nils-herrmann/clean_scirepeval huggingface dataset:
Comparison of neurological and functional outcomes after administration of granulocyte-colony-stimulating factor in motor-complete versus motor-incomplete postrehabilitated, chronic spinal cord injuries: a phase I/II study.

Granulocyte-colony-stimulating factor (G-CSF) is a major growth factor in the activation and differentiation of granulocytes. This cytokine has been widely and safely employed in different disease conditions over many years. The administration of the growth factors in spinal cord injury (SCI) has been reported elsewhere; here we have tried to see the effect of SCI severity on the neurological outcomes after neuroprotective treatment for SCI with G-CSF. Seventy-four consecutive patients with SCI of at least 6 months' duration, with stable neurological status in the last 3 months, having informed consent for the treatment were included in the study. All the patients had undergone at least 3 months of standard rehabilitation. Patients were assessed by the American Spinal Injury Association (ASIA) scale, Spinal Cord Independence Measure (SCIM) III, and International Association of Neurorestoratology-Spinal Cord Injury Functional Rating Scale (IANR-SCIFRS) just before intervention and periodically until 6 months after subcutaneous administration of 5 µg/kg per day of G-CSF for 7 consecutive days. Multiple linear regression models were performed for statistical evaluation of lesion completeness and level of injury on changes in ASIA motor, light touch, pinprick, IANR-SCIFRS, and SCIM III scores, as a phase I/II comparative study. The study consisted of 52 motor-complete and 22 motor-incomplete SCI patients. There was no significant difference regarding age and sex, chronicity, and level of SCI between the two groups. Motor-incomplete patients had significantly more improvement in ASIA motor score compared to the motor-complete patients (7.68 scores, p < 0.001); also they had significant improvement in light touch (6.42 scores, p = 0.003) and pinprick sensory scores (4.89 scores, p = 0.011). Therefore, G-CSF administration in motor-incomplete SCIs is associated with significantly higher motor improvement, and also the higher the initial ASIA Impairment Scale (AIS) grade, the less would be the final AIS change, and incomplete cases are more welcome into the future studies. This manuscript is published as part of the International Association of Neurorestoratology (IANR) special issue of Cell Transplantation.
Time course and extent of functional recovery during the first postoperative year after minimally invasive total hip arthroplasty with two different surgical approaches--a randomized controlled trial.

While others have reported short-term comparisons between various minimally invasive surgical (MIS) approaches to total hip arthroplasty (THA) and their conventional analogues, longer-term data is lacking, as is information indicating whether MIS approaches to THA provide a biomechanically complete recovery. Furthermore, different MIS approaches have not been compared. Our approaches of interest were a one-incision modified Watson-Jones, and a two-incision approach.


HYPOTHESES
(1) There are significant differences in gait recovery patterns between the two surgical groups and (2) THA subjects have significant differences in function one year after surgery compared to control subjects. To test these hypotheses, THA candidates (n=26) were randomized to receive one of these MIS approaches and evaluated preoperatively, and postoperatively at 3 weeks, and at 3, 6 and 12 months. Evaluations included three-dimensional gait analysis and 24-hour step-counts. The same data were obtained from 25 control subjects. Recovery time-course was assessed using repeated measures ANOVA. T-tests were used to compare controls with the pooled group of THA subjects. We found no differences between the two THA surgical groups regarding the time-course of recovery (p≥0.591). Although recovery was statistically complete by 3 months postoperatively for all variables, there were significant differences from controls at 12 months. Most notably, the external hip adduction moment, which reflects hip abductor function, was more than one standard deviation below normal (p<0.001). THA subject inactivity could not explain the gait differences, since one year after surgery daily step counts were not significantly different from controls (p=0.346). More work is necessary to determine ways to improve biomechanical outcomes for today's patients with high expectations for function and implant longevity.
Prediction of chemotherapy outcome in patients with metastatic soft tissue sarcomas based on dynamic FDG PET (dPET) and a multiparameter analysis

Dynamic PET studies with 18F-FDG were performed in patients with metastatic soft tissue sarcomas who received conventional chemotherapy with doxorubicin hydrochloride (Adriamycin) and ifosfamide (AI-G). The goal of the study was to evaluate the impact of full kinetic analysis and assess its value with regard to the therapy outcome based on survival data. The evaluation included 17 patients with 29 metastatic lesions of soft tissue sarcomas, who were treated with chemotherapy consisting of an AI-G regimen prior to high-dose chemotherapy and peripheral blood stem cell transplantation where applicable. Patients were examined prior to onset of therapy and after completion of the first cycle of AI-G. Restaging data (n = 17) based on Response Evaluation Criteria in Solid Tumors were available. Survival data (n = 14) served for reference. The following parameters were retrieved from the dynamic PET studies: standardized uptake value (SUV), fractal dimension, two-compartment model with computation of k1, k2, k3, k4 (unit: 1/min), the fractional blood volume and the FDG influx calculated according to Patlak. The mean SUV was 6.9 prior to therapy and 4.7 after one cycle. The mean influx was 0.066 prior to therapy in comparison to 0.058 after one cycle. We dichotomized the patients according to the median survival time of 320 days into response (n = 6) and non-response (n = 8). The mean SUV was 7.6 in the group of responders and 5.4 in the group of non-responders prior to therapy. Responders revealed a mean SUV of 3.8 after therapy as compared to 5.0 SUV for non-responders. We used discriminant analysis to classify the patients into the two response groups. The classification of the non-responders was generally higher (negative predictive value > 61%) than for the responders. Finally, the combined use of the four predictor variables, namely mean SUV and k1 of both studies led to the highest accuracy of 90% for both groups. The data demonstrate that only a multiparameter analysis based on a combination of the absolute values of mean SUV and k1 of a baseline study and a follow-up study after completion of one cycle was the best combination for a group-based analysis, into response or non-response. The quantitative assessment of the FDG kinetics in tumours should be used to quantify the “inhibitory effect” of chemotherapy and to individualize treatment. The main effect of the AI-G therapy may be on angiogenesis (k1 effect) rather than on proliferation.
A pragmatic randomized controlled study of the effectiveness and cost consequences of exercise therapy in hip osteoarthritis.

To evaluate the short- and long-term effectiveness of exercise training in relation to pain, function and direct costs to health care systems attributable to hip osteoarthritis.



Prospective, two-year randomized controlled trial.



An outpatient primary health care setting.



One hundred and twenty men and women aged from 55 to 80, with radiologically diagnosed hip osteoarthritis with associated clinical symptoms.



The combined exercise and general practitioner (GP) care group received 12 supervised (once per week) exercise sessions at the baseline and four additional booster sessions one year later. Both groups received standard GP care.



The WOMAC Osteoarthritis Index, physical functioning score of RAND-36 (SF-36), the use and health care system costs of doctor visits and physiotherapy associated with hip osteoarthritis, number of total hip replacements, the use of analgesic and non-steroidal anti-inflammatory drugs (NSAIDs), performance-based outcome scores and body mass index (BMI).



There were no differences between the groups with respect to WOMAC hip pain, physical functioning score of RAND-36, performance-based outcome scores or BMI. The effect of the exercise intervention on WOMAC function was statistically significant at 6 months (mean = -7.5; 95% confidence interval (CI) -13.9 to -1.0; P = 0.02) and 18 months (mean = -7.9; 95% CI -15.3 to -0.4; P = 0.04). There were no statistically significant differences in the total health care system costs between the groups.



The mostly home-based exercise training programme provided in this study did not result in reduced hip pain over the two-year follow-up period.
Effect of a vocationally-focused brief cognitive behavioural intervention on employment-related outcomes for individuals with mood and anxiety disorders.

Despite an increasing emphasis on the importance of vocational success to the quality of life of individuals with mental illness (Bond, Drake, & Becker, 2008), minimal work has examined the impact of cognitive behavioural interventions that focus on vocational stressors. Vocational stressors commonly faced by persons with mental illness include difficulties with work task completion, obtaining employment, and coping with interpersonal stressors (Becker et al., 1998). The purpose of this pilot study was to examine the effectiveness of a brief cognitive behavioural therapy group intervention that targets vocational stressors for individuals whose vocational functioning had been significantly impacted by mental illness. Participants included 16 individuals with mood and anxiety disorder diagnoses. After this intervention, it was found that employed persons reported an improved sense of mastery in the completion of work tasks, improved satisfaction with work supervision, and decreased satisfaction with advancement and job security. Unemployed participants reported improved expectancy for employment success.
[Effect of sacha inchi oil (plukenetia volúbilis l) on the lipid profile of patients with hyperlipoproteinemia].

We performed a pilot, experimental, open study in order to know the effect, effective dosage and secondary effects of sacha inchi´s (Plukenetia Huallabamba) [corrected] oil on the lipid profiles of patients with hypercholesterolemia. We included 24 patients of ages 35 to 75, to whom we measured total cholesterol (TC), HDL, triglycerides (Tg), glucose (G), non-esterified fatty acids (NEFA) and insulin (I) levels in blood, then we randomized them to receive sacha inchi oil orally 5 ml or 10 ml of a suspension of sacha inchi oil (2gr/5ml) for four months. The oil intake produced a decrease in the mean values of TC, and NEFA, and a rise in HDL in both subgroups. The subgroup receiving 10 ml was associated to an increase in the insulin levels. Sacha inchi oil appears to have beneficial effects on the lipid profile of patients with dyslipidemia, but their efficacy and security should be evaluated in randomized clinical trials.
A comparative study on the efficacies of gonadotropin-releasing hormone (GnRH) agonist and GnRH antagonist in neoadjuvant androgen deprivation therapy combined with transperineal prostate brachytherapy for localized prostate cancer

Neoadjuvant androgen deprivation therapy (ADT) has been suggested to confer several clinical benefits in patients with prostate cancer (PCa) undergoing transperineal prostate brachytherapy (TPPB). Unlike gonadotropin-releasing hormone (GnRH) receptor agonists, a GnRH antagonist such as degarelix can achieve castrate levels of testosterone without testosterone flare. However, normalization of serum testosterone levels following completion of neoadjuvant ADT in either form of treatment has never been compared in clinical trials. This is a single-center, open-label, randomized controlled study that will compare the efficacy and safety of degarelix with those of existing GnRH agonists combined with 125I-TPPB. A total of 56 patients with low/intermediate-risk clinically localized PCa will be enrolled and randomized to one of two treatment groups: the GnRH agonist group and the degarelix group. Patients in the GnRH agonist group will receive leuprorelin acetate or goserelin acetate, and those in the degarelix group will receive the initial dose of 240 mg as 2 subcutaneous injections of 120 mg each, and then 80 mg of maintenance doses every 4 weeks for 12 weeks. Those randomly assigned to the 12-week intervention period will subsequently undergo 48-weeks of follow-up after 125I-TPPB. The primary endpoint is defined as normalization of serum testosterone levels (>50 ng/dL) following completion of neoadjuvant ADT. All patients will be assessed every 4 weeks for the first 24 weeks, then every 12 weeks for the next 36 weeks after administrations of these drugs. Secondary endpoints are the proportion of normalized serum luteinizing hormone (LH) and follicle-stimulating hormone (FSH), the percent reduction in prostate specific antigen (PSA) compared with pretreatment levels, the percent reduction in total prostate volume (TPV) during neoadjuvant ADT, the percent increase in TPV after 125I-TPPB, the percent reduction in hemoglobin, serum alkaline phosphatase (ALP), changes in free testosterone and bone mineral content measurement, the proportion of patients who have serum testosterone levels over 50 ng/dL at 12 weeks following completion of neoadjuvant ADT, and the improvement of quality of life (QOL). The present study will provide additional insight regarding the benefit and potency of degarelix and will examine its potential as a new option for administration in neoadjuvant ADT. Identification number: UMIN000015519 .
Correlation of Caveolin-1 Expression with Prognosis in Patients with Gastric Cancer after Gastrectomy.

Upregulation of caveolin-1 (Cav-1) expression is correlated with histopathological grade and poor prognosis in several human cancers. However, in gastric cancer, its clinical utility as a useful prognostic molecular marker remains unclear.



The prognostic importance of Cav-1 expression was retrospectively analyzed by immunohistochemistry in 148 patients with gastric cancer who had undergone radical gastrectomy.



Cav-1 expression was positive in 23 (15.5%) patients and negative in 125 (84.5%) patients. Tumor location, tumor grade, lymph node involvement, pT stage, pTNM stage, and the presence of recurrence were found to be significantly associated with Cav-1 expression. The median disease-free survival (DFS) of patients with negative Cav-1 expression was significantly better than that of patients with positive Cav-1 expression (not reached vs. 10.2 months, p < 0.001). Moreover, patients with positive Cav-1 expression had a worse median overall survival (OS) compared to patients with negative Cav-1 expression (14.2 vs. 40.3 months, p = 0.004). In the multivariate analysis, Cav-1 expression (positive vs. negative) was an independent prognostic factor for DFS (p < 0.001, hazard ratio (HR) 2.58) and OS (p = 0.031, HR 1.87), as was lymph node metastasis.



Our results suggest that positive Cav-1 expression is associated with progression and poor prognosis in gastric cancer patients after radical gastrectomy. Targeting Cav-1 would be a potential option for future gastric cancer treatment.
Prediction of Cardiac Risk prior to Elective Abdominal Aortic Surgery: Role of Multiple Gated Acquisition Scan

Debate continues regarding the value of cardiac testing before major vascular surgery. Studies looking at whether a low radioisotope left ventricular ejection fraction (LVEF) could reliably predict postoperative cardiac events have produced conflicting results. Technetium-99m multiple gated acquisition (MUGA) scanning was employed in 122 patients undergoing elective abdominal aortic aneurysm surgery to estimate the resting LVEF and to detect regional or global myocardial wall motion abnormalities (WMAs). Adverse cardiac outcomes were predicted using logistic regression analysis. Among this group of patients, 20 did not proceed to surgery for a variety of reasons, and 102 underwent surgical repair. More than half of the patients (55%) had a history of cardiac disease. The mean ± SD LVEF was 55.5% ± 11.1%. Altogether, 31 patients had WMAs, and 21 had both WMAs and an abnormal LVEF (≤ 50%). Altogether, 20 cardiac complications were encountered in 17 patients (17%). Logistic regression analysis identified four significant predictors of cardiac complications: history of cardiac disease [odds ratio (OR) 10.43; 95% confidence interval (CI) 1.3 and 80.5], the presence of WMAs (OR 10.1, CI 1.4 and 74.6), additional procedures (OR 12.1, CI 1.4 and 103.0), and reoperation during the postoperative period (OR 6.4, CI 1.4 and 30.4). This is the largest reported British series of cardiac testing using MUGA scans prior to abdominal aortic reconstruction. Only the presence of WMAs (not the resting LVEF) was useful for predicting postoperative cardiac events. A history of cardiac disease, additional procedures, and reoperation during the postoperative period also place a patient at high risk for cardiac complications. A normal LVEF is by no means reassuring that a patient is at low risk of suffering an adverse cardiac outcome.
A Prospective International Multicenter Study of AKI in the Intensive Care Unit.

AKI is frequent and is associated with poor outcomes. There is limited information on the epidemiology of AKI worldwide. This study compared patients with AKI in emerging and developed countries to determine the association of clinical factors and processes of care with outcomes.



This prospective observational study was conducted among intensive care unit patients from nine centers in developed countries and five centers in emerging countries. AKI was defined as an increase in creatinine of ≥0.3 mg/dl within 48 hours.



Between 2008 and 2012, 6647 patients were screened, of whom 1275 (19.2%) developed AKI. A total of 745 (58% of those with AKI) agreed to participate and had complete data. Patients in developed countries had more sepsis (52.1% versus 38.0%) and higher Acute Physiology and Chronic Health Evaluation (APACHE) scores (mean±SD, 61.1±27.5 versus 51.1±25.2); those from emerging countries had more CKD (54.3% versus 38.3%), GN (6.3% versus 0.9%), and interstitial nephritis (7.0% versus 0.6%) (all P<0.05). Patients from developed countries were less often treated with dialysis (15.5% versus 30.2%; P<0.001) and started dialysis later after AKI diagnosis (2.0 [interquartile range, 0.75-5.0] days versus 0 [interquartile range, 0-5.0] days; P=0.02). Hospital mortality was 22.0%, and 13.3% of survivors were dialysis dependent at discharge. Independent risk factors associated with hospital mortality included older age, residence in an emerging country, use of vasopressors (emerging countries only), dialysis and mechanical ventilation, and higher APACHE score and cumulative fluid balance (developed countries only). A lower probability of renal recovery was associated with residence in an emerging country, higher APACHE score (emerging countries only) and dialysis, while mechanical ventilation was associated with renal recovery (developed countries only).



This study contrasts the clinical features and management of AKI and demonstrates worse outcomes in emerging than in developed countries. Differences in variations in care may explain these findings and should be considered in future trials.
Feasibility and preliminary outcomes of a school-based intervention for inner-city, ethnic minority adolescents with undiagnosed asthma.

To describe and test the feasibility of asthma self-management for adolescents with undiagnosed asthma (ASMA-Undx), an 8-week school-based intervention for urban adolescents comprised of three group and five individual coaching sessions, and academic detailing for their primary care providers (PCPs).



Thirty high school students (mean age 15.9; 92% female; 72% Latino/a) who reported symptoms of persistent asthma, but no diagnosis were randomized to ASMA-Undx or a no-treatment control group. Interviews were conducted pre- and post-intervention.



All intervention students participated in the three group sessions; 64% received all five individual coaching sessions. Academic detailing telephone calls made by a pediatric pulmonologist reached 83% of the students' PCPs. Relative to controls, a significantly greater proportion of ASMA-Undx students were diagnosed (79% versus 6%, respectively), and prescribed asthma medication (57% versus 6%, respectively). Barriers to diagnosis and treatment included students' and parents' lack of knowledge about asthma.



ASMA-Undx is a feasible and promising intervention to assist urban adolescents with undiagnosed asthma obtain a diagnosis and treatment.



ASMA-Undx has the potential to reach many adolescents because it is school-based. It can serve as a model for interventions targeting other pediatric illnesses.
A prospective, multicenter, open-label assessment of atomoxetine in non-North American children and adolescents with ADHD

The aim of this study was to study treatment response to atomoxetine in a large, multicenter study of non-North American patients with ADHD. A total of 604 children and adolescents with ADHD were enrolled in a 10-week open-label trial with atomoxetine prior to randomization to a double-blind relapse prevention phase at 33 sites in the United Kingdom, continental Europe, Israel, South Africa, and Australia. All patients had ADHD symptom severity at least 1.5 standard deviations above United States age and gender norms for their diagnostic subtype as measured by the investigator-scored ADHD Rating Scale (ADHD RS). Outcomes were assessed by analysis of change in the ADHD RS; functional and psychosocial outcomes were assessed using the Child Health Questionnaire (CHQ). At endpoint, ADHD RS total scores decreased by an average of 56.7%, and 69% of patients were rated as having no or minimal symptoms. Significant improvement was observed in psychosocial and functional outcomes. Discontinuations attributed to adverse events were < 4%. These open-label data, gathered in an international setting, add to our knowledge of the value of atomoxetine in treating ADHD symptoms, as well as its safety and tolerability.
Remission of type 2 diabetes after Roux-en-Y gastric bypass or sleeve gastrectomy is associated with a distinct glycemic profile.

Roux-en-Y gastric bypass (RYGBP) and sleeve gastrectomy (SG) have been associated with a high remission rate of type 2 diabetes mellitus (T2DM). However, whether such remission is associated with full restoration of postprandial glucose profile and/or the potentially nonrestored glycemic profile is associated with altered beta cell function, and relapse of T2DM over time is unknown.



Cross-sectional studies comparing (1) glucose and proinsulin/insulin response to a standardized liquid mixed meal (SLMM) challenge (n = 31), (2) glucose response in normal living conditions assessed using continuous glucose monitoring (CGM) (n = 16), and prospective observational study comparing (3) rates of relapse of T2DM after surgery (n = 232) in subjects with remission of T2DM ensuing RYGBP or SG.



In RYGB individuals, SLMM elicited faster and sharper rise in plasma glucose compared with SG, with 88.2% and 42.9% of the study subjects presenting respectively a peak glucose more than 180 mg/dL (all, P < 0.05). During CGM, average percent time in hyperglycemic and hypoglycemic range was larger in RYGBP (respectively, 4.6% and 12.7%) compared with SG subjects (respectively, 0.4% and 3.2%; both P < 0.05). However, (1) no differences were found in fasting or stimulated proinsulin/insulin ratio, and (2) higher rates of T2DM relapse were observed after SG (hazard ratio: 2.339; P = 0.034).



Remission of T2DM after RYGBP and SG is associated with distinct glycemic profiles. However, longer time spent in hyperglycemia and in hypoglycemia after RYGBP compared with SG is not associated with persistence of altered beta cell function or higher rates of relapse of T2DM over time.