nils-herrmann/clean_scirepeval huggingface dataset:
Prophylaxis against atrial fibrillation after cardiac surgery: beneficial effect of perioperative metoprolol.

Multiple agents have been investigated to prevent atrial fibrillation (AF) after cardiac surgery. Several studies have investigated the use of β-blockers such as metoprolol or amiodarone with promising results. We aimed to investigate perioperative pharmacologic prophylaxis against AF using metoprolol, and amiodarone in combination with metoprolol.



We conducted a prospective, randomised, single-blind, controlled pilot study in patients undergoing elective cardiac surgery. Subjects were randomised pre-operatively to one of three treatment groups: standard therapy (control) or metoprolol (5 mg IV over 5 min on commencement of bypass then 5 mg IV qid for 24h then 25-50 mg tds orally until discharge) or amiodarone (300 mg over 1h starting shortly after the commencement of bypass, then 900 mg over 24h then 400 mg orally tds until discharge) plus metoprolol as above. Patients had ECG monitoring for the occurrence of AF for six days or until discharge.



Two hundred and fifteen patients were enrolled. Between-group differences in AF in an intention-to-treat analysis were not significant: control 34% (23-45%), metoprolol 35% (24-46%), combined 22% (12-33%) (p = 0.21). However 87 patients (40%) did not receive the assigned treatment mainly due to side effects, especially bradycardia. The remaining 128 patients were analysed on a per-protocol basis with the overall difference between the three groups bordering on significance: control 34% (23-45%), metoprolol 26% (9-43%), combined 11% (0-23%) (p = 0.06). Logistic regression analysis, correcting for age and gender, was used to separate the individual effects of metoprolol and amiodarone in the presence of metoprolol which showed that compared to control there was a significant effect of metroprolol on AF incidence (O.R. 0.31 (0.10-0.99), p = 0.048) but not of amiodarone (O.R. 0.97 (0.19-5.02), p = 0.97).



(1) Perioperative metoprolol but not amiodarone itself in combination with metoprolol is associated with a significant reduction in postoperative AF. (2) Perioperative administration of metoprolol and combination of metoprolol with amiodarone is associated with a high incidence of side effects, especially bradycardia. (3) Further studies are indicated to confirm these preliminary findings but in the meantime it would not be unreasonable to implement the use of perioperative metoprolol for routine prophylaxis of AF.
Postallograft lenalidomide induces strong NK cell-mediated antimyeloma activity and risk for T cell-mediated GvHD: Results from a phase I/II dose-finding study.

Lenalidomide may prevent relapses after allogeneic stem cell transplantation by promoting the immune-mediated graft-versus-tumor effect. We performed a prospective phase I/II study to define the dose-limiting toxicity and the immunologic effects of lenalidomide given early (day 100-180) after allograft for four cycles in patients with multiple myeloma. According to the Fibonacci design, 24 patients with a median age of 53 years were included. Dose-limiting toxicity was organ toxicity owing to graft-versus-host disease, and the maximum tolerable dose was 5 mg. The incidence of graft-versus-host disease after lenalidomide was 38%, occurring after a median of 22 days, and was beside organ toxicity, a leading cause to discontinue the study in 29% of the patients. Immune monitoring revealed a significant increase in peripheral γ-interferon-secreting CD4(+) and CD8(+) T cells within the first week of lenalidomide treatment followed by a delayed increase in T regulatory cells. Furthermore, natural killer (NK) cells isolated from the peripheral blood of patients evidenced a significantly improved antimyeloma activity after lenalidomide treatment. The immune effect might have contributed to the increased CR rate from 24-42% after lenalidomide treatment because nonresponding patients showed significantly less natural killer and T cell activation.
Graft patency and late outcomes for patients with ST-segment elevation myocardial infarction who underwent coronary surgery.

The aim of our study was to assess the long-term clinical outcomes and the grafts patency rates of patients with ST-segment elevation myocardial infarction (STEMI) who underwent urgent or emergency coronary artery bypass grafting (CABG).



Participants in two previous studies comprising 207 STEMI patients undergoing on-pump (145 patients) or off-pump (62 patients) coronary artery bypass graft (CABG) surgery in our institution were prospectively followed to assess late mortality, graft patency, and major adverse cardiac-related event (MACE) rates. Graft patency was evaluated by multi-detector computed tomography angiography 64-slice scan. Mean times of graft implantation were 38±16 months and 37±14 months in on-pump and off-pump, respectively. Follow-up data were obtained in all patients and was 100% complete.



Late mortality rate was 7.4% (10 patients) in the on-pump and 6.5% (4 patients) in off-pump groups (p=0.45). Five-year overall survival rate (±SE) was 93.5±2.1% and 92.6±1.9% in the off-pump vs on-pump, respectively. Five years' freedom from cardiac-related death was 94.9±2.9% in the on-pump group vs 96.8±3.2% in the off-pump group (p=0.25). Five years' freedom from cardiac-related events was 89.7±1.6% in the on-pump group versus 93.5±1.8% in the off-pump group (p=0.32). In all patients, a total of 449/491 (91.5%) grafts were patent. Percentages of overall grafts classified as patent were similar in the on-pump group (90.7% - 322/355 conduits) versus the off-pump group (91% - 133/146 conduits). Graft patency rates were also similar between the two groups with regard to arterial and saphenous vein conduits, and with regard to different branches of the coronary arteries grafted.



Our data suggest that off-pump CABG patients have the same late mortality, MACEs, and graft patency rates as conventional cardioplegic cardiac arrest CABG patients. In our opinion, urgent or emergency CABG for patients with STEMI can be done either way.
Validation of noninvasive body sensor network technology in the detection of agitation in dementia.

Agitated behaviors are one of the most frequent reasons that patients with dementia are placed in long-term care settings. This study aims to validate the ability of a custom Body Sensor Network (BSN) to capture the presence of agitation against currently accepted subjective measures, the Cohen-Mansfield Agitation Inventory (CMAI) and the Aggressive Behavior Scale (ABS) and to discriminate between agitation and cognitive decline.



Six patients identified as being at high risk for agitated behaviors were enrolled in this study. The devices were applied at three sites for three hours while behaviors were annotated simultaneously and subsequently repeated twice for each enrolled subject.



We found that the BSN was a valid measure of agitation based on construct validity testing and secondary validation using non-parametric ANOVAs.



The BSN shows promise from these pilot results. Further testing with a larger sample is needed to replicate these results.
Activation of YAP1 is associated with poor prognosis and response to taxanes in ovarian cancer.

We aimed to investigate the clinical significance of the activation of Yes-Associated Protein 1 (YAP1), a key downstream effector of Hippo tumor-suppressor pathway, in ovarian cancer.



A gene expression signature reflecting activation of YAP1 was developed from gene expression data of 267 samples from patients with ovarian cancer. A refined ovarian cancer YAP1 signature was validated in an independent ovarian cancer cohort (n=185). Associations between the YAP1 signature and prognosis were assessed using Kaplan-Meier plots, the log-rank test, and a Cox proportional hazards model.



We identified a 612-gene expression signature reflecting YAP1 activation in ovarian cancer. In multivariate analysis, the signature was an independent predictor of overall survival (hazard ratio=1.66; 95% confidence interval=1.1 to 2.53; p=0.01). In subset analysis, the signature identified patients likely to benefit from taxane-based adjuvant chemotherapy.



Activation of YAP1 is significantly associated with prognosis and the YAP1 signature can predict response to taxane-based adjuvant chemotherapy in patients with ovarian cancer.
Continuous vs thrice-daily ceftazidime for elective intravenous antipseudomonal therapy in cystic fibrosis

We hypothesized that a continuous 24-h infusion of 100 mg/kg per day ceftazidime (treatment C) would result in equivalent or even superior anti-infectious efficacy in chronic Pseudomonus aeruginosa (PA) infection in patients with cystic fibrosis (CF) in comparison to the usual application of 200 mg/kg per day ceftazidime in three doses (treatment T). This was a randomized crossover study comparing outcome after 14 days and 35 days. Tobramycin administered once daily (10 mg/kg per day) was administered concomitantly in both groups. The primary end-point was a decrease in the leukocyte count, and the secondary endpoints were clinical and lung function parameters, Pseudomonas quantification in sputum, and inflammation markers (immunogloblulin [Ig] G, C-reactive protein [CRP]) in serum. All patients received antibiotics electively as 14-day courses on a regular basis, not for acute exacerbations. Fifty-six patients (29 females, mean patient age 14.4 years, age range 5–37) initially received treatments C or T, followed by the alternative treatment after amean interval of 37 (± 21) weeks. After 2 weeks of antibiotic treatment, the overall study group showed significant improvements compared to baseline for body weight, leukocyte counts, CRP, forced expiratory volume in 1 s (FEV1), FVC (forced vital capacity), and bacterial load in the airways, with no significant differences between treatment groups. Both regimens were well tolerated. Threeweeks after cessation of antimicrobial therapy, leukocytes and PA density had returned to pre-treatment values. We conclude that continuous or thrice-daily dosing of intravenous ceftazidime, both combined with once-daily tobramycin, are equally effective application regimens for elective antipseudomonal therapy in clinically stable patients with CF.
Impact of Stepping Stones on incidence of HIV and HSV-2 and sexual behaviour in rural South Africa: cluster randomised controlled trial

To assess the impact of Stepping Stones, a HIV prevention programme, on incidence of HIV and herpes simplex type 2 (HSV-2) and sexual behaviour.



Cluster randomised controlled trial.



70 villages (clusters) in the Eastern Cape province of South Africa.



1360 men and 1416 women aged 15-26 years, who were mostly attending schools.



Stepping Stones, a 50 hour programme, aims to improve sexual health by using participatory learning approaches to build knowledge, risk awareness, and communication skills and to stimulate critical reflection. Villages were randomised to receive either this or a three hour intervention on HIV and safer sex. Interviewers administered questionnaires at baseline and 12 and 24 months and blood was tested for HIV and HSV-2.



incidence of HIV. Other outcomes: incidence of HSV-2, unwanted pregnancy, reported sexual practices, depression, and substance misuse.



There was no evidence that Stepping Stones lowered the incidence of HIV (adjusted incidence rate ratio 0.95, 95% confidence interval 0.67 to 1.35). The programme was associated with a reduction of about 33% in the incidence of HSV-2 (0.67, 0.46 to 0.97; P=0.036)-that is, Stepping Stones reduced the number of new HSV-2 infections over a two year period by 34.9 (1.6 to 68.2) per 1000 people exposed. Stepping Stones significantly improved a number of reported risk behaviours in men, with a lower proportion of men reporting perpetration of intimate partner violence across two years of follow-up and less transactional sex and problem drinking at 12 months. In women desired behaviour changes were not reported and those in the Stepping Stones programme reported more transactional sex at 12 months.



Stepping Stones did not reduce incidence of HIV but had an impact on several risk factors for HIV-notably, HSV-2 and perpetration of intimate partner violence.
Tablet Technology for Rehabilitation after Spinal Cord Injury: a Proof-of-Concept

Spinal cord injury (SCI) is a damage to the spinal cord resulting in a change, either temporary or permanent, in motor, sensory, or autonomic functions. Patients with SCI usually have permanent and often devastating neurologic deficits and disability. Trunk motor control is crucial for postural stability and propulsion after low thoracic SCI and several rehabilitative strategies are aimed at trunk stability and control. Tablet technology and gaming systems are novel and potentially useful strategies that apply relevant concepts in rehabilitation for these patients. In this study we combined the traditional training of trunk control with exercises administered through two iPad games apps, 2 or 3 times a week. All the participant patients showed increasing game scores during the treatment, as well as increasing Trunk Recovery Scale scores, showing a significant improvement in trunk control. Also the personal judgment of the patients, collected through evaluation questionnaires, was very positive.
Randomized Clinical Trial of the Effects of Perioperative Use of Immune-enhancing Enteral Formula on Metabolic and Immunological Status in Patients Undergoing Esophagectomy

Although perioperative immune-enhancing enteral formula (IEEF) is effective to decrease the rate of infectious complications, it is not clear whether perioperative use of IEEF decreases the incidence of postoperative complications and improves clinical outcome in patients who have undergone esophagectomy. A prospective randomized clinical trial was performed to examine the effects of perioperative IEEF on nutritional and immunological status in patients with esophageal carcinoma who have been treated with esophagectomy. A total of 30 patients were randomly assigned to two groups, each receiving 3 days of preoperative and postoperative enteral nutrition through jejunostomy started within 24 h after operation, either with immune-enhancing enteral formula (group IEEF, n = 16) or with regular polymeric enteral formula (group C, n = 14). Preoperative and postoperative nutritional and immunological parameters and clinical outcome were examined. A significant increase in the serum concentration of ornithine was noted in group IEEF and it peaked at 5 days after surgery. The equivalent values were significantly lower in group C. There was no difference in serum dochosahexaic acid between the two groups. The n−3/n−6 fatty acid ratio in group IEEF was significantly higher than in group C at 7 days after surgery. Peripheral percent lymphocyte fraction and total lymphocyte count in group IEEF were both significantly higher than those in group C. While T cell fraction of peripheral lymphocytes in group IEEF at 3 days after surgery, B cell fraction in group IEEF at 5 and 7 days after surgery was significantly higher than those in group C, suggesting that perioperative IEEF caused a shift towards B cell proliferation. Perioperative use of IEEF caused a significant increase in the total lymphocyte count at 3 and 5 days after operation and caused a shift toward B cell proliferation, which may possibly be beneficial to decrease the incidence of postoperative infectious complications.
Higher anticholinergic drug scale (ADS) scores are associated with peripheral but not cognitive markers of cholinergic blockade. Cross sectional data from 21 Norwegian nursing homes.

This study evaluated a presumed gradual decline in cognitive function in nursing home residents when the anticholinergic drug scale (ADS) score increased above 3.



The study population was recruited from 21 nursing homes in Norway. Criteria for inclusion were ADS score ≥ 3 and no severe dementia, defined as Clinical Dementia Rating (CDR) score < 3. Primary cognitive end points were CERAD 10-word lists for recall and Mini Mental State Examination (MMSE). Secondary end points were activity of daily living (ADL), mouth dryness and serum anticholinergic activity (SAA). The patients were stratified into subgroups according to ADS score, i.e. a reference group with score 3 and test groups with scores 4, 5 or ≥6. End points were compared by analyses of covariance (ancova).



Overall, 230 of the 1101 screened nursing home residents (21%) had an ADS score ≥3. After exclusion 101 residents were recruited and among these, 87 managed to participate in the study. No significant differences were detected in cognitive function or ADL when ADS increased above 3 (P > 0.10), but in vivo (mouth dryness) and in vitro (SAA) measures of peripheral anticholinergic activity were significantly higher in patients with an ADS score ≥6 (P < 0.01).



The present study does not support a progressive decline in cognitive function with ADS score above 3. This might indicate that the ADS score model has limited potential to predict the clinical risk of central anticholinergic side effects in frail elderly patients receiving multiple anticholinergic drugs.
Lobeglitazone, a Novel Thiazolidinedione, Improves Non-Alcoholic Fatty Liver Disease in Type 2 Diabetes: Its Efficacy and Predictive Factors Related to Responsiveness

Despite the rapidly increasing prevalence of non-alcoholic fatty liver disease (NAFLD) in type 2 diabetes (T2D), few treatment modalities are currently available. We investigated the hepatic effects of the novel thiazolidinedione (TZDs), lobeglitazone (Duvie) in T2D patients with NAFLD. We recruited drug-naïve or metformin-treated T2D patients with NAFLD to conduct a multicenter, prospective, open-label, exploratory clinical trial. Transient liver elastography (Fibroscan®; Echosens, Paris, France) with controlled attenuation parameter (CAP) was used to non-invasively quantify hepatic fat contents. Fifty patients with CAP values above 250 dB/m were treated once daily with 0.5 mg lobeglitazone for 24 weeks. The primary endpoint was a decline in CAP values, and secondary endpoints included changes in components of glycemic, lipid, and liver profiles. Lobeglitazone-treated patients showed significantly decreased CAP values (313.4 dB/m at baseline vs. 297.8 dB/m at 24 weeks; P = 0.016), regardless of glycemic control. Lobeglitazone improved HbA(1C) values (7.41% [57.5 mM] vs. 6.56% [48.2 mM]; P < 0.001), as well as the lipid and liver profiles of the treated patients. Moreover, multivariable linear regression analysis showed that hepatic fat reduction by lobeglitazone was independently associated with baseline values of CAP, liver stiffness, and liver enzymes, and metformin use. Lobeglitazone treatment reduced intrahepatic fat content, as assessed by transient liver elastography, and improved glycemic, liver, and lipid profiles in T2D patients with NAFLD. Further randomized controlled trials using liver histology as an end point are necessary to evaluate the efficacy of lobeglitazone for NAFLD treatment.
Association of the B-vitamins pyridoxal 5'-phosphate (B(6)), B(12), and folate with lung cancer risk in older men.

A nested case-control study was conducted within the Alpha-Tocopherol, Beta-Carotene Cancer Prevention Study cohort to test for associations between selected B-vitamins (folate, vitamin B(6), vitamin B(12)) and incident lung cancer. This trial was conducted in Finland between 1985 and 1993. Serum was analyzed for these nutrients and homocysteine among 300 lung cancer cases and matched controls (1:1). Odds ratios and 95% confidence intervals were determined in conditional and unconditional (controlling for the matching factors) logistic regression models, after adjusting for body mass index, years of smoking, and number of cigarettes smoked per day. No significant associations were seen between serum folate, vitamin B(12), or homocysteine and lung cancer risk. The authors found significantly lower risk of lung cancer among men who had higher serum vitamin B(6) levels. Compared with men with the lowest vitamin B(6) concentration, men in the fifth quintile had about one half of the risk of lung cancer (odds ratio = 0.51; 95% confidence interval: 0.23, 0.93; p-trend = 0.02). Adjusting for any of the other serum factors (folate, B(12), and homocysteine) either alone or jointly did not significantly alter these estimates. This is the first report from a prospectively conducted study to suggest a role for vitamin B(6) in lung cancer.
Advisor-Teller Money Manager (ATM) therapy for substance use disorders.

Patients with concomitant psychiatric and substance use disorders are commonly assigned representative payees or case managers to help manage their funds, but money management has not been conceptualized as a theory-based treatment. This randomized clinical trial was conducted to determine the effect of a money management-based therapy, advisor-teller money manager (ATM), on substance abuse or dependence.



Ninety patients at a community mental health center who had a history of cocaine or alcohol abuse or dependence were assessed after random assignment to 36 weeks of ATM (N=47) or a control condition in which use of a financial workbook was reviewed (N=43). Patients assigned to ATM were encouraged to deposit their funds into a third-party account, plan weekly expenditures, and negotiate monthly budgets. Substance use calendars and urine toxicology tests were collected every other week for 36 weeks and again 52 weeks after randomization.



Patients assigned to ATM had significantly more negative toxicologies for cocaine metabolite over time than patients in the control group, and treating clinicians rated ATM patients as significantly more likely to be abstinent from illicit drugs. Self-reported abstinence from alcohol did not significantly differ between groups. Unexpectedly, patients assigned to ATM were more likely to be assigned a representative payee or a conservator than control participants during the follow-up period (ten of 47 versus two of 43). One patient in ATM assaulted the therapist when his check had not arrived.



ATM is an efficacious therapy for the treatment of cocaine abuse or dependence among people with concomitant psychiatric illness but requires protection of patient autonomy and staff safety.
Cervical myeloradiculopathy with entrapment neuropathy: a study based on the double-crush concept

In an attempt to formulate a standardised approach to the diagnosis and management of patients with the double-crush syndrome, we reviewed 65 surgical cases (39 men and 26 women) with cervical myeloradiculopathy associated with entrapment neuropathy in the arm by examining the clinical features, results of nerve conduction velocity studies and distribution of the vertebral levels of compression. Fifty-three patients (average age, 43 years) presented with a carpal tunnel syndrome at the wrist and cervical lesions (41 with spondylosis and 12 with ossified posterior longitudinal ligament), while 12 had a cubital tunnel syndrome at the elbow with cervical lesions (eight with spondylosis and four with ossification of the posterior longitudinal ligament). In the former group, the lesions were found mostly at C5–6 and C6–7 levels, while in the latter group involvement of C6–7 was frequently observed. Two patients in each group required additional cervical decompression after carpal or cubital tunnel release. A retrospective review of our patients suggested that it is reasonable to pursue an accurate diagnosis followed by treatment based on individual neurological and electrophysiological findings, but taking into consideration the significant level of physical impairment associated with cord compromise, we believe that it may be reasonable to perform a cervical decompression rather than peripheral nerve release in such cases. Our findings suggest that one should be aware of a double-crush during examination of patients complaining of neck and hand problems.