nils-herrmann/clean_scirepeval huggingface dataset:
Effects of Needle-Arthroscopic Lavage with Different Volumes of Fluid on Knee Synovitis in Rheumatoid Arthritis

To determine the appropriate volume of physiological fluid needed to effectively reduce synovitis and to determine the indications for intra-articular lavage of knee joints with rheumatoid arthritis (RA), intra-articular lavage with different volumes of physiological fluid via needle arthroscopy were performed on 102 rheumatoid knees in 98 patients (25 males, 77 females) with an average age of 46 years at the time of operation. Intra-articular lavage of a knee joint with 5 or 10 l of physiological fluid gave better clinical results than did intra-articular lavage with 0.5–1.5 l. There was no difference between the beneficial effects of intra-articular lavage using 5 l or 10 l of fluid. The preoperative conditions (CRP, frequency of the susceptible factors of HLA-DRB1 alleles, radiological change in the knee joint) and the intraoperative chondroscopic assessments were correlated with clinical improvement. Our study demonstrated that intra-articular lavage with 5 l of physiological fluid performed using needle arthroscopy was beneficial. The following points at least should be checked before performing intra-articular lavage: (1) CRP is not elevated to a high level (≥5 mg/dl), (2) the patient does not have susceptible factors in both HLA-DRB1 alleles, (3) the grade of rheumatoid knee is below Larsen II in preoperative X-ray findings, and (4) the degree of cartilage damage is not more than grade 3 in arthroscopic findings.
Efficacy and Safety of Alirocumab 150 mg Every 4 Weeks in Patients With Hypercholesterolemia Not on Statin Therapy: The ODYSSEY CHOICE II Study

The PCSK9 antibody alirocumab (75 mg every 2 weeks; Q2W) as monotherapy reduced low-density lipoprotein-cholesterol (LDL-C) levels by 47%. Because the option of a monthly dosing regimen is convenient, ODYSSEY CHOICE II evaluated alirocumab 150 mg Q4W in patients with inadequately controlled hypercholesterolemia and not on statin (majority with statin-associated muscle symptoms), receiving treatment with fenofibrate, ezetimibe, or diet alone.



Patients were randomly assigned to placebo, alirocumab 150 mg Q4W or 75 mg Q2W (calibrator arm), with dose adjustment to 150 mg Q2W at week (W) 12 if W8 predefined LDL-C target levels were not met. The primary efficacy endpoint was LDL-C percentage change from baseline to W24. Mean baseline LDL-C levels were 163.9 mg/dL (alirocumab 150 mg Q4W, n=59), 154.5 mg/dL (alirocumab 75 mg Q2W, n=116), and 158.5 mg/dL (placebo, n=58). In the alirocumab 150 mg Q4W and 75 mg Q2W groups (49.1% and 36.0% of patients received dose adjustment, respectively), least-squares mean LDL-C changes from baseline to W24 were -51.7% and -53.5%, respectively (placebo [+4.7%]; both groups P<0.0001 versus placebo). In total, 63.9% and 70.3% of alirocumab-treated patients achieved their LDL-C targets at W24. Treatment-emergent adverse events occurred in 77.6% (alirocumab 150 mg Q4W), 73.0% (alirocumab 75 mg Q2W), and 63.8% (placebo) of patients, with injection-site reactions among the most common treatment-emergent adverse events.



Alirocumab 150 mg Q4W can be considered in patients not on statin with inadequately controlled hypercholesterolemia as a convenient option for lowering LDL-C.
Prophylactic Nasogastric Decompression for Routine Gastrectomy.

To determine the necessity of using nasogastric tubes for patients with gastrectomy.



A non-randomized controlled trial with two arms.


PLACE AND DURATION OF STUDY
Sichuan Provincial Peoples' Hospital, China, from February 2012 to January 2014.



One hundred and twenty one patients undergoing gastrectomy were assigned into intubation group and control group based on patient's own will. The intubation group was intubated with a nasogastric tube before operation and extubated at the earliest evidence of passed flatus. Clinical outcomes, such as operation time, bleeding volume, time to passage of flatus, postoperative complications, and length of stay were recorded and compared between the two groups along with patient characteristics.



The two groups did not differ in patient characteristics with similar distribution of gender, age, diagnosis, tumor location and operation type. Nasogastric intubation before surgery was not associated with statistically significant difference in total surgery duration, bleeding volume of operation or postoperative complications. In addition, patients without nasogastric tubes resumed oral diet earlier (52.5 ± 14.1 vs.18.4 ± 2.0 hours, p < 0.05) and had shorter time to first passage of flatus (43.8 ± 11.2 vs. 49.0 ± 13.3 hours, p=0.02).



It is safe to give up nasogastric intubation for patients undergoing elective gastrectomy and may even result in a better patient outcome.
Cerecyte coil trial: procedural safety and clinical outcomes in patients with ruptured and unruptured intracranial aneurysms.

This study arose from a need to systematically evaluate the clinical and angiographic outcomes of intracranial aneurysms treated with modified coils. We report the procedural safety and clinical outcomes in a prospective randomized controlled trial of endovascular coiling for ruptured and unruptured intracranial aneurysms, comparing polymer-loaded Cerecyte coils with bare platinum coils in 23 centers worldwide.



Five hundred patients between 18 and 70 years of age with a ruptured or unruptured target aneurysm planning to undergo endovascular coiling were randomized to receive Cerecyte or bare platinum coils. Analysis was by intention to treat.



Two hundred forty-nine patients were allocated to Cerecyte coils and 251 to bare platinum coils. Baseline characteristics were balanced. For ruptured aneurysms, in-hospital mortality was 2/114 (1.8%) with Cerecyte versus 0/119 (0%) bare platinum coils. There were 8 (3.4%) adverse procedural events resulting in neurological deterioration: 5/114 (4.4%) with Cerecyte versus 3/119 (2.5%) with bare platinum coils (P = .22). The 6-month mRS score of ≤2 was not significantly different in 103/109 (94.5%) patients with Cerecyte and 110/112 (98.2%) patients with bare platinum coils. Poor outcome (mRS score of ≥3 or death) was 6/109 (5.5%) with Cerecyte versus 2/112 (1.8%) with bare platinum coils (P = .070). For UIAs, there was no in-hospital mortality. There were 7 (2.7%) adverse procedural events with neurological deterioration, 5/133 (3.8%) with Cerecyte versus 2/131 (1.5%) with bare platinum coils (P = .13). There was a 6-month mRS score of ≤2 in 114/119 (95.8%) patients with Cerecyte versus 123/123 (100%) patients with bare platinum coils. There was poor outcome (mRS ≥3 and 1 death) in 5/119 (4.2%) patients with Cerecyte versus 0/123 (0%) patients with bare platinum coils (P = .011).



There was a statistical excess of poor outcomes in the Cerecyte arm at discharge in the ruptured aneurysm group and at 6-month follow-up in the unruptured group. Overall adverse clinical outcomes and in-hospital mortality were exceptionally low in both groups.
Therapies for active rheumatoid arthritis after methotrexate failure.

Few blinded trials have compared conventional therapy consisting of a combination of disease-modifying antirheumatic drugs with biologic agents in patients with rheumatoid arthritis who have active disease despite treatment with methotrexate--a common scenario in the management of rheumatoid arthritis.



We conducted a 48-week, double-blind, noninferiority trial in which we randomly assigned 353 participants with rheumatoid arthritis who had active disease despite methotrexate therapy to a triple regimen of disease-modifying antirheumatic drugs (methotrexate, sulfasalazine, and hydroxychloroquine) or etanercept plus methotrexate. Patients who did not have an improvement at 24 weeks according to a prespecified threshold were switched in a blinded fashion to the other therapy. The primary outcome was improvement in the Disease Activity Score for 28-joint counts (DAS28, with scores ranging from 2 to 10 and higher scores indicating more disease activity) at week 48.



Both groups had significant improvement over the course of the first 24 weeks (P=0.001 for the comparison with baseline). A total of 27% of participants in each group required a switch in treatment at 24 weeks. Participants in both groups who switched therapies had improvement after switching (P<0.001), and the response after switching did not differ significantly between the two groups (P=0.08). The change between baseline and 48 weeks in the DAS28 was similar in the two groups (-2.1 with triple therapy and -2.3 with etanercept and methotrexate, P=0.26); triple therapy was noninferior to etanercept and methotrexate, since the 95% upper confidence limit of 0.41 for the difference in change in DAS28 was below the margin for noninferiority of 0.6 (P=0.002). There were no significant between-group differences in secondary outcomes, including radiographic progression, pain, and health-related quality of life, or in major adverse events associated with the medications.



With respect to clinical benefit, triple therapy, with sulfasalazine and hydroxychloroquine added to methotrexate, was noninferior to etanercept plus methotrexate in patients with rheumatoid arthritis who had active disease despite methotrexate therapy. (Funded by the Cooperative Studies Program, Department of Veterans Affairs Office of Research and Development, and others; CSP 551 RACAT ClinicalTrials.gov number, NCT00405275.)
Atorvastatin decreases apolipoprotein C-III in apolipoprotein B-containing lipoprotein and HDL in type 2 diabetes: a potential mechanism to lower plasma triglycerides.

Apolipoprotein (apo)C-III is a constituent of HDL (HDL apoC-III) and of apoB-containing lipoproteins (LpB:C-III). It slows the clearance of triglyceride-rich lipoproteins (TRLs) by inhibition of the activity of the enzyme lipoprotein lipase (LPL) and by interference with lipoprotein binding to cell-surface receptors. Elevated plasma LpB:C-III is an independent risk factor for cardiovascular disease. We studied the effect of atorvastatin on plasma LpB:C-III and HDL apoC-III.



We studied the effect of 30 weeks' treatment with 10 and 80 mg atorvastatin on plasma apoC-III levels in a randomized, double-blind, placebo-controlled trial involving 217 patients with type 2 diabetes and fasting plasma triglycerides between 1.5 and 6.0 mmol/l.



Baseline levels of total plasma apoC-III, HDL apoC-III, and LpB:C-III were 41.5 +/- 10.0, 17.7 +/- 5.5, and 23.8 +/- 7.7 mg/l, respectively. Plasma apoC-III was strongly correlated with plasma triglycerides (r = 0.74, P < 0.001). Atorvastatin 10- and 80-mg treatment significantly decreased plasma apoC-III (atorvastatin 10 mg, 21%, and 80 mg, 27%), HDL apoC-III (atorvastatin 10 mg, 22%, and 80 mg, 28%) and LpB:C-III (atorvastatin 10 mg, 23%, and 80 mg, 28%; all P < 0.001). The decrease in plasma apoC-III, mainly in LpB:C-III, strongly correlated with a decrease in triglycerides (atorvastatin 10 mg, r = 0.70, and 80 mg, r = 0.78; P < 0.001). Atorvastatin treatment also leads to a reduction in the HDL apoC-III-to-HDL cholesterol and HDL apoC-III-to-apoA-I ratios, indicating a change in the number of apoC-III per HDL particle (atorvastatin 10 mg, -21%, and 80 mg, -31%; P < 0.001).



Atorvastatin treatment resulted in a significant dose-dependent reduction in plasma apoC-III, HDL apoC-III, and LpB:C-III levels in patients with type 2 diabetes. These data indicate a potentially important antiatherogenic effect of statin treatment and may explain (part of) the triglyceride-lowering effect of atorvastatin.
Treatment with inhaled steroids in patients with symptoms suggestive of asthma but with normal lung function.

A total of 144 patients with lower airway symptoms suggestive of asthma, but who did not fulfil the functional criteria of asthma, were included in a randomised, double-blind, placebo-controlled 8-week "proof-of-concept" study with mometasone furoate (MF), 400 microg once daily. The primary efficacy variable was the mean change from baseline in six morning and evening weekly symptom scores: cough, sputum production, wheeze, shortness of breath, chest tightness and exercise-induced cough/wheeze. Total symptom scores were calculated after treatment for 4 and 8 weeks. Compared with placebo, MF improved total morning symptom score at 8 weeks. Changes in total evening symptom scores did not differ between treatments. MF improved all individual symptom scores more than placebo, although the differences in changes between treatments were not always statistically significant. Morning and evening peak expiratory flow rates increased with MF compared with placebo. MF reduced eosinophils and the levels of eosinophilic cationic protein in induced sputum. The results show that symptoms suggestive of asthma exist in patients without significant beta(2)-agonist reversibility or diurnal variability in peak flow. Once-daily MF may benefit some of these patients and a short course with inhaled corticosteroids may be tried. Responders should be better identified in further studies.
Extracting Context Information from Wi-Fi Captures

Inferring a user's current situation is the basis of context-aware services. However, users rarely provide access to their sensor data, and hence extracting context information remains challenging in real-world scenarios. In this paper, we present an overall concept for inferring mobility, location, and role information from users based on passively recorded Wi-Fi signals. Several methods are investigated and an extended Viterbi-based approach is presented to determine dwelling and motion periods. This information is used to enhance the mobility model for probabilistic indoor localization. In addition, we compute various features to classify users according to their role. The presented concept is evaluated on simulated data and discussed on real Wi-Fi captures. Our results show, that the proposed Viterbi-based approach performs best for inferring mobility states and can improve the localization accuracy in most instances. Furthermore, it helps to increase the classification performance and indicates strong cluster tendencies in our real-world dataset.
Bilateral subthalamic stimulation effects on oral force control in Parkinson's disease

Dysarthria in Parkinson's disease (PD) consists of articulatory, phonatory and respiratory impairment. Bilateral subthalamic nucleus (STN) stimulation greatly improves motor disability, but its long-term effect on speech within a large group of patients has not been precisely evaluated. The aim of this study was to determine the effect of bilateral STN stimulation on oral force control in PD. We measured forces of the upper lip, lower lip and tongue in twenty-six PD patients treated with bilateral STN stimulation. Measurements of the articulatory organ force, as well as a motor evaluation using the Unified Parkinson's Disease Rating Scale (UPDRS), were made with and without STN stimulation. Maximal voluntary force (MVF), reaction time (RT), movement time (MT), imprecision of the peak force (PF) and the hold phase (HP) were all improved with STN stimulation during the articulatory force task, as well as the motor examination scores of the UPDRS. It seems that the beneficial STN stimulation-induced effect on articulatory forces persisted whatever the duration of post-surgical follow-up. However, dysarthria evaluated by the UPDRS was worse in two subgroups of patients with a one to two year and three to five year post-surgical follow-up, in comparison with a subgroup of patients with a three month follow-up. STN stimulation has a beneficial long-term effect on the articulatory organs involved in speech production, and this indicates that parkinsonian dysarthria is associated, at least in part, with an alteration in STN neuronal activity. Nevertheless, to confirm the persistence of the beneficial effect of STN stimulation on parkinsonian dysarthria, a longitudinal evaluation is still needed.
Deriving modified Rankin scores from medical case-records.

Modified Rankin score (mRS) is traditionally graded using a face-to-face or telephone interview. Certain stroke assessment scales can be derived from a review of a patient's case-record alone. We hypothesized that mRS could be successfully derived from the narrative within patient case-records.



Sequential patients attending our cerebrovascular outpatient clinic were included. Two independent, blinded clinicians, trained in mRS, assessed case-records to derive mRS. They scored "certainty" of their grading on a 5-point Likert scale. Agreement between derived and traditional face-to-face mRS was calculated using attribute agreement analysis.



Fifty patients with a range of disabilities were included. Case-record appraisers were poor at deriving mRS (k=0.34 against standard). Derived mRS grades showed poor agreement between observers (k=0.33). There was no relationship between certainty of derived mRS and proportion of correct grades (P=0.727).



Accurate mRS cannot be derived from standard hospital records. Direct mRS interview is still required for clinical trials.
Comparative effectiveness of MRI in breast cancer (COMICE) trial: a randomised controlled trial

MRI might improve diagnosis of breast cancer, reducing rates of reoperation. We assessed the clinical efficacy of contrast-enhanced MRI in women with primary breast cancer.



We undertook an open, parallel group trial in 45 UK centres, with 1623 women aged 18 years or older with biopsy-proven primary breast cancer who were scheduled for wide local excision after triple assessment. Patients were randomly assigned to receive either MRI (n=816) or no further imaging (807), with use of a minimisation algorithm incorporating a random element. The primary endpoint was the proportion of patients undergoing a repeat operation or further mastectomy within 6 months of random assignment, or a pathologically avoidable mastectomy at initial operation. Analysis was by intention to treat. 
816 patients were randomly assigned to MRI and 807 to no MRI. Addition of MRI to conventional triple assessment was not significantly associated with reduced a reoperation rate, with 153 (19%) needing reoperation in the MRI group versus 156 (19%) in the no MRI group, (odds ratio 0.96, 95% CI 0.75-1.24; p=0.77).



Our findings are of benefit to the NHS because they show that MRI might be unnecessary in this population of patients to reduce repeat operation rates, and could assist in improved use of NHS services.



National Institute for Health Research's Health Technology Assessment Programme.
Increased frequency of JC virus type 2 and of dual infection with JC virus type 1 and 2 in Italian progressive multifocal leukoencephalopathy patients

To verify the possibility of different role of JC virus genotypes in the etiology of progressive multifocal leukoencephalopathy, we analysed several JC virus isolates amplified from AIDS patients with and without progressive multifocal leukoencephalopathy and healthy controls by nucleotide sequencing. Cerebrospinal fluid (CSF), peripheral blood mononuclear cells (PBMCs) and urine from 52 AIDS patients suffering from various neurological diseases including 21 cases of progressive multifocal leukoencephalopathy, and PBMCs and urine from healthy subjects were evaluated by nested polymerase chain reaction (PCR) for the presence of DNA belonging to the highly conserved large T antigen (LT) of JC virus. The different JC virus subtypes were identified by nucleotide sequence analysis of the virion protein (VP1) genomic region. JC virus DNA was detected in all the CSF samples from the progressive multifocal leukoencephalopathy patients, but not in the CSF from non-progressive multifocal leukoencephalopathy cases, while the frequency of JC virus DNA detection in the PBMCs and urine did not differ among the three groups studied. JC virus type 2 was detected only in progressive multifocal leukoencephalopathy patients, and in particular in 52.4% of their CSF samples. Moreover, in the CSF of 19.0% of the progressive multifocal leukoencephalopathy cases, dual infection with both JC virus types 1 and 2 was found. The data obtained in this study indicate that the unexpected involvement of JC virus type 2, a strain not common in Italy, and the high frequency of dual infection with both JC virus types 1 and 2 in progressive multifocal leukoencephalopathy CSF, can be indications of risk factors for progressive multifocal leukoencephalopathy development.
Randomized controlled trial of supportive-expressive group therapy and body-mind-spirit intervention for Chinese non-metastatic breast cancer patients

This study aimed to evaluate the efficacy of supportive-expressive group (SEG) therapy and body-mind-spirit (BMS) intervention on emotional suppression and psychological distress in Chinese breast cancer patients. This three-arm randomized controlled trial assigned 157 non-metastatic breast cancer patients to BMS, SEG, or social support control group. SEG focused on emotional expression and group support, whereas BMS emphasized relaxation and self-care. All groups received 2-h weekly sessions for 8 weeks. The participants completed measurements on emotional suppression, perceived stress, anxiety, and depression at baseline and three follow-up assessments in 1 year. Using latent growth modeling, overall group difference was found for emotional suppression (χ 2(2) = 8.88, p = 0.012), marginally for perceived stress (χ 2(2) = 5.70, p = 0.058), but not for anxiety and depression (χ 2(2) = 0.19–0.94, p > 0.05). Post-hoc analyses revealed a significant and moderate reduction (Cohen d = 0.55, p = 0.007) in emotional suppression in SEG compared to control group, whereas BMS resulted in a marginally significant and moderate fall (d = 0.46, p = 0.024) in perceived stress. Neither SEG nor BMS significantly improved anxiety and depression (d < 0.20, p > 0.05). The present results did not demonstrate overall effectiveness for either BMS or SEG therapy in the present sample of Chinese non-metastatic breast cancer patients. The participants appear to derive only modest benefits in terms of their psychological well-being from either intervention.
Prevention of Anastomotic Leakage after Total Gastrectomy with Perioperative Supplemental Oxygen Administration: A Prospective Randomized, Double-blind, Controlled, Single-center Trial

The role of supplemental oxygen therapy in the healing of esophagojejunal anastomosis is still very much in an experimental stage. The aim of the present prospective, randomized study was to assess the effect of administration of perioperative supplemental oxygen therapy on esophagojejunal anastomosis, where the risk of leakage is high. We enrolled 171 patients between January 2009 and April 2012 who underwent elective open esophagojejunal anastomosis for gastric cancer. Patients were assigned randomly to an oxygen/air mixture with a fraction of inspired oxygen (FiO2) of 30 % (n = 85) or 80 % (n = 86). Administration commenced after induction of anesthesia and was maintained for 6 h after surgery. The overall anastomotic leak rate was 14.6 % (25 of 171): 17 patients (20 %) had an anastomotic dehiscence in the 30 % FiO2 group and 8 (9.3 %) in the 80 % FiO2 group (P < 0.05). The risk of anastomotic leak was 49 % lower in the 80 % FiO2 group (relative risk 0.61; 95 % confidence interval 0.40–0.95) versus 30 % FiO2. Supplemental 80 % FiO2 provided during and for 6 h after major gastric cancer surgery to reduce postoperative anastomotic dehiscence should be considered part of ongoing quality improvement activities related to surgical care, with few risks to the patient and little associated cost.