaled corticosteroid despite marked salbutamol use, which occurred in 3/9 patients in the Standard group.Delay in obtaining medical review in association with high β2-agonist use is common in patients before hospital presentation with severe exacerbations of asthma. The SMART regimen reduced nonadherence with inhaled corticosteroid therapy during severe exacerbations.
Application of a new suture material called the U-Clip for composite and sequential grafting with off-pump coronary bypass surgery.

The U-Clip was found to facilitate the interrupted anastomosis of coronary artery bypass grafts (CABG). This device may be beneficial especially in multivessel off-pump CABG (OPCAB) using composite grafts or sequential anastomosis. The aim of this study was to evaluate our early clinical experience using the U-Clip in OPCAB cases.



This retrospective study included 118 patients who underwent off-pump CABG between 2001 and 2004. The mean age of the 91 men and 27 women was 69.5 +/- 8.0 years (range, 47-85). The U-Clip was adopted for sewing 73 proximal ends of the free graft to the side or end of the inflow conduit to prepare the composite graft. The U-Clip was also applied to 112 distal anastomoses, especially to the side-to-side anastomosis of the sequential graft.



Hospital mortality rate was 0.8% (1/118). The early patency rate of distal anastomoses using the U-Clip was 95% (96/101). The early patency rate of proximal anastomoses using the U-Clip was 98.4% (62/63). Interim angiography was performed in 12 patients (range, 3.8-42 months; average, 16 months). In these 12 patients, a total of 8 proximal anastomoses of conduits using the U-Clip were all patent without stenosis. The patency rate of a total of 10 distal anastomoses in the 12 patients using the U-Clip was 100%.



The U-Clip-interrupted anastomosis enables a safe, definite, and rapid end-to-end or end-to-side connection of arterial grafts. We therefore consider the U-Clip to be a useful suture material especially for multivessel OPCAB using multiple arterial grafts.
Nurse-Led Medicines' Monitoring for Patients with Dementia in Care Homes: A Pragmatic Cohort Stepped Wedge Cluster Randomised Trial

People with dementia are susceptible to adverse drug reactions (ADRs). However, they are not always closely monitored for potential problems relating to their medicines: structured nurse-led ADR Profiles have the potential to address this care gap. We aimed to assess the number and nature of clinical problems identified and addressed and changes in prescribing following introduction of nurse-led medicines' monitoring.



Pragmatic cohort stepped-wedge cluster Randomised Controlled Trial (RCT) of structured nurse-led medicines' monitoring versus usual care.



Five UK private sector care homes.



41 service users, taking at least one antipsychotic, antidepressant or anti-epileptic medicine.



Nurses completed the West Wales ADR (WWADR) Profile for Mental Health Medicines with each participant according to trial step.



Problems addressed and changes in medicines prescribed.



Information was collected from participants' notes before randomisation and after each of five monthly trial steps. The impact of the Profile on problems found, actions taken and reduction in mental health medicines was explored in multivariate analyses, accounting for data collection step and site.



Five of 10 sites and 43 of 49 service users approached participated. Profile administration increased the number of problems addressed from a mean of 6.02 [SD 2.92] to 9.86 [4.48], effect size 3.84, 95% CI 2.57-4.11, P <0.001. For example, pain was more likely to be treated (adjusted Odds Ratio [aOR] 3.84, 1.78-8.30), and more patients attended dentists and opticians (aOR 52.76 [11.80-235.90] and 5.12 [1.45-18.03] respectively). Profile use was associated with reduction in mental health medicines (aOR 4.45, 1.15-17.22).



The WWADR Profile for Mental Health Medicines can improve the quality and safety of care, and warrants further investigation as a strategy to mitigate the known adverse effects of prescribed medicines.
Can treatment with Cocculine improve the control of chemotherapy-induced emesis in early breast cancer patients? A randomized, multi-centered, double-blind, placebo-controlled Phase III trial

Chemotherapy induced nausea and vomiting (CINV) remains a major problem that seriously impairs the quality of life (QoL) in cancer patients receiving chemotherapy regimens. Complementary medicines, including homeopathy, are used by many patients with cancer, usually alongside with conventional treatment. A randomized, placebo-controlled Phase III study was conducted to evaluate the efficacy of a complex homeopathic medicine, Cocculine, in the control of CINV in non-metastatic breast cancer patients treated by standard chemotherapy regimens. Chemotherapy-naïve patients with non-metastatic breast cancer scheduled to receive 6 cycles of chemotherapy including at least three initial cycles of FAC 50, FEC 100 or TAC were randomized to receive standard anti-emetic treatment plus either a complex homeopathic remedy (Cocculine, registered in France for treatment of nausea and travel sickness) or the matching placebo (NCT00409071 clinicaltrials.gov). The primary endpoint was nausea score measured after the 1st chemotherapy course using the FLIE questionnaire (Functional Living Index for Emesis) with 5-day recall. Secondary endpoints were: vomiting measured by the FLIE score, nausea and vomiting measured by patient self-evaluation (EVA) and investigator recording (NCI-CTC AE V3.0) and treatment compliance. From September 2005 to January 2008, 431 patients were randomized: 214 to Cocculine (C) and 217 to placebo (P). Patient characteristics were well-balanced between the 2 arms. Overall, compliance to study treatments was excellent and similar between the 2 arms. A total of 205 patients (50.9%; 103 patients in the placebo and 102 in the homeopathy arms) had nausea FLIE scores > 6 indicative of no impact of nausea on quality of life during the 1st chemotherapy course. There was no difference between the 2 arms when primary endpoint analysis was performed by chemotherapy stratum; or in the subgroup of patients with susceptibility to nausea and vomiting before inclusion. In addition, nausea, vomiting and global emesis FLIE scores were not statistically different at any time between the two study arms. The frequencies of severe (Grade ≥ 2) nausea and vomiting were low in our study (nausea: P: 17.6% vs C: 15.7%, p=0.62; vomiting: P: 10.8% vs C: 12.0%, p=0.72 during the first course). This double-blinded, placebo-controlled, randomised Phase III study showed that adding a complex homeopathic medicine (Cocculine) to standard anti-emetic prophylaxis does not improve the control of CINV in early breast cancer patients.
Adult granulosa cell tumor presenting with massive ascites, elevated CA-125 level, and low 18F-fluorodeoxyglucose uptake on positron emission tomography/computed tomography

Adult granulosa cell tumors (AGCTs) presenting with massive ascites and elevated serum CA-125 levels have rarely been described in the literature. An ovarian mass, massive ascites, and elevated serum CA-125 levels in postmenopausal women generally suggest a malignant ovarian tumor, particularly advanced epithelial ovarian cancer. AGCT has low (18)F-fluorodeoxyglucose uptake on positron emission tomography/computed tomography due to its low metabolic activity. In the present report, we describe a case of an AGCT with massive ascites, elevated serum CA-125 level, and low (18)F-fluorodeoxyglucose uptake on positron emission tomography/computed tomography.
A prospective study on the impact of heart rate control achieved with metoprolol on cardiac performance, motor function and quality of life in Chinese chronic heart failure patients.

To prospectively evaluate the impact of metoprolol achieved heart rate (HR) on cardiac-motor function and quality of life (QoL) in chronic heart failure (CHF) patients.



Between February 2013 to April 2016, association of HR reduction with haemodynamic indices, motor function and QoL in CHF patients with HR>80bpm receiving metoprolol 23.75mg or 47.5mgq.d was studied. Overall, 154 patients (median age, 66.39years; males, n=101; females, n=53) were enrolled, whose average resting HR decreased significantly from baseline value of 82.72±6.73 to 69.38±3.57, 67.72±2.61, 66.50±3.14 and 64.86±3.21bpm in the 1st, 3rd, 6th and 12th months post metoprolol intervention, respectively (P<0.0001). Similarly, the ejection fraction (r=-0.6461, P<0.0001), cardiac output (r=-0.5238, P<0.0001), cardiac index (r=-0.5378, P<0.0001) and veterans specific activity questionnaire scores (r=-0.4088, P<0.0001) were significantly associated with the reduction in HR after 12months. The improvement in 6-min walk test was independent of HR reduction (P=0.005). Similarly, QoL as measured by short form-8 questionnaire (SF-8) but not Minnesota Living with Heart Failure was significantly improved at the 12th-month. However, this was not associated with the reductions in HR.



Metoprolol achieved HR control was associated with improvement in cardiac performance and motor function but not QoL in patients with CHF.
Indications for allogeneic stem cell transplantation in chronic lymphocytic leukemia: the EBMT transplant consensus

The aim of this project was to identify situations where allogeneic stem cell transplantation (allo-SCT) might be considered as a preferred treatment option for patients with B-cell chronic lymphocytic leukemia (CLL). Based on a MEDLINE search and additional sources, a consented proposal was drafted, refined and approved upon final discussion by an international expert panel. Key elements of the consensus are (1) allo-SCT is a procedure with evidence-based efficacy in poor-risk CLL; (2) although definition of ‘poor-risk CLL’ requires further investigation, allo-SCT is a reasonable treatment option for younger patients with (i) non-response or early relapse (within 12 months) after purine analogues, (ii) relapse within 24 months after having achieved a response with purine-analogue-based combination therapy or autologous transplantation, and (iii) patients with p53 abnormalities requiring treatment; and (3) optimum transplant strategies may vary according to distinct clinical situations and should be defined in prospective trials. This is the first attempt to define standard indications for allo-SCT in CLL. Nevertheless, whenever possible, allo-SCT should be performed within disease-specific prospective clinical protocols in order to continuously refine transplant indications according to new developments in risk assessment and treatment of CLL.
T-cell suicide gene therapy prompts thymic renewal in adults after hematopoietic stem cell transplantation.

The genetic modification of T cells with a suicide gene grants a mechanism of control of adverse reactions, allowing safe infusion after partially incompatible hematopoietic stem cell transplantation (HSCT). In the TK007 clinical trial, 22 adults with hematologic malignancies experienced a rapid and sustained immune recovery after T cell-depleted HSCT and serial infusions of purified donor T cells expressing the HSV thymidine kinase suicide gene (TK+ cells). After a first wave of circulating TK+ cells, the majority of T cells supporting long-term immune reconstitution did not carry the suicide gene and displayed high numbers of naive lymphocytes, suggesting the thymus-dependent development of T cells, occurring only upon TK+ -cell engraftment. Accordingly, after the infusions, we documented an increase in circulating TCR excision circles and CD31+ recent thymic emigrants and a substantial expansion of the active thymic tissue as shown by chest tomography scans. Interestingly, a peak in the serum level of IL-7 was observed after each infusion of TK+ cells, anticipating the appearance of newly generated T cells. The results of the present study show that the infusion of genetically modified donor T cells after HSCT can drive the recovery of thymic activity in adults, leading to immune reconstitution.
Trends in CD4 counts in HIV-infected patients with HIV viral load monitoring while on combination antiretroviral treatment: results from The TREAT Asia HIV Observational Database

The aim of this study was to examine the relationship between trends in CD4 counts (slope) and HIV viral load (VL) after initiation of combination antiretroviral treatment (cART) in Asian patients in The TREAT Asia HIV Observational Database (TAHOD).



Treatment-naive HIV-infected patients who started cART with three or more and had three or more CD4 count and HIV VL tests were included. CD4 count slopes were expressed as changes of cells per microliter per year. Predictors of CD4 count slopes from 6 months after initiation were assessed by random-effects linear regression models.



A total of 1676 patients (74% male) were included. The median time on cART was 4.2 years (IQR 2.5-5.8 years). In the final model, CD4 count slope was associated with age, concurrent HIV VL and CD4 count, disease stage, hepatitis B or C co-infection, and time since cART initiation. CD4 count continues to increase with HIV VL up to 20,000 copies/mL during 6-12 months after cART initiation. However, the HIV VL has to be controlled below 5,000, 4,000 and 500 copies/mL for the CD4 count slope to remain above 20 cells/microliter per year during 12-18, 18-24, and beyond 24 months after cART initiation.



After cART initiation, CD4 counts continued to increase even when the concurrent HIV VL was detectable. However, HIV VL needed to be controlled at a lower level to maintain a positive CD4 count slope when cART continues. The effect on long-term outcomes through the possible development of HIV drug resistance remains uncertain.
Effects of DHA- Rich n-3 Fatty Acid Supplementation on Gene Expression in Blood Mononuclear Leukocytes: The OmegAD Study

Dietary fish oil, rich in n-3 fatty acids (n-3 FAs), e.g. docosahexaenoic acid (DHA) and eicosapentaenoic acid (EPA), regulate inflammatory reactions by various mechanisms, e.g. gene activation. However, the effects of long-term treatment with DHA and EPA in humans, using genome wide techniques, are poorly described. Hence, our aim was to determine the effects of 6 mo of dietary supplementation with an n-3 FA preparation rich in DHA on global gene expression in peripheral blood mononuclear cells.



In the present study, blood samples were obtained from a subgroup of 16 patients originating from the randomized double-blind, placebo-controlled OmegAD study, where 174 Alzheimer disease (AD) patients received daily either 1.7 g of DHA and 0.6 g EPA or placebo for 6 months. In blood samples obtained from 11 patients receiving n-3 FA and five placebo, expressions of approximately 8000 genes were assessed by gene array. Significant changes were confirmed by real-time PCR. At 6 months, the n-3 FAs group displayed significant rises of DHA and EPA plasma concentrations, as well as up- and down-regulation of nine and ten genes, respectively, was noticed. Many of these genes are involved in inflammation regulation and neurodegeneration, e.g. CD63, MAN2A1, CASP4, LOC399491, NAIP, and SORL1 and in ubiqutination processes, e.g. ANAPC5 and UBE2V1. Down-regulations of ANAPC5 and RHOB correlated to increases of plasma DHA and EPA levels.



We suggest that 6 months of dietary n-3 FA supplementation affected expression of genes that might influence inflammatory processes and could be of significance for AD.
Salmon calcitonin nasal spray in the prevention of corticosteroid-induced osteoporosis.

The objectives were to determine the efficacy and safety of nasal salmon calcitonin 200 IU daily in the prevention of corticosteroid-induced osteoporosis. A minimized, double-blind, placebo-controlled trial was carried out in corticosteroid-treated patients with polymyalgia rheumatica. The setting was a tertiary care university-affiliated hospital and a total of 31 patients were enrolled. The primary outcome measure was the percentage change in bone mineral density of the lumbar spine in the two treatment groups from baseline to 1 yr of follow-up. The mean +/- S.D. bone mineral density of the lumbar spine in the calcitonin-treated group decreased by 1.29 +/- 6.76% and in the placebo group by 4.95 +/- 3.50% after 12 months. The observed difference of 3.65 +/- 2.10% between groups is statistically significant (P < 0.05). Nasal salmon calcitonin prevented loss of bone in the lumbar spine as measured by dual-energy X-ray absorptiometry.
Effects of tiagabine in combination with intravenous nicotine in overnight abstinent smokers

Preclinical studies suggest that medications enhancing the brain gamma amino butyric acid (GABA) system attenuate the rewarding effects of stimulants including nicotine. These preclinical studies have not been followed up in systematic human studies. This study was conducted to examine the effects of a GABAergic medication, tiagabine, on acute physiological and subjective effects of intravenous (i.v.) nicotine and on tobacco withdrawal symptoms in overnight abstinent smokers. The proposed mechanism of action for tiagabine is selective inhibition of GABA transporter type I, which leads to increases in synaptic GABA levels. Eight male and four female smokers participated in a double-blind, placebo-controlled, crossover study. In each of three experimental sessions, participants were treated orally with a single 4- or 8-mg dose of tiagabine or placebo. Two hours following the medication treatment, participants received i.v. saline, followed 30 min later by 1.5 mg/70 kg i.v. nicotine. Tiagabine treatment did not affect the heart rate or blood pressure changes induced by nicotine. There was a significant treatment effect for the subjective responses to nicotine, such that tiagabine, compared to placebo, attenuated the ratings of “good effects” and “drug liking.” Tiagabine treatment at 8 mg attenuated the craving for cigarettes and enhanced the cognitive performance in the Classical Stoop Tests, compared to placebo or 4 mg tiagabine condition. These results suggest that GABA enhancing medication tiagabine may reduce the rewarding effects of nicotine and improve cognitive performance in abstinent smokers. The utility of GABA medications for smoking cessation needs to be examined further in controlled clinical trials.
Fiberoptic bronchoscopy during nasal non-invasive ventilation in acute respiratory failure.

Various methods have been described for safely performing fiberoptic bronchoscopy (FB) while applying non-invasive positive pressure ventilation (NIPPV) in patients with acute respiratory failure (ARF).



To evaluate the safety of a new method to perform FB in patients with ARF.



Patients with ARF in whom FB was indicated were studied. The primary end-point was a mean drop in oxygen saturation (S(a)O(2)) after the procedure. During nasal NIPPV, FB was performed via the mouth using a bite block sealed with an elastic glove finger allowing bronchoscope insertion.



Thirty-five patients were included in the final study (63 ± 17 years, 74% men, P(a)O(2)/F(i)O(2) ratio 168 ± 63). A total of 35 bronchoaspirates, 21 protected brushings, 11 bronchoalveolar lavages and 8 bronchial biopsies were done. The cardiorespiratory variables at the start and end of FB were: S(a)O(2) 93 ± 3 to 94 ± 5%, heart rate 95 ± 17 to 99 ± 22 b.p.m. and respiratory rate 24 ± 11 to 25 ± 11 respirations/min. The lowest S(a)O(2) value reached during the procedure was 86 ± 3% and the maximal ETCO(2) rise was 41 ± 4 mm Hg. Leakage was <50 ml/s in 32 patients. The clinical course was favorable in 66%. Invasive ventilation was necessary in 11%, 5 ± 4 days after FB. Twelve patients (33%) died 3 ± 2 days after FB as a result of their underlying disease.



The system allowed to perform FB safely in patients with ARF. Although there is a relatively high rate of intubation and invasive mechanical ventilation due to illness severity, there was no worsening of oxygenation or complications attributable to the procedure.