nils-herrmann/clean_scirepeval huggingface dataset:
An Analysis of Behavioral and Genetic Risk Factors for Chemotherapy-Induced Nausea and Vomiting in Japanese Subjects.

There are individual differences in the frequency of chemotherapy-induced nausea and vomiting (CINV) in cancer patients. We investigated the individual variability in susceptibility to CINV with focus on both behavioral factors and genetic factors in Japanese cancer patients. We performed a prospective study to investigate the association between patient attributes (backgrounds and habits as well as gene polymorphisms) and anorexia, nausea, or vomiting in 55 Japanese cancer patients undergoing chemotherapy at Nagoya University Hospital. We found that gender (female), use of non-steroidal anti-inflammatory drugs, susceptibility to motion sickness, and anxiety were associated with the frequency of CINV. Gene polymorphisms of rs1076560 (dopamine D2 receptor gene), rs6766410 (serotonin 5-HT3C receptor gene) and rs4680 (catechol-O-methyltransferase gene) were also associated. Our data suggest that these attributes may thus be risk factors for CINV. Our results provide novel information that can be used to predict the incidence of CINV in Japanese patients undergoing chemotherapy; this can help provide a substantial improvement in supportive care for patients with different types of cancer.
NIEHS to study developmental effects of pesticides.

The effect of adjuvant immunotherapy with a single neighbourhood injection of 2 mg C. parvum (CP) was investigated in a randomized study involving 43 patients with carcinoma of the cervix uteri, all of whom were treated by radical surgery. All patients had carcinoma confined to the cervix, the upper part of the vagina or the parametrial region. When the malignancy had spread to the parametrial region, additional postoperative radiotherapy was given. 22 patients received immunotherapy 10 days before surgery, whereas the remaining 21 control patients received no immune stimulation. Only minor side effects of CP were encountered. Follow-up shows a relapse rate of 5% in the CP treated group and of 29% in the controls (P less than 0.05). A further 15 patients with more advanced malignancies were added to our studies. In these, CP stimulation had no effect on relapse rates, but the relapse-free intervals were longer after immune stimulation: control 3.5 months (mean) +/- 1.5 (s.d.), CP 13.0 months +/- 7.0 (P less than 0.05). The number of peripheral T cells and the ability to become sensitized to DNCB were increased after CP stimulation. A decrease was found in the number of blood monocytes and the number of monocytes capable of transforming into active macrophages, indicating a possible sequestration of these cells in the tissues.
Supporting recovery in patients with psychosis through care by community-based adult mental health teams (REFOCUS): a multisite, cluster, randomised, controlled trial.

Mental health policy in many countries is oriented around recovery, but the evidence base for service-level recovery-promotion interventions is lacking.



We did a cluster, randomised, controlled trial in two National Health Service Trusts in England. REFOCUS is a 1-year team-level intervention targeting staff behaviour to increase focus on values, preferences, strengths, and goals of patients with psychosis, and staff-patient relationships, through coaching and partnership. Between April, 2011, and May, 2012, community-based adult mental health teams were randomly allocated to provide usual treatment plus REFOCUS or usual treatment alone (control). Baseline and 1-year follow-up outcomes were assessed in randomly selected patients. The primary outcome was recovery and was assessed with the Questionnaire about Processes of Recovery (QPR). We also calculated overall service costs. We used multiple imputation to estimate missing data, and the imputation model captured clustering at the team level. Analysis was by intention to treat. 
14 teams were included in the REFOCUS group and 13 in the control group. Outcomes were assessed in 403 patients (88% of the target sample) at baseline and in 297 at 1 year. Mean QPR total scores did not differ between the two groups (REFOCUS group 40·6 [SD 10·1] vs control 40·0 [10·2], adjusted difference 0·68, 95% CI -1·7 to 3·1, p=0·58). High team participation was associated with higher staff-rated scores for recovery-promotion behaviour change (adjusted difference -0·4, 95% CI -0·7 to -0·2, p=0·001) and patient-rated QPR interpersonal scores (-1·6, -2·7 to -0·5, p=0·005) at follow-up than low participation. Patients treated in the REFOCUS group incurred £1062 (95% CI -1103 to 3017) lower adjusted costs than those in the control group.



Although the primary endpoint was negative, supporting recovery might, from the staff perspective, improve functioning and reduce needs. Implementation of REFOCUS could increase staff recovery-promotion behaviours and improve patient-rated recovery.



National Institute for Health Research.
Lumacaftor-Ivacaftor in Patients with Cystic Fibrosis Homozygous for Phe508del CFTR.

Cystic fibrosis is a life-limiting disease that is caused by defective or deficient cystic fibrosis transmembrane conductance regulator (CFTR) protein activity. Phe508del is the most common CFTR mutation.



We conducted two phase 3, randomized, double-blind, placebo-controlled studies that were designed to assess the effects of lumacaftor (VX-809), a CFTR corrector, in combination with ivacaftor (VX-770), a CFTR potentiator, in patients 12 years of age or older who had cystic fibrosis and were homozygous for the Phe508del CFTR mutation. In both studies, patients were randomly assigned to receive either lumacaftor (600 mg once daily or 400 mg every 12 hours) in combination with ivacaftor (250 mg every 12 hours) or matched placebo for 24 weeks. The primary end point was the absolute change from baseline in the percentage of predicted forced expiratory volume in 1 second (FEV1) at week 24.



A total of 1108 patients underwent randomization and received study drug. The mean baseline FEV1 was 61% of the predicted value. In both studies, there were significant improvements in the primary end point in both lumacaftor-ivacaftor dose groups; the difference between active treatment and placebo with respect to the mean absolute improvement in the percentage of predicted FEV1 ranged from 2.6 to 4.0 percentage points (P<0.001), which corresponded to a mean relative treatment difference of 4.3 to 6.7% (P<0.001). Pooled analyses showed that the rate of pulmonary exacerbations was 30 to 39% lower in the lumacaftor-ivacaftor groups than in the placebo group; the rate of events leading to hospitalization or the use of intravenous antibiotics was lower in the lumacaftor-ivacaftor groups as well. The incidence of adverse events was generally similar in the lumacaftor-ivacaftor and placebo groups. The rate of discontinuation due to an adverse event was 4.2% among patients who received lumacaftor-ivacaftor versus 1.6% among those who received placebo.



These data show that lumacaftor in combination with ivacaftor provided a benefit for patients with cystic fibrosis homozygous for the Phe508del CFTR mutation.
Can balloon aortic valvuloplasty help determine appropriate transcatheter aortic valve size?

We sought to study the potential role of balloon aortic valvuloplasty (BAV) in sizing the aortic annulus in patients before transcatheter heart valve (THV) implantation.



Despite clinicians' growing experience with THV procedures, the best method of annulus sizing remains unclear.



Twenty-three patients with aortic stenosis (<1.0 cm(2)) who were undergoing surgical valve replacement were enrolled. Pre-operative echocardiographic measurements of the annulus and computed tomography measurements of valve calcium were made. Intraoperatively, a valvuloplasty balloon of known size and inflatable pressure was inserted into the aortic valve and inflated. The development of intraballoon pressure in addition to the nominal inflation pressure (AIBP) reflected the apposition of balloon and valve. Surgical annulus was measured by cylindrical sizers.



In patients with tricuspid valves, AIBP was generated in 11 of 12 patients when the balloon diameter was greater than the surgically measured annulus, regardless of leaflet calcification (2 of 10 patients when balloon < or = surgical annulus). In bicuspid valves, high AIBP ( approximately 1 atm) was encountered with balloons that were within 1 mm of annulus size, and leaflet dehiscence occurred with larger balloons (n = 2 patients). Annulus size was underestimated by transthoracic echocardiogram and transesophageal echocardiogram compared with surgery (p < 0.001): transthoracic echocardiogram = 21.5 +/- 1.8 mm, transesophageal echocardiogram = 22.0 +/- 1.6 mm and surgical = 23.2 +/- 1.9 mm (range 20 to 27 mm, mode 22 mm).



These data suggest that measuring AIBP during balloon aortic valvuloplasty in tricuspid valves is an important adjunctive measurement of the aortic annulus and may help in determining the appropriate THV size.
Widespread sensory hypersensitivity is a feature of chronic whiplash-associated disorder but not chronic idiopathic neck pain.

To investigate sensory changes present in patients with chronic whiplash-associated disorders and chronic idiopathic neck pain using a variety of quantitative sensory tests to better understand the pain processing mechanisms underlying persistent symptoms.



A case control study was used with 29 subjects with chronic whiplash-associated disorders, 20 subjects with chronic idiopathic neck pain, and 20 pain-free volunteers. Pressure pain thresholds were measured over the articular pillars of C2-C3, C5-C6, the median, radial, and ulnar nerve trunks in the arm and over a remote site, the muscle belly of tibialis anterior. Heat pain thresholds, cold pain thresholds, and von Frey hair sensibility were measured over the cervical spine, tibialis anterior, and deltoid insertion. Anxiety was measured with the Short-Form of the Spielberger State Anxiety Inventory.



Pressure pain thresholds were decreased over cervical spine sites in both subject groups when compared with controls (P < 0.05). In the chronic whiplash-associated disorders group, pressure pain thresholds were also decreased over the tibialis anterior, median, and radial nerve trunks (P < 0.001). Heat pain thresholds were decreased and cold pain thresholds increased at all sites (P < 0.03). No differences in heat pain thresholds or cold pain thresholds were evident in the idiopathic neck pain group at any site compared with the control group (P > 0.27). No abnormalities in von Frey hair sensibility were evident in either neck pain group (P > 0.28).



Both chronic whiplash-associated disorders and idiopathic neck pain groups were characterized by mechanical hyperalgesia over the cervical spine. Whiplash subjects showed additional widespread hypersensitivity to mechanical pressure and thermal stimuli, which was independent of state anxiety and may represent changes in central pain processing mechanisms. This may have implications for future treatment approaches.
Vagal withdrawal to a sad film predicts subsequent recovery from depression.

Cardiac vagal tone, as indexed by abnormalities in the level and/or reactivity of respiratory sinus arrhythmia (RSA), has been related to psychiatric impairment, including risk for depression. Longitudinal studies of depression have focused on RSA levels and have found mixed support for the hypothesis that low RSA levels predict a more pernicious course of depression. The current investigation focuses on the relation between RSA reactivity and the course of depression. We measured depressed persons' RSA reactivity to sadness-, fear-, and amusement-inducing emotion films and reassessed participants' diagnostic status 6 months later. Depressed persons who exhibited a higher degree of vagal withdrawal to the sad film were more likely to recover from depression. Implications for the study of RSA in depression are discussed.
Symptoms and the distress they cause: comparison of an aldosterone antagonist and a calcium channel blocking agent in patients with systolic hypertension.

Although there has been increasing recognition that a substantial part of the cardiovascular, central nervous system, and renal conditions induced by renin-angiotensin-aldosterone system activation reflects an action of aldosterone, the potential influence of therapy designed to block aldosterone has been limited by the fact that spironolactone (until recently the only aldosterone antagonist available) exerts a substantial array of adverse effects. We sought to compare the magnitude of the distress induced by a widely used calcium channel blocking agent, amlodipine, and a new aldosterone antagonist, eplerenone, in patients treated for systolic hypertension.



A total of 269 patients older than 50 years with systolic hypertension were randomized to either eplerenone, 50 mg/d, or amlodipine, 2.5 mg/d, and titrated to a maximum 200-mg eplerenone dose or 10-mg amlodipine dose. Patients were followed up for 24 weeks. Quality-of-life questionnaires (SF-36 Health Survey) and a validated instrument for assessing symptom distress (Symptom Distress Index) were administered at randomization and 24 weeks after starting treatment.



The systolic blood pressure response to eplerenone and amlodipine did not differ (eplerenone = -20.5 mm Hg and amlodipine = -20.1 mm Hg). For the quality-of-life analysis, 119 patients were randomized to eplerenone and 122 to amlodipine. No significant treatment group differences in the Symptom Distress Index were detected at baseline. There was an overall significant treatment effect on symptom distress in favor of eplerenone (P =.03). Indeed, Symptom Distress Index showed significant worsening distress in 36 of 71 symptoms in the amlodipine arm and none in the eplerenone arm. Significant treatment effect in favor of eplerenone was observed in 5 symptoms: ankle swelling, weight gain, nocturia, increased urination, and shortness of breath. Patients with symptom distress also showed an erosion of psychosocial measures of quality of life (P<.001).



The aldosterone antagonist eplerenone is substantially better tolerated than the widely used calcium-channel blocking agent amlodipine, with comparable reductions in systolic blood pressure. This feature should improve therapeutics in patients in whom blockade of aldosterone's effect would be helpful.
Olmesartan improves endothelial function in hypertensive patients: link with extracellular superoxide dismutase

Endothelial dysfunction in essential hypertension is an independent predictor for future cardiovascular events. Although inhibition of the renin-angiotensin system (RAS) reportedly improves endothelial function through its effects on oxidative stress and inflammation, questions remain regarding the factors that are pivotal for improvement of endothelial function by RAS inhibition. We therefore performed a prospective, randomized crossover trial in which an angiotensin II type 1 receptor antagonist, olmesartan and calcium channel blocker, amlodipine, were compared in 31 essential hypertensive patients. Results showed that, although both treatments achieved comparable lowering of blood pressure (BP), olmesartan, but not amlodipine, significantly improved endothelial function as evaluated by flow-mediated vasodilation (FMD) in the brachial artery. Although no significant changes in diabetic and lipid parameters were observed with either drug, olmesartan slightly decreased estimated glomerular filtration rate, which, surprisingly, translated into decreased microalbuminuria. In a similar vein, olmesartan reduced serum C-reactive protein and increased urine antioxidant levels compared with baseline, and reduced urine 8-epi-prostaglandin F2α levels compared with both baseline and amlodipine. Finally, although overall changes in plasma extracellular superoxide dismutase (EC-SOD) levels were not modulated by either treatment, for olmesartan there was a positive correlation between changes in FMD and those in EC-SOD levels. In conclusion, olmesartan improved endothelial function in hypertensive patients independent of its BP-lowering effect, which was due, at least in part, to its antioxidative property. Therefore, olmesartan might provide a greater long-term benefit for hypertensive patients with impaired endothelial function than amlodipine.
Comparison of the outcomes for laparoscopic gastrectomy performed by the same surgeon between a low-volume hospital and a high-volume center

The volume–outcome relationship in laparoscopic surgery is controversial. This study was designed to identify differences in laparoscopic gastrectomy outcomes between a low-volume hospital and a high-volume center and to provide guidelines for overcoming the problems associated with a low-volume hospital. From April 2009 to November 2012, one surgeon performed 134 totally laparoscopic distal gastrectomies (TLDGs) at a high-volume center (HVC; ASAN Medical Center) and at a low-volume hospital (LVH; Hanyang University Guri Hospital). All laparoscopically assisted gastrectomies were excluded from this study. During the early period of laparoscopic gastrectomy at the low-volume hospital, TLDG with Roux-en-Y gastrojejunostomy (RYGJ) was performed according to the surgeon’s choice. The reconstruction method was classified as gastroduodenostomy (GD) or RYGJ. Early surgical outcomes achieved at the LVH were investigated and compared with those obtained at the HVC. The early surgical outcomes differed significantly between the two hospitals. In particular, the postoperative complication rate for the patients who underwent TLDG RYGJ at the LVH was higher than at the HVC (LVH 15.4 % vs. HVC 0 %; p = 0.037). Furthermore, significant differences were observed in the mean operation time (TLDG GD: LVH 141.0 min vs. HVC 117.4 min, p = 0.001; TLDG RYGJ: LVH 186.3 min vs. HVC 134.6 min, p = 0.009) and length of hospital stay (TLDG GD: LVH 8.1 days vs. HVC 7.2 days, p = 0.044; TLDG RYGJ: LVH 11.5 day vs. HVC 6.8 day, p = 0.009). Although all the operations were performed by one experienced surgeon, the early surgical outcomes differed significantly between the low- and high-volume hospitals. Low-volume hospitals often lack well-trained surgical professionals such as first assistants and scrub nurses. Therefore, the authors recommend that a surgeon who works at an LVH should assess potential personnel shortages and find a solution before operating.
Asymmetric collimation can significantly reduce patient radiation dose during pulmonary vein isolation.

Current fluoroscopic and 3D image-guided treatment of atrial fibrillation (AF) by radiofrequency ablation is characterized by a substantial amount of X-ray radiation. We investigated the potential of an asymmetric collimation technique to reduce dose.



For 30 patients, referred for AF ablation, we determined the received fluoroscopy dose for various collimation scenarios: a single collimation window encompassing all veins as used in most labs (Sc 1), an optimal adjusted symmetric collimation window encompassing each two ipsilateral veins (Sc 2) or each individual vein (Sc 3) and an optimal asymmetric collimation window encompassing each two ipsilateral veins (Sc 4) or each individual vein (Sc 5). Twenty patients were studied retrospectively and 10 were studied prospectively. Total fluoroscopy effective dose for all collimation strategies amounted to 45 ± 31 mSv for a single collimation field (Sc 1), 36 ± 25 mSv (Sc 2), and 24 ± 14 mSv (Sc 3) for a symmetrically adjusted collimation window and 15 ± 10 (Sc 4) and 5 ± 3 mSv (Sc 5) for an asymmetrically adjusted collimation approach. Validation of symmetric (Sc 2) and asymmetric (Sc 4) collimation in 10 patients confirmed the retrospective analysis.



Implementation and effective application of an optimal asymmetric collimation approach would yield an average three- to nine-fold reduction of fluoroscopy dose during AF ablation procedures. This reduction exceeds what has been previously reported by implementing an electromagnetic catheter tracking approach. Furthermore, it can be easily integrated in the clinical workflow with limited additional one-time cost. Manufacturers of imaging systems should consider its implementation a priority, and physicians should adopt it in their workflow.
Clinic value of two-dimensional speckle tracking combined with adenosine stress echocardiography for assessment of myocardial viability.

To evaluate whether myocardial strain under adenosine stress calculated from two-dimensional echocardiography by automatic frame-by-frame tracking of natural acoustic markers enables objective description of myocardial viability in clinic.



Two-dimensional echocardiography and two-dimensional speckle tracking imaging (2D STI) at rest were performed first and once again after adenosine was infused at 140 ug/kg/min over a period of 6 minutes in 36 stable patients with previous myocardial infarction. Then radionuclide myocardial perfusion/metabolic imaging served as the "gold standard" to define myocardial viability was given in all patients within 1 day. Two-dimensional speckle tracking images were acquired at rest and after adenosine administration. An automatic frame-by-frame tracking system of natural acoustic echocardiographic markers was used to calculate 2D strain variables including peak-systolic circumferential strain (CS(peak-sys)), radial strain (RS(peak-sys)), and longitudinal strain (LS(peak-sys)). Those segments with abnormal motion from visual assessment of two-dimensional echocardiography were selected for further study. As a result, 126 regions were viable whereas 194 were nonviable among 320 abnormal motion segments in 36 patients according to radionuclide imaging. At rest, there were no significant changes of 2D strain between the viable and nonviable myocardium. After adenosine administration (140 ug/kg/min), CS(peak-sys) had a little change of the viable myocardium while RS(peak-sys) and LS(peak-sys) increased significantly compared with those at rest. In nonviable group, CS(peak-sys), RS(peak-sys), and LS(peak-sys) had no significant changes during adenosine administration. After adenosine administration, RS(peak-sys) and LS(peak-sys) in viable group increased significantly compared with nonviable group. Obtained strain data were highly reproducible and affected in small intraobserver and interobserver variabilities. A change of radial strain more than 9.5% has a sensitivity of 83.9% and a specificity of 81.4% for viable whereas a change of longitudinal strain more than 14.6% allowed a sensitivity of 86.7% and a specificity of 90.2%.



2D STI combined with adenosine stress echocardiography could provide a new and reliable method to identify myocardium viability.