nils-herrmann/clean_scirepeval huggingface dataset:
Umbilical cord mesenchymal stem cell transplantation in active and refractory systemic lupus erythematosus: a multicenter clinical study

In our present single-center pilot study, umbilical cord (UC)-derived mesenchymal stem cells (MSCs) had a good safety profile and therapeutic effect in severe and refractory systemic lupus erythematosus (SLE). The present multicenter clinical trial was undertaken to assess the safety and efficacy of allogeneic UC MSC transplantation (MSCT) in patients with active and refractory SLE.



Forty patients with active SLE were recruited from four clinical centers in China. Allogeneic UC MSCs were infused intravenously on days 0 and 7. The primary endpoints were safety profiles. The secondary endpoints included major clinical response (MCR), partial clinical response (PCR) and relapse. Clinical indices, including Systemic Lupus Erythematosus Disease Activity Index (SLEDAI) score, British Isles Lupus Assessment Group (BILAG) score and renal functional indices, were also taken into account.



The overall survival rate was 92.5% (37 of 40 patients). UC-MSCT was well tolerated, and no transplantation-related adverse events were observed. Thirteen and eleven patients achieved MCR (13 of 40, 32.5%) and PCR (11 of 40, 27.5%), respectively, during 12 months of follow up. Three and four patients experienced disease relapse at 9 months (12.5%) and 12 months (16.7%) of follow-up, respectively, after a prior clinical response. SLEDAI scores significantly decreased at 3, 6, 9 and 12 months follow-up. Total BILAG scores markedly decreased at 3 months and continued to decrease at subsequent follow-up visits. BILAG scores for renal, hematopoietic and cutaneous systems significantly improved. Among those patients with lupus nephritis, 24-hour proteinuria declined after transplantation, with statistically differences at 9 and 12 months. Serum creatinine and urea nitrogen decreased to the lowest level at 6 months, but these values slightly increased at 9 and 12 months in seven relapse cases. In addition, serum levels of albumin and complement 3 increased after MSCT, peaked at 6 months and then slightly declined by the 9- and 12-month follow-up examinations. Serum antinuclear antibody and anti-double-stranded DNA antibody decreased after MSCT, with statistically significant differences at 3-month follow-up examinations.



UC-MSCT results in satisfactory clinical response in SLE patients. However, in our present study, several patients experienced disease relapse after 6 months, indicating the necessity to repeat MSCT after 6 months.
Body fat measurement in adolescent girls with type 1 diabetes: a comparison of skinfold equations against dual‐energy X‐ray absorptiometry

Skinfold measurement is an inexpensive and widely used technique for assessing the percentage of body fat (%BF). This study assessed the accuracy of prediction equations for %BF based on skinfold measurements compared to dual-energy X-ray absorptiometry (DXA) in girls with type 1 diabetes and healthy age-matched controls.



We included 49 healthy girls and 44 girls with diabetes aged 12-19 years old, comparing the predicted %BF based on skinfold measurements and the %BF values obtained by a Lunar DPX-L scanner. The agreement between the methods was assessed using an Bland-Altman plot.



The skinfold measurements were significantly higher in girls with diabetes (p = 0.003) despite a nonsignificant difference in total %BF (p = 0.1). A significant association between bias and %BF was found for all tested equations in the Bland-Altman plots. Regression analysis showed that the association between skinfold measurements and %BF measured by DXA differed significantly (p = 0.039) between the girls with diabetes and the healthy controls.



The accuracy of skinfold thickness equations for assessment of %BF in adolescent girls with diabetes is poor in comparison with DXA measurements as criterion. Our findings highlight the need for the development of new prediction equations for girls with type 1 diabetes.
"Crawling Out of the Cocoon": Patients' Experiences of a Physical Therapy Exercise Intervention in the Treatment of Major Depression.

Although the effectiveness of physical exercise for depression has been studied for many years, few studies have described patients' experiences of what exercise means to them, beyond the biological focus. Moreover, exercise as a treatment for depression is rarely explored in a physical therapy context.



The purpose of this study was to explore a physical therapy exercise intervention, as experienced by people with major depression.



This study had an inductive approach and used qualitative content analysis.



Semistructured interviews were conducted with 13 people who participated in physical therapist-guided aerobic exercise in a randomized controlled trial. All participants were diagnosed with major depression according to the Diagnostic and Statistical Manual of Mental Disorders. Data were collected and analyzed in an inductive manner using qualitative content analysis according to Graneheim and Lundman.



Four categories emerged: (1) struggling toward a healthy self, (2) challenging the resistance, (3) feeling alive but not euphoric, and (4) needing someone to be there for you. The participants experienced that although the exercise intervention was hard work, it enhanced the feeling of being alive and made them feel that they were doing something good for themselves. These feelings were a welcome contrast to the numbness and stagnation they experienced during depression.



The study was conducted in Swedish primary care. Transferability of results must be viewed in relation to context.



Exercise in a physical therapy context can improve the patients' perception of their physical ability and create a sense of liveliness, improving their depressed state. The therapeutic relationship is essential for supporting the patient's vulnerability and ambiguity in an empathic and perceptive way.
Asymmetric Dimethylarginine Limits the Efficacy of Simvastatin Activating Endothelial Nitric Oxide Synthase.

Asymmetric dimethylarginine (ADMA), an endogenous inhibitor of endothelial nitric oxide synthase (eNOS), is considered a risk factor for the pathogenesis of cardiovascular diseases. Simvastatin, a lipid-lowering drug with other pleiotropic effects, has been widely used for treatment of cardiovascular diseases. However, little is known about the effect and underlying molecular mechanisms of ADMA on the effectiveness of simvastatin in the vascular system.



We conducted a prospective cohort study to enroll 648 consecutive patients with coronary artery disease for a follow-up period of 8 years. In patients with plasma ADMA level ≥0.49 μmol/L (a cut-off value from receiver operating characteristic curve), statin treatment had no significant effect on cardiovascular events. We also conducted randomized, controlled studies using in vitro and in vivo models. In endothelial cells, treatment with ADMA (≥0.5 μmol/L) impaired simvastatin-induced nitric oxide (NO) production, endothelial NO synthase (eNOS) phosphorylation, and angiogenesis. In parallel, ADMA markedly increased the activity of NADPH oxidase (NOX) and production of reactive oxygen species (ROS). The detrimental effects of ADMA on simvastatin-induced NO production and angiogenesis were abolished by the antioxidant, N-acetylcysteine, NOX inhibitor, or apocynin or overexpression of dimethylarginine dimethylaminohydrolase 2 (DDAH-2). Moreover, in vivo, ADMA administration reduced Matrigel plug angiogenesis in wild-type mice and decreased simvastatin-induced eNOS phosphorylation in aortas of apolipoprotein E-deficient mice, but not endothelial DDAH-2-overexpressed aortas.



We conclude that ADMA may trigger NOX-ROS signaling, which leads to restricting the simvastatin-conferred protection of eNOS activation, NO production, and angiogenesis as well as the clinical outcome of cardiovascular events.
Experience of a pediatric HIV clinic in Guatemala City.

To describe the clinical experience of a Guatemalan pediatric HIV clinic and referral center, and fill the gap in literature available on pediatric HIV in Guatemala, a country facing a growing HIV epidemic.



Analyses were performed on data available from the clinical databases maintained by the Clínica Familiar Luis Angel García within the Hospital General San Juan de Dios in Guatemala City, Guatemala.



From January 1997-June 2006, a total of 536 children (individuals under 13 years of age) were registered at the clinic, 54% of them female. At the initial visit, 241 were known to be HIV infected, while 295 were known to have been exposed to HIV, but were of undetermined infection status. Of the 295 with undetermined status, serostatus was determined in 173, and 57 (33%) were HIV positive. The patients came from all 24 departments of Guatemala, but the majority (64%) was from Guatemala City. Most had perinatal exposure; three patients had been sexually exposed to HIV (all male); and the mode of infection could not be determined for six children. In the cohort of children whose infection status was initially undetermined, the provision of antiretroviral (ARV) medication (both pre- and neonatal), in addition to Cesarean section, was associated with an odds ratio of 0.06 for HIV infection (P < 0.001) when compared to children who had no interventions. Highly active antiretroviral therapy (HAART) was administered to 167 HIV-infected children. There were 44 known deaths in this cohort; no deaths occurred among the children who were not infected.



Pediatric HIV/AIDS is present in all parts of Guatemala. Programs to prevent mother to child transmission and to provide appropriate treatment to families living with HIV/AIDS must be a public health priority.
Prevalence of risk factors for foot ulceration in a general haemodialysis population

It is well documented that diabetic foot ulceration contributes to increased morbidity and mortality associated with renal replacement therapy. Much less is known about the risk of foot ulceration and lower limb amputation in the non-diabetic dialysis population. The aim of this study was to determine if the prevalence of risks factors for lower limb amputation in a stable haemodialysis population was greater in the diabetic cohort compared with the non-diabetic cohort. The study design is a prospective observational cohort study. Sixty patients attending a satellite haemodialysis unit in Cardiff were invited to have a comprehensive foot assessment as part of a Podiatry service review. The medical notes and hospital information system were used to identify the diabetic cohort. Patients were classified according to diabetic status (diabetic versus non-diabetic). The Renal Foot Screening Tool was developed to prospectively identify risk factors associated with foot ulceration. The assessment included peripheral neuropathy (PN), peripheral arterial disease (PAD) and foot pathology (FP). Fifty-seven patients gave informed verbal consent prior to inclusion. Risk factors for foot ulceration were recorded at baseline in the diabetic (n = 24) and non-diabetic (n = 33) groups and mortality data was revisited after a 3-year period. FP was identified in 79% of patients. Eighteen per cent of the non-diabetic patients had PN. PAD was identified in 45% of diabetic and 30% of non-diabetic patients. Forty-nine per cent of the total cohort had ≥2 of the 3 independent risk factors for foot ulceration (16/24 diabetic versus 12/33 non-diabetic). The presence of PAD and PN was predictive of mortality independent of age. The limitations of this study are its small sample size and patients were from a single satellite dialysis unit. There was a high prevalence of risk factors for foot ulceration in this population, which were not confined to the diabetic cohort. These findings suggest that non-diabetic patients on haemodialysis therapy are also at risk of developing foot ulceration. Further work on strategies to monitor and prevent FP in this high-risk cohort is needed to minimize morbidity and mortality associated with foot ulceration.
Thyroxine transfer from cerebrospinal fluid into choroid plexus and brain is affected by brefeldin A, low sodium, BCH, and phloretin, in ventriculo-cisternal perfused rabbits

Thyroxine (T4) hormone is synthesized by the thyroid gland and then released into the systemic circulation where it binds to a number of proteins. Dysfunction in T4 transport mechanisms has been demonstrated in multiple central nervous system (CNS) diseases including Alzheimer's disease. In the presence of different compounds that inhibit potential T4 transport mechanisms, this study investigated the transfer of T4 from cerebrospinal fluid (CSF) into Choroid Plexus (CP) and other brain tissues. The compounds used were brefeldin A, low sodium artificial CSF (aCSF), BCH, phloretin, and taurocholate (TA).



Radiolabeled T4 ((125)I-T4) was perfused continuously into the CSF and was assessed in several brain compartments with reference molecule (14)C-mannitol and blue dextran, using the in vivo ventriculo-cisternal perfusion (V-C) technique in the rabbit. The aCSF containing the drug of interest was infused after 1 h of perfusion. Drugs were applied independently to the aCSF after 1 h of control perfusion.



Of interest, in presence of low sodium or BCH, the percentage recovery of (125)I-T4, was increased compared to controls, with concomitant increase in T4 clearance. Conversely, brefeldin A, phloretin, and TA did not exert any significant effect on the recovery and clearance of (125)I-T4 assessed in aCSF. On the other hand, the uptake of (125)I-T4 into CP was raised by 18 fold compared to controls in the presence of brefeldin A. In addition, low sodium, BCH, or phloretin alone, enhanced the uptake of (125)I-T4 by almost 3-fold, whereas TA did not show any significant effect. Finally, the uptake and distribution of (125)I-T4 into other brain regions including ependymal region (ER) and caudate putamen (CAP) were significantly higher than in controls.



Our study suggests the involvement of different mechanisms for the transfer of (125)I-T4 from CSF into CP and other brain regions. This transfer may implicate sodium-dependent mechanisms, amino acid "L" system, or organic anion transporting polypeptide (OATP).
Reduction of chemotherapy-induced febrile leucopenia by prophylactic use of ciprofloxacin and roxithromycin in small-cell lung cancer patients: an EORTC double-blind placebo-controlled phase III study.

CDE (cyclophosphamide, doxorubicin, etoposide) is one of the standard chemotherapy regimens in the treatment of small-cell lung cancer (SCLC), with myelosuppression as dose-limiting toxicity. In this trial the impact of prophylactic antibiotics on incidence of febrile leucopenia (FL) during chemotherapy for SCLC was evaluated.



Patients with chemo-naïve SCLC were randomized to standard-dose CDE (C 1,000 mg/m2 day 1, D 45 mg/m2 day 1, E 100 mg/m2 days 1-3. i.v., q 3 weeks, x5) or to intensified CDE chemotherapy (125% dose, q 2 weeks, x4, with filgrastim 5 microg/kg/day days 4-13) to assess the impact on survival (n = 240 patients). Patients were also randomized to prophylactic antibiotics (ciprofloxacin 750 mg plus roxithromycin 150 mg, bid. days 4-13) or to placebo in a 2 x 2 factorial design (first 163 patients). This manuscript focuses on the antibiotics question.



The incidence of FL during the first cycle was 25% of patients in the placebo and 11% in the antibiotics arm (P = 0.010; 1-sided), with an overall incidence through all cycles of 43% vs. 24% respectively (P = 0.007; 1-sided). There were less Gram-positive (12 vs. 4), Gram-negative (20 vs. 5) and clinically documented (38 vs. 15) infections in the antibiotics arm. The use of therapeutic antibiotics was reduced (P = 0.013; 1-sided), with less hospitalizations due to FL (31 vs. 17 patients, P = 0.013: 1-sided). However, the overall number of days of hospitalization was not reduced (P = 0.05; 1-sided). The number of infectious deaths was nil in the antibiotics vs. five (6%) in the placebo arm (P = 0.022; 2-sided).



Prophylactic ciprofloxacin plus roxithromycin during CDE chemotherapy reduced the incidence of FL, the number of infections, the use of therapeutic antibiotics and hospitalizations due to FL by approximately 50%, with reduced number of infectious deaths. For patients with similar risk for FL, the prophylactic use of antibiotics should be considered.
Impaired immune response to voluntary arm-crank ergometer exercise in patients with cervical spinal cord injury

Non-randomized study.The mechanism underlying exercise-induced argumentation of natural killer cell cytotoxic activity (NKCA) in humans remains unclear. To address this, NKCA responses were studied during and after exercise in persons with cervical spinal cord injury (CSCI) and dysfunctional sympathetic nervous system.Kibikogen Rehabilitation Center for Employment Injuries.We examined the NKCA responses to 20-min arm-crank ergometer exercise at 60% of maximum oxygen consumption in eight persons with CSCI (between C6 and C7) and six able-bodied subjects. NKCA, adrenaline, and cortisol were measured before, immediately after exercise, 1 h after exercise, and 2 h after exercise.In able-bodied subjects, NKCA increased immediately after exercise (P<0.01) and then decreased to below the pre-exercise level 1 h after exercise, before recovering to the baseline level at 2 h after exercise. Plasma adrenaline concentrations increased significantly immediately after exercise (P<0.01) and returned to the baseline level 1 h after exercise. The plasma cortisol level did not change throughout the study. In contrast, NKCA, plasma concentrations of adrenaline, and cortisol did not change throughout the study in subjects with CSCI.Conclusion:In subjects with CSCI, the lack of response in NKCA throughout the experiment is probably mainly due to a dysfunctional sympathetic nervous system.
Brief Report: Impact of Option B+ on the Infant PMTCT Cascade in Lilongwe, Malawi

This observational study compared uptake of infant prevention of mother-to-child transmission of HIV services pre/post implementation of Option B+ in Lilongwe, Malawi. There were 845 (pre) and 998 (post) births. Post-B+, infants had longer median predelivery maternal antiretroviral therapy {62 days [interquartile range (IQR): 38-94] pre-B+ vs. 95 days [IQR: 61-131] post-B+; P < 0.0001} and improved polymerase chain reaction testing (82.0% vs. 86.5%; P = 0.01) at younger median age [7.6 weeks (IQR: 6.6-10.9) vs. 6.9 (IQR: 6.4-8.1); P < 0.0001]. Proportion testing polymerase chain reaction positive decreased (4.6% vs. 2.6%; P = 0.03). Proportion of HIV-infected infants starting antiretroviral therapy (75% vs. 77.3%) and age at initiation [19.7 weeks (IQR: 15.4-31.1) vs. 16 (IQR: 13.3-17.9)] remained unchanged. These findings suggest modest improvements in infant care with Option B+.
Reversibility of the endothelial dysfunction after CPAP therapy in OSAS patients.

The obstructive sleep apnoea syndrome (OSAS) is a common airways disease which often involves cardiovascular structures, causing vessel inflammation as well as hypoxia, induced by difficulties in the passage of air through the upper airways. Aim of our research is to evaluate the effects of Continuous Positive Airway Pressure (CPAP) on the syndrome itself and the patients cardiovascular risk profile, practically adopting Flow-Mediated Vasodilation (FMD) technique to evaluate endothelial function.



We enrolled 63 patients (49 males and 14 female, mean age: 54 ± 10 years) subdivided into four groups: high cardiovascular risk factors, no CPAP therapy, CPAP therapy started less- and more than 3 months before. The patients underwent FMD of the brachial artery using a high resolution ultrasonograph connected to an image analysis system. The maximum recovery value was calculated as the ratio (maximum-baseline) of the change in diameter over the baseline value. Data obtained from this study demonstrate the significant reversibility of FMD in patients treated for more than 3 months with CPAP therapy (Group 4).



Our study shows the importance of administering CPAP therapy for more than 3 months in patients suffering from OSAS to improve EF to a level equal to high cardiovascular risk subjects probably due to a recovery from the systemic hypoxia. Besides, our work points out the importance of FMD as a "clinical" tool able to point out any improvement or regression after therapies.
Shunt Surgery Versus Endoscopic Sclerotherapy for Long-Term Treatment of Variceal Bleeding—Early Results of a Randomized Trial

As an additional service to our readers we have developed a section with the aim to review and comment on important work in the area of HPB and provide it with commentaries by leading scientists in the field. It is our hope that this will increase the value of our journal. We are happy to inform our readers that Professor John Terblanche has kindly accepted to be Editor of this section. John Terblanche will, through his extensive reading, identify important contributions and invite experts around the world to comment on them. We hope that readers who identify significant contributions in journals will send copies of the work to Professor Terblanche with the suggestion that the work might be reviewed and discussed. It is our hope that this cooperation will be successful. The Editor strongly desires to have a lively journal with active participation by its readers.  In September 1982, a prospective randomized trial comparing shunt surgery and endoscopic sclerotherapy for the elective management of variceal hemorrhage in patients with cirrhosis was initiated. Twenty-seven patients have received shunts (distal splenorenal 23, nonselective 4) and 30 patients have had chronic sclerotherapy. Eighty-six per cent of patients had alcoholic cirrhosis and 33% were Child's class C. After a mean follow-up of 25 months, 19% of shunt and 57% of sclerotherapy patients have had rebleeding (p 0.003). Kaplan-Meier survival 85
Asenapine for long-term treatment of bipolar disorder: a double-blind 40-week extension study.

Asenapine is approved in the United States for acute treatment of manic or mixed episodes of bipolar I disorder with or without psychotic features. We report the results of long-term treatment with asenapine in patients with bipolar I disorder.



Patients completing either of two 3-week efficacy trials and a subsequent 9-week double-blind extension were eligible for this 40-week double-blind extension. Patients in the 3-week trials were randomized to flexible-dose asenapine (5 or 10mg BID), placebo, or olanzapine (5-20mg QD; included for assay sensitivity only). Patients entering the extension phase maintained their preestablished treatment; those originally randomized to placebo received flexible-dose asenapine (placebo/asenapine). Safety and tolerability endpoints included adverse events (AEs), extrapyramidal symptoms, laboratory values, and anthropometric measures. Efficacy, a secondary assessment, was measured as change in Young Mania Rating Scale (YMRS) total score from 3-week trial baseline to week 52 with asenapine or olanzapine; the placebo/asenapine group was assessed for safety only.



Incidence of treatment-emergent AEs was 71.9%, 86.1%, and 79.4% with placebo/asenapine, asenapine, and olanzapine, respectively. The most frequent treatment-emergent AEs were headache and somnolence with placebo/asenapine; insomnia, sedation, and depression with asenapine; and weight gain, somnolence, and sedation with olanzapine. Among observed cases, mean ± SD changes in YMRS total score at week 52 were -28.6 ± 8.1 and -28.2 ± 6.8 for asenapine and olanzapine, respectively.



The study did not have a long-term placebo group.



In this 52-week extension in patients with bipolar mania, asenapine was well tolerated and long-term maintenance of efficacy was supported.