nils-herrmann/clean_scirepeval huggingface dataset:
Functional recovery and neural differentiation after transplantation of allogenic adipose-derived stem cells in a canine model of acute spinal cord injury

In this study, we evaluated if the implantation of allogenic adipose-derived stem cells (ASCs) improved neurological function in a canine spinal cord injury model. Eleven adult dogs were assigned to three groups according to treatment after spinal cord injury by epidural balloon compression: C group (no ASCs treatment as control), V group (vehicle treatment with PBS), and ASC group (ASCs treatment). ASCs or vehicle were injected directly into the injured site 1 week after spinal cord injury. Pelvic limb function after transplantation was evaluated by Olby score. Magnetic resonance imaging, somatosensory evoked potential (SEP), histopathologic and immunohistichemical examinations were also performed. Olby scores in the ASC group increased from 2 weeks after transplantation and were significantly higher than C and V groups until 8 weeks (p < 0.05). However, there were no significant differences between the C and V groups. Nerve conduction velocity based on SEP was significantly improved in the ASC group compared to C and V groups (p < 0.05). Positive areas for Luxol fast blue staining were located at the injured site in the ASC group. Also, GFAP, Tuj-1 and NF160 were observed immunohistochemically in cells derived from implanted ASCs. These results suggested that improvement in neurological function by the transplantation of ASCs in dogs with spinal cord injury may be partially due to the neural differentiation of implanted stem cells.
The determination of three subcutaneous adipose tissue compartments in non-insulin-dependent diabetes mellitus women with artificial neural networks and factor analysis

The optical device LIPOMETER allows for non-invasive, quick, precise and safe determination of subcutaneous fat distribution, so-called subcutaneous adipose tissue topography (SAT-Top). In this paper, we show how the high-dimensional SAT-Top information of women with type-2 diabetes mellitus (non-insulin-dependent diabetes mellitus (NIDDM)) and a healthy control group can be analysed and represented in low-dimensional plots by applying factor analysis and special artificial neural networks. Three top-down sorted subcutaneous adipose tissue compartments are determined (upper trunk, lower trunk, legs). NIDDM women provide significantly higher upper trunk obesity and significantly lower leg obesity ('apple' type), as compared with their healthy control group. Further, we show that the results of the applied networks are very similar to the results of factor analysis.
[ST-elevation myocardial infarction: angiotensin receptor blockers are effective with preserved ejection fraction].

Die prospektive Kohortenanalyse aus Korea greift die wichtige Frage auf, inwieweit eine Therapie mit einem AT1Blocker (Sartan) das Risiko für Tod oder Myokardinfarkt senken kann. Yang et al. untersuchten Patienten nach einem STEMI, die eine erhaltene linksventrikuläre Funktion hatten. Bisher gab es Daten zu AT1-Blockern nach STEMI nur bei Patienten mit eingeschränkter linksventrikulärer Funktion. In früheren Studien konnte hier gezeigt werden, dass Valsartan bei einer Ejektionsfraktion < 40 % und Zeichen einer Herzinsuffizienz eine equipotente Alternative zu ACE-Hemmern ist.
Biomarkers in relation to the effects of ticagrelor in comparison with clopidogrel in non-ST-elevation acute coronary syndrome patients managed with or without in-hospital revascularization: a substudy from the Prospective Randomized Platelet Inhibition and Patient Outcomes (PLATO) trial.

Risk stratification and the use of specific biomarkers have been proposed for tailoring treatment in patients with non-ST-elevation acute coronary syndrome (NSTE-ACS). We investigated the prognostic importance of high-sensitivity troponin T (hs-TnT), N-terminal pro-brain natriuretic peptide (NT-proBNP), and growth differentiation factor-15 (GDF-15) in relation to randomized treatment (ticagrelor versus clopidogrel) and management strategy (with or without revascularization) in the NSTE-ACS subgroup of the Platelet Inhibition and Patient Outcomes (PLATO) trial.



Of 18 624 patients in the PLATO trial, 9946 had an entry diagnosis of NSTE-ACS and baseline blood samples available. During index hospitalization, 5357 were revascularized, and 4589 were managed without revascularization. Hs-TnT, NT-proBNP, and GDF-15 were determined and assessed according to predefined cutoff levels. Median follow-up was 9.1 months. Increasing levels of hs-TnT were associated with increasing risk of cardiovascular death, myocardial infarction, and stroke in medically managed patients (P<0.001), but not in those managed invasively. NT-proBNP and GDF-15 levels were associated with the same events independent of management strategy. Ticagrelor versus clopidogrel reduced the rate of cardiovascular death, myocardial infarction, and stroke in patients with NSTE-ACS and hs-TnT ≥14.0 ng/L in both invasively and noninvasively managed patients; in patients with hs-TnT <14.0 ng/L, there was no difference between ticagrelor and clopidogrel in the noninvasive group



Hs-TnT, NT-proBNP, and GDF-15 are predictors of cardiovascular death, myocardial infarction, and stroke in patients with NSTE-ACS managed noninvasively, and NT-proBNP and GDF-15 also in those managed invasively. Elevated hs-TnT predicts substantial benefit of ticagrelor over clopidogrel both in invasively and noninvasively managed patients, but no apparent benefit was seen at normal hs-TnT.
Association between perioperative dexmedetomidine and arrhythmias after surgery for congenital heart disease.

Dexmedetomidine is commonly used after congenital heart surgery and may be associated with a decreased incidence of postoperative tachyarrhythmias. Using a large cohort of patients undergoing congenital heart surgery, we examined for an association between dexmedetomidine use in the immediate postoperative period and subsequent arrhythmia development.



A total of 1593 surgical procedures for congenital heart disease were performed. Dexmedetomidine was administered in the immediate postoperative period after 468 (29%) surgical procedures. When compared with 1125 controls, the group receiving dexmedetomidine demonstrated significantly fewer tachyarrhythmias (29% versus 38%; P<0.001), tachyarrhythmias receiving intervention (14% versus 23%; P<0.001), bradyarrhythmias (18% versus 22%; P=0.03), and bradyarrhythmias receiving intervention (12% versus 16%; P=0.04). After propensity score matching with 468 controls, the arrhythmia incidence between groups became similar: tachyarrhythmias (29% versus 31%; P=0.66), tachyarrhythmias receiving intervention (14% versus 17%; P=0.16), bradyarrhythmias (18% versus 15%; P=0.44), and bradyarrhythmias receiving intervention (12% versus 9%; P=0.17). After excluding controls exposed to dexmedetomidine at a later time in the hospitalization, dexmedetomidine was associated with increased odds of bradyarrhythmias receiving intervention (odds ratio, 2.18; 95% confidence interval, 1.02-4.65). Furthermore, there was a dose-dependent increase in the odds of bradyarrhythmias (odds ratio, 1.04; 95% confidence interval, 1.01-1.07) and bradyarrhythmias receiving intervention (odds ratio, 1.05; 95% confidence interval, 1.01-1.08).



Although dexmedetomidine exposure in the immediate postoperative period is not associated with a clinically meaningful difference in the incidence of tachyarrhythmias after congenital heart surgery, it may be associated with increased odds of bradyarrhythmias.
Two simple questions to assess outcome after stroke: a European study.

The "2 simple questions" were designed as an efficient way of measuring outcome after stroke. We assessed the sensitivity and specificity of this tool, adapted for use in 8 European centers, and used it to compare outcomes across centers.



Data were taken from the Biomed II prospective study of stroke care and outcomes. Three-month poststroke data from 8 European centers were analyzed. Sensitivity and specificity were assessed by comparing responses to the 2 simple questions with Barthel Index and modified Rankin scale scores. Adjusting for case mix, logistic regression was used to compare patients in each center with "good" outcome (not dependent and fully recovered) at 3 months.



Data for 793 patients were analyzed. For the total sample, the dependency question had a sensitivity of 88% and a specificity of 77%; the recovery question had a sensitivity of 78% and a specificity of 90%. Dependency data from Riga had much lower sensitivity. There was variation in good outcome between centers (P:=0.0015). Compared with the reference center (Kaunas), patients in Dijon, Florence, and Menorca were more likely to have good outcome, after adjusting for case mix.



Dependency and recovery questions showed generally high sensitivity and specificity. There were significant differences across centers in outcome, but reasons for these are unclear. Such differences raise particular questions about how patients interpreted and answered the simple questions and the extent to which expectations of recovery and perceived needs for assistance vary cross-culturally.
[Gender-specific differences in quality of life of patients with type 2 diabetes with or without participating in DMP].

Disease management programmes (DMP) are supposed to improve the care of patients with type 2 diabetes or other chronic conditions. One stated aim is the improvement of the health-related quality of life. Within the ELSID study (controlled study for the evaluation of the DMP for patients with type 2 diabetes) there has been a survey of insurants of the general regional health funds (AOK) by means of the SF-36. The aim of this survey is a comparison of patients participating in the Diabetes DMP with those who are not participating in the program with regard to their quality of life.



A random sample of 3,546 patients with type 2 diabetes out of the total sample of the ELSID study (20,625) was asked to complete the SF-36.



1,532 questionnaires were returned (response rate 43.2%). 1,399 were analysed. Within all scales of the SF-36, men achieved higher scores than women. Differentiated in participants and non-participants in the DMP, in men there were lower scores for the participants than for the non-participants. In women this proportion was reversed.



This cross-sectional-study provides first indications for gender-specific differences within the quality of life of patients with diabetes participating in the DMP compared to patients who are not participating. These differences should be considered more intensely within further research of DMP evaluation and the configuration of the programmes in the future.
Change in the extent of colonoscopic and histological involvement in ulcerative colitis over time

ObjectiveColonoscopy has replaced barium enema as the method for determining the extent of disease in patients with ulcerative colitis (UC). Normally, the extent of disease is determined by direct visualization of the mucosa, but biopsies are also used with increasing frequency. Very little is known about the extent to which these two ways of assessing the extent of disease are correlated and whether the correlation differs over time. The aim of this study was to determine the changes in extent of disease assessed by direct visualization and by histological examination of the mucosa at the time of diagnosis and after 1 yr of follow-up in a cohort of incident cases of UC patients.MethodsAll new cases of UC in a defined population were identified during a 4-yr period (496 patients). Of these, 384 patients (78%) were available for follow-up and were subjected to a second colonoscopy with representative biopsies taken from both normal and affected mucosa.ResultsAfter 1 yr there were macroscopical signs of progression in 14%; 22% showed regression, and 30% had a normal colonoscopy. The histological changes from diagnosis until follow-up showed progression in 20%, 24% showed regression, and 24% had normal histological findings. Histological examination showed more extensive disease than did direct visualization in 4% of patients at diagnosis and in 28% at follow-up, whereas direct visualization showed more extensive disease than did histological examination in 18% of patients at diagnosis and 12% at follow-up. The best correlation at both diagnosis and follow-up was seen in pancolitis (99% and 88%, respectively).ConclusionsWith regard to the extent of colonic involvement in the UC patients, we found less agreement between endoscopic and histological evaluation at the follow-up examination than at the start of the study. This could indicate that biopsies represent a better indicator than endoscopical examination for long term prognosis. Further studies are needed to confirm this finding.
Statin use and risk for cataract: a nested case-control study of 2 populations in Canada and the United States.

In current literature the association between statin use and cataracts is inconsistent and controversial. We sought to further examine the effect of statin use on the risk of cataract and need for surgical intervention in 2 North American populations.



This retrospective nested case-control study derived data from the British Columbia (BC) Ministry of Health databases from 2000-2007 and the IMS LifeLink database from 2001-2011 to form 2 patient cohorts. The BC cohort was comprised of female and male patients; 162,501 patients were matched with 650,004 control subjects. The IMS LifeLink cohort was comprised of male patients aged 40-85 years; 45,065 patients were matched with 450,650 control subjects. Patients with statin use for > 1 year before the initial ophthalmology visit were identified. Diagnosis and surgical management of cataract were followed. Conditional logistic regression models were used to analyze data.



For the BC cohort, the crude rate ratio (RR) for use of any statin was 1.30, and the adjusted RR was 1.27 (95% confidence interval, 1.24-1.30). The adjusted RRs for each individual statin were all statistically significant. For the IMS LifeLink cohort, the crude RR for use of any statin was 1.13, and the adjusted RR was 1.07 (95% confidence interval, 1.04-1.10).



This study demonstrates that statin use is significantly associated with cataract requiring surgical intervention. This relationship was consistent in both North American cohorts. Further assessment of this relationship is recommended, especially because of increased statin use and the importance of acceptable vision in old age when cardiovascular disease is common.
Effect of ionized serum calcium on outcomes in acute kidney injury needing renal replacement therapy: secondary analysis of the acute renal failure trial network study.

Hypocalcemia is very common in critically ill patients. While the effect of ionized calcium (iCa) on outcome is not well understood, manipulation of iCa in critically ill patients is a common practice. We analyzed all-cause mortality and several secondary outcomes in patients with acute kidney injury (AKI) by categories of serum iCa among participants in the Acute Renal Failure Trial Network (ATN) Study.



This is a post hoc secondary analysis of the ATN Study which was not preplanned in the original trial. Risk of mortality and renal recovery by categories of iCa were compared using multiple fixed and adjusted time-varying Cox regression models. Multiple linear regression models were used to explore the impact of baseline iCa on days free from ICU and hospital.



A total of 685 patients were included in the analysis. Mean age was 60 (SD=15) years. There were 502 male patients (73.3%). Sixty-day all-cause mortality was 57.0%, 54.8%, and 54.4%, in patients with an iCa<1, 1-1.14, and ≥1.15 mmol/L, respectively (p=0.87). Mean of days free from ICU or hospital in all patients and the 28-day renal recovery in survivors to Day 28 were not significantly different by categories of iCa. The hazard for death in a fully adjusted time-varying Cox regression survival model was 1.7 (95% CI: 1.3-2.4) comparing iCa<1 to iCa≥1.15 mmol/L. No outcome was different for levels of iCa>1 mmol/L.



Severe hypocalcemia with iCa<1 mmol/L independently predicted mortality in patients with AKI needing renal replacement therapy.
Use of risedronate to prevent bone loss following a single course of glucocorticoids: findings from a proof-of-concept study in inflammatory bowel disease

We performed a randomised controlled trial (RCT) to determine whether risedronate 35 mg once weekly prevents bone loss following an 8-week reducing course of prednisolone given for an exacerbation of inflammatory bowel disease (IBD). The greatest change in bone mineral density (BMD) was at Ward’s triangle (WT), which fell by 2.2% in the placebo group, compared with a reduction of 0.8% in the risedronate group. Whether bisphosphonates can prevent bone loss associated with intermittent glucocorticoid (GC) therapy is unknown, reflecting the difficulty in performing RCTs in this context. To explore the feasibility of RCTs to examine this question, lumbar spine (LS; L2–4) and hip dual X-ray absorptiometry (DXA) scans were performed in 78 patients commencing a GC therapy course for a relapse of IBD. They were then randomised to receive placebo or risedronate 35 mg weekly for 8 weeks, after which the DXA scan was repeated. For LS BMD, there was no change in the placebo group (0.1 ± 0.4, p = 0.9), but there was an increase after risedronate (0.8 ± 0.4, p = 0.04; mean% ± SEM by paired Student’s t test). There were small decreases in both groups at the total hip (−0.5 ± 0.3, p = 0.04; −0.5 ± 0.3, p < 0.05, placebo and risedronate, respectively). At WT, BMD fell after placebo (−2.2 ± 0.5, p = 0.001) but not risedronate (−0.8 ± 0.5, p = 0.09; p = 0.05 for between-group comparison). RCTs can be used to examine whether bisphosphonates prevent bone loss associated with intermittent GC therapy, providing metabolically active sites such as WT are employed as the primary outcome.
Histological change after interferon therapy in chronic hepatitis C in view of iron deposition in the liver

We examined the efficacy of interferon (IFN) therapy for chronic hepatitis C (CHC) in view of the change of liver histology and iron staining before and after IFN therapy. Enrolled in this study were 109 patients with CHC who completed IFN treatment and were followed for at least 1 yr after the end of IFN therapy. Serum iron, unsaturated-iron-binding capacity (UIBC), and total-iron-binding capacity (TIBC) were assessed before IFN therapy. Knodell’s histological activity index (HAI) score and iron staining were examined in 55 patients in whom liver biopsy was performed at two points: before and 1 yr after IFN therapy. Serum iron levels before IFN therapy did not correlate with the response to IFN. The HAI score significantly decreased after IFN therapy in complete responders (p<0.01) and biochemical responders (p<0.01). Three factors in the HAI, periportal necrosis, intralobular necrosis, and portal inflammation, but not fibrosis, were significantly decreased in complete responders (p<0.01) and biochemical responders (p<0.01). Of 55 patients, 23 (41.8%) were positive for iron staining before IFN therapy and 14 of 55 (25.5%) after IFN therapy. The positive rate for iron staining tended to decrease after IFN therapy, not correlating to the response to IFN, but the change was not statistically significant. In conclusion, the histological improvement by IFN therapy was mostly seen in necroinflammatory changes but not in fibrosis at least 1 yr after IFN, and iron staining tended to decrease after IFN therapy.
Phase I and pharmacokinetic study of the novel anthracycline derivative 5-imino-13-deoxydoxorubicin (GPX-150) in patients with advanced solid tumors

GPX-150) is a doxorubicin analog modified in two locations to prevent formation of cardiotoxic metabolites and reactive oxygen species. Preclinical studies have demonstrated anti-cancer activity without cardiotoxicity. A phase I study was performed in order to determine the maximum-tolerated dose (MTD) of GPX-150 in patients with metastatic solid tumors.  GPX-150 was administered as an intravenous infusion every 21 days for up to 8 cycles. An accelerated dose escalation was used for the first three treatment groups. The dosing groups were (A) 14 mg/m2, (B) 28 mg/m2, (C), 56 mg/m2, (D) 84 mg/m2, (E) 112 mg/m2, (F) 150 mg/m2, (G) 200 mg/m2, and (H) 265 mg/m2. Pharmacokinetic samples were drawn during the first 72 h of cycle 1.  The MTD was considered to be reached at the highest dosing level of 265 mg/m2 since dose reduction was required in 5 of 6 patients for neutropenia. The most frequent adverse events were neutropenia, anemia, fatigue, and nausea. No patients experienced cardiotoxicity while on the study. The best overall response was stable disease in four (20 %) patients. Pharmacokinetic analysis revealed an AUC of 8.0 (±2.6) μg · h/mL, a clearance of 607 (±210) mL/min/m2 and a t1/2β of 13.8 (±4.6) hours.  GPX-150 administered every 21 days has an acceptable side effect profile and no cardiotoxicity was observed. Further investigation is needed to determine the efficacy of GPX-150 in anthracycline-sensitive malignancies.
Mitoxantrone combined with paclitaxel as salvage therapy for platinum-refractory ovarian cancer: laboratory study and clinical pilot trial.

This report describes preclinical and early clinical investigations of the mitoxantrone/paclitaxel combination (NT) for patients with platinum-refractory ovarian cancer. The preclinical activity of NT was studied ex vivo, evaluating native tumor specimens with the ATP tumor chemosensitivity assay. Of 24 tumors tested, 20 (83%) were sensitive to NT, whereas 7 (29%) responded to mitoxantrone and 8 (33%) responded to paclitaxel. In the majority of tumors assayed (19 of 24), potentiating or major independent effects between both agents were found. Subsequently, a clinical pilot trial of NT was initiated for patients with platinum-refractory ovarian cancer. Patients had failed one to four (median, two) prior chemotherapy regimens. In 11 cases, NT was administered every three weeks with 8 mg/m2 mito-xantrone and 180 mg/m2 paclitaxel (NT-I). Seven patients were treated biweekly with 6 mg/m2 mitoxantrone and weekly with 100 mg/m2 paclitaxel (NT-II). During 92 NT courses, myelosuppression with leucopenia, anemia, and thrombocytopenia was the limiting toxicity, occurring more frequently with NT-II. No patient required hospitalization due to any life-threatening complication. Five complete and nine partial remissions were observed with both NT-I and NT-II, accounting for an overall 78% response rate, with a median progression-free survival of 40 weeks. One patient showed early progression during therapy. Currently, three patients (NT-I, two; NT-II, one) have died due to progressive relapsed ovarian cancer, so that the median overall survival is not reached after a median follow-up of 40.5+ weeks. Both schedules were found to be equal in terms of response rate and overall survival. NT is highly active and practical for salvage treatment of ovarian cancer. NT-II may be preferred due to both clinical activity and patients' acceptance. However, NT-I seems to be a less myelotoxic alternative. Both schedules warrant further clinical investigation.