nils-herrmann/clean_scirepeval huggingface dataset:
Routine Drainage of the Operative Bed Following Elective Distal Pancreatectomy Does Not Reduce the Occurrence of Complications

: Routine drainage of the operative bed following elective pancreatectomy remains controversial. Data specific to distal pancreatectomy (DP) have not been examined in a multi-institutional collaborative.  Data from the American College of Surgeons-National Surgical Quality Improvement Program Pancreatectomy Demonstration Project were utilized. The impact of drain placement on development of pancreatectomy-related and overall morbidity were analyzed. Propensity scores for drain placement were calculated, and nearest neighbor matching was used to create a matched cohort. Groups were compared using bivariate and logistic regression analyses. : Over 14 months, 761 patients undergoing DP were accrued; 606 were drained. Propensity score matching was possible in 116 patients. Drain and no drain groups were not different with respect to multiple preoperative and operative variables. All pancreatic fistulas (p < 0.01) and overall morbidity (p < 0.05) were more common in patients who received a drain. The placement of a drain did not reduce the incidence of clinically relevant pancreatic fistula nor the need for postoperative procedures.  Placement of drains following elective distal pancreatectomy was associated with a higher overall morbidity and pancreatic fistulas. Drains did not reduce intra-abdominal septic morbidity, clinically relevant pancreatic fistulas, nor the need for postoperative therapeutic intervention.
ADFR therapy in the prevention of bone loss after menopause

Estrogens retard bone loss after menopause and constitute the most logical therapy for the prevention of postmenopausal osteoporosis. Estrogens are contraindicated in some circumstances and some postmenopausal women are unwilling to accept them. We have used ADFR therapy as an alternative in the prevention of postmenopausal bone loss. One hundred women in the early postmenopausal period (6–24 months since the last menses) were introduced into the study. 50 were treated with placebo and 50 were treated with ADFR therapy (phosphorus 1.5 gr/day during 3 days, followed by SCT 100 UI/day during 10 days and calcium 1 gr/day). After 77 days without any therapy we repeated the cycles every 3 months. Bone mass was evaluated at the beginning and at 3, 6, 12 and 18 months by dual-photon absorptionmetry lumbar spine. In the control group, the mean spinal BMD decreased 7.31% after 12 months and 6.16% after 18 months (p>0.05). The ADFR group only had a mean spinal BMD decrease of 3.79% and 1.1% after 12 and 18 months respectively (NS). Bone loss was greater in control than in ADFR group after 12 and 18 months (p<0.05 at both times). We conclude that phosphorus and calcitonin like ADFR therapy may be a useful alternative to estrogen for the prevention of accelerated bone loss after menopause.
Rilpivirine versus efavirenz with tenofovir and emtricitabine in treatment-naive adults infected with HIV-1 (ECHO): a phase 3 randomised double-blind active-controlled trial

Efavirenz with tenofovir-disoproxil-fumarate and emtricitabine is a preferred antiretroviral regimen for treatment-naive patients infected with HIV-1. Rilpivirine, a new non-nucleoside reverse transcriptase inhibitor, has shown similar antiviral efficacy to efavirenz in a phase 2b trial with two nucleoside/nucleotide reverse transcriptase inhibitors. We aimed to assess the efficacy, safety, and tolerability of rilpivirine versus efavirenz, each combined with tenofovir-disoproxil-fumarate and emtricitabine.



We did a phase 3, randomised, double-blind, double-dummy, active-controlled trial, in patients infected with HIV-1 who were treatment-naive. The patients were aged 18 years or older with a plasma viral load at screening of 5000 copies per mL or greater, and viral sensitivity to all study drugs. Our trial was done at 112 sites across 21 countries. Patients were randomly assigned by a computer-generated interactive web response system to receive either once-daily 25 mg rilpivirine or once-daily 600 mg efavirenz, each with tenofovir-disoproxil-fumarate and emtricitabine. Our primary objective was to show non-inferiority (12% margin) of rilpivirine to efavirenz in terms of the percentage of patients with confirmed response (viral load <50 copies per mL intention-to-treat time-to-loss-of-virological-response [ITT-TLOVR] algorithm) at week 48. Our primary analysis was by intention-to-treat. We also used logistic regression to adjust for baseline viral load. 
346 patients were randomly assigned to receive rilpivirine and 344 to receive efavirenz and received at least one dose of study drug, with 287 (83%) and 285 (83%) in the respective groups having a confirmed response at week 48. The point estimate from a logistic regression model for the percentage difference in response was -0.4 (95% CI -5.9 to 5.2), confirming non-inferiority with a 12% margin (primary endpoint). The incidence of virological failures was 13% (rilpivirine) versus 6% (efavirenz; 11%vs 4% by ITT-TLOVR). Grade 2-4 adverse events (55 [16%] on rilpivirine vs 108 [31%] on efavirenz, p<0.0001), discontinuations due to adverse events (eight [2%] on rilpivirine vs 27 [8%] on efavirenz), rash, dizziness, and abnormal dreams or nightmares were more common with efavirenz. Increases in plasma lipids were significantly lower with rilpivirine.



Rilpivirine showed non-inferior efficacy compared with efavirenz, with a higher virological-failure rate, but a more favourable safety and tolerability profile.
HER2 Status Determination: Analyzing the Problems to Find the Solutions

Misdiagnosis in the evaluation of HER2 status in breast cancer may have consequent negative impact on clinical decision-making. Therefore, it has become ever more important to share procedures and interpretation criteria for HER2 testing among laboratories. Herein, we report an interlaboratory survey among 9 hospitals located in the central-south regions of Italy. The centers sent a series of 36 slides, 4 for each HER2 score, to the revising centers. We found a good concordance in HER2 scoring for 0 and 3+ score, but a very low concordance for 1+ and 2+ scores. To focus on factors that may lead to discordant results, we report 4 cases which summarized the most common source of discrepancy in HER2 testing. This methodological approach will help the individual laboratory to minimize technical variables and to reduce the percentage of erroneous interpretations of HER2 status.
Prevalence of vertebral fractures in an urban population in Croatia aged fifty and older

To establish the prevalence of vertebral fractures according to age groups, sex and vertebral level in a sample of a Croatian urban population aged ≥50. We also tried to establish how many people had been diagnosed with osteoporosis by their family physician.  Lateral thoracic and lumbar spinal radiographs were obtained in 425 ambulatory people (156 men and 269 women) aged ≥50 and living in the community as a random sample of the City of Zagreb (Croatia) population. An interviewer-administered questionnaire was used to obtain information on prior traumatic vertebral fractures and whether the person had been diagnosed with osteoporosis. Vertebral fractures in the population sample were defined using the morphometric method proposed by McCloskey et al., and normal values of the ratios of dimensions in non-fractured vertebrae with the iterative algorithm described by Melton et al.  The prevalence of individuals with vertebral fractures was 11.8% (15.8% of men and 9.7% of women), ranking Zagreb mid-scale among other European cities. The prevalence of individuals with vertebral fractures rose with age. Sixty-nine (1.24%) of 5525 analysed vertebrae had been fractured. The most common fractures were those of lower thoracic and upper lumbar vertebrae. The elderly tend to sustain multiple fractures. Forty-one (9.6%) people had been previously diagnosed as having osteoporosis. Extrapolation to the Croatian population implies that approximately 90,000 men and 77,000 women aged ≥50 have vertebral fractures.  Vertebral osteoporotic fractures are common in the Croatian population aged ≥50; however, awareness of osteoporosis appears to be low.
Impact of prevalent and incident vertebral fractures on utility: results from a patient-based and a population-based sample

Data are scarce on the impact of vertebral fractures (VFX) on utility. The objective of this study was to assess the impact of prevalent and incident VFX on utility in both a patient-based and population-based sample. Data from the Multiple Outcomes of Raloxifene Evaluation (MORE) study (n = 550 for prevalent VFX and n = 174 for incident VFX) and the European Prospective Osteoporosis Study (EPOS) (n = 236) were used. Utility was assessed by the index score of the EQ-5D. In the MORE study, highly statistically significant associations were found between utility and the presence of prevalent VFX (p < 0.001), number of prevalent VFX (p < 0.001), severity of prevalent VFX (p < 0.001), the combination of number and severity of prevalent VFX (p = 0.001) and location of prevalent VFX (p = 0.019). The mean utility was significantly lower among women who suffered an incident VFX (utility = 0.67) than among women who did not (utility = 0.77) (p = 0.005), although utility loss was not significantly different between the two groups (p = 0.142). In EPOS, the combination of number and severity of incident VFX was significantly related to utility (p = 0.030). In conclusion, utility is lower among persons with prevalent and incident VFX, especially in a patient-based sample. Utility loss was not significantly different between women without and with incident VFX.
Comparison of domiciliary nebulized salbutamol and salbutamol from a metered-dose inhaler in stable chronic airflow limitation.

Nineteen patients (12 men) mean age, 63.4 years (range, 32 to 78), with stable chronic airflow limitation, mean FEV, 0.55 L (range, 0.3 to 1.05 L), completed an eight-week, double-blind, double cross-over study comparing nebulized salbutamol and salbutamol from a metered-dose inhaler (MDI). Salbutamol from both delivery systems produced bronchodilation. The doses of salbutamol inhaled via the nebulizer and MDI producing maximal bronchodilation were established by cumulative dose-response curves. The contents of the nebulizer and MDI were inhaled four times a day, one system containing salbutamol and the other a placebo. Cross-over of salbutamol from one system to the other occurred every two weeks. There was no significant difference between the two delivery methods in daily peak expiratory flow rate (PEFR), severity of symptoms, or extra bronchodilator usage. Two weekly laboratory assessments of spirometry, PEFR, and exercise tolerance also showed no significant differences. Careful assessment is recommended before the provision of domiciliary nebulizers.
Ticagrelor or prasugrel for pre-hospital protocols in STEMI?

Nathalie Fournier , Richard Toesca , Jacques Bessereau , Anne Champenois , André Mazille , Stéphane Luigi , Serge Yvorra , Franck Paganelli , Pierre-Marie Brun , Pierre Michelet , Daniel Meyran , Jean-Pierre Auffray , Laurent Bonello e,⁎ a Pole RUSH, hôpital de la Timone, Marseille, France b Service d'accueil des urgences, Hôpital de Martigues, France c Service de cardiologie, Hôpital de Martigues, Martigues, France d Département de cardiologie, Hôpital Universitaire Nord, Marseille, France e SMUR de Marseille, Bataillon des Marins Pompiers, Marseille, France
Emerging resistant bacteria strains in bloodstream infections of acute leukaemia patients: results of a prospective study by the Rete Ematologica Lombarda (Rel)

Multiresistant bacterial infections are a potentially life-threatening condition in acute leukaemia (AL) patients. We aimed to better define the very recent epidemiology and outcome of bloodstream infections (BSIs) in a real-life setting. We prospectively collected all consecutive febrile/infectious episodes occurring in AL patients admitted to 9 haematology units. In 293 AL patients, 433 BSIs were diagnosed. Gram-positive (GP) bacteria were isolated in 44.8 % BSI and Gram-negative (GN) in 38.3 %, while polymicrobial aetiology- or fungi-related events were identified in 15.7 and 1.1 % of the cases, respectively. GP was observed more frequently in patients not in complete remission (p = 0.04), while GN during consolidation cycles (p = 0.003). Extended spectrum β-lactamase-producing strains accounted for 23.2 % of enterobacteria. They were associated with previous antibiotic exposure, including fluoroquinolones prophylaxis (p = 0.01). Carbapenem-resistant (CR) strains occurred in 9 % of enterobacteria. Among Pseudomonas aeruginosa strains, 21.6 % were multiresistant. Overall 30-day mortality was 8.5 %. CR GN and multiresistant P. aeruginosa BSIs were independent predictors of death (p = 0.002), as well as relapsed/resistant AL (18.3 %; p = 0.0002) and the presence of pulmonary infiltrates (26.6 %; p < 0.001). Although GP still predominate over GN BSI, the percentage of antibiotic resistant GN strains is considerable in AL patients and it is associated with poor prognosis.
Capturing missing edges in social networks using vertex similarity

We introduce the graph vertex similarity measure, Relation Strength Similarity (RSS), that utilizes a network's topology to discover and capture similar vertices. The RSS has the advantage that it is asymmetric; can be used in a weighted network; and has an adjustable "discovery range" parameter that enables exploration of friend of friend connections in a social network. To evaluate RSS we perform experiments on a coauthorship network from the CiteSeerX database. Our method significantly outperforms other vertex similarity measures in terms of the ability to predict future coauthoring behavior among authors in the CiteSeerX database for the near future 0 to 4 years out and reasonably so for 4 to 6 years out.
Dexamethasone, paclitaxel, etoposide, cyclophosphamide (d-TEC) and G-CSF for stem cell mobilisation in multiple myeloma

Forty-one patients with multiple myeloma were treated with a novel stem cell mobilisation regimen. The primary end points were adequate stem cell mobilising ability (>1% circulating CD34-positive cells) and collection (⩾4 × 106 CD34-positive cells/kg), and safety. The secondary end point was activity against myeloma. The regimen (d-TEC) consisted of dexamethasone, paclitaxel 200 mg/m2 i.v., etoposide 60 mg/kg i.v., cyclophosphamide 3 g/m2 i.v., and G-CSF 5–10 μg/kg/day i.v. A total of 84 cycles were administered to these 41 individuals. Patient characteristics included a median age of 53 years, a median of five prior chemotherapy cycles, and a median interval of 10 months from diagnosis of myeloma to first cycle of d-TEC. Seventy-five percent of the patients had stage II or III disease, 50% had received carmustine and/or melphalan previously, and 25% had received prior radiation therapy. Eighty-eight percent of patients mobilised adequately after the first cycle of d-TEC and 91% mobilized adequately after the second cycle. An adequate number of stem cells were collected in 32 patients. Of the remaining nine patients, three mobilised, but stem cells were not collected, two mobilised but stem cell collection was <4 × 106 CD34-positive cells/kg, three did not mobilise, and one died of disease progression. Major toxicities included pancytopenia, alopecia, fever and stomatitis. One patient died from multi-organ failure and progressive disease. Fifty percent of evaluable patients demonstrated a partial response and 28.6% of patients had a minor response. This novel dose-intense regimen was safe, capable of stem cell mobilisation and collection, even in heavily pre-treated patients, and active against the underlying myeloma. Bone Marrow Transplantation (2001) 28, 137–143.
Effect of adjuvant chemotherapy with fluorouracil plus folinic acid or gemcitabine vs observation on survival in patients with resected periampullary adenocarcinoma: the ESPAC-3 periampullary cancer randomized trial.

Patients with periampullary adenocarcinomas undergo the same resectional surgery as that of patients with pancreatic ductal adenocarcinoma. Although adjuvant chemotherapy has been shown to have a survival benefit for pancreatic cancer, there have been no randomized trials for periampullary adenocarcinomas.



To determine whether adjuvant chemotherapy (fluorouracil or gemcitabine) provides improved overall survival following resection.



The European Study Group for Pancreatic Cancer (ESPAC)-3 periampullary trial, an open-label, phase 3, randomized controlled trial (July 2000-May 2008) in 100 centers in Europe, Australia, Japan, and Canada. Of the 428 patients included in the primary analysis, 297 had ampullary, 96 had bile duct, and 35 had other cancers.



One hundred forty-four patients were assigned to the observation group, 143 patients to receive 20 mg/m2 of folinic acid via intravenous bolus injection followed by 425 mg/m2 of fluorouracil via intravenous bolus injection administered 1 to 5 days every 28 days, and 141 patients to receive 1000 mg/m2 of intravenous infusion of gemcitabine once a week for 3 of every 4 weeks for 6 months.



The primary outcome measure was overall survival with chemotherapy vs no chemotherapy; secondary measures were chemotherapy type, toxic effects, progression-free survival, and quality of life.



Eighty-eight patients (61%) in the observation group, 83 (58%) in the fluorouracil plus folinic acid group, and 73 (52%) in the gemcitabine group died. In the observation group, the median survival was 35.2 months (95%% CI, 27.2-43.0 months) and was 43.1 (95%, CI, 34.0-56.0) in the 2 chemotherapy groups (hazard ratio, 0.86; (95% CI, 0.66-1.11; χ2 = 1.33; P = .25). After adjusting for independent prognostic variables of age, bile duct cancer, poor tumor differentiation, and positive lymph nodes and after conducting multiple regression analysis, the hazard ratio for chemotherapy compared with observation was 0.75 (95% CI, 0.57-0.98; Wald χ2 = 4.53, P = .03).



Among patients with resected periampullary adenocarcinoma, adjuvant chemotherapy, compared with observation, was not associated with a significant survival benefit in the primary analysis; however, multivariable analysis adjusting for prognostic variables demonstrated a statistically significant survival benefit associated with adjuvant chemotherapy.
High-dose (9 MU) long-term (60 weeks) alfa-interferon therapy for chronic hepatitis patients infected with HCV genotype 1b

Efficacy of standard regimens (e.g., 3–6 MU for 24 weeks) of alfa-IFN therapy for chronic hepatitis C has been limited, particularly in patients with HCV/1b. To see if higher-dose longer term treatment is more effective, we tried a 9 MU 60-week regimen. HCV/1b-infected chronic hepatitis patients received 9 MU IFNα2a everyday but Sunday for 2 weeks and thrice a week for next 10 weeks, and 76 patients became HCV RNA-negative while 81 remained positive. The RNA-negative patients were then randomized to receive 3 MU (group I, n=37) or 9 MU (group II, n=39) for 48 weeks. Of the RNA-positive patients, only those with normal ALT received another 9 MU 48-week treatment (group III, n=45). Sustained responders (SR) were defined as those with negative RNA and normal ALT 6 months after the therapy. SR rates based on intent-to-treat principle did not differ significantly between groups I and II (30% vs 41%), but those based on the protocol-compatible cases showed a significant difference (32% vs 56%, p=0.034). SR rate in group III was significantly lower than those in group II. Adverse effects of IFN, developed more frequently in groups II and III than in group I, were mostly reversible. In conclusion, our results encourage 9 MU 60-week IFNα treatment in HCV/1b-infected patients with careful attention to adverse effects, and suggest that the treatment should be discontinued if HCV RNA does not disappear within 12 weeks.
Are the Pathological Characteristics of Prostate Cancer More Aggressive or More Indolent Depending upon the Patient Age?

To identify pathological characteristics of prostate cancer according to patient age at diagnosis.  A retrospective review of 2,929 men diagnosed with prostate cancer was performed. Pathological characteristics were compared across age groups: ≤55, 56-75, and >75 years.  The study cohort included 133 patients (4.5%), 2,033 patients (69.5%), and 763 patients (26.0%) in the three age groups, respectively. The median pathological Gleason sums in the three age groups were 8, 7, and 8, respectively. The Gleason sum, primary Gleason score, and second primary Gleason score were significantly different among the three age groups (Z = 12.975, p = 0.002; Z = 9.264, p = 0.010; Z = 6.692, p = 0.035, resp.). The percentages of Gleason pattern 5 tumors for the three age groups were 44.4%, 32.3%, and 36.8%, respectively; they were significantly different (χ2 = 11.641, p = 0.003). The percentages of tumors with Gleason score grade groups 3-5 for the three age groups were 66.9%, 60.5%, and 66.3%, respectively; they were significantly different (χ2 = 9.401, p = 0.009).  The present study indicated that men aged ≤55 years or >75 years show higher levels of clinically significant prostate cancer compared to patients between the ages of 55 and 75 years. Younger and more elderly male patients are more likely to have a more aggressive disease.
Predictors of outcome after anterior temporal lobectomy: positron emission tomography.

We assessed the relationship between temporal lobe metabolism measured quantitatively and qualitatively with PET using [18F]-fluorodeoxyglucose (FDG) and postoperative seizure frequency after anterior temporal lobectomy. Forty-three patients with refractory partial epilepsy had anterior temporal lobectomy and preoperative assessment with PET-FDG. Qualitative PET analysis was performed visually by two blinded observers, and quantitative PET analysis was performed using an anatomic template for six control and six temporal lobe subregions, deriving an asymmetry index for each region. Seizure outcome was assessed 1 year after surgery; patients were classified as being seizure-free or as having persistent seizures. Qualitative data were analyzed using Fisher's exact test and the t test, and quantitative data were analyzed using a repeated-measures ANOVA. Thirty-two patients (74%) were seizure-free at follow-up, and 11 had persistent seizures, although most improved. Twenty-nine of 35 patients (83%) with restricted temporal lobe hypometabolism by visual analysis were seizure-free, compared with three of eight patients (37.5%) with normal scans or multilobar hypometabolism. Quantitative analysis revealed that an asymmetry of mesial temporal lobe glucose consumption (uncal region) correlated with improved surgical outcome (p < 0.02). We developed a logistic regression model to predict individual outcome based on the asymmetry in uncal metabolism. Lateral temporal metabolism did not correlate with outcome. We conclude that both visual PET analysis and quantitative PET analysis predict outcome after temporal lobectomy, although quantitative measures offer more precise information.