nils-herrmann/clean_scirepeval huggingface dataset:
Granulocyte Colony Stimulating Factor and Physiotherapy after Stroke: Results of a Feasibility Randomised Controlled Trial: Stem Cell Trial of Recovery EnhanceMent after Stroke-3 (STEMS-3 ISRCTN16714730)

Granulocyte-colony stimulating factor (G-CSF) mobilises endogenous haematopoietic stem cells and enhances recovery in experimental stroke. Recovery may also be dependent on an enriched environment and physical activity. G-CSF may have the potential to enhance recovery when used in combination with physiotherapy, in patients with disability late after stroke.



A pilot 2 x 2 factorial randomised (1:1) placebo-controlled trial of G-CSF (double-blind), and/or a 6 week course of physiotherapy, in 60 participants with disability (mRS >1), at least 3 months after stroke. Primary outcome was feasibility, acceptability and tolerability. Secondary outcomes included death, dependency, motor function and quality of life measured 90 and 365 days after enrolment.



Recruitment to the trial was feasible and acceptable; of 118 screened patients, 92 were eligible and 32 declined to participate. 60 patients were recruited between November 2011 and July 2013. All participants received some allocated treatment. Although 29 out of 30 participants received all 5 G-CSF/placebo injections, only 7 of 30 participants received all 18 therapy sessions. G-CSF was well tolerated but associated with a tendency to more adverse events than placebo (16 vs 10 patients, p = 0.12) and serious adverse events (SAE) (9 vs 3, p = 0.10). On average, patients received 14 (out of 18 planned) therapy sessions, interquartile range [12, 17]. Only a minority (23%) of participants completed all physiotherapy sessions, a large proportion of sessions (114 of 540, 21%) were cancelled due to patient (94, 17%) and therapist factors (20, 4%). No significant differences in functional outcomes were detected in either the G-CSF or physiotherapy group at day 90 or 365.



Delivery of G-CSF is feasible in chronic stroke. However, the study failed to demonstrate feasibility for delivering additional physiotherapy sessions late after stroke therefore a definitive study using this trial design is not supported. Future work should occur earlier after stroke, alongside on-going clinical rehabilitation.
The negative impact of incomplete angiographic revascularization on clinical outcomes and its association with total occlusions: the SYNTAX (Synergy Between Percutaneous Coronary Intervention with Taxus and Cardiac Surgery) trial.

The study sought to evaluate the clinical impact of angiographic complete (CR) and incomplete (ICR) revascularization and its association with the presence of total occlusions (TO), after percutaneous coronary intervention (PCI) or coronary artery bypass graft (CABG) surgery in the "all-comers" SYNTAX (Synergy Between Percutaneous Coronary Intervention with Taxus and Cardiac Surgery) trial.



In patients with complex coronary artery disease undergoing PCI or CABG, the long-term prognostic implications of CR versus ICR is unsettled.



In this post hoc study, consisting of randomized (n = 1,800) and nested PCI (n = 198) and CABG (n = 649) registries, 4-year clinical outcomes were compared in groups, with and without angiographic CR, in the PCI and CABG arms. Clinical outcomes were analyzed with Kaplan-Meier estimates, log-rank comparisons, and Cox regression analyses. Multivariate predictors of ICR were determined. Similar analyses were undertaken in the TO and non-TO treated groups of both study arms.



Angiographic CR was achieved in 52.8% of the PCI arm and 66.9% of the CABG arm. Within the PCI and CABG arms, ICR (compared with CR) seemed to be a surrogate marker of a greater burden of anatomical coronary complexity and clinical comorbidity and was associated with significantly higher frequencies of 4-year mortality, all-cause revascularization, stent thrombosis (PCI arm), and major adverse cardiac and cerebrovascular events. The presence of a TO was the strongest independent predictor of ICR after PCI (hazard ratio: 2.70, 95% confidence interval: 1.98 to 3.67, p < 0.001). Eight hundred and forty patients (PCI: 26.3%, CABG: 36.4%, p < 0.001) were identified to have 1,007 TOs, with 68.1% of TOs located in the proximal-mid coronary vasculature. The findings associating ICR (compared with CR) with higher frequencies of 4-year mortality and major adverse cardiac and cerebrovascular events remained consistent in the TO-treated groups in the PCI and CABG arms.



Within the PCI and CABG arms of the all-comers SYNTAX trial, angiographically determined ICR has a detrimental impact on long-term clinical outcomes, including mortality. This effect remained consistent in patients with and without TOs.
The safety of Mohs surgery: a prospective multicenter cohort study.

Complications associated with Mohs surgery have been evaluated by single-surgeon studies. While these studies provide evidence for the safety of the procedure, prospective, multicenter studies afford a higher level of clinical evidence and establish further the safety profile of Mohs surgery in the ambulatory setting.



This study was designed to prospectively evaluate major and minor complications as well as postoperative pain associated with Mohs surgery.



A multicenter prospective cohort study was conducted evaluating the rate of major and minor complications as well as postoperative pain associated with the treatment of skin cancer using Mohs surgery in 1550 patients with 1792 tumors. Follow-up was obtained in 1709 of the 1792 tumors treated (95.3%).



No major complications occurred during Mohs surgery or reconstruction. A total of 44 (2.6%) minor primary postoperative complications occurred during the study. On a scale from 0 to 10, the average peak postoperative pain level was 1.99.



Limitations of the study include the variability of practice patterns across practice sites as well as the 4.7% of patients lost to follow-up.



Mohs surgery is performed with a high degree of safety and is well tolerated by patients.
Appropriateness and reliability testing of the modified Richmond Agitation-Sedation Scale in Spanish patients with advanced cancer.

A tool to quantify agitation severity and sedation level in patients with advanced cancer is needed.



To test the appropriateness and reliability of the Richmond Agitation-Sedation Scale (RASS) in Spanish patients with advanced cancer.



The original RASS was translated into Spanish according to the standard guidelines. Face validity was assessed by members of the palliative care team, and interrater reliability was assessed, using a weighted kappa, from observations of patients admitted to the palliative care unit. The association between scores of the RASS, Ramsay Sedation Scale, and Glasgow Coma Scale was evaluated using Spearman's ρ.



Three hundred twenty-two observations were performed in 156 patients: 116 observations were performed for delirious patients, 76 observations for sedated patients, and 130 observations for patients admitted for other symptom control. The weighted kappa values were practically equal to or greater than 0.90 between nurses and nurses and physicians. The agreement level between observers for each RASS score was roughly 90%. The correlation between the RASS and the Ramsay and Glasgow Scale values was analyzed for 196 observations recorded in 80 patients. The sedation scale of the RASS had a strong correlation with both the Ramsay (Spearman's ρ, -0.89; P < 0.001) and the Glasgow Coma Scales (Spearman's ρ, 0.85; P < 0.001).



These data support the use of the RASS in Spanish patients with advanced cancer.
Diffusion tensor analysis of corpus callosum in progressive supranuclear palsy

Progressive supranuclear palsy (PSP) is a neurodegenerative disease featuring parkinsonism, supranuclear ophthalmoplegia, dysphagia, and frontal lobe dysfunction. The corpus callosum which consists of many commissure fibers probably reflects cerebral cortical function. Several previous reports showed atrophy or diffusion abnormalities of anterior corpus callosum in PSP patients, but partitioning method used in these studies was based on data obtained in nonhuman primates. In this study, we performed a diffusion tensor analysis using a new partitioning method for the human corpus callosum. Seven consecutive patients with PSP were compared with 29 age-matched patients with Parkinson’s Disease (PD) and 19 age-matched healthy control subjects. All subjects underwent diffusion tensor magnetic resonance imaging, and the corpus callosum was partitioned into five areas on the mid-sagittal plane according to a recently established topography of human corpus callosum (CC1—prefrontal area, CC2—premotor and supplementary motor area, CC3—motor area, CC4—sensory area, CC5—parietal, temporal, and occipital area). Fractional anisotropy (FA) and apparent diffusion coefficient (ADC) were measured in each area and differences between groups were analyzed. In the PSP group, FA values were significantly decreased in CC1 and CC2, and ADC values were significantly increased in CC1 and CC2. Receiver operating characteristic analysis showed excellent reliability of FA and ADC analyses of CC1 for differentiating PSP from PD. The anterior corpus callosum corresponding to the prefrontal, premotor, and supplementary motor cortices is affected in PSP patients. This analysis can be an additional test for further confirmation of the diagnosis of PSP.
Associations of depression with impaired glucose regulation, newly diagnosed diabetes and previously diagnosed diabetes in Chinese adults.

To examine the association between depression and impaired glucose regulation, newly diagnosed diabetes and previously diagnosed diabetes in middle-aged and elderly Chinese people, and whether depression was associated with different treatment regimens or durations of diabetes.



A cross-sectional study was performed among 229,047 adults living in the community aged ≥ 40 years from 25 centres in China. The self-reported depression rating scale Patient Health Questionnaire 9 (PHQ-9) was used to diagnose probable and sub-threshold depression. Glucose metabolism status was determined according to World Health Organization 1999 diagnostic criteria.



The numbers of participants with normal glucose regulation, impaired glucose regulation, newly diagnosed diabetes and previously diagnosed diabetes were 120,458, 59,512, 24,826 and 24,251, respectively. The prevalence of sub-threshold depression in the total sample of participants was 4.8% (4.8%, 4.8%, 4.4% and 5.6% from normal glucose regulation to previously diagnosed diabetes, respectively), and the prevalence of probable depression was 1.1% (1.1%, 1.0%, 0.9% and 1.8% from normal glucose regulation to previously diagnosed diabetes, respectively). Compared with participants with normal glucose regulation, those with previously diagnosed diabetes had increased odds of probable depression [odds ratio (OR) = 1.61, 95% confidence interval (CI) 1.39-1.87] and sub-threshold depression (OR = 1.14, 95% CI 1.06-1.24), after adjustment for multiple confounding factors. Newly diagnosed diabetes or impaired glucose regulation was not associated with depression. Among those with previously diagnosed diabetes, insulin treatment was associated with greater odds of depression compared with no treatment or oral anti-diabetic medicine.



Previously diagnosed diabetes, but not newly diagnosed diabetes or impaired glucose regulation, was associated with a higher prevalence of depression. Patients receiving insulin were more likely to have depression than those not receiving treatment or being treated with oral anti-diabetic medicine.
Fermentation of Korean red ginseng by Lactobacillus plantarum M-2 and its immunological activities.

We investigated ginsenoside transformation by fermentation of red ginseng with Lactobacillus plantarum M-2. We also examined the anti-metastasis and immune-stimulating activities of EtOH extracts of fermented red ginseng (FRG-E) in animal and human subjects. Total sugar decreased from 85.5 mg mL(-1) to 44.1 mg mL(-1) with increasing culture time during the fermentation with L. plantarum M-2. Uronic acid content reached a maximum level (534.3 μg mL(-1)) at 3 days of fermentation and decreased thereafter. Ginsenoside metabolites increased from 4,637.0 to 7,581.1 μg mL(-1) after 4 days. The prophylactic intraperitoneal injection of FRG-E (500 μg mouse(-1)) inhibited lung metastasis about 81.1%, while the inhibitory effect against tumor metastasis by treatment of EtOH extract from non-fermented red ginseng (NFRG-E) was 66.9%. Immunoglobulin A (IgA) and G (IgG) levels in the serum of healthy subjects were higher after FRG-E administration than at baseline, whereas NFRG-E induced reductions of these variables related to immunity. At 1 week, the change in IgA level by FRG-E (5.14 mg mL(-1)) was significantly higher than that by NFRG-E (-14.50 mg mL(-1); p < 0.05). It was concluded that the immunological activities of FRG-E were higher than those of NFRG-E, indicating that fermentation helped enhance the immunological activities of red ginseng.
Pancreatic acinar cells—a normal finding at the gastroesophageal junction? Data from a prospective Central European multicenter study

Pancreatic acinar cells are a well-recognized finding at the gastroesophageal junction, but their histogenesis and biological significance are unclear. From the prospective Central European multicenter histoGERD trial, we recruited 1,071 individuals undergoing gastroscopy for various non-selected reasons. Biopsy material was systematically sampled from the gastroesophageal junction and from the stomach. The study aimed to assess the prevalence of pancreatic acinar cells and to relate their presence to various histologic and clinical features. Overall, pancreatic acinar cells were observed in 184 (17.2 %) participants. Individuals diagnosed with pancreatic acinar cells were slightly younger than those without (median 50 vs. 53 years; p = 0.009). There was no association with patients’ symptoms and/or complaints or with an endoscopic diagnosis of esophagitis or Barrett’s esophagus. Regarding histology, pancreatic acinar cells were not associated with features of the squamous epithelium indicating reflux disease, such as basal cell hyperplasia, papillary elongation, dilation of intercellular spaces, and inflammatory cell number, but were associated with the presence of cardiac mucosa (p < 0.001), oxyntocardiac mucosa (p < 0.001), and intestinal metaplasia (p = 0.038), respectively. No association with Helicobacter pylori infection or diagnosis of gastritis was noted. In conclusion, pancreatic acinar cells are a common finding at the gastroesophageal junction, and no association with either reflux disease (histologically or endoscopically) or diagnosis of gastritis was observed. These data suggest a congenital rather than an acquired (metaplastic) origin of pancreatic acinar cells at the gastroesophageal junction. This questions the term “pancreatic acinar metaplasia” which is currently widely used for their diagnosis.
Screening and Follow-Up Monitoring for Substance Use in Primary Care: An Exploration of Rural–Urban Variations

Rates of substance use in rural areas are close to those of urban areas. While recent efforts have emphasized integrated care as a promising model for addressing workforce shortages in providing behavioral health services to those living in medically underserved regions, little is known on how substance use problems are addressed in rural primary care settings. To examine rural–urban variations in screening and monitoring primary care- based patients for substance use problems in a state-wide mental health integration program. This was an observational study using patient registry. The study included adult enrollees (n = 15,843) with a mental disorder from 133 participating community health clinics. We measured whether a standardized substance use instrument was used to screen patients at treatment entry and to monitor symptoms at follow-up visits. While on average 73.6 % of patients were screened for substance use, follow-up on substance use problems after initial screening was low (41.4 %); clinics in small/isolated rural settings appeared to be the lowest (13.6 %). Patients who were treated for a mental disorder or substance abuse in the past and who showed greater psychiatric complexities were more likely to receive a screening, whereas patients of small, isolated rural clinics and those traveling longer distances to the care facility were least likely to receive follow-up monitoring for their substance use problems. Despite the prevalent substance misuse among patients with mental disorders, opportunities to screen this high-risk population for substance use and provide a timely follow-up for those identified as at risk remained overlooked in both rural and urban areas. Rural residents continue to bear a disproportionate burden of substance use problems, with rural–urban disparities found to be most salient in providing the continuum of services for patients with substance use problems in primary care.
Uridine supplementation for the treatment of antiretroviral therapy-associated lipoatrophy: a randomized, double-blind, placebo-controlled trial.

Highly active antiretroviral therapy (HAART) is associated with loss of subcutaneous fat (lipoatrophy) presumably due to mitochondrial toxicity of nucleoside reverse transcriptase inhibitors. In vitro, uridine abrogates thymidine analogue-induced toxicity in adipocytes.



A total of 20 patients with HAART-associated lipoatrophy were randomized to receive either a dietary uridine supplement (36 g three times a day for 10 consecutive days/month) or placebo, for 3 months. Body composition was measured using dual energy X-ray absorptiometry, magnetic resonance imaging and proton spectroscopy. Data are mean +/- standard error of mean.



The mean increases in limb fat (880 +/- 140 versus 230 +/- 270 g; P < 0.05), intra-abdominal fat (210 +/- 80 versus -80 +/- 70 cm3; P < 0.05) and total body fat (1920 +/- 240 versus 240 +/- 520 g; P < 0.01) were significantly greater in the uridine than in the placebo group. Within the uridine group, the changes from baseline to 3 months were statistically significant in total limb fat (P < 0.001), intra-abdominal fat (P < 0.05) and total body fat (P < 0.001). The proportion of limb fat to total fat increased from 18% to 25% (P < 0.05) in the uridine group. Liver fat content and lean body mass remained unchanged in both groups. High-density lipoprotein-cholesterol concentrations decreased in the uridine and increased in the placebo group, whereas fasting serum insulin concentrations did not change. Uridine supplementation was well tolerated and the virological effect of HAART was not affected.



Uridine supplementation significantly and predominantly increased subcutaneous fat mass in lipoatrophic HIV-infected patients during unchanged HAART.
Does the baricity of bupivacaine influence intrathecal spread in the prolonged sitting position before elective cesarean delivery? A prospective randomized controlled study.

Difficulties in inserting an epidural catheter while performing combined spinal-epidural anesthesia for cesarean delivery may lead to undue delays between the spinal injection of the local anesthetic mixture and the adoption of the supine position with lateral tilt. We hypothesized that this delay may affect the intrathecal distribution of local anesthetic of different baricities such that hypobaric local anesthetic would lead to a higher sensory block level.



Healthy parturients with uncomplicated pregnancies undergoing elective cesarean delivery under combined spinal-epidural anesthesia were enrolled in this prospective double-blind randomized controlled trial. The subjects were allocated to receive hyperbaric (hyperbaric group), isobaric (isobaric group), or hypobaric (hypobaric group) spinal bupivacaine 10 mg. After the spinal injection, the subjects remained in the sitting position for 5 minutes (to simulate difficulty in inserting the epidural catheter) before being helped into the supine lateral tilt position. The primary outcome was the sensory block level during the 25 minutes after the spinal injection. Other end points included motor block score, maternal hypotension, and vasopressor requirements.



Data from 89 patients were analyzed. Patient characteristics were similar in all groups. The median [interquartile range] (95% confidence interval) sensory levels after spinal injection were significantly higher with decreasing baricity: hyperbaric T10 [T11-8] (T10-9), isobaric T9 [T10-7] (T9-7), and hypobaric T6 [T8-4] (T8-5) (P < 0.001, Cuzick trend). All patients in the hypobaric group reached a sensory block level of T4 at 25 minutes after spinal injection compared with 80% of the patients in both the isobaric and hyperbaric groups (P = 0.04; difference 20%, 95% confidence interval of difference 4%-33%). Significantly more patients in the hypobaric group had complete lower limb motor block (Bromage score = 4) (hyperbaric 43%, isobaric 63%, and hypobaric 90%; P < 0.001). The incidences of maternal hypotension and nausea and vomiting were similar among groups, although the ephedrine requirements were significantly increased in the isobaric and hypobaric groups by factors of 1.83 and 3.0, respectively, compared with the hyperbaric group (P < 0.001, Cuzick trend).



We demonstrated that when parturients undergoing cesarean delivery were maintained in the sitting position for 5 minutes after spinal injection of the local anesthetic, hypobaric bupivacaine resulted in sensory block levels that were higher compared with isobaric and hyperbaric bupivacaine, respectively, during the study period.
Significant Changes in the Intestinal Environment After Surgery in Patients with Colorectal Cancer

There have been very few detailed reports of the intestinal environment after surgical treatment for colorectal cancer (CRC). We analysed faecal microbiota, organic acids and pH to investigate the influence of colorectal surgery on the intestinal environment. Faecal samples from 81 CRC patients were collected before the start of pre-operative preparation the day before surgery, as well as 7 days or more after surgery. Thirteen groups of intestinal microbiota, eight types of organic acids, and pH were measured using 16S rRNA-targeted reverse transcription-quantitative PCR, high-performance liquid chromatography and a pH meter, respectively. Total bacterial counts (10.3 ± 0.6 vs. 9.4 ± 1.2 log10 cells/g; p < 0.001) and the numbers of 6 groups of obligate anaerobes were significantly decreased after surgery. In contrast, the populations of Enterobacteriaceae, Enterococcus, Staphylococcus and Pseudomonas were significantly increased. Post-operatively, the concentration of total organic acids was lower (77.9 ± 40.1 vs. 50.1 ± 37.0 μmol/g; p < 0.001) than the pre-operative concentration, and a significant reduction in short-chain fatty acids (SCFAs) was observed. Significant changes in the intestinal environment, including marked decreases in obligate anaerobes, increases in pathogenic bacteria, and reductions in SCFAs, were detected after surgery for CRC.