nils-herrmann/clean_scirepeval huggingface dataset:
Local infusion analgesia using intra-articular double lumen catheter after total knee arthroplasty: a double blinded randomized control study

Although intra-operative local infiltration analgesia has gained increasing popularity in joint replacement surgery, it is not clear whether postoperative local infusion analgesia using an indwelling catheter provides clinically important additional effects. We, therefore, conducted a randomized controlled trial to clarify the efficacy of the originally developed local infusion analgesia technique in total knee arthroplasty. Forty patients were randomly allocated to the local infusion analgesia or control group. Patients in the local infusion analgesia group received intermittent bolus intra-articular injection of analgesics consisting of ropivacaine, dexamethasone, and isepamicin until postoperative 48 h. Primary outcome was pain severity at rest using 100-mm visual analogue scale. Pain severity in patients of the local infusion analgesia group was lower than control group, and there were significant differences between groups at POD1 (p = 0.025) and POD3 (p = 0.007). Reduction of postoperative pain was associated with a decrease in C-reactive protein level and earlier achievement of straight leg raise. In addition, postoperative drain volume was reduced in the local infusion analgesia group. Although larger studies are needed to examine its safety, the local infusion analgesia alone provided clinically significant analgesic effects and rapid recovery in total knee arthroplasty. Randomized controlled trial, Level I.
Clinical Comparison With Short-Term Follow-Up of Bioresorbable Vascular Scaffold Versus Everolimus-Eluting Stent in Primary Percutaneous Coronary Interventions.

Objective of this study was to assess the clinical performance of bioresorbable vascular scaffold (BVS) compared to everolimus-eluting stent (EES) in subjects with ST-segment elevation myocardial infarction (STEMI). We included all consecutive patients with STEMI who underwent percutaneous coronary intervention (PCI) with BVS implantation in centers participating to the Italian ABSORB Prospective Registry (BVS-RAI) and PCI with EES in the same centers during the same period. The 2 groups were compared. The primary end point was patient-oriented composite end point (POCE) including cardiac death, myocardial infarction, and target lesion revascularization (TLR) at the longest available follow-up. BVS or EES thrombosis at follow-up was also evaluated. Of the 563 patients with STEMI included, 122 received BVS and 441 EES. Procedural success was obtained in 549 (97.5%) cases without significant differences between the 2 groups (BVS 99.3% vs EES 97.0%, p = 0.2). At a median of 220-day (interquartile range 178 to 369) follow-up, no significant differences were observed in terms of POCE (BVS 4.9% vs EES 7.0%, p = 0.4); death (BVS 0.8%, EES 2.0%, p = 0.4), MI (BVS 4.1%, EES 2.0%, p = 0.2), TLR (BVS 4.1%, EES 4.5%, p = 0.8), device thrombosis (BVS 2.5%, EES 1.4%, p = 0.4). All TLR cases were successfully managed with re-PCI in both groups. A propensity matching of the study populations showed no significant differences regarding POCE at the longest available follow-up (odds ratio 0.53, 0.1 to 4.3). In conclusion, in this direct prospective comparison, BVS was associated with similar clinical results compared to EES in the STEMI setting. Larger and adequately powered randomized trials are needed to fully assess the potential clinical benefit of BVS versus the current standard of care in patients with STEMI.
A randomized pilot study of MOtiVation and Enhancement (MOVE) Training for negative symptoms in schizophrenia

Among individuals with schizophrenia, those who have persistent and clinically significant negative symptoms (PNS) have the poorest functional outcomes and quality of life. The NIMH-MATRICS Consensus Statement indicated that these symptoms represent an unmet therapeutic need for large numbers of individuals with schizophrenia. No psychosocial treatment model addresses the entire constellation of PNS.



51 patients with PNS were randomized into one of two groups for a period of 9 months: 1) MOtiVation and Enhancement (MOVE) or 2) treatment as usual. MOVE is a home based, manual-driven, multi-modal treatment that employs a number of cognitive and behavioral principles to address the broad range of factors contributing to PNS and their functional consequences. The components of MOVE include: Environmental supports to prompt initiation and persistence, in-vivo skills training to ameliorate deficits and encourage interaction, cognitive behavioral techniques to address self-defeating attitudes, in-vivo training in emotional processing to address affective blunting and problems in identifying emotions, and specific techniques to address the deficits in anticipatory pleasure. Patients were assessed at baseline and each 3 months with multiple measures of negative symptoms.



Repeated measures analyses of variance for mixed models indicated significant Group by Time effects for the Negative Symptom Assessment (NSA; p<.02) and the Clinical Assessment Interview for Negative Symptoms (CAINS; p<.04). Group differences were not significant until 9 months of treatment and were not significant for the Brief Negative Symptom Scale (BNSS).



Further investigation of a comprehensive treatment for PNS, such as MOVE, is warranted.
Influence of gravity compensation training on synergistic movement patterns of the upper extremity after stroke, a pilot study

The majority of stroke patients have to cope with impaired arm function. Gravity compensation of the arm instantaneously affects abnormal synergistic movement patterns. The goal of the present study is to examine whether gravity compensated training improves unsupported arm function. Seven chronic stroke patients received 18 half-hour sessions of gravity compensated reach training, in a period of six weeks. During training a motivating computer game was played. Before and after training arm function was assessed with the Fugl-Meyer assessment and a standardized, unsupported circle drawing task. Synergistic movement patterns were identified based on concurrent changes in shoulder elevation and elbow flexion/extension angles. Median increase of Fugl-Meyer scores was 3 points after training. The training led to significantly increased work area of the hemiparetic arm, as indicated by the normalized circle area. Roundness of the drawn circles and the occurrence of synergistic movement patterns remained similar after the training. A decreased strength of involuntary coupling might contribute to the increased arm function after training. More research is needed to study working mechanisms involved in post stroke rehabilitation training. The used training setup is simple and affordable and is therefore suitable to use in clinical settings.
The 90-Day Mortality After Pancreatectomy for Cancer Is Double the 30-Day Mortality: More than 20,000 Resections From the National Cancer Data Base

Operative mortality traditionally has been defined as the rate within 30 days or during the initial hospitalization, and studies that established the volume–outcome relationship for pancreatectomy used similar definitions. Pancreatectomies reported to the National Cancer Data Base (NCDB) during 2007–2010 were examined for 30- and 90-day mortality. Unadjusted mortality rates were compared by type of resection, stage, comorbidities, and average annual hospital volume. Hierarchical logistic regression models generated risk-adjusted odds ratios for 30- and 90-day mortality. After 21,482 pancreatectomies, the unadjusted 30-day mortality rate was 3.7 % (95 % confidence interval [CI] 3.4–3.9 %), which doubled at 90 days to 7.4 % (95 % CI 7.0–7.8). The unadjusted and risk-adjusted mortality rates were higher at 30 days with increasing age, increasing stage, male gender, lower income, low hospital volume, resections other than distal pancreatectomy, Medicare or Medicaid insurance coverage, residence in a Southern census division, history of prior cancer, and multiple comorbidities. The lowest-volume hospitals (<5 per year) performed 19 % of the pancreatectomies, with a risk-adjusted odds ratios for mortality that were 4.2 times higher (95 % CI 3.1–5.8) at 30 days and remained 1.9 times higher (95 % CI 1.5–2.3) at 30–90 days compared with hospitals that had high volumes (≥40 per year). Mortality rates within 90 days after pancreatic resection are double those at 30 days. The volume–outcome relationship persists in the NCDB. Reporting mortality rates 90 days after pancreatectomy is important. Hospitals should be aware of their annual volume and mortality rates 30 and 90 days after pancreatectomy and should benchmark the use of high-volume hospitals.
Focal therapy for localized prostate cancer: a phase I/II trial.

Men with localized prostate cancer currently face a number of treatment options that treat the entire prostate. These can cause significant sexual and urinary side effects. Focal therapy offers a novel strategy that targets the cancer rather than the prostate in an attempt to preserve tissue and function.



A prospective, ethics committee approved trial was conducted to determine the side effects of focal therapy using high intensity focused ultrasound. Multiparametric magnetic resonance imaging (T2-weighted, dynamic contrast enhanced, diffusion-weighted) and template transperineal prostate mapping biopsies were used to identify unilateral disease. Genitourinary side effects and quality of life outcomes were assessed using validated questionnaires. Posttreatment biopsies were performed at 6 months and followup was completed to 12 months.



A total of 20 men underwent high intensity focused ultrasound hemiablation. Mean age was 60.4 years (SD 5.4, range 50 to 70) with mean prostate specific antigen 7.3 ng/ml (SD 2.8, range 3.4 to 11.8). Of the men 25% had low risk and 75% had intermediate risk cancer. Return of erections sufficient for penetrative sex occurred in 95% of men (19 of 20). In addition, 90% of men (18 of 20) were pad-free, leak-free continent while 95% were pad-free. Mean prostate specific antigen decreased 80% to 1.5 ng/ml (SD 1.3) at 12 months. Of the men 89% (17 of 19, 1 refused biopsy) had no histological evidence of any cancer, and none had histological evidence of high volume or Gleason 7 or greater cancer in the treated lobe. In addition, 89% of men achieved the trifecta status of pad-free, leak-free continence, erections sufficient for intercourse and cancer control at 12 months.



Our results appear sufficiently promising to support the further evaluation of focal therapy as a strategy to decrease some of the harms and costs associated with standard whole gland treatments.
Ivabradine for the treatment of stable angina pectoris in octogenarians

In patients >80 years (octogenarians), there is an increased incidence of bradycardia due to age-related alteration of the sinus node, AV node, and the conduction system. Therefore, the treatment of angina pectoris with beta-blockers may be limited by bradycardia. The REDUCTION multicenter study evaluated the efficacy of ivabradine in stable angina pectoris in everyday practice. This subgroup analysis evaluated the efficacy and safety of ivabradine in octogenarians. A total of 4,954 patients were included in the REDUCTION study for treatment of stable angina pectoris. This group included 382 octogenarians (mean age 83 ± 2.9 years) who were followed up over 4 months. Patients were treated with ivabradine in flexible doses (2.5, 5, or 7.5 mg bid). Heart rate (HR), angina pectoris attacks, nitrate consumption, overall efficacy, and tolerance were evaluated. After 4 months of treatment with ivabradine, HR was reduced by 12.0 ± 12.0 bpm from 83.0 ± 15.4 to 71.0 ± 10.1 bpm (p < 0.0001). Angina pectoris attacks were reduced from 3.0 ± 4.6 to 0.8 ± 1.8 per week (p < 0.0001). Consumption of nitrates decreased from 4.2 ± 5.1 to 1.2 ± 2.7 (p < 0.0001). Four patients reported suspected adverse drug reactions. In one patient a syncope occurred. There was no symptomatic bradycardia reported. Efficacy and tolerance were assessed as ‘very good/good’ for 95 and 99%. The results demonstrate that ivabradine efficiently reduces HR, number of angina attacks, and nitrate consumption in octogenarian patients. The treatment was safe and well tolerated without relevant bradycardia.
Thalidomide in the treatment of cancer cachexia: a randomised placebo controlled trial.

Proinflammatory cytokines, especially tumour necrosis factor alpha (TNF-alpha), play a prominent role in the pathogenesis of cancer cachexia. Thalidomide, which is an inhibitor of TNF-alpha synthesis, may represent a novel and rational approach to the treatment of cancer cachexia.



To assess the safety and efficacy of thalidomide in attenuating weight loss in patients with cachexia secondary to advanced pancreatic cancer.



Fifty patients with advanced pancreatic cancer who had lost at least 10% of their body weight were randomised to receive thalidomide 200 mg daily or placebo for 24 weeks in a single centre, double blind, randomised controlled trial. The primary outcome was change in weight and nutritional status.



Thirty three patients (16 control, 17 thalidomide) were evaluated at four weeks, and 20 patients (eight control, 12 thalidomide) at eight weeks. At four weeks, patients who received thalidomide had gained on average 0.37 kg in weight and 1.0 cm(3) in arm muscle mass (AMA) compared with a loss of 2.21 kg (absolute difference -2.59 kg (95% confidence interval (CI) -4.3 to -0.8); p = 0.005) and 4.46 cm(3) (absolute difference -5.6 cm(3) (95% CI -8.9 to -2.2); p = 0.002) in the placebo group. At eight weeks, patients in the thalidomide group had lost 0.06 kg in weight and 0.5 cm(3) in AMA compared with a loss of 3.62 kg (absolute difference -3.57 kg (95% CI -6.8 to -0.3); p = 0.034) and 8.4 cm(3) (absolute difference -7.9 cm(3) (95% CI -14.0 to -1.8); p = 0.014) in the placebo group. Improvement in physical functioning correlated positively with weight gain (r = 0.56, p = 0.001).



Thalidomide was well tolerated and effective at attenuating loss of weight and lean body mass in patients with cachexia due to advanced pancreatic cancer.
Five-year findings of the Hypertension Detection and Follow-up Program

The Hypertension Detection and Follow-up Program (HDFP) data are reported by diastolic blood pressure (DBP) stratum for four race-sex subgroups. For Stratum I (entry DBP 90–104 mm Hg) in each of the race-sex subgroups (black male, black female, white male, and white female), Stepped Care (SC) participants experienced a reduced mortality as compared to Referred Care (RC). For black males and females in all three entry DBP strata, mortality was lower in the SC than RC. Only in three subgroups did the SC mortality exceed RC: Stratum II (entry DBP 105–114 mm Hg) white females and Stratum III (entry DBP 115+ mm Hg) white males and females. Possible explanations for these deviant findings are discussed. The HDFP was designed to determine the difference in total 5-year mortality between SC and RC; subgroup analyses may be subject to large chance variation and must be interpreted with great caution. The value of vigorous treatment of “mild” hypertension (Stratum I) in males and females, black and white, and the value of treatment for all blood pressure strata in blacks are confirmed by this analysis.
Efficacy and safety of torcetrapib, a novel cholesteryl ester transfer protein inhibitor, in individuals with below-average high-density lipoprotein cholesterol levels.

This study was designed to evaluate the efficacy and safety of torcetrapib, a cholesteryl ester transfer protein (CETP) inhibitor, in subjects with low high-density lipoprotein cholesterol (HDL-C) levels.



Evidence suggests HDL-C is atheroprotective. A proven mechanism for increasing the level of HDL-C is the inhibition of CETP.



A total of 162 subjects with below-average HDL-C (men <44 mg/dl; women <54 mg/dl) who were not taking lipid-modifying therapy were randomized to double-blind treatment with torcetrapib 10, 30, 60, or 90 mg/day or placebo ( approximately 30 subjects per group).



The percent change from baseline to Week 8 with torcetrapib (least-squares mean difference from placebo) was dose-dependent and ranged from 9.0% to 54.5% for HDL-C (p < or = 0.0001 for 30 mg and higher doses) and from 3.0% to -16.5% for low-density lipoprotein cholesterol (LDL-C) (p < 0.01 for 90-mg dose). Low-density lipoprotein cholesterol lowering was less in subjects with higher (>150 mg/dl) versus lower levels of baseline triglycerides; at 60 mg, the change in LDL-C was 0.1% versus -22.2% (p < 0.0001), respectively. Particle size for both HDL and LDL increased with torcetrapib. There were no dose-related increases in the frequency of adverse events. Significant blood pressure increases were noted in 2 of 140 subjects.



Torcetrapib resulted in substantial dose-dependent elevations in HDL-C, accompanied by moderate decreases in LDL-C at the higher doses. Torcetrapib was generally well tolerated.
[A prospective trial comparing consecutive series of open retropubic and robot-assisted laparoscopic radical prostatectomy in a centre: Oncologic and functional outcomes].

Radical prostatectomy (RP) is an oncologic and functional challenge. Few series compare prospectively the two approaches, open retropubic (ORP) and laparoscopic robot-assisted RP (LRARP). The objective was to compare the oncological and functional results of ORP and LRARP.



From January 2009 to March 2012, two practiced surgeons conducted 304 consecutive RP: respectively 129 ORP and 175 LRARP. Preoperative, perioperative and postoperative data (location and size of positive surgical margins [PSM]) were recorded prospectively and compared with oncological results (PSM, biochemical recurrence-free survival [BCR]) and functional outcomes (urinary and erectile) by self-validated questionnaires (USP, IIEF-15). The comparison was made by the Chi(2) test and Student t-test for qualitative and quantitative variables.



The preoperative data 2 groups were comparable. MCP rate was 13.2% for the ORP and 20% for the LRARP (ns) and was 1.4% and 29.6% (ORP) versus 9.4% and 36.7% (LRARP) for pT2 and pT3 for respectively (P=0.078). BCR was the same in both groups (95.2% at 13.1 months). At 12 months, the results of continence showed no difference (P=0.49) and about erectile function, the EF-score was significantly higher in LRARP: 22 versus 17 for the ORP (P=0.03).



Oncological results were comparable after ORP and LRARP. The recovery of continence was excellent regardless of the surgical technique, the recovery of erectile function a bit faster by LRARP.
Tenofovir monotherapy versus tenofovir plus lamivudine or telbivudine combination therapy in treatment of lamivudine-resistant chronic hepatitis B.

Tenofovir disoproxil fumarate (TDF) monotherapy is a therapeutic option for chronic hepatitis B (CHB) patients infected with hepatitis B virus (HBV) variants resistant to lamivudine (LAM). We evaluated the antiviral efficacy and safety of TDF alone compared to those of TDF plus LAM or telbivudine (LdT) combination in patients harboring HBV variants with genotypic resistance to LAM. This multicenter retrospective study included consecutive patients who had LAM-resistant HBV variants and were treated with TDF alone (monotherapy group) or TDF combined with LAM or LdT (combination therapy group) for at least 6 months. Inverse probability of treatment weighting (IPTW) for the entire cohort was applied to control for treatment selection bias. Overall, 153 patients (33 in the monotherapy group and 120 in the combination therapy group) were analyzed. The overall probability of achieving complete virologic suppression at month 12 was 91.6%: 88.6% in the monotherapy group and 92.6% in the combination therapy group. Combination therapy was not superior to monotherapy in viral suppression before and after IPTW (P=0.562 and P=0.194, respectively). Hepatitis B e antigen (HBeAg) loss, biochemical response, and virologic breakthrough did not differ between treatment groups. The probabilities of complete virologic suppression were comparable between treatment groups in the subsets according to HBeAg status and HBV DNA levels at baseline. No patient experienced any significant renal dysfunction during the treatment period. In conclusion, TDF monotherapy has antiviral efficacy comparable to that of TDF plus LAM or LdT combination therapy, with a favorable safety profile in CHB patients with LAM-resistant HBV variants.
Hyperhomocysteinemia in patients with pulmonary embolism is associated with impaired plasma fibrinolytic capacity

Hyperhomocysteinemia (HHcy) affects haemostasis and shifts its balance in favour of thrombosis. In vitro and in vivo studies suggested that HHcy may impair fibrinolysis either by influencing the plasma levels of fibrinolytic factors or by altering the fibrinogen structure. We investigated the influence of mild HHcy levels on plasma fibrinolytic potential by using clot lysis time (CLT) and fibrin susceptibility to plasmin-induced lysis in 94 patients with previous pulmonary embolism and no pulmonary hypertension. CLT was measured as lysis time of tissue factor induced clots exposed to exogenous tissue plasminogen activator (t-PA). The rate of in vitro plasmin-mediated cleavage of fibrin β-chain was assessed over a 6-h period on fibrin clots, which were obtained by exposition to thrombin of purified fibrinogen. Homocysteine plasma levels were measured by Abbott Imx immunoassay and we considered as altered the values above 15 μmol/L according to the literature. In 68 patients homocysteine levels were below 15 μmol/L (NHcy) and in 26 they were above (HHcy). Significant differences were observed between the two groups regarding plasma fibrinolytic potential (p = 0.016), TAFIact (expressed as clot lysis ratio) (p = 0.02), t-PA (0.008) and PLG (0.037), but not for the other assessed components. The HHcy-patients had a threefold higher risk to have an impaired fibrinolysis. Instead, a multivariate logistic regression analysis adjusted for significances of univariate showed that HHcy (OR 5.2 95 % CI 1.7–15.9; p = 0.003) and BMI (OR 5.0 95 % CI 1.6–15.9; p = 0.006) resulted independently associated with impaired fibrinolytic activity. HHcy affects TAFI-mediated hypofibrinolysis but not fibrin(ogen) structure or function as documented by fibrin degradation analysis.
Making it "pay a bit better": design challenges for micro rural enterprise

This paper reports on a field study of small market in Wales undertaken as part of broader research project aimed at developing IT solutions to support rural enterprise. The project is predicated on the assumption that the primary challenge facing rural enterprise is that of scale and that IT solutions could and should add value by enabling growth. The study suggests that many rural enterprises are micro in character, that they are not driven by the need to grow, and that value is and can be added in different ways that reflect the social values oriented to and employed by micro businesses and their consumers. The paper elaborates vernacular understandings of supply chains and their coordination, along with business and consumer motivations to consider alternative possibilities for design that place emphasis on making micro rural enterprise "pay a bit better" rather than scaling it up.