nils-herrmann/clean_scirepeval huggingface dataset:
Evaluation of the sentinel lymph node algorithm with blue dye labeling for early-stage endometrial cancer in a multicentric setting.

Sentinel lymph node (SLN) removal may be a midterm between no and full pelvic dissection in early endometrial cancer. Whereas the use of blue dye alone in SLN detection has a poor accuracy, its integration in an SLN algorithm may yield better results and overcome hurdles such as the requirement of nuclear medicine facility.



Sixty-six patients with clinical stage I endometrial cancer were prospectively enrolled in a multicentre study between May 2003 and June 2009. Patent blue was injected intraoperatively into the cervix. We retrospectively assessed the accuracy of a previously described SLN algorithm consisting of the following sequence: (1) pelvic node area is inspected for removal of all mapped SLN and (2) excision of every suspicious non-SLN, (3) in the absence of mapping in a hemipelvis, a standard ipsilateral lymphadenectomy is then performed.



Sentinel nodes were identified in 41 patients (62.1%), mostly in interiliac and obturator areas. None was detected in the para-aortic area. Detection was bilateral in 23 cases (56.1%). Seven patients (10.6%) had positive nodes. The false-negative rate was 40% using SLN detection alone. When the algorithm was applied, the false-negative rate was 14.3%. The use of a SLN algorithm would have avoided 53% of lymphadenectomies



Our multicentric evaluation validates the use of a SLN algorithm based on blue-only sentinel node mapping in early-stage endometrial cancer. The application of such SLN algorithm should be evaluated in a prospective context and might lead to decrease unnecessary lymphadenectomies.
Aripiprazole augmentation for treatment of patients with chronic or recurrent major depressive disorder: a 12-week prospective open-label multicentre study.

Patients with chronic or recurrent major depressive disorder (MDD) have faced a dearth of treatment options. The present study evaluated the effectiveness and tolerability of aripiprazole augmentation for the treatment of chronic or recurrent MDD. This was the first 12-week prospective, multicentre, open-label study of the effectiveness and tolerability of flexibly dosed aripiprazole as an augmentation to ongoing antidepressant treatment in patients with chronic or recurrent MDD. The primary outcome measure for effectiveness was changes between baseline and endpoint (week 12) in total scores on the Montgomery-Asberg Depression Rating Scale. Adverse events (AEs) occurring throughout the trial are also reported. The Montgomery-Asberg Depression Rating Scale total scores decreased significantly between the baseline and the endpoint (magnitude of difference=-11.6, P<0.0001). At the endpoint, the response rate was 55.2% and the remission rate was 41.3%. Adjunctive aripiprazole treatment administered from week 1 through the endpoint was associated with remission and significant treatment responses. More than half (55.8%) of those taking adjunctive aripiprazole completed the study and relatively few patients discontinued participation because of AEs. None of the patients discontinued participation in the study because of an inadequate therapeutic response. Common AEs included headache, akathisia, insomnia and constipation. The mean dose of aripiprazole at the endpoint was 6.6 mg/day. Adjunctive aripiprazole may be effective and tolerable for patients with chronic or recurrent MDD. Adequately powered and controlled clinical trials should be conducted to confirm our open-label study findings.
Symptomatic intracerebral hemorrhage and recanalization after IV rt-PA: a multicenter study.

Symptomatic intracerebral hemorrhage (sICH) is the most unfavorable complication after IV thrombolytic treatment. We aimed to determine the relationship between early recanalization and the risk of sICH.



Patients with acute stroke received IV tissue plasminogen activator (rt-PA) within 3 hours of symptom onset with transcranial Doppler (TCD) monitoring at four academic centers. sICH was defined as parenchymal hemorrhage on CT in relation to neurologic worsening (NIH Stroke Scale [NIHSS] > or = 4) within 72 hours after treatment. Poor outcome was defined as modified Rankin Scale 3-6 at 3 months. Early recanalization was graded with Thrombolysis in Brain Ischemia (TIBI) system. Multiple logistic regression analyses were used to identify predictors of sICH.



A total of 349 patients received rt-PA at median 134 +/- 32 minutes (mean age 69 +/- 13 years, 186 men [53%]). Median pretreatment NIHSS score was 16 points (interquartile range: 12-20). Median time to TCD was 130 +/- 40 minutes. At the end of rt-PA infusion, 135 patients (38%) had no recanalization, 101 (29%) partial, and 113 (32%) complete recanalization. sICH occurred in 26 patients (7.4%). Of the 135 patients without early recanalization, 18 (13%) had sICH, as compared to 4 (4%) of the 109 subjects with partial recanalization and 4 (3.5%) of 113 with complete recanalization, p = 0.005. After adjustment for age, sex, baseline NIHSS score, glucose, blood pressure, and time to treatment, patients with persistent occlusion had sixfold higher risk of sICH (OR = 6, 95% CI 1.5-21.3, p = 0.01).



The risk of tPA-related symptomatic intracerebral hemorrhage (sICH) is low after early and complete restoration of blood flow. Arterial occlusion persistent beyond tissue plasminogen activator infusion emerges as an independent predictor of higher risk of sICH in patients treated with systemic thrombolysis.
Factors associated with viral rebound in HIV-1-infected individuals enrolled in a therapeutic HIV-1 gag vaccine trial.

Human immunodeficiency virus type 1 (HIV-1) vaccines directed to the cell-mediated immune system could have a role in lowering the plasma HIV-1 RNA set point, which may reduce infectivity and delay disease progression.



Randomized, placebo-controlled trial involving HIV-1-infected participants who received a recombinant adenovirus serotype 5 (rAd5) HIV-1 gag vaccine or placebo. Sequence-based HLA typing was performed for all 110 participants who initiated analytic treatment interruption (ATI) to assess the role of HLA types previously associated with HIV prognosis. Plasma HIV-1 gag and pol RNA sequences were obtained during the ATI. Virologic endpoints and HLA groups were compared between treatment arms using the 2-sample rank sum test. A linear regression model was fitted to derive independent correlates of ATI week 16 plasma viral load (w16 PVL).



Vaccinated participants with neutral HLA alleles had lower median w16 PVLs than did vaccinated participants with protective HLA alleles (P = .01) or placebo participants with neutral HLA alleles (P = .02). Factors independently associated with lower w16 PVL included lower pre-antiretroviral therapy PVL, greater Gag sequence divergence from the vaccine sequence, decreased proportion of HLA-associated polymorphisms in Gag, and randomization to the vaccine arm.



Therapeutic vaccination with a rAd5-HIV gag vaccine was associated with lower ATI week 16 PVL even after controlling for viral and host genetic factors.
Expectations, perceptions, and physiotherapy predict prolonged sick leave in subacute low back pain

Brief intervention programs for subacute low back pain (LBP) result in significant reduction of sick leave compared to treatment as usual. Although effective, a substantial proportion of the patients do not return to work. This study investigates predictors of return to work in LBP patients participating in a randomized controlled trial comparing a brief intervention program (BI) with BI and physical exercise.



Predictors for not returning to work was examined in 246 patients sick listed 8-12 weeks for low back pain. The patients had participated in a randomized controlled trial, with BI (n = 122) and BI + physical exercise (n = 124). There were no significant differences between the two intervention groups on return to work. The groups were therefore merged in the analyses of predictors. Multiple logistic regression analysis was used to identify predictors for non return to work at 3, 12, and 24 months of follow-up.



At 3 months of follow-up, the strongest predictors for not returning to work were pain intensity while resting (OR = 5.6; CI = 1.7-19), the perception of constant back strain when working (OR = 4.1; CI = 1.5-12), negative expectations for return to work (OR = 4.2; CI = 1.7-10), and having been to a physiotherapist prior to participation in the trial (OR = 3.3; CI = 1.3-8.3). At 12 months, perceived reduced ability to walk far due to the complaints (OR = 2.6; CI = 1.3-5.4), pain during activities (OR = 2.4; CI = 1.1-5.1), and having been to a physiotherapist prior to participation in the trial (OR = 2.1; CI = 1.1-4.3) were the strongest predictors for non return to work. At 24 months age below 41 years (OR = 2.9; CI = 1.4-6.0) was the only significant predictor for non return to work.



It appears that return to work is highly dependant on individual and cognitive factors. Patients not returning to work after the interventions were characterized by negative expectations, perceptions about pain and disability, and previous physiotherapy treatment. This is the first study reporting that previous treatment by physiotherapists is a risk factor for long-term sick leave. This has not been reported before and is an interesting finding that deserves more scrutiny.
Prehospital rapid sequence intubation improves functional outcome for patients with severe traumatic brain injury: a randomized controlled trial.

To determine whether paramedic rapid sequence intubation in patients with severe traumatic brain injury (TBI) improves neurologic outcomes at 6 months compared with intubation in the hospital.



Severe TBI is associated with a high rate of mortality and long-term morbidity. Comatose patients with TBI routinely undergo endo-tracheal intubation to protect the airway, prevent hypoxia, and control ventilation. In many places, paramedics perform intubation prior to hospital arrival. However, it is unknown whether this approach improves outcomes.



In a prospective, randomized, controlled trial, we assigned adults with severe TBI in an urban setting to either prehospital rapid sequence intubation by paramedics or transport to a hospital emergency department for intubation by physicians. The primary outcome measure was the median extended Glasgow Outcome Scale (GOSe) score at 6 months. Secondary end-points were favorable versus unfavorable outcome at 6 months, length of intensive care and hospital stay, and survival to hospital discharge.



A total of 312 patients with severe TBI were randomly assigned to paramedic rapid sequence intubation or hospital intubation. The success rate for paramedic intubation was 97%. At 6 months, the median GOSe score was 5 (interquartile range, 1-6) in patients intubated by paramedics compared with 3 (interquartile range, 1-6) in the patients intubated at hospital (P = 0.28).The proportion of patients with favorable outcome (GOSe, 5-8) was 80 of 157 patients (51%) in the paramedic intubation group compared with 56 of 142 patients (39%) in the hospital intubation group (risk ratio, 1.28; 95% confidence interval, 1.00-1.64; P = 0.046). There were no differences in intensive care or hospital length of stay, or in survival to hospital discharge.



In adults with severe TBI, prehospital rapid sequence intubation by paramedics increases the rate of favorable neurologic outcome at 6 months compared with intubation in the hospital.
A novel Gymnema sylvestre extract stimulates insulin secretion from human islets in vivo and in vitro.

Many plant-based products have been suggested as potential antidiabetic agents, but few have been shown to be effective in treating the symptoms of Type 2 diabetes mellitus (T2DM) in human studies, and little is known of their mechanisms of action. Extracts of Gymnema sylvestre (GS) have been used for the treatment of T2DM in India for centuries. The effects of a novel high molecular weight GS extract, Om Santal Adivasi, (OSA(R)) on plasma insulin, C-peptide and glucose in a small cohort of patients with T2DM are reported here. Oral administration of OSA(R) (1 g/day, 60 days) induced significant increases in circulating insulin and C-peptide, which were associated with significant reductions in fasting and post-prandial blood glucose. In vitro measurements using isolated human islets of Langerhans demonstrated direct stimulatory effects of OSA(R) on insulin secretion from human ß-cells, consistent with an in vivo mode of action through enhancing insulin secretion. These in vivo and in vitro observations suggest that OSA(R) may provide a potential alternative therapy for the hyperglycemia associated with T2DM.
Delayed Gastric Emptying in Advanced Parkinson Disease: Correlation With Therapeutic Doses.

Gastrointestinal dysfunction is often described in patients with Parkinson disease (PD), and gastrointestinal symptoms are usually attributed to gastroparesis. The consequent delayed gastric emptying (GE) may be an important pharmacokinetic mechanism underlying some of the response fluctuations that develop after long-term levodopa (L-dopa) therapy.The aim of this prospective study was to assess GE time by a liquid meal scintigraphy, in PD patients, and to correlate them with demographic, clinical, and therapeutic data.



Scintigraphy with radiolabeled albumin nanocolloids added to acidified orange juice was performed in 51 consecutive PD patients 1 hour after their usual dopaminergic therapy first dose and after a 12-hour fast. Demographic, neurologic, gastrointestinal, and pharmacologic data were collected.



Fifty-one patients were divided into 2 groups using the cutoff point obtained in normal subjects (40 minutes): group 1 included 29 patients with GE T½ of 27.60 ± 7.30 minutes (normal), group 2 showed a GE T½ of 84.90 ± 53.80 minutes (delayed). The most striking significant difference between the 2 groups was the dopa-decarboxylase inhibitor mean dose that was significantly higher in the group of patients with delayed GE (201.32 ± 97.26 vs 127.65 ± 79.74; P = 0.005).



The impairment of gastric motility, frequently represented in PD patients, occurs in approximately 42% of patients with motor complications. A mechanism that may explain the GE delay is the effect of L-dopa on dopaminergic receptors in the stomach. Therefore, the dosage of dopa-decarboxylase inhibitor, increasing the L-dopa concentration, may contribute to GE delay and its consequent effect on drug delivery and efficacy.
Efficacy of combined use of miglitol in Type 2 diabetes patients receiving insulin therapy-placebo-controlled double-blind comparative study

Combination therapy with an α-glucosidase inhibitor and insulin is commonly performed for type 2 diabetes mellitus. We conducted a placebo-controlled double-blind comparative study to investigate the efficacy of combination therapy with miglitol and insulin. The patients with T2DM on insulin therapy were randomly assigned to either a miglitol treatment group (Group M) or a placebo group (Group P) and treated for 12 weeks. Meal tolerance tests were conducted at the observation period, week 0 and week 12 of the treatment period. Mean values of decrease in 1-h- and 2-h postprandial plasma glucose level were significantly larger in Group M than in Group P (60.3 ± 70.1 mg/dl vs. −5.1 ± 68.2 mg/dl (P < 0.001)), as was HbA1c as well (0.36 ± 0.66% vs. −0.03 ± 0.56% (P < 0.001)). Adverse events included abdominal distension and flatulence, which were significantly more frequent in Group M. The frequency of nocturnal hypoglycemia events tended to be reduced in Group M. Combined use of insulin and miglitol is useful for postprandial glucose regulation and improves glycemic control.
Oral calcium supplementation reduces intraplatelet free calcium concentration and insulin resistance in essential hypertensive patients.

We evaluated the effect of oral calcium supplementation on blood pressure, calcium metabolism, and insulin resistance in essential hypertension. After receiving a standard diet with 500 mg of calcium per day during a 4-week period, 20 nondiabetic, essential hypertensive patients were randomized in a double-blind fashion to receive oral calcium supplementation (1500 mg of calcium per day) or placebo for 8 weeks. At the end of the 4-week period of low-calcium diet and after the 8-week period of intervention, we measured blood pressure (by both office and 24-hour ambulatory blood pressure monitoring), calcium-regulating hormones [urinary hydroxyproline and serum osteocalcin, parathormone, and 1,25(OH)2-vitamin D3], intraplatelet free calcium concentration, fasting plasma glucose and insulin levels, and the insulin-sensitivity index (euglycemic-hyperinsulinemic clamp). Compared with patients maintained at low calcium intake, essential hypertensive patients under oral calcium supplementation significantly reduced serum osteocalcin (from 22.2 +/- 1.9 to 17.9 +/- 2.0 micrograms/L; P = .0015), parathormone (from 4.20 +/- 0.38 to 3.30 +/- 0.36 pmol/L; P = .0003), and 1,25(OH)2-vitamin D3 (from 98.0 +/- 11.0 to 61.6 +/- 5.7 pmol/L; P = .0062). Likewise, we found a significant reduction in intraplatelet free calcium concentration (from 35.9 +/- 1.2 to 26.5 +/- 0.8 nmol/L; P = .0005) and fasting plasma insulin levels (from 71.8 +/- 5.9 to 64.6 +/- 6.2 pmol/L; P = .05) and a significant increase in the insulin-sensitivity index (from 2.89 +/- 0.77 to 4.00 +/- 0.95 mg.kg-1.min-1; P = .0007). None of these parameters were significantly modified in patients maintained at low calcium intake. Office and 24-hour mean values of systolic and diastolic blood pressure did not change after 8 weeks of oral calcium supplementation or placebo.
Draft Genome Sequence of the Shellfish Larval Probiotic Bacillus pumilus RI06-95

Bacillus pumilus RI06-95 is a marine bacterium isolated in Narragansett, Rhode Island, which has shown probiotic activity against marine pathogens in larval shellfish. We report the genome of B. pumilus RI06-95, which provides insight into the microbe's probiotic ability and may be used in future studies of the probiotic mechanism.
Lack of association between CAG repeat polymorphism in the androgen receptor gene and the outcome of rheumatoid arthritis treatment with leflunomide

Leflunomide (LEF) is a disease-modifying antirheumatic drug used for treating rheumatoid arthritis (RA) and the action of which may be modified by sex hormones. The aim of this study was to examine the association between CAG repeat polymorphism in the androgen receptor (AR) gene and the response to treatment with LEF in women with RA. We studied 114 women diagnosed with RA and treated with LEF (20 mg daily). Follow-up was 12 months. CAG repeat polymorphism was determined using polymerase chain reaction (PCR) and subsequent fragment analysis by capillary electrophoresis. Analysis revealed no statistically significant associations between CAG repeat polymorphism in the AR gene and improvement of disease activity parameters: erythrocyte sedimentation rate, serum C-reactive protein, patient’s global assessment of disease activity on a visual analog scale (VAS), disease activity score of 28 joints (DAS28), and swollen and tender joint count. Our results suggest no correlation between CAG repeat polymorphism in the AR gene and response to treatment with LEF in women with RA.
Recurrent carotid stenosis : results of the asymptomatic carotid atherosclerosis study.

We sought to determine the incidence of recurrent carotid stenosis in patients in the Asymptomatic Carotid Atherosclerosis Study (ACAS) who had undergone carotid endarterectomy and were prospectively followed with Doppler ultrasound for up to 5 years.



The ACAS database was interrogated to determine the rate of recurrent carotid stenosis (>/=60%) based up angiogram-validated Doppler data, with a 90% and a 95% positive predictive value, as well as information concerning the technologists' interpretation of percent stenosis. These 3 parameters are reported for each of 3 time intervals: within 3 months of operation (residual disease), between 3 and 18 months (early restenoses), and between 18 and 60 months (late restenosis).



Of the 825 patients randomized to the surgical arm of the study, 720 actually underwent carotid endarterectomy, and 645 had complete ultrasound data. The aggregate incidence of residual and recurrent carotid stenosis for all time intervals ranged from 12.7% to 20.4%, depending on the positive predictive value confidence level desired. Residual disease occurred in 4.1% to 6.5%; true, early restenosis was found in 7.6% to 11.4%; and late restenosis occurred in 1.9% to 4.9%. None of the traditional risk factors showed a statistically significant effect on recurrent stenosis. The use of patch angioplasty closure reduced overall risk of restenosis from 21.2% to 7.1%, from 16.7% to 4.6%, and from 27.4% to 8.2%, depending on the PPV confidence level desired (P<0.001). Of the 136 patients judged to have recurrent stenosis, only 8 (5.9%) underwent reoperation (only 1 for symptoms). There was no correlation between late stroke and recurrent stenosis.



Carotid endarterectomy is a durable procedure with a low rate of true restenosis, particularly when patch angioplasty is used to close the arteriotomy.
Effect of oral ALA supplementation on oxidative stress and insulin sensitivity among overweight/obese adults: a double-blinded, randomized, controlled, cross-over intervention trial.

Fournier PE, Thuny F, Richet H, et al. Comprehensive diagnostic strategy for blood culture-negative endocarditis: a prospective study of 819 new cases.  A deadly aversion to pork. Lancet 2011;377:1542.  Li JS, Sexton DJ, Mick N, et al. Proposed modifications to the Duke criteria for the diagnosis of infective endocarditis.
The Role of Core-Needle Biopsy as a First-Line Diagnostic Tool for Initially Detected Thyroid Nodules.

The aim of this study was to evaluate the role of core-needle biopsy (CNB) as a first-line diagnostic tool for initially detected thyroid nodules.



This observational study evaluated 632 initially detected thyroid nodules in 632 consecutive patients who underwent CNB between October 2008 and December 2011. CNB results were categorized into the six categories of the Bethesda System. A final diagnosis of malignancy was based on surgery or CNB, whereas a final diagnosis of benign nodules was based on surgery, two benign biopsy results, or benign cytology of stable size after one year. The rates of Bethesda category 1 and inconclusive results, diagnostic performance, unnecessary surgery, and complications were evaluated. Subgroup analysis based on nodule size was performed. Risk factors for inconclusive results were evaluated by multivariate logistic regression analysis.



The rates of Bethesda category 1 and inconclusive results by CNB were 1.3% and 5.9%, respectively. The diagnostic accuracy, sensitivity, specificity, positive predictive value, and negative predictive value for the diagnosis of malignancy were 97.6%, 90.0%, 100%, 100%, and 92.3%, respectively. The rate of unnecessary surgery was 0.5%, and the complications rate was 0.2%. Based on subgroup analysis, the diagnostic performance was not significantly associated with nodule size. There were no independent risk factors associated with inconclusive results.



CNB showed low rates of Bethesda category 1 and inconclusive results and a high diagnostic accuracy. CNB also minimized unnecessary surgery. CNB seems to be a promising diagnostic tool for patients with initially detected thyroid nodules.