nils-herrmann/clean_scirepeval huggingface dataset:
Prevalence and predictors of severe acute pancreatitis in patients with acquired immune deficiency syndrome (AIDS)

Recent case control data suggested that a severe course of acute pancreatitis in HIV+ patients was 1) common (50% of cases), 2) poorly predicted by Ranson's criteria (sensitivity 41%), and 3) accurately predicted by a diagnosis of AIDS (positive predictive value 67%). However, the definition of severity included length of stay in hospital and excluded commonly accepted markers (local complications, systemic complications, and need for surgery). The aim of this study was to determine 1) the prevalence of severity and 2) the value of these predictors with regard to severity, as defined by commonly accepted standardized criteria in patients with AIDS and acute pancreatitis.A retrospective review identified 50 patients with AIDS exhibiting clinical, laboratory, and/or radiological features of acute pancreatitis.Only five patients followed a severe course as defined by accepted markers. Of these patients, 29 had values available for at least nine of 11 of Ranson's criteria (sensitivity 80%, specificity 54%). Points were awarded most commonly for decreased serum Ca2+ (n = 14) and elevated serum LDH (n = 7).CONCLUSIONS:In patients with AIDS and acute pancreatitis at our institutions, 1) the prevalence of severity and 2) the sensitivity of Ranson's criteria with regard to severity is comparable to that reported in large historical case series of immunocompetent patients. Pseudohypocalcemia and/or elevation in LDH are frequent, likely due to the catabolic infectious disease state.
Impact of gender on the density of intraplaque neovascularization: a quantitative contrast-enhanced ultrasound study.

Atherosclerosis is the main underlying cause of the majority of cardiovascular events. Although cardiovascular diseases (CVD) are a major challenge in both males and females, gender specific differences in the prevalence of CVD have been observed. This may indicate that there are differences in the development of atherosclerosis between males and females. The presence of intraplaque neovessels (IPN) is an imaging marker for plaque vulnerability. The aim of this study was to investigate the impact of gender on IPN.



A total of 159 patients with ≥1 cardiovascular risk factor were included in this prospective study (mean age 56.9±8.7 years, 47% females). Patients had no symptoms of carotid atherosclerotic disease. All patients underwent a standard carotid ultrasound examination in conjunction with contrast-enhanced ultrasound (CEUS). The presence of atherosclerotic plaques was assessed according to the Mannheim consensus. IPN was assessed using a visual grading scale and semi-automated quantification software.



Subclinical atherosclerosis was detected using standard carotid ultrasound and CEUS in 64 females (86%) and in 79 males (93%) (p=0.177). The mean atherosclerotic plaque sizes were not significantly different (p=0.068). Semi-automated quantification of IPN demonstrated that females had significant more IPN compared to males (p<0.05). After adjustment for clinical variables this association remained significant (p<0.05).



In this population at increased risk for CVD, females had significantly more IPN compared to males. This suggests that the females had a more vulnerable atherosclerotic plaque type.
Topical testosterone for breast cancer patients with vaginal atrophy related to aromatase inhibitors: a phase I/II study.

Controversy exists about whether vaginal estrogens interfere with the efficacy of aromatase inhibitors (AIs) in breast cancer patients. With the greater incidence of vaginal atrophy in patients on AIs, a safe and effective nonestrogen therapy is necessary. We hypothesized that vaginal testosterone cream could safely treat vaginal atrophy in women on AIs.



Twenty-one postmenopausal breast cancer patients on AIs with symptoms of vaginal atrophy were treated with testosterone cream applied to the vaginal epithelium daily for 28 days. Ten women received a dose of 300 μg, 10 received 150 μg, and one was not evaluable. Estradiol levels, testosterone levels, symptoms of vaginal atrophy, and gynecologic examinations with pH and vaginal cytology were compared before and after therapy.



Estradiol levels remained suppressed after treatment to <8 pg/mL. Mean total symptom scores improved from 2.0 to 0.7 after treatment (p < .001) and remained improved 1 month thereafter (p = .003). Dyspareunia (p = .0014) and vaginal dryness (p <.001) improved. The median vaginal pH decreased from 5.5 to 5.0 (p = .028). The median maturation index rose from 20% to 40% (p < .001). Although improvement in total symptom score was similar for both doses (-1.3 for 300 μg, -0.8 for 150 μg; p = .37), only the 300-μg dose was associated with improved pH and maturation values.



A 4-week course of vaginal testosterone was associated with improved signs and symptoms of vaginal atrophy related to AI therapy without increasing estradiol or testosterone levels. Longer-term trials are warranted.
Effects of alpha1-acid glycoprotein on the clinical pharmacokinetics of 7-hydroxystaurosporine.

UCN-01 (7-hydroxystaurosporine) is a small molecule cyclin-dependent kinase modulator currently under clinical development as an anticancer agent. In vitro studies have demonstrated that UCN-01 is strongly bound to the acute-phase reactant alpha (1)-acid glycoprotein (AAG). Here, we examined the role of protein binding as a determinant of the pharmacokinetic behavior of UCN-01 in patients.



Pharmacokinetic data were obtained from a group of 41 patients with cancer receiving UCN-01 as a 72-hour i.v. infusion (dose, 3.6 to 53 mg/m(2)/day).



Over the tested dose range, total drug clearance was distinctly nonlinear (P = 0.0076) and increased exponentially from 4.33 mL/hour (at 3.6 mg/m(2)/day) to 24.1 mL/hour (at 54 mg/m(2)/day). As individual values for AAG increased, values for clearance decreased in a linear fashion (R(2) = 0.264; P = 0.0008), although the relationship was shallow, and the data showed considerable scatter. Interestingly, no nonlinearity in the unbound concentration (P = 0.083) or fraction at the peak plasma concentration of UCN-01 was apparent (P = 0.744).



The results suggest the following: (1) that extensive binding to AAG may explain, in part, the unique pharmacokinetic profile of UCN-01 described previously with a small volume of distribution and slow systemic clearance, and (2) that measurement of total UCN-01 concentrations in plasma is a poor surrogate for that of the pharmacologically active fraction unbound drug.
Comparative RNA-sequencing analysis of myocardial and circulating small RNAs in human heart failure and their utility as biomarkers.

Heart failure (HF) is associated with high morbidity and mortality and its incidence is increasing worldwide. MicroRNAs (miRNAs) are potential markers and targets for diagnostic and therapeutic applications, respectively. We determined myocardial and circulating miRNA abundance and its changes in patients with stable and end-stage HF before and at different time points after mechanical unloading by a left ventricular assist device (LVAD) by small RNA sequencing. miRNA changes in failing heart tissues partially resembled that of fetal myocardium. Consistent with prototypical miRNA-target-mRNA interactions, target mRNA levels were negatively correlated with changes in abundance for highly expressed miRNAs in HF and fetal hearts. The circulating small RNA profile was dominated by miRNAs, and fragments of tRNAs and small cytoplasmic RNAs. Heart- and muscle-specific circulating miRNAs (myomirs) increased up to 140-fold in advanced HF, which coincided with a similar increase in cardiac troponin I (cTnI) protein, the established marker for heart injury. These extracellular changes nearly completely reversed 3 mo following initiation of LVAD support. In stable HF, circulating miRNAs showed less than fivefold differences compared with normal, and myomir and cTnI levels were only captured near the detection limit. These findings provide the underpinning for miRNA-based therapies and emphasize the usefulness of circulating miRNAs as biomarkers for heart injury performing similar to established diagnostic protein biomarkers.
Phase I study of oral JM216 given twice daily

JM216 [bis-acetato-ammine-dichloro-cyclohexylamine-platinum(IV)] is an oral platinum complex that is currently in phase II trials in ovarian cancer and lung cancer on a daily-times-5 schedule. This trial examined an alternative schedule of two doses given 12 h apart, which may be better tolerated by patients. A total of 19 patients were given 50 cycles of treatment at doses ranging from 150 to 350 mg/m2 b.i.d. The study was stopped before the MTD was reached due to non-linear pharmacokinetics. Toxicity was similar to that encountered in previous phase I studies, with nausea, vomiting and diarrhoea being seen at all dose levels, although this was generally mild and short-lived, and grade 3 and 4 myelosuppression being seen at dose levels ranging from 250 to 350 mg/m2. There was no nephro-, oto-, or neurotoxicity, but one patient had an allergic reaction at 300 mg/m2 on the fifth and sixth cycles. No response was seen, but two patients with mesothelioma had stable disease and received six cycles. There was considerable interpatient variability in plasma pharmacokinetics at all dose levels. There was no relationship between dose and AUC (dose 1 and dose 2) or Cmax after dose 1. In a limited number of patients the first dose was given in the morning rather than in the evening, apparently resulting in lower AUC, Cmax and T max values at the 250-mg/m2 dose level, but this was not seen in one patient at 300 mg/m2. This study confirms that the pharmacokinetics of JM216 is non-linear and highly variable due to saturable absorption and that the daily times 5 schedule is the optimal schedule for further phase II trials.
Hydration status and stroke-in-evolution after ischemic stroke: a preliminary study.

Stroke-in-evolution (SIE) after ischemic stroke is associated with poor outcomes (1–4). As findings from our previous study suggest a link between hydration status and SIE (5), we tested the hypothesis that rehydration therapy, administered on the basis of urine-specific gravity (USG) findings, would reduce the development of SIE. Our study included patients with ischemic stroke (study group, n = 121) treated between October 2007 and April 2012. A USG > 1·010 was taken to indicate dehydration, and patients were fed via nasogastric tube, given bolus intravenous fluid support, and advised to drink water as necessary. We also included a cohort of patients who received standard rehydration therapy on the basis of physical examination findings (control group, n = 278). On admission, there were significant between-group differences in diastolic blood pressure, mean blood pressure, and blood urea nitrogen/creatinine ratio, blood creatinine concentration, and white blood cell count. The proportion of patients who developed SIE was numerically lower in the study (6·7%; 8/121) compared with the control group (11·5%; 32/278). The National Institutes of Health Stroke Scale (NIHSS) scores were significantly lower in the study compared with the control group on days 1, 2, and 3 (all P < 0·05). There were no significant within-group differences in NIHSS scores in the study group, whereas NIHSS scores significantly decreased with time in the control group (P < 0·05). Although we found that a lower proportion of patients in the study group developed SIE than patients in the control group, there was no evidence of improved outcomes. As there were several betweengroup differences in baseline characteristics that may have skewed our results, we suggest that larger scale, better controlled studies are needed to further investigate the potential effectiveness of rehydration therapy on the basis of USG monitoring for reducing the incidence of SIE after ischemic stroke.
A Single-centre Early Phase Randomised Controlled Three-arm Trial of Open, Robotic, and Laparoscopic Radical Cystectomy (CORAL).

Laparoscopic radical cystectomy (LRC) and robot-assisted radical cystectomy (RARC) are increasingly popular, but high-level evidence for these techniques remains lacking.



To compare the outcomes of patients undergoing open radical cystectomy (ORC), RARC, and LRC.



From March 2009 to July 2012, 164 patients requiring radical cystectomy for muscle-invasive bladder cancer or high-risk non-muscle-invasive bladder cancer were invited to participate, with an aim of recruiting 47 patients into each arm. Overall, 93 were suitable for trial inclusion; 60 (65%) agreed and 33 (35%) declined.



ORC, RARC, or LRC with extracorporeal urinary diversion.


OUTCOME MEASUREMENTS AND STATISTICAL ANALYSIS
Primary end points were 30- and 90-d complication rates. Secondary end points were perioperative clinical, pathologic, and oncologic outcomes, and quality of life (QoL). The Fisher exact test and analysis of variance were used for statistical analyses.



The 30-d complication rates (classified by the Clavien-Dindo system) varied significantly between the three arms (ORC: 70%; RARC: 55%; LRC: 26%; p=0.024). ORC complication rates were significantly higher than LRC (p<0.01). The 90-d complication rates did not differ significantly between the three arms (ORC: 70%; RARC: 55%; LRC 32%; p=0.068). Mean operative time was significantly longer in RARC compared with ORC or LRC. ORC resulted in a slower return to oral solids than RARC or LRC. There were no significant differences in QoL measures. Major limitations are the small sample size and potential surgeon bias.



The 30-d complication rates varied by type of surgery and were significantly higher in the ORC arm than the LRC arm. There was no significant difference in 90-d Clavien-graded complication rates between the three arms.



We compared patients having open, robotic, or laparoscopic bladder removal surgery for bladder cancer and found no difference in Clavien-graded complication rates at 90 d.
A randomized phase II trial of platinum salts in basal-like breast cancer patients in the neoadjuvant setting. Results from the GEICAM/2006-03, multicenter study

Chemotherapy remains as the only systemic treatment option available for basal-like breast cancer (BC) patients. Preclinical models and several phase II studies suggested that platinum salts are active drugs in this BC subtype though there is no randomized study supporting this hypothesis. This study investigates if the addition of carboplatin to a combination of an alkylating agent together with anthracyclines and taxanes is able to increase the efficacy in the neoadjuvant treatment context. Patients with operable breast cancer and immunophenotypically defined basal-like disease (ER-/PR-/HER2- and cytokeratin 5/6+ or EGFR+) were recruited. Patients were randomized to receive EC (epirubicin 90 mg/m2 plus cyclophosphamide 600 mg/m2 for 4 cycles) followed either by D (docetaxel 100 mg/m2 × 4 cycles; EC–D) or DCb (docetaxel 75 mg/m2 plus carboplatin AUC 6 × 4 cycles; EC–DCb). The primary end point was pathological complete response (pCR) in the breast following the Miller and Payne criteria. Ninety-four patients were randomized (46 EC–D, 48 EC–DCb). pCR rate in the breast was seen in 16 patients (35 %) with EC–D and 14 patients (30 %) with EC–DCb (P value = 0.61). pCR in the breast and axilla was seen in 30 % of patients in both arms. The overall clinical response rate was 70 % (95 % CI 56–83) in the EC–D arm and 77 % (95 % CI 65–87) in the EC–DCb arm. Grade 3/4 toxicity was similar in both arms. The addition of carboplatin to conventional chemotherapy with EC–D in basal-like breast cancer patients did not improve the efficacy probably because they had already received an alkylating agent. These findings should be taken into consideration when developing new agents for this disease.
The effects of journaling for women with newly diagnosed breast cancer.

Forty-three women newly diagnosed with breast cancer participated in this study, which examined the role of expressive journal writing characteristics on mood over the course of a 12-week support group. Writing was analyzed using the linguistic inquiry and word count program. Writing characteristics that were examined included: average word count, number of journal entries, positive and negative emotion words, the ratio of positive to negative words, and the use of cognitive mechanism words (i.e. insight and causal words). Regression analyses revealed that increased levels of anxiety and depression, post-intervention, were predicted by the prevalence of negative emotion in writing. Unique variance in mood (anxiety and depression) was accounted for by expression of negative emotion (7 and 6%, respectively). These relationships were significant (p<0.05) and remained significant even after accounting for pre-intervention levels of distress, and for the quantity and frequency of writing. These findings suggest the need for additional research into the naturalistic application of journaling so that appropriate recommendations for writing (e.g. focus, timing, amount) can be offered to patients who might choose to utilize this approach for coping with the stresses of cancer diagnosis and treatment.
The effect of primary thyroid surgery on the morbidity of reoperative thyroid surgery.

This study aims to investigate the effect of primary surgery on the morbidity of reoperative thyroid surgery.



Fifty-seven patients (14 male, 43 female; mean age 41 years; range 21 to 70 years), who underwent reoperative thyroid surgery in our clinic between January 2007 and January 2012 were retrospectively analyzed in terms of vocal cord paralysis, temporary or permanent hypoparathyroidism, and other complications. The patients were classified into two groups. The first group consisted of 42 completion thyroidectomy patients that had undergone the primary operation of unilateral total lobectomy + isthmusectomy in our clinic, whereas the second group consisted of 15 patients that had undergone bilateral subtotal or near total thyroidectomy in another center. Complication rates were compared between the groups.



Complication rates were observed as permanent vocal cord paralysis in one patient (1.7%), permanent hypocalcemia in two patients (3.5%) and temporary hypocalcemia in four patients (7%). None of the patients had temporary vocal cord paralysis. The complications in the second group were significantly higher than the first group (p=0.021).



The minimal operation should be hemithyroidectomy (total lobectomy and isthmusectomy) to minimize the complications. This approach removes the need for the intervention to the previous surgery field during reoperative thyroid surgery.
Antibodies to core antigen of hepatitis B virus in patients on renal replacement therapy: association with demographic, clinical and laboratory data.

Total antibodies to core antigen of hepatitis B virus (anti-HBc) are a marker for previous or current infection with hepatitis B virus (HBV). Our aim was to examine the prevalence and incidence of anti-HBc in relation to demographic, clinical and laboratory data of patients treated with intermittent hemodialysis (IHD).



Predictors for anti-HBc positivity were evaluated in prevalence IHD patients with negative testing for surface antigen of HBV (HBsAg, n = 1,105) using the stepwise backward regression analysis. Patients starting IHD (n = 336) were introduced into the one-year prospective study evaluating seroconversion for anti-HBc.



Anti-HBc positivity (19.5% of all patients) was predicted by lack of vaccination against HBV with developed protective titer of antibodies to HBsAg (beta = 0.592, p = 0.000), vintage of renal replacement therapy (RRT, beta = 0.206, p = 0.000), history of hepatitis (beta = 0.101, p = 0.000), and activity of alanine aminotransferase (beta = 0.057, p = 0.037). In 85 prospective patients who finished first IHD year, seroconversion rate for anti-HBc was 1.23 episodes/100 patient-years.



Lack of or not effective vaccination against HBV is the strongest predictor for prevalence of anti-HBc positivity in RRT patients. Periodical determination of anti-HBc, usually not required, may be helpful in evaluation of current epidemiological status and risk for further HBV infection in dialysis centers.
Learning Human Interaction using a Smart Rollator, the i-Walker

In addition, the retirement from the working life, and the consequent reduction of physical and social activity, contribute to the increased incidence of falls in older adults. Moreover, elderly people suffer different kinds of cognitive decline, such as dementia or attention problems, which also accentuate gait disorders. Assistive technologies (AT) play a key role in today's society, especially when it comes to the older adults. They aim to maintain or improve individual's functioning and independence and to enhance overall well-being. ATs have enabled improvements in their Quality of Life, extending their autonomy and community living and allowing them to stay active in a safe and independent way. During the last decade, research has focused on developing ATs with sensor systems integrated in the device or located in the human body. Efforts are focused especially on mobility assistance for different targets of people and activity recognition, which could be used, for instance, to monitor elderly population while performing activities of daily living.
Ethnomedicines used in Trinidad and Tobago for urinary problems and diabetes mellitus

This paper is based on ethnobotanical interviews conducted from 1996-2000 in Trinidad and Tobago with thirty male and female respondents.



A non-experimental validation was conducted on the plants used for urinary problems and diabetes mellitus: This is a preliminary step to establish that the plants used are safe or effective, to help direct clinical trials, and to inform Caribbean physicians of the plants' known properties to avoid counter-prescribing.



The following plants are used to treat diabetes: Antigonon leptopus, Bidens alba, Bidens pilosa, Bixa orellana, Bontia daphnoides, Carica papaya, Catharanthus roseus, Cocos nucifera, Gomphrena globosa, Laportea aestuans, Momordica charantia, Morus alba, Phyllanthus urinaria and Spiranthes acaulis. Apium graviolens is used as a heart tonic and for low blood pressure. Bixa orellana, Bontia daphnoides, Cuscuta americana and Gomphrena globosa are used for jaundice. The following plants are used for hypertension: Aloe vera, Annona muricata, Artocarpus altilis, Bixa orellana, Bidens alba, Bidens pilosa, Bonta daphnoides, Carica papaya, Cecropia peltata, Citrus paradisi, Cola nitida, Crescentia cujete, Gomphrena globosa, Hibiscus sabdariffa, Kalanchoe pinnata, Morus alba, Nopalea cochinellifera, Ocimum campechianum, Passiflora quadrangularis, Persea americana and Tamarindus indicus. The plants used for kidney problems are Theobroma cacao, Chamaesyce hirta, Flemingia strobilifera, Peperomia rotundifolia, Petiveria alliacea, Nopalea cochinellifera, Apium graveolens, Cynodon dactylon, Eleusine indica, Gomphrena globosa, Pityrogramma calomelanos and Vetiveria zizanioides. Plants are also used for gall stones and for cooling.



Chamaesyce hirta, Cissus verticillata, Kalanchoe pinnata, Peperomia spp., Portulaca oleraceae, Scoparia dulcis, and Zea mays have sufficient evidence to support their traditional use for urinary problems, "cooling" and high cholesterol. Eggplant extract as a hypocholesterolemic agent has some support but needs more study. The plants used for hypertension, jaundice and diabetes that may be safe and justify more formal evaluation are Annona squamosa, Aloe vera, Apium graveolens, Bidens alba, Carica papaya, Catharanthus roseus, Cecropia peltata, Citrus paradisi, Hibsicus sabdariffa, Momordica charantia, Morus alba, Persea americana, Phyllanthus urinaria, Tamarindus indicus and Tournefortia hirsutissima. Several of the plants are used for more than one condition and further trials should take this into account.