nils-herrmann/clean_scirepeval huggingface dataset:
Physical functioning, pain and quality of life after amputation for musculoskeletal tumours: a national survey.

Patients who have limb amputation for musculoskeletal tumours are a rare group of cancer survivors. This was a prospective cross-sectional survey of patients from five specialist centres for sarcoma surgery in England. Physical function, pain and quality of life (QOL) outcomes were collected after lower extremity amputation for bone or soft-tissue tumours to evaluate the survivorship experience and inform service provision. Of 250 patients, 105 (42%) responded between September 2012 and June 2013. From these, completed questionnaires were received from 100 patients with a mean age of 53.6 years (19 to 91). In total 60 (62%) were male and 37 (38%) were female (three not specified). The diagnosis was primary bone sarcoma in 63 and soft-tissue tumour in 37. A total of 20 tumours were located in the hip or pelvis, 31 above the knee, 32 between the knee and ankle and 17 in the ankle or foot. In total 22 had hemipelvectomy, nine hip disarticulation, 35 transfemoral amputation, one knee disarticulation, 30 transtibial amputation, two toe amputations and one rotationplasty. The Toronto Extremity Salvage Score (TESS) differed by amputation level, with poorer scores at higher levels (p < 0.001). Many reported significant pain. In addition, TESS was negatively associated with increasing age, and pain interference scores. QOL for Cancer Survivors was significantly correlated with TESS (p < 0.001). This relationship appeared driven by pain interference scores. This unprecedented national survey confirms amputation level is linked to physical function, but not QOL or pain measures. Pain and physical function significantly impact on QOL. These results are helpful in managing the expectations of patients about treatment and addressing their complex needs.
Initial results in the assessment of multiple myeloma using 18F-FDG PET

This prospective study was undertaken to investigate the appearance of multiple myeloma on fluorine-18 fluorodeoxyglucose positron emission tomography (FDG-PET). Furthermore, the accuracy of FDG-PET in detecting myeloma lesions and its influence on patient management were evaluated. Forty-three patients with known multiple myeloma (n=28) or solitary plasmacytoma (n=15) underwent FDG-PET. The results of routinely performed radiographs and of scans obtained using all available imaging modalities (MRI, CT), as well as the clinical course, were used for verification of detected lesions. Focally increased tracer uptake was observed in 38 of 41 known osteolytic bone lesions (sensitivity 92.7%) in 23 patients. In addition, 71 further bone lesions which were negative on radiographs were detected in 14 patients. Twenty-six (36.6%) of these lesions could be confirmed in ten patients. As a result of FDG-PET imaging, clinical management was influenced in five (14.0%) patients. The positive predictive value for active disease was 100% in patients with focal or mixed focal/diffuse skeletal FDG uptake and 75% in patients with diffuse bone marrow uptake. Depending on the interpretation of the PET scans in patients with diffuse bone marrow uptake, the sensitivity ranged from 83.8% to 91.9% and the specificity from 83.3% to 100%. FDG-PET thus proved highly accurate in detecting multiple myeloma, and revealed a greater extent of disease than routine radiographs in 14 of 23 (60.9%) patients who had osteolytic bone lesions. FDG-PET might contribute to the initial staging of solitary plasmacytoma.
A controlled crossover study of the selective serotonin reuptake inhibitor citalopram in irritable bowel syndrome.

Selective serotonin reuptake inhibitors (SSRIs) are frequently used in the treatment of irritable bowel syndrome (IBS) although evidence of their efficacy is scarce.



Twenty three non-depressed IBS patients were recruited from a tertiary care centre and included in a crossover trial comparing six weeks of treatment with the SSRI citalopram (20 mg for three weeks, 40 mg for three weeks) with placebo. IBS symptom severity was the primary outcome measure, and depression and anxiety scores were also measured. The effect of acute administration of citalopram on colonic sensitivity and on colonic response to feeding was investigated as a putative predictor of symptomatic response to the drug.



After three and six weeks of treatment, citalopram significantly improved abdominal pain, bloating, impact of symptoms on daily life, and overall well being compared with placebo. There was only a modest effect on stool pattern. Changes in depression or anxiety scores were not related to symptom improvement. The effect of acute administration of citalopram during a colonic barostat study did not predict clinical outcome. Analysis of the first treatment period as a double blind parallel arm study confirmed the benefit of citalopram over placebo.



The SSRI citalopram significantly improves IBS symptoms, including abdominal pain, compared with placebo. The therapeutic effect is independent of effects on anxiety, depression, and colonic sensorimotor function.
Day and Night Closed-Loop Control in Adults With Type 1 Diabetes

To compare two validated closed-loop (CL) algorithms versus patient self-control with CSII in terms of glycemic control.



This study was a multicenter, randomized, three-way crossover, open-label trial in 48 patients with type 1 diabetes mellitus for at least 6 months, treated with continuous subcutaneous insulin infusion. Blood glucose was controlled for 23 h by the algorithm of the Universities of Pavia and Padova with a Safety Supervision Module developed at the Universities of Virginia and California at Santa Barbara (international artificial pancreas [iAP]), by the algorithm of University of Cambridge (CAM), or by patients themselves in open loop (OL) during three hospital admissions including meals and exercise. The main analysis was on an intention-to-treat basis. Main outcome measures included time spent in target (glucose levels between 3.9 and 8.0 mmol/L or between 3.9 and 10.0 mmol/L after meals).



Time spent in the target range was similar in CL and OL: 62.6% for OL, 59.2% for iAP, and 58.3% for CAM. While mean glucose level was significantly lower in OL (7.19, 8.15, and 8.26 mmol/L, respectively) (overall P = 0.001), percentage of time spent in hypoglycemia (<3.9 mmol/L) was almost threefold reduced during CL (6.4%, 2.1%, and 2.0%) (overall P = 0.001) with less time ≤2.8 mmol/L (overall P = 0.038). There were no significant differences in outcomes between algorithms.



Both CAM and iAP algorithms provide safe glycemic control.
Clinical validation of the watershed sign as a marker for neuropsychiatric systemic lupus erythematosus.

To study the relationship between single-photon-emission computed tomography (SPECT) brain imaging and neuropsychiatric signs/symptoms in a cohort of patients with systemic lupus erythematosus (SLE), analyzed using a stereotactic surface projection (SSP) technique.



Thirty-seven SLE patients were referred for 99mTc-ethyl cysteinate dimer SPECT brain imaging because of neuropsychiatric signs/symptoms. Nineteen normal controls were studied with the identical protocol. Reconstructed images were computed and Z scores were calculated using the SSP technique with the 2-sample t-tests comparing normal controls with SLE patients, and patients with mild cognitive dysfunction with those with severe cognitive dysfunction. The clinical characteristics of SLE patients were collected by retrospective chart review and categorized according to American College of Rheumatology case definitions for neuropsychiatric SLE. Cognitive dysfunction was rated by the treating physician on a scale of 0-3.



Thirty of 37 SLE patients had abnormal SPECT results. SLE patients had reduced perfusion in the watershed areas of the frontal lobes bilaterally compared with controls. Additionally, SLE patients with severe cognitive dysfunction had more severe perfusion deficits than those with mild cognitive dysfunction. In some patients with severe cognitive dysfunction, the watershed areas had Z scores > or =4 SDs below controls.



A convenience sample of patients with SLE and neuropsychiatric signs/symptoms demonstrated reduced perfusion in the watershed areas of the frontal lobes on SPECT scanning analyzed by the SSP technique. The severity of findings correlated with severity of cognitive dysfunction. The area of the brain affected is one that is susceptible to ischemia.
Relation of Telemetry Use and Mortality Risk, Hospital Length of Stay, and Readmission Rates in Patients With Respiratory Illness.

The 2004 American Heart Association expert opinion-based guidelines restrict telemetry use primarily to patients with current or high-risk cardiac conditions. Respiratory infections have emerged as a common source of hospitalization, and telemetry is frequently applied without indication in efforts to monitor patient decompensation. In this retrospective study, we aimed to determine whether telemetry impacts mortality risk, length of stay (LOS), or readmission rates in hospitalized patients with acute respiratory infection not meeting American Heart Association criteria. A total of 765 respiratory infection patient encounters with Diagnosis-Related Groups 193, 194, 195, 177, 178 and 179 admitted in 2013 to 2015 to 2 tertiary community-based medical centers (Mayo Clinic, Arizona, and Mayo Clinic, Florida) were evaluated, and outcomes between patients who underwent or did not undergo telemetry were compared. Overall, the median LOS was longer in patients who underwent telemetry (3.0 days vs 2.0 days, p <0.0001). No differences between cohorts were noted in 30-day readmission rates (0.6% vs 1.3%, p = 0.32), patient mortality while hospitalized (0.6% vs 1.3%, p = 0.44), mortality at 30 days (7.9% vs 7.7%, p = 0.94), or mortality at 90 days (13.5% vs 13.5%, p = 0.99). Telemetry predicted LOS for both univariate (estimate 1.18, 95% confidence interval 1.06 to 1.32, p = 0.003) and multivariate (estimate 1.17, 95% confidence interval 1.06 to 1.30, p = 0.003) analyses after controlling for severity of illness but did not predict patient mortality. In conclusion, this study identified that patients with respiratory infection who underwent telemetry without clear indications may face increased LOS without reducing their readmission risk or improving the overall mortality.
Prospective study of positron emission tomography for evaluation of the activity of lapatinib, a dual inhibitor of the ErbB1 and ErbB2 tyrosine kinases, in patients with advanced tumors.

To evaluate the role of FDG-PET in assessing anti-tumor efficacy of molecular targeted drugs, we prospectively performed FDG-PET and CT for response evaluation in patients treated with lapatinib, a dual inhibitor of ErbB1 and ErbB2 tyrosine kinases.



Lapatinib was given orally once a day at doses ranging from 1200 to 1800 mg in a phase I study. CT and FDG-PET were performed before treatment, and at 1, 2 and 3 months after the initiation of the treatment and every 2 months thereafter.



A total of 29 FDG-PET examinations were performed in eight patients with various solid tumors and the metabolic activity in the tumor was evaluated as SUVmax. The best responses, as assessed by CT, were as follows; one partial response, four stable disease and three disease progression. The partial response was observed in a patient with trastuzumab-resistant breast cancer, whose SUVmax was decreased by 60% from baseline. In all of the four patients whose best response was stable disease, the SUVmax was decreased by 6-42% one month after the start of treatment. Prolonged stable disease (10 months) was observed in a patient with colon cancer, whose SUVmax was decreased by 42%. In the patient group with disease progression, SUVmax was increased in two out of three patients.



FDG-PET detected decreases in the metabolic activity of the tumors in patients who experienced clinical benefits on treatment with lapatinib. Thus, FDG-PET may be useful for the evaluation of molecular targeted drugs, such as lapatinib.
Prostate cancer - evidence of exercise and nutrition trial (PrEvENT): study protocol for a randomised controlled feasibility trial.

A growing body of observational evidence suggests that nutritional and physical activity interventions are associated with beneficial outcomes for men with prostate cancer, including brisk walking, lycopene intake, increased fruit and vegetable intake and reduced dairy consumption. However, randomised controlled trial data are limited. The 'Prostate Cancer: Evidence of Exercise and Nutrition Trial' investigates the feasibility of recruiting and randomising men diagnosed with localised prostate cancer and eligible for radical prostatectomy to interventions that modify nutrition and physical activity. The primary outcomes are randomisation rates and adherence to the interventions at 6 months following randomisation. The secondary outcomes are intervention tolerability, trial retention, change in prostate specific antigen level, change in diet, change in general physical activity levels, insulin-like growth factor levels, and a range of related outcomes, including quality of life measures.



The trial is factorial, randomising men to both a physical activity (brisk walking or control) and nutritional (lycopene supplementation or increased fruit and vegetables with reduced dairy consumption or control) intervention. The trial has two phases: men are enrolled into a cohort study prior to radical prostatectomy, and then consented after radical prostatectomy into a randomised controlled trial. Data are collected at four time points (cohort baseline, true trial baseline and 3 and 6 months post-randomisation).



The Prostate Cancer: Evidence of Exercise and Nutrition Trial aims to determine whether men with localised prostate cancer who are scheduled for radical prostatectomy can be recruited into a cohort and subsequently randomised to a 6-month nutrition and physical activity intervention trial. If successful, this feasibility trial will inform a larger trial to investigate whether this population will gain clinical benefit from long-term nutritional and physical activity interventions post-surgery.  Evidence of Exercise and Nutrition Trial (PrEvENT) is registered on the ISRCTN registry, ref number ISRCTN99048944. Date of registration 17 November 2014.
Young Adults at Risk for Excess Alcohol Consumption Are Often Not Asked or Counseled About Drinking Alcohol

Excessive alcohol consumption is most widespread among young adults. Practice guidelines recommend screening and physician advice, which could help address this common cause of injury and premature death. To assess the proportion of persons ages 18–39 who, in the past year, saw a physician and were asked about their drinking and advised what drinking levels pose health risk, and whether this differed by age or whether respondents exceeded low-risk drinking guidelines [daily (>4 drinks for men/>3 for women) or weekly (>14 for men/>7 for women)]. Survey of young adults selected from a national internet panel established using random digit dial telephone techniques. Adults age 18–39 who ever drank alcohol, n = 3,409 from the internet panel and n = 612 non-panel telephone respondents. Respondents were asked whether they saw a doctor in the past year; those who did see a doctor were asked whether a doctor asked about their drinking, advised about safe drinking levels, or counseled to reduce drinking. Of respondents, 67% saw a physician in the past year, but only 14% of those exceeding guidelines were asked and advised about risky drinking patterns. Persons 18–25 were the most likely to exceed guidelines (68% vs. 56%, p < 0.001) but were least often asked about drinking (34% vs. 54%, p < 0.001). Despite practice guidelines, few young adults are asked and advised by physicians about excessive alcohol consumption. Physicians should routinely ask all adults about their drinking and offer advice about levels that pose health risk, particularly to young adults.
Symptomatic venous thromboembolism and mortality in orthopaedic surgery – an observational study of 45 968 consecutive procedures

Little information exists on the presentation of symptomatic venous thromboembolism (VTE) in orthopaedic surgery when a defined protocol for thromboprophylaxis is used. The objective with this study was to establish the VTE rate and mortality rate in orthopaedic surgery.



We performed a prospective, single centre observational cohort study of 45 968 consecutive procedures in 36 388 patients over a 10 year period. Follow-up was successful in 99.3%. The primary study outcome was the incidence of symptomatic deep vein thrombosis (DVT), symptomatic pulmonary embolism (PE) and mortality at 6 weeks, specified for different surgical procedures. The secondary outcome was to describe the DVT distribution in proximal and distal veins and the proportion of VTEs diagnosed after hospital discharge. For validation purposes, a retrospective review of VTEs diagnosed 7-12 weeks postoperatively was also performed.



In total, 514 VTEs were diagnosed (1.1%; 95% CI: 1.10-1.14), the majority (84%) after hospital discharge (432 out of 514).With thromboprophylaxis, high incidence of VTE was found after internal fixation (IF) of pelvic fracture (12%; 95% CI: 5-26), knee replacement surgery (3.7%; 95% CI: 2.8-5.0), after internal fixation (IF) of proximal tibia fracture (3.8%; 95% CI: 2.3-6.3) and after IF of ankle fracture (3.6%; 95% CI: 2.9-4.4). Without thromboprophylaxis, high incidence of VTE was found after Achilles tendon repair (7.2%; 95% CI: 5.5-9.4). In total 1094 patients deceased (2.4%; 95% confidence interval (CI): 2.33- 2.44) within 6 weeks of surgery. Highest mortality was seen after lower limb amputation (16.3%, CI: 13.8-19.1) and after hip hemiarthroplasty due to hip fracture (9.6%, CI; 7.6-12.1).



The overall incidence of VTE is low after orthopaedic surgery but our study highlights surgical procedures after which the risk for VTE remains high and improved thromboprophylaxis is needed.
Intralesional abciximab and thrombus aspiration in patients with large anterior myocardial infarction: one-year results from the INFUSE-AMI trial.

Whether intralesional abciximab administration and thrombus aspiration confer clinical benefits to patients undergoing primary percutaneous coronary intervention for ST-segment-elevation myocardial infarction is controversial.



A total of 452 patients with ST-segment-elevation myocardial infarction caused by proximal or mid left anterior descending artery occlusion undergoing primary percutaneous coronary intervention with bivalirudin anticoagulation were randomized in a 2×2 factorial design to bolus abciximab delivered locally at the infarct lesion site versus no abciximab and to manual thrombus aspiration versus no aspiration. Treatment with intralesional abciximab, thrombus aspiration, or both therapies compared with no active therapy before stent implantation resulted in lower 1-year rates of death (4.5% versus 10.4%; P=0.03), severe heart failure (4.2% versus 10.3%; P=0.02), and stent thrombosis (0.9% versus 3.8%; P=0.046). Between 30 days and 1 year of follow-up, treatment with intralesional abciximab compared with no abciximab was associated with a lower rate of death (1.4% versus 4.9%; P=0.04) and composite major adverse ischemic events (3.3% versus 7.8%; P=0.04), with nonsignificantly different overall 1-year rates of mortality, composite ischemic events, and heart failure-related events. Thrombus aspiration compared with no aspiration was associated with lower rates of new-onset severe heart failure between 30 days and 1 year (0.9% versus 4.5%; P=0.02) and of rehospitalization for heart failure from randomization to 1 year (0.9% versus 5.4%; P=0.0008), with nonsignificantly different rates of mortality.



Intralesional abciximab and thrombus aspiration may have long-term benefits in patients with anterior ST-segment-elevation myocardial infarction presenting early after symptom onset and undergoing primary percutaneous coronary intervention with bivalirudin anticoagulation.
Impact of anteroinferior transseptal puncture on creation of a complete block at the mitral isthmus in patients with atrial fibrillation

Achieving complete mitral isthmus (MI) conduction block for atrial fibrillation (AF) ablation remains challenging. We hypothesized that transseptal puncture (TSP) at the anteroinferior aspect of the atrial septum (anteroinferior TSP) could shorten the distance to the MI and improve catheter contact and stability, enabling complete MI block. This study investigated the efficacy of anteroinferior TSP for MI ablation in AF patients. Three hundred and twenty consecutive patients (mean age: 62 ± 9 years, 84 % male) with persistent AF undergoing AF ablation, including MI ablation, were enrolled. MI ablation was performed through the conventional (posterior) TSP site (group C, n = 170) or the anteroinferior TSP site (group A, n = 150). Left atrial diameter (LAD) enlargement was greater in group A than in group C (45.8 ± 5.3 mm vs. 44.1 ± 5.0 mm, p = 0.002). Complete MI block at the initial session was significantly higher in group A than in group C (141/150 [94 %] vs. 144/170 [85 %], p = 0.011). At the repeat session for AF recurrence, the rate of persistent complete MI block was significantly higher in group A than in group C (36/48 [75 %] vs. 28/67 [42 %], p < 0.001). LAD (p = 0.011) and left ventricular diastolic dimension (p = 0.037) were significant predictors of failed MI block, while anteroinferior TSP was significantly associated with successful MI block (p < 0.001). Anteroinferior TSP could improve the initial success rate and long-term persistence of complete MI block for AF ablation.
Anti-Aβ Oligomer IgG and Surface Sialic Acid in Intravenous Immunoglobulin: Measurement and Correlation with Clinical Outcomes in Alzheimer’s Disease Treatment

The fraction of IgG antibodies with anti-oligomeric Aβ affinity and surface sialic acid was compared between Octagam and Gammagard intravenous immunoglobulin (IVIG) using two complementary surface plasmon resonance methods. These comparisons were performed to identify if an elevated fraction existed in Gammagard, which reported small putative benefits in a recent Phase III clinical trial for Alzheimer's Disease. The fraction of anti-oligomeric Aβ IgG was found to be higher in Octagam, for which no cognitive benefits were reported. The fraction and location of surface-accessible sialic acid in the Fab domain was found to be similar between Gammagard and Octagam. These findings indicate that anti-oligomeric Aβ IgG and total surface sialic acid alone cannot account for reported clinical differences in the two IVIG products. A combined analysis of sialic acid in anti-oligomeric Aβ IgG did reveal a notable finding that this subgroup exhibited a high degree of surface sialic acid lacking the conventional α2,6 linkage. These results demonstrate that the IVIG antibodies used to engage oligomeric Aβ in both Gammagard and Octagam clinical trials did not possess α2,6-linked surface sialic acid at the time of administration. Anti-oligomeric Aβ IgG with α2,6 linkages remains untested as an AD treatment.