nils-herrmann/clean_scirepeval huggingface dataset:
Intravenous calcitriol for treatment of hyperparathyroidism in children on hemodialysis

This double-blind, placebo-controlled study evaluated the safety and efficacy of intravenous (IV) calcitriol (Calcijex) for treatment of secondary hyperparathyroidism (2°HPT) in pediatric end-stage renal disease (ESRD) patients on hemodialysis (HD). After a 2 to 6-week washout period of all vitamin D compounds, patients with two consecutive PTH values >400 pg mL−1, calcium levels ≤10.5 mg dL−1 and calcium×phosphorus product values ≤70 mg2 dL−2 were eligible for the treatment phase. Patients received a bolus injection of calcitriol or placebo three times a week, immediately after dialysis for up to 12 weeks. Initial doses (0.5–1.5 μg) were based on the severity of 2ºHPT. The dose was increased every two weeks by 0.25 μg until there was at least a 30% decrease in PTH from baseline, or Ca>11.0 mg dL−1, or Ca×P>75 mg2 dL−2. Overall, 11/21 (52%) patients in the calcitriol group had two consecutive ≥30% decreases from baseline in serum PTH compared with 5/26 (19%) patients in the placebo group (P=0.03). The mean total alkaline phosphatase decreased from 274 to 232 IU L−1 in the calcitriol group and increased from 547 to 669 IU L−1 in the placebo group (P=0.002). The mean bone-specific alkaline phosphatase decreased from 72.5 to 68 μg L−1 in the calcitriol group and increased from 105.3 to 148.5 μg L−1 in the placebo group (P=0.03). The incidence of two consecutive occurrences of elevated calcium×phosphorus (Ca×P>75 mg2 dL−2) product was higher in the calcitriol group than in the placebo group (P=0.01). Two consecutive occurrences of phosphorus >6.5 mg dL−1 occurred in 71% of the calcitriol group and 46% of the placebo group (P=0.14). Calcium levels >10.5 mg dL−1 were more common in the calcitriol group than in the placebo group (P=0.01). There was a direct relationship between serum phosphorus concentration and the percentage change in PTH from baseline in both the calcitriol group (r=0.46; P<0.0001) and the placebo group (r=0.21; P=0.0005). This study demonstrates that IV calcitriol, at initial doses of 0.5–1.5 μg, effectively reduces PTH levels in pediatric HD patients and that patients should be closely monitored for hyperphosphatemia and elevated Ca×P product.
Effects of metformin and rosiglitazone treatment on insulin signaling and glucose uptake in patients with newly diagnosed type 2 diabetes: a randomized controlled study.

The effect of metformin or rosiglitazone monotherapy versus placebo on insulin signaling and gene expression in skeletal muscle of patients with newly diagnosed type 2 diabetes was determined. A euglycemic-hyperinsulinemic clamp, combined with skeletal muscle biopsies and glucose uptake measurements over rested and exercised muscle, was performed before and after 26 weeks of metformin (n = 9), rosiglitazone (n = 10), or placebo (n = 11) treatment. Insulin-mediated whole-body and leg muscle glucose uptake was enhanced 36 and 32%, respectively, after rosiglitazone (P < 0.01) but not after metformin or placebo treatment. Insulin increased insulin receptor substrate 1 (IRS-1) tyrosine phosphorylation, IRS-1-associated phosphatidylinositol (PI) 3-kinase activity, and phosphorylation of Akt Ser473 and AS160, a newly described Akt substrate that plays a role in GLUT4 exocytosis, approximately 2.3 fold before treatment. These insulin signaling parameters were unaltered after metformin, rosiglitazone, or placebo treatment. Expression of selected genes involved in glucose and fatty acid metabolism in skeletal muscle was unchanged between the treatment groups. Low-intensity acute exercise increased insulin-mediated glucose uptake but was without effect on insulin signaling. In conclusion, the insulin-sensitizing effects of rosiglitazone are independent of enhanced signaling of IRS-1/PI 3-kinase/Akt/AS160 in patients with newly diagnosed type 2 diabetes.
Internalizing symptoms: effects of a preventive intervention on developmental pathways from early adolescence to young adulthood.

This study examined the mediated and moderated effects of a universal family-focused preventive intervention, delivered during young adolescence, on internalizing symptoms assessed in young adulthood. Sixth grade students (N=446; 52% female; 98% White) and their families from 22 rural Midwestern school districts were randomly assigned to the experimental conditions in 1993. Self-report questionnaires were administered at seven time points (pre-test to young adulthood-age 21) to those receiving the Iowa Strengthening Families Program (ISFP) and to the control group. Results showed that growth factors of adolescent internalizing symptoms (grades 6-12) were predicted by ISFP condition and risk status (defined as early substance initiation). Moderation of the condition effect by risk status was found, with higher-risk adolescents benefitting more from the ISFP. Results also supported the hypothesis that the ISFP's effect on internalizing symptoms in young adulthood was mediated through growth factors of adolescents' internalizing symptoms; risk moderation, however, was only marginally significant in young adulthood. The relative reduction rate on clinical or subclinical levels of young adult internalizing symptoms was 28%, indicating that for every 100 young adults displaying clinical or subclinical levels of internalizing symptoms from school districts not offering an intervention, there could be as few as 72 displaying those levels of symptoms in school districts that offered middle school prevention programming. These findings highlight how the positive effects of family-focused universal interventions can extend to non-targeted outcomes and the related potential public-health impact of scaling up these interventions.
Additional effects of aPDT on nonsurgical periodontal treatment with doxycycline in type II diabetes: a randomized, controlled clinical trial

The association of doxycycline and periodontal treatment in non-controlled diabetes mellitus (DM) has shown positive results on clinical and metabolic parameters. Antimicrobial photodynamic therapy (aPDT) is a local and painless antimicrobial treatment that can be applied in periodontal treatment without systemic risks. The aim of this study was to evaluate the potential improvement of aPDT on clinical and metabolic effects in patients with type 2 diabetes mellitus in conjunction with nonsurgical periodontal treatment plus doxycycline. Thirty patients with type 2 diabetes and diagnosis of chronic periodontitis were treated with scaling and root planning (SRP; N = 15) or SRP plus phenothiazine chloride photosensitizer-induced aPDT (SRP + aPDT, N = 15). Patients of both groups took doxycycline (100 mg/day) for 2 weeks and plaque index, bleeding on probe (BOP), probing pocket depth (PPD), suppuration, clinical attachment level (CAL), and glycated hemoglobin levels (HbA1c) were measured at baseline and 3 months after therapy. An improvement in clinical parameters such as PPD, CAL, S, and BOP between groups was observed but without statistical significance (p > 0.05). Intragroup analysis showed a significant reduction of HbA1c (8.5 ± 0.9 to 7.5 ± 0.1, p < 0.01) in the SRP + aPDT group. The differences of HbA1c between baseline and 3 months were greater for the SRP + aPDT (11.4 %) than SRP (10 %) (0.87 ± 0.9 and 0.4 ± 0.84 respectively; p < 0.05). A single application of the aPDT as an adjunct to periodontal treatment did not show additional benefits in the clinical parameters but resulted in a slight greater decrease in HbA1c.
To return or to discard? Randomised trial on gastric residual volume management.

The control of gastric residual volume (GRV) is a common nursing intervention in intensive care; however the literature shows a wide variation in clinical practice regarding the management of GRV, potentially affecting patients' clinical outcomes. The aim of this study is to determine the effect of returning or discarding GRV, on gastric emptying delays and feeding, electrolyte and comfort outcomes in critically ill patients.



A randomised, prospective, clinical trial design was used to study 125 critically ill patients, assigned to the return or the discard group. Main outcome measure was delayed gastric emptying. Feeding outcomes were determined measuring intolerance indicators, feeding delays and feeding potential complications. Fluid and electrolyte measures included serum potassium, glycaemia control and fluid balance. Discomfort was identified by significant changes in vital signs.



Patients in both groups presented similar mean GRV with no significant differences found (p=0.111), but participants in the intervention arm showed a lower incidence and severity of delayed gastric emptying episodes (p=0.001). No significant differences were found for the rest of outcome measurements, except for hyperglycaemia.



The results of this study support the recommendation to reintroduce gastric content aspirated to improve GRV management without increasing the risk for potential complications.
The beneficial effects of weekly low-dose vitamin A supplementation on acute lower respiratory infections and diarrhea in Ecuadorian children.

Previous studies of large-dose vitamin A supplementation on respiratory morbidity have produced conflicting results in a variety of populations. The influence of malnutrition has not been examined in the majority of these trials. We hypothesized that weekly low-dose vitamin A supplementation would prevent respiratory and diarrheal disease morbidity and that malnutrition might influence the efficacy of vitamin A supplementation.



In a randomized, double-blind, placebo-controlled field trial of 400 children, 6 to 36 months of age in a high Andean urban slum, half of the children received 10 000 IU of vitamin A weekly and half received placebo for 40 weeks. Children were visited weekly at home by physicians and assessed for acute diarrheal disease and acute respiratory infections.



Acute diarrheal disease and acute respiratory infection did not differ globally or by severity between supplement-treated and placebo groups. However, the incidence of acute lower respiratory infection (ALRI) was significantly lower in underweight (weight-for-age z score [WAZ] <-2 SD) supplement-treated children than in underweight children on placebo (8.5 vs 22.3 per 10(3) child-weeks; rate ratio: 0.38 [95% CI: 0.17-0.85]). ALRI incidence was significantly higher in normal-weight (WAZ >-2 SD) supplement-treated children than in normal-weight children on placebo (9.8 vs 4.4 per 10(3) child-weeks; rate ratio: 2.21 [95% CI: 1.24-3.93]). By logistic regression analysis the risk of ALRI was lower in underweight supplement-treated children than in underweight children on placebo (point estimate 0.148 [95% CI: 0.034-0.634]). In contrast, risk of ALRI was higher in normal-weight supplement-treated children (WAZ >-1 SD to mean) than in normal-weight children on placebo in the same WAZ stratum (point estimate: 2.51 [95% CI: 1.24-5.05]). The risk of severe diarrhea was lower in supplement-treated children 18 to 23 months of age than in children on placebo in this age group (point estimate: 0.26 [95% CI: 0.06-1.00]).



Weekly low-dose (10 000 IU) vitamin A supplementation in a region of subclinical deficiency protected underweight children from ALRI and paradoxically increased ALRI in normal children with body weight over -1 SD. Protection from severe diarrhea was consistent with previous trials. Additional research is warranted to delineate potential beneficial and detrimental interactions between nutritional status and vitamin A supplementation regarding ALRI.
Bone loss after total hip arthroplasty

The aim of the present study is to evaluate periprosthetic bone loss and to compare it with the bone loss in other areas of the body. We also aim to shed light on the course of bone mineral density (BMD) in patients with cemented femoral prosthesis in comparison with those with uncemented ones. We analyzed the BMD using dual-energy X-ray absorptiometry (DEXA) in a consecutively recruited convenience sample of 50 patients with cemented and uncemented total hip arthroplasty (THA). BMD was measured within the first month after surgery as well as 1 year later. In ten of the patients (20%) previously undiagnosed osteoporosis was revealed. Osteoporosis was significantly more frequently detected in patients with cemented compared to those with uncemented femoral stem. We found a significant loss in BMD in the periprosthetic femoral region compared with no losses in other body regions (lumbar spine, radius, contralateral hip). The magnitude of this loss was the highest in Gruen-Zone 7 (mean 15.2% per year). We found no BMD loss difference between patients with cemented and uncemented prosthesis in the Gruen-Zone 2–7. In conclusion these periprosthetic losses may be due to local factors such as periprosthetic bone remodeling, as they contrast with the course of BMD in the lumbar spine, radius and not operated hip.
Monitoring of intracranial pressure in patients with severe traumatic brain injury: an Austrian prospective multicenter study

The goals of this study were to elucidate reasons why patients did or did not receive intracranial pressure (ICP) monitoring and to describe factors influencing hospital mortality after severe traumatic brain injury (TBI). Prospective multicenter cohort study. 88,274 patients consecutively admitted to 32 medical, surgical and mixed Austrian ICUs between 1998 and 2004. None. 1,856 patients (2.1% of all ICU admissions) exhibited severe TBI (GCS < 9); of these, 1,031 (56%) had ICP monitoring. The “worst” and the “best” cases were both less likely to receive ICP monitoring. Younger patients, female patients, and patients with isolated TBI were more likely to receive ICP monitoring. Compared with large centers ICP was monitored more frequently [odds ratio (OR) 3.09, CI 2.42–3.94] in medium-sized centers. The 20% of patients with the highest likelihood to receive ICP monitoring were monitored in 91% of cases, and had the lowest hospital mortality (31%, OR 0.78, CI 0.37–1.64). Multivariate analysis revealed that severity of illness, TBI severity, isolated TBI, and the number of cases treated per year were associated with hospital outcome. Compared with the large centers, ORs for hospital mortality were 1.85 (CI 1.42–2.40) for patients from medium-sized centers and 1.91 (CI 1.24–2.93) for patients from small centers. ICP monitoring may possibly have some beneficial effects, but this needs further evaluation. Patients with severe TBI should be admitted to experienced centers with high patient volumes since this might improve hospital mortality rates.
Pioglitazone Improves Fat Distribution, the Adipokine Profile and Hepatic Insulin Sensitivity in Non-Diabetic End-Stage Renal Disease Subjects on Maintenance Dialysis: A Randomized Cross-Over Pilot Study

Fat redistribution, increased inflammation and insulin resistance are prevalent in non-diabetic subjects treated with maintenance dialysis. The aim of this study was to test whether pioglitazone, a powerful insulin sensitizer, alters body fat distribution and adipokine secretion in these subjects and whether it is associated with improved insulin sensitivity.



This was a double blind cross-over study with 16 weeks of pioglitazone 45 mg vs placebo involving 12 subjects.



At the end of each phase, body composition (anthropometric measurements, dual energy X-ray absorptometry (DEXA), abdominal CT), hepatic and muscle insulin sensitivity (2-step hyperinsulinemic euglycemic clamp with 2H2-glucose) were measured and fasting blood adipokines and cardiometabolic risk markers were monitored.



Four months treatment with pioglitazone had no effect on total body weight or total fat but decreased the visceral/sub-cutaneous adipose tissue ratio by 16% and decreased the leptin/adiponectin (L/A) ratio from 3.63 × 10(-3) to 0.76 × 10(-3). This was associated with a 20% increase in hepatic insulin sensitivity without changes in muscle insulin sensitivity, a 12% increase in HDL cholesterol and a 50% decrease in CRP.



Pioglitazone significantly changes the visceral-subcutaneous fat distribution and plasma L/A ratio in non diabetic subjects on maintenance dialysis. This was associated with improved hepatic insulin sensitivity and a reduction of cardio-metabolic risk markers. Whether these effects may improve the outcome of non diabetic end-stage renal disease subjects on maintenance dialysis still needs further evaluation.
Alcohol and Tobacco Increases Risk of High Risk HPV Infection in Head and Neck Cancer Patients: Study from North-East Region of India

Human papilloma virus (HPV) associated Head and Neck Cancers (HNCs) have generated significant amount of research interest in recent times. Due to high incidence of HNCs and lack of sufficient data on high-risk HPV (hr-HPV) infection from North -East region of India, this study was conceived to investigate hr-HPV infection, its types and its association with life style habits such as tobacco, alcohol consumption etc.



A total of one hundred and six primary HNC tumor biopsy specimens were collected. These samples were analyzed for hr-HPV DNA (13 HPV types) using hybrid capture 2 (HC2) assay and genotyping was done by E6 nested multiplex PCR (NMPCR).



The presence of hr-HPV was confirmed in 31.13% (n = 33) and 24.52% (n = 26) of the HNC patients by nested multiplex PCR (NMPCR) and HC2 assay respectively. Among hr-HPV positive cases, out of thirteen hr- HPV types analyzed, only two prevalent genotypes, HPV-16 (81.81%) followed by HPV-18 (18.18%) were found. Significant association was observed between hr-HPV infection with alcohol consumption (p <0.001) and tobacco chewing (p = 0.02) in HNC cases. Compared to HPV-18 infection the HPV-16 was found to be significantly associated with tobacco chewing (p = 0.02) habit.



Our study demonstrated that tobacco chewing and alcohol consumption may act as risk factors for hr-HPV infection in HNCs from the North-East region of India. This was the first study from North-East India which also assessed the clinical applicability of HC2 assay in HNC patient specimens. We suggest that alcohol, tobacco and hr- HPV infection act synergistically or complement each other in the process of HNC development and progression in the present study population.
Kinetics of phenobarbital in normal subjects and epileptic patients

The kinetics of phenobarbital (PB) were evaluated in six normal subjects and six epileptic patients treated with phenytoin or carbamazepine. Each normal subject received three single doses of PB: PB-sodium 130 mg i.v. (IV), PB sodium 130 mg i.m. (IM), and PB acid 100 mg orally (PO), in random order at least one month apart. After IV PB distributive half-lives varied from 0.13 to 0.70 h, disposition half-lives were 75 to 126 h, steady state volume of distribution (Vss) was 0.54±0.03 l/kg, and clearance (CL) was 3.8±0.77 ml/h/kg. Absolute bioavailability of IM PB was 101±13%, of PO PB (corrected for dose) 100±11%. Peak serum PB concentrations were achieved from 2 to 8 h after IM administration, and from 0.5 to 4 h after PO administration. Epileptic patients exhibited similar PB kinetics: disposition half-lives were 77 to 128 h, Vss 0.61±0.05 l/kg, and Cl 3.9±0.76 ml/h/kg. Phenobarbital appears to represent an exception among antiepileptic drugs, in that pharmacokinetic data obtained in normals can reasonably be extrapolated to the epileptic population.
[Early diagnosis, early care--"Fr1da" screening of children for type 1 diabetes].

Typ-1-Diabetes wird bei einem Drittel der betroffenen Kinder und Jugend lichen erst diagnostiziert, wenn eine lebensbedrohliche Ketoazidose auftritt. Dies könnte sich durch ein Screening auf Inselautoantikörper im Blut ändern, wie erste Ergebnisse der „Fr1da“-Studie in Bayern zeigen. Darüber hinaus wird getestet, ob die Gabe von oralem Insulin die Manifestation eines Typ-1-Diabetes verhindern kann.
Addition of clopidogrel to aspirin in 45,852 patients with acute myocardial infarction: randomised placebo-controlled trial.

Despite improvements in the emergency treatment of myocardial infarction (MI), early mortality and morbidity remain high. The antiplatelet agent clopidogrel adds to the benefit of aspirin in acute coronary syndromes without ST-segment elevation, but its effects in patients with ST-elevation MI were unclear.



45,852 patients admitted to 1250 hospitals within 24 h of suspected acute MI onset were randomly allocated clopidogrel 75 mg daily (n=22,961) or matching placebo (n=22,891) in addition to aspirin 162 mg daily. 93% had ST-segment elevation or bundle branch block, and 7% had ST-segment depression. Treatment was to continue until discharge or up to 4 weeks in hospital (mean 15 days in survivors) and 93% of patients completed it. The two prespecified co-primary outcomes were: (1) the composite of death, reinfarction, or stroke; and (2) death from any cause during the scheduled treatment period. Comparisons were by intention to treat, and used the log-rank method. 
Allocation to clopidogrel produced a highly significant 9% (95% CI 3-14) proportional reduction in death, reinfarction, or stroke (2121 [9.2%] clopidogrel vs 2310 [10.1%] placebo; p=0.002), corresponding to nine (SE 3) fewer events per 1000 patients treated for about 2 weeks. There was also a significant 7% (1-13) proportional reduction in any death (1726 [7.5%] vs 1845 [8.1%]; p=0.03). These effects on death, reinfarction, and stroke seemed consistent across a wide range of patients and independent of other treatments being used. Considering all fatal, transfused, or cerebral bleeds together, no significant excess risk was noted with clopidogrel, either overall (134 [0.58%] vs 125 [0.55%]; p=0.59), or in patients aged older than 70 years or in those given fibrinolytic therapy.



In a wide range of patients with acute MI, adding clopidogrel 75 mg daily to aspirin and other standard treatments (such as fibrinolytic therapy) safely reduces mortality and major vascular events in hospital, and should be considered routinely.
Inflammatory, lipid, thrombotic, and genetic markers of coronary heart disease risk in the women's health initiative trials of hormone therapy.

Clinical trials of postmenopausal hormone therapy (HT) have shown increased risk of coronary heart disease (CHD) in the first few years after initiation of therapy and no overall benefit.



This nested case-control study evaluates a range of inflammatory, lipid, thrombotic, and genetic markers for their association with CHD in the 4 years after randomization and assesses whether any of these markers modified or mediated the initially increased risk associated with HT in postmenopausal women aged 50 to 79 years at baseline. Conjugated equine estrogens, 0.625 mg/d, or placebo was given to 10 739 hysterectomized women, and the same estrogen plus medroxyprogesterone acetate, 2.5 mg/d, was given to 16 608 women with an intact uterus.



In multivariate-adjusted analyses of 359 cases and 820 controls in the combined trials, baseline levels of 12 of the 23 biomarkers studied were associated with CHD events: interleukin 6, matrix metalloproteinase 9, high-density lipoprotein cholesterol, low-density lipoprotein cholesterol, total cholesterol, triglycerides, D-dimer, factor VIII, von Willebrand factor, leukocyte count, homocysteine, and fasting insulin. Biomarkers tended to be more strongly associated with CHD in the initial 2 years after randomization. The genetic polymorphism glycoprotein IIIa leu33pro was significantly associated with CHD. Baseline low-density lipoprotein cholesterol interacted significantly with HT so that women with higher levels were at higher risk for CHD when given HT (P = .03 for interaction). The levels of several biomarkers were changed by HT, but these changes did not seem to be associated with future CHD events.



Several thrombotic, inflammatory, and lipid biomarkers were associated with CHD events in postmenopausal women, but only low-density lipoprotein cholesterol modified the effect of HT. Further research is needed to identify the mechanisms by which HT increases the risk of CHD.