nils-herrmann/clean_scirepeval huggingface dataset:
Effects of 12-month, 2000IU/day vitamin D supplementation on treatment naïve and vitamin D deficient Saudi type 2 diabetic patients

To determine whether 12-month, 2000IU/day vitamin D supplementation cardiometabolically improves treatment naïve type 2 diabetes mellitus (T2DM) Saudi patients with vitamin D deficiency. 



This 12-month interventional study was conducted at primary health centers in 5 different residential areas in Riyadh, Saudi Arabia between January 2013 and January 2014. Forty-five Saudi  T2DM  patients were enrolled. Baseline anthropometrics, glycemic, and lipid profiles were measured and repeated after 6 and 12 months. All subjects were provided with 2000IU vitamin D supplements for one year.  



Vitamin D deficiency at baseline was 46.7%, 31.8% after 6 months, and 35.6% after 12 months, indicating an overall improvement in the vitamin D status in the entire cohort. Insulin and homeostatic model assessment-insulin resistance (HOMA-IR) after 12 months were significantly lower than a 6 months (p less than 0.05), but comparable to baseline values. Mean levels of triglycerides increased overtime from baseline (1.9±0.01 mmol/l) to 12 months (2.1±0.2 mmol). This modest increase in serum triglycerides was parallel to the insignificant decrease in circulating high-density lipoprotein -cholesterol levels. 



Twelve-month vitamin D supplementation of 2000IU per day in a cohort of treatment naïve Saudi patients with T2DM resulted in improvement of several cardiometabolic parameters including systolic blood pressure, insulin, and HOMA-IR. Further studies that include a placebo group are suggested to reinforce findings.
Early immunotherapy using autologous adult stem cells reversed the effect of anti-pancreatic islets in recently diagnosed type 1 diabetes mellitus: Preliminary results

Bone marrow stem cell treatment has been proven a promising therapeutic strategy and showed significant results given the strong immune modulating properties. We have investigated the safety and efficacy of autologous bone marrow stem cell transplantation through liver puncture in two patients with recently diagnosed type 1 diabetes mellitus.



The procedure was approved by the Institutional Ethics Committee. In 2011, in three young patients, type 1 diabetes mellitus diagnosis was confirmed, with the presence of positive antibodies and ketoacidosis. Two patients was treated with autologous bone marrow stem cell stimulated with filgrastim and transplantation, through liver puncture, as immune modulators. One patients was treated with conventional treatment and participate in this experiment as a control group. The families of the patients signed the informed consent. No specific statistical analysis was performed. The patients had less than 8 years old, diagnosis of type 1 diabetes for less than 60 days, body mass index less than 22 kg/m2, normal complete blood count, coagulation and renal function, no lesions in target organs, glycosylated hemoglobin (HbA1c) level less than 13.70%, c-peptide level less than 0.67 ng/ml, positive results of Islets Cells Antibody (ICA), Glutamic Acid Decarboxylase (GAD) and insulin antibody.



In two patients treated, the follow up at 12 months showed negative value in ICA, GAD and anti insulin antibody levels, with an increased levels of c peptide and decreased levels of blood glucose and HbA1c.



Treatment with autologous bone marrow stem cells is easy and effective as it reversed the production and effect of anti pancreatic islet antibody and significantly resulted in an increased c-peptide concentration.
Subjective responses to alcohol in the lab predict neural responses to alcohol cues.

Subjective responses to alcohol represent a biologically based, genetically moderated, and clinically informative marker of alcoholism risk; however, the physiology underlying this phenotype remains unclear. This study tested whether subjective responses during alcohol administration predict neural responses to alcohol cues in the scanner and whether these neural responses differ between OPRM1 genotypes.



Twenty alcohol-dependent individuals were recruited (10 G-allele carriers; 6 women; Mage = 29.4) for a within-subjects alcohol administration in the laboratory and a functional magnetic resonance imaging session consisting of an alcohol taste cues task. Laboratory assessments of alcohol high, liking, craving, and positive and negative reinforcement during alcohol administration were entered as predictors of neural response to the presentation of alcohol cues versus water cues in the scanner and further tested for OPRM1 genotype moderation (whole-brain cluster-corrected at Z > 1.96, p < .05).



Alcohol craving during alcohol administration predicted less neural activity, whereas alcohol reinforcement predicted greater neural activity to alcohol cues versus water cues in regions including the precuneus, posterior cingulate gyrus, and lingual gyrus. Alcohol high predicted greater neural activity to alcohol cues in regions including the precuneus and anterior cingulate cortex. OPRM1 genotype was found to moderate these relationships. No results were observed for alcohol liking.



This study provides initial evidence that subjective responses to alcohol, namely craving, high, and the reinforcing properties of alcohol, predict neural markers of alcohol cue reactivity. These results support the validity of laboratory and neuroimaging measures of subjective responses to alcohol and offer an integration of these methods in a sample of alcohol-dependent individuals.
Phase I and pharmacokinetic study of pazopanib and lapatinib combination therapy in patients with advanced solid tumors

This phase I, open-label, dose-escalation study assessed the maximum-tolerated dose, safety, pharmacokinetics, and preliminary antitumor activity of pazopanib plus lapatinib combination therapy in patients with solid tumors. Patients were to take pazopanib and lapatinib orally once daily in a fasting condition. During the escalation phase, pazopanib and lapatinib doses were escalated in serial patient cohorts, and a limited blood sampling scheme was applied for pharmacokinetic evaluation. In the expansion phase, potential pharmacokinetic interaction between pazopanib and lapatinib was evaluated more extensively. Seventy-five patients were treated. Multiple dosing levels were studied, combining pazopanib up to 800 mg/day with lapatinib up to 1,500 mg/day. Dose-limiting toxicities observed included grade 3 neutropenia, fatigue, asymptomatic decline in left ventricular ejection fraction, diarrhea, and liver enzyme elevations. The most common drug-related adverse events were diarrhea, nausea, anorexia, fatigue, vomiting, rash, hair depigmentation, and hypertension. The dose recommended for further evaluation was pazopanib 800 mg plus lapatinib 1,500 mg (paz-800/lap-1500). No clinically significant drug-drug interaction was observed at the paz-400/lap-1000 level. However, at paz-800/lap-1500, an increase in both the AUC0-t and Cmax of pazopanib was observed. Four partial responses were observed in patients with renal cancer (n = 2), giant-cell tumor of the bone (n = 1), and thyroid cancer (n = 1). Stable disease for ≥18 weeks was seen in 12 patients. Pazopanib and lapatinib can be administered in combination at their respective single-agent doses with an acceptable safety profile. Further evaluation of the combination will be pursued, exploring both paz-800/lap-1500 and paz-400/lap-1000.
Spanish adaptation and validation of the Brief Negative Symptoms Scale.

Negative symptoms prevalent in schizophrenia are associated with poor outcome. Developing new instruments to identify new treatments was highlighted at the NIMH-MATRICS Consensus Development Conference on Negative Symptoms. The new Brief Negative Symptoms scale (BNSS) demonstrated strong psychometric properties, but there is a need for validating it in non-English languages. A multi-center study was conducted to validate the Spanish version of the BNSS (BNSS-Sp) in 20 schizophrenia patients, following the original BNSS validation methodology. We found strong inter-rater, test-retest and internal consistency properties (for the total BNSS-Sp, intraclass correlation coefficient=0.97, Pearson's correlation coefficient r=0.95 (p<0.001), Cronbach's alpha=0.98).
The impact on retrieval effectiveness of skewed frequency distributions

We present an analysis of word senses that provides a fresh insight into the impact of word ambiguity on retrieval effectiveness with potential broader implications for other processes of information retrieval. Using a methodology of forming artifically ambiguous words, known as pseudowords, and through reference to other researchers' work, the analysis illustrates that the distribution of the frequency of occurrance of the senses of a word plays a strong role in ambiguity's impact of effectiveness. Further investigation shows that this analysis may also be applicable to other processes of retrieval, such as Cross Language Information Retrieval, query expansion, retrieval of OCR'ed texts, and stemming. The analysis appears to provide a means of explaining, at least in part, reasons for the processes' impact (or lack of it) on effectiveness.
Reserpine and alpha-methyldopa in the treatment of tardive dyskinesia

Thirty inpatients with evidence of tardive dyskinesia secondary to antipsychotic medications participated in this double-blind, controlled, randomized study comparing reserpine, α-methyldopa and placebo. Reserpine at doses of 0.75–1.5 mg daily, or α-methyldopa at doses of 750–1,500 mg daily, produced a statistically significant improvement in tardive dyskinesia symptomatology compared to the results obtained with placebo.
Neoadjuvant irinotecan, cisplatin, and concurrent radiation therapy with celecoxib for patients with locally advanced esophageal cancer

Patients with locally advanced esophageal cancer who are treated with trimodality therapy have a high recurrence rate. Preclinical evidence suggests that inhibition of cyclooxygenase 2 (COX2) increases the effectiveness of chemoradiation, and observational studies in humans suggest that COX-2 inhibition may reduce esophageal cancer risk. This trial tested the safety and efficacy of combining a COX2 inhibitor, celecoxib, with neoadjuvant irinotecan/cisplatin chemoradiation. This single arm phase 2 trial combined irinotecan, cisplatin, and celecoxib with concurrent radiation therapy. Patients with stage IIA-IVA esophageal cancer received weekly cisplatin 30 mg/m2 plus irinotecan 65 mg/m2 on weeks 1, 2, 4, and 5 concurrently with 5040 cGy of radiation therapy. Celecoxib 400 mg was taken orally twice daily during chemoradiation, up to 1 week before surgery, and for 6 months following surgery. Forty patients were enrolled with stage IIa (30 %), stage IIb (20 %), stage III (22.5 %), and stage IVA (27.5 %) esophageal or gastroesophageal junction cancer (AJCC, 5th Edition). During chemoradiation, grade 3–4 treatment-related toxicity included dysphagia (20 %), anorexia (17.5 %), dehydration (17.5 %), nausea (15 %), neutropenia (12.5 %), diarrhea (10 %), fatigue (7.5 %), and febrile neutropenia (7.5 %). The pathological complete response rate was 32.5 %. The median progression free survival was 15.7 months and the median overall survival was 34.7 months. 15 % (n = 6) of patients treated on this study developed brain metastases. The addition of celecoxib to neoadjuvant cisplatin-irinotecan chemoradiation was tolerable; however, overall survival appeared comparable to prior studies using neoadjuvant cisplatin-irinotecan chemoradiation alone. Further studies adding celecoxib to neoadjuvant chemoradiation in esophageal cancer are not warranted.
Statin for prevention of atrial fibrillation after off-pump coronary artery bypass grafting in Japanese patients.

The purpose of the present study was to assess the preventive effect of preoperative statin treatment on atrial fibrillation (AF) after elective isolated off-pump coronary artery bypass grafting (off-pump CABG) in propensity score-matched Japanese patients.



Among 770 consecutive patients undergoing isolated CABG by the same surgeon (99.2% with off-pump technique without conversion to cardiopulmonary bypass) between 2002 and 2009, after excluding emergency (n=150), chronic AF (n=30), and use of cardiopulmonary bypass (n=6), 584 patients were retrospectively reviewed. Of this cohort, 364 patients received statin at least 5 days before operation and 220 patients received no statin. We identified 195 propensity score-matched pairs. Propensity scores were created based on 8 preoperative factors (C statistics, 0.69). There was no significant difference between the 2 groups in baseline characteristics, perioperative medications, or operative procedures. AF occurred in 14.4% in the statin group and in 24.6% in the no statin group (P=0.01). Multivariate logistic regression including potential univariate predictors identified statin (odds ratio [OR] =0.49; 95% confidence interval [95%CI] =0.22-0.81; P=0.01), age (OR =1.33 per 10-year increase; 95%CI =1.04-1.69; P=0.02), and transfusion (OR =2.21; 95%CI =1.38-3.55; P=0.01) as independent predictors of postoperative AF.



Preoperative statin significantly reduces the incidence of AF after elective isolated off-pump CABG in Japanese patients.
Quality of life by proxy and mortality in institutionalized older adults with dementia.

This study aimed at analyzing the effect of quality of life (QoL) on mortality in older adults with dementia living in long-term care facilities.



A prospective observational cohort study was carried out on 412 residents aged older than 60 years, diagnosed with dementia according to the Diagnostic and Statistical Manual of Mental Disorders, fourth edition. Besides assessment of QoL (EQ-5D index by proxy) and perceived health status (EQ-VAS), baseline measurements included severity of dementia (Clinical Dementia Rating Scale [CDR]), comorbidity (number of self-reported chronic conditions), disability evaluation (Barthel Index), cognitive state (Mini Examen Cognoscitivo, a validated and modified Spanish version of the Mini-Mental State Examination) and depression (Cornell Depression Scale for Dementia). Sociodemographic and clinical variables were analyzed as potential effect modifiers and confounders in the relationship between QoL and mortality using a multivariate logistic regression analysis.



After an 18-month follow up, 138 residents had died. Adjusting for CDR and Barthel Index, the odds of mortality were multiplied by 0.25 (95% CI 0.09-0.70) and 0.79 (95% CI 0.26-2.42) for every unit of change in the EQ-5D index in the residents with Cornell score <6 and ≥ 6, respectively.



The present study suggests that the effect of QoL on mortality in institutionalized adults with dementia should take into account the presence or absence of depression. In addition, residents with a greater disability and more advanced dementia should be a target for interventions in rehabilitation care.
Radiosynoviorthesis of the knee: A doubleblind trial of 1 versus 5 mCi Gold-198

Since the minimal effective dosage for radiosynovectomy is not known, we have performed a doubleblind controlled trial of 1 mCi vs. 5 mCi198 Au in 60 knees of 46 patients with persistent rheumatoid synovitis. The therapeutic effect was assessed with a clinical score,99mTc pertechnetate uptake measurements and plain X-rays. With regard to clinical parameters no statistical differences between the two groups were found, but results indicate a trend towards a better outcome in patients treated with 5 mCi.99mTc uptake improved significantly in patients treated with the higher dose and not in the low dose group. Weighing ease of treatment and risk of side effects against the small difference in effectiveness, we conclude that the use of less than 5 mCi of198Au may be justified. During the study the injection technique was changed, enabling a comparison of two methods. Leakage to lymph nodes and liver decreased when the needle was flushed with normal saline after administration of the radiocolloid.
Effect of Low Perceived Social Support on Health Outcomes in Young Patients With Acute Myocardial Infarction: Results From the VIRGO (Variation in Recovery: Role of Gender on Outcomes of Young AMI Patients) Study

Social support is an important predictor of health outcomes after acute myocardial infarction (AMI), but social support varies by sex and age. Differences in social support could account for sex differences in outcomes of young patients with AMI.



Data from the Variation in Recovery: Role of Gender on Outcomes of Young AMI Patients (VIRGO) study, an observational study of AMI patients aged ≤55 years in the United States and Spain, were used for this study. Patients were categorized as having low versus moderate/high perceived social support using the ENRICHD Social Support Inventory. Outcomes included health status (Short Form-12 physical and mental component scores), depressive symptoms (Patient Health Questionnaire), and angina-related quality of life (Seattle Angina Questionnaire) evaluated at baseline and 12 months. Among 3432 patients, 21.2% were classified as having low social support. Men and women had comparable levels of social support at baseline. On average, patients with low social support reported lower functional status and quality of life and more depressive symptoms at baseline and 12 months post-AMI. After multivariable adjustment, including baseline health status, low social support was associated with lower mental functioning, lower quality of life, and more depressive symptoms at 12 months (all P<0.001). The relationship between low social support and worse physical functioning was nonsignificant after adjustment (P=0.6). No interactions were observed between social support, sex, or country.



Lower social support is associated with worse health status and more depressive symptoms 12 months after AMI in both young men and women. Sex did not modify the effect of social support.
The impact of educational interventions on modifiable risk factors for osteoporosis after a fragility fracture

The purpose of this study was to investigate the impact of two educational interventions on the intake of calcium and vitamin D supplements and modifiable risk factors for osteoporosis in women ≥50 years with a fragility fracture (FF). Within 6–8 months of fracture, women were randomized to one of three intervention groups: usual care (UC), written materials (WM), or videocassette and written materials (VC). The written materials for patients and their physician provided information on osteoporosis, FF, and available treatments; written materials for physician were provided through patients. The videocassette presented similar information as the written material, but in greater depth. Twelve months after randomization, the effectiveness of the interventions was assessed. The study cohort consisted of 1,175 women undiagnosed and untreated for osteoporosis. After 12 months, the mean intake of Ca supplements increased by 33, 93, and 91 mg/day for the UC, WM, and VC groups, respectively (p value, WM vs UC = 0.163; VC vs UC = 0.026); the corresponding mean increases for vitamin D were 58, 105, and 118 IU/day (p value, WM vs UC = 0.214; VC vs UC = 0.012). The proportion of women who increased their Ca and vitamin D intake by supplements was similar in all three groups. The intervention had a greater impact in those not taking supplements at randomization and had no impact on modifiable risk factors. In women without diagnosis and treatment for osteoporosis, the interventions seem effective at increasing the amounts of Ca and vitamin D supplements, but not effective at inciting more women to increase their consumption. Therefore, the clinical significance of the impact of the intervention is difficult to evaluate.
Statistical limitations of percent ideal body weight as measure for nutritional failure in patients with cystic fibrosis.

For the past decade, percentage of ideal body weight (%IBW) was recommended by European and US nutrition consensus reports as preferred clinical measure of nutritional status in children with cystic fibrosis (CF). We and others have demonstrated that the %IBW method underestimates the prevalence of nutritional failure in CF, but the underlying mechanism for this methodological flaw remains incompletely defined.



We performed model calculations from cross sectional growth data of healthy and CF-children to assess the methodological limitations of %IBW calculation.



Here we demonstrate that an intrinsic limitation of %IBW method is that it largely ignores the statistical principle of regression to the mean. The key assumption of %IBW is that ideal weight-for-age is on exactly the same percentile ranking as height-for-age. We show that this assumption is only valid if the individual's height is close to the reference median. When the stature deviates from the median of the reference population, however, the increments of height-for-age and weight-for-age percentiles are not the same. In consequence, %IBW method systematically underestimates the ideal weight for smaller-than-average individuals, like CF-patients, which results in significant underestimation of the prevalence of malnutrition in this group of patients.



There is increasing scientific evidence that calculation of %IBW as a measure of nutritional status in children with CF is flawed and should be discontinued. It is expected that future guidelines will recommend the use of alternative measures of weight-for-height proportion, e.g. BMI percentiles, to assess underweight and malnutrition in patients with CF.
Isoflavone-rich soy protein isolate suppresses androgen receptor expression without altering estrogen receptor-beta expression or serum hormonal profiles in men at high risk of prostate cancer.

The purpose of this study was to determine the effects of soy protein isolate consumption on circulating hormone profiles and hormone receptor expression patterns in men at high risk for developing advanced prostate cancer. Fifty-eight men were randomly assigned to consume 1 of 3 protein isolates containing 40 g/d protein: 1) soy protein isolate (SPI+) (107 mg/d isoflavones); 2) alcohol-washed soy protein isolate (SPI-) (<6 mg/d isoflavones); or 3) milk protein isolate (0 mg/d isoflavones). For 6 mo, the men consumed the protein isolates in divided doses twice daily as a partial meal replacement. Serum samples collected at 0, 3, and 6 mo were analyzed for circulating estradiol, estrone, sex hormone-binding globulin, androstenedione, androstanediol glucuronide, dehydroepiandrosterone sulfate, dihydrotestosterone, testosterone, and free testosterone concentrations by RIA. Prostate biopsy samples obtained pre- and postintervention were analyzed for androgen receptor (AR) and estrogen receptor-beta expression by immunohistochemistry. At 6 mo, consumption of SPI+ significantly suppressed AR expression but did not alter estrogen receptor-beta expression or circulating hormones. Consumption of SPI- significantly increased estradiol and androstenedione concentrations, and tended to suppress AR expression (P = 0.09). Although the effects of SPI- consumption on estradiol and androstenedione are difficult to interpret and the clinical relevance is uncertain, these data show that AR expression in the prostate is suppressed by soy protein isolate consumption, which may be beneficial in preventing prostate cancer.