nils-herrmann/clean_scirepeval huggingface dataset:
Vitamin D supplementation improves cytokine profiles in patients with congestive heart failure : a double-blind , randomized , placebo-controlled trial 1 – 3

Elevated circulating concentrations of proinflammatory cytokines may contribute to the pathogenesis of congestive heart failure (CHF). In vitro studies suggest that vitamin D suppresses proinflammatory cytokines and increases antiinflammatory cytokines.  We evaluated the effect of vitamin D supplementation on the survival rate and different biochemical variables in patients with CHF.  One hundred twenty-three patients randomly received either 50 g vitamin D3/d plus 500 mg Ca/d [D( ) group] or placebo plus 500 mg Ca/d [D(–) group] for 9 mo. Biochemical variables were assessed at baseline and after 9 mo. The survival rate was calculated for a follow-up period of 15 mo.  Ninety-three patients completed the study. Significant treatment effects were observed on logarithmic-transformed serum concentrations of 25-hydroxyvitamin D (P 0.001), parathyroid hormone (P 0.007), tumor necrosis factor (P 0.006), and interleukin 10 (P 0.042). 25-Hydroxyvitamin D increased by 26.8 ng/mL in the D( ) group but increased only by 3.6 ng/mL in the D(–) group. Compared with baseline, parathyroid hormone was significantly lower and the antiinflammatory cytokine interleukin 10 was significantly higher in the D( ) group after 9 mo. The proinflammatory cytokine tumor necrosis factor increased in the D(–) group but remained constant in the D( ) group. The survival rate did not differ significantly between the study groups during the follow-up period.  Vitamin D3 reduces the inflammatory milieu in CHF patients and might serve as a new antiinflammatory agent for the future treatment of the disease. Our data provide evidence for the involvement of an impaired vitamin D–parathyroid hormone axis in the progression of CHF. Am J Clin Nutr 2006;83:754–9.
Prevention of mother-to-child transmission of HIV-1 through breast-feeding by treating infants prophylactically with lamivudine in Dar es Salaam, Tanzania: the Mitra Study.

To investigate the possibility of reducing mother-to-child transmission (MTCT) of HIV-1 through breast-feeding by prophylactic antiretroviral (ARV) treatment of the infant during the breast-feeding period.



An open-label, nonrandomized, prospective cohort study in Tanzania (Mitra).



HIV-1-infected pregnant women were treated according to regimen A of the Petra trial with zidovudine (ZDV) and lamivudine (3TC) from week 36 to 1 week postpartum. Infants were treated with ZDV and 3TC from birth to 1 week of age (Petra arm A) and then with 3TC alone during breast-feeding (maximum of 6 months). Counseling emphasized exclusive breast-feeding. HIV transmission was analyzed using the Kaplan-Meier survival technique. Cox regression was used for comparison with the breast-feeding population in arm A of the Petra trial, taking CD4 cell count and other possible confounders into consideration.



There were 398 infants included in the transmission analysis in the Mitra study. The estimated cumulative proportion of HIV-1-infected infants was 3.8% (95% confidence interval [CI]: 2.0 to 5.6) at week 6 after delivery and 4.9% (95% CI: 2.7 to 7.1) at month 6. The median time of breast-feeding was 18 weeks. High viral load and a low CD4 T-cell count at enrollment were associated with transmission. The Kaplan-Meier estimated risk of HIV-1 infection at 6 months in infants who were HIV-negative at 6 weeks was 1.2% (95% CI: 0.0 to 2.4). The cumulative HIV-1 infection or death rate at 6 months was 8.5% (95% CI: 5.7 to 11.4). No serious adverse events related to the ARV treatment of infants occurred. The HIV-1 transmission rate during breast-feeding in the Mitra study up to 6 months after delivery was more than 50% lower than in the breast-feeding population of Petra arm A (relative hazard=2.61; P=0.001; adjusted values). The difference in transmission up to 6 months was significant also in the subpopulation of mothers with CD4 counts>or=200 cells/microL.



The rates of MTCT of HIV-1 in the Mitra study at 6 weeks and 6 months after delivery are among the lowest reported in a breast-feeding population in sub-Saharan Africa. Prophylactic 3TC treatment of infants to prevent MTCT of HIV during breast-feeding was well tolerated by the infants and could be a useful strategy to prevent breast milk transmission of HIV when mothers do not need ARV treatment for their own health.
Osmophobia in migraine classification: a multicentre study in juvenile patients.

This study was planned to investigate the diagnostic utility of osmophobia as criterion for migraine without aura (MO) as proposed in the Appendix (A1.1) of the International Classification of Headache Disorders (ICHD-II, 2004).



We analysed 1020 patients presenting at 10 Italian juvenile headache centres, 622 affected by migraine (M) and 328 by tension-type headache (TTH); 70 were affected by headache not elsewhere classified (NEC) in ICHD-II. By using a semi-structured questionnaire, the prevalence of osmophobia was 26.9%, significantly higher in M than TTH patients (34.6% vs 14.3%).



Osmophobia was correlated with: (i) family history of M and osmophobia; and (ii) other accompanying symptoms of M. By applying these 'new' criteria, we found an agreement with the current criteria for the diagnosis of migraine without aura (MO) in 96.2% of cases; 54.3% of previously unclassifiable patients received a 'new' diagnosis.



In conclusion, this study demonstrates that this new approach, proposed in the Appendix (A1.1), appears easy to apply and should improve the diagnostic standard of ICHD-II in young patients too.
Pharmacokinetics of amantadine in children with impaired consciousness due to acquired brain injury: preliminary findings using a sparse-sampling technique.

To evaluate the pharmacokinetics of amantadine in children with impaired consciousness from acquired brain injury.



Randomized, double-blind, placebo-controlled, crossover study with sparse sampling for pharmacokinetics.



Tertiary care pediatric hospital.



Children, ages 6-18 years, with impaired consciousness 5-10 weeks after acquired brain injury.



Subjects received amantadine for 3 weeks. Subjects were randomized to placebo or amantadine 4 mg/kg/day for 7 days followed by 6 mg/kg/day for 14 days. Crossover was after a 7-day washout period.



The Coma/Near-Coma Scale and Coma Recovery Scale-Revised were done 3 times per week to evaluate arousal and consciousness. Plasma concentrations of amantadine were determined for pharmacokinetic parameter estimation and evaluation of the exposure-response relationship. Adverse events were monitored.



Nine subjects met the final inclusion and exclusion criteria, 7 of whom agreed to participate. Five subjects completed both arms of the study. Amantadine total body clearance was 0.17 L/h/kg with a half-life of 13.9 hours. Higher exposure of amantadine (average concentration of amantadine during 6 mg/kg/day > 1.5 mg/L) may be associated with better recovery of consciousness.



Amantadine was well-tolerated in children with acquired brain injury and demonstrates pharmacokinetics similar to those reported for healthy young adults. Based on the preliminary data, higher dosing may be considered in the setting of brain injury.
Elevated asthma and indoor environmental exposures among Puerto Rican children of East Harlem.

East Harlem in New York City, a community with a large Puerto Rican population, has among the highest rates of asthma hospitalizations and mortality in the United States, but it is not known if the high rates are related to the ethnic composition, environmental or community factors, or if the higher rates reflect differentials in access to appropriate asthma care. A survey was conducted to: (a) estimate the prevalence of current asthma by ethnicity among school-age children, (b) assess indoor environmental risk factors for childhood asthma, and (c) assess health care utilization and school absences associated with childhood asthma.



A cross-sectional survey of parents of elementary school children, using a self-administered questionnaire with a 12-month recall on asthma symptoms based on the International Study of Asthma and Allergies in Childhood.



Two public elementary schools in East Harlem (n = 1615 students 5-12 years of age).



Among the 1319 respondents (response rate 82%), the prevalence for current asthma (doctor or nurse diagnosis at any time plus wheezing in the past 12 months) was 23%. Puerto Rican children had a prevalence of 35%. Puerto Rican children reported both higher symptomatic frequencies and higher rates of physician diagnosis. Living in a home where cockroaches, rats, or mice had been seen in the past month and with a dust-enhancing heating system also was associated with having asthma, regardless of ethnicity. Compared with other children with asthma, Puerto Rican children with asthma were more likely to live in homes where rats or mice had been seen in the past month. Regardless of ethnicity, children with more frequent, more severe asthma symptoms and incomplete asthma action plans were more likely to have visited the emergency department in the past year. Puerto Rican children were more likely to have missed school because of their asthma in the past year.



The prevalence of current asthma was significantly higher among Puerto Ricans, who had higher symptomatic frequency and greater diagnosis rates. Although all children with asthma in the East Harlem study appear to be sensitive to selected indoor environmental risk factors, only Puerto Rican children with asthma appear to be sensitive to the presence of rodents in their buildings. However, their higher school absence rate suggests problems with routine asthma management that could be addressed by improved medical management, programs to help parents manage their children's asthma, or school staff assistance with medications.
Comparison of hypothermia and normothermia after severe traumatic brain injury in children (Cool Kids): a phase 3, randomised controlled trial

On the basis of mixed results from previous trials, we assessed whether therapeutic hypothermia for 48-72 h with slow rewarming improved mortality in children after brain injury.



In this phase 3, multicenter, multinational, randomised controlled trial, we included patients with severe traumatic brain injury who were younger than 18 years and could be enrolled within 6 h of injury. We used a computer-generated randomisation sequence to randomly allocate patients (1:1; stratified by site and age [<6 years, 6-15 years, 16-17 years]) to either hypothermia (rapidly cooled to 32-33°C for 48-72 h, then rewarmed by 0·5-1·0°C every 12-24 h) or normothermia (maintained at 36·5-37·5°C). The primary outcome was mortality at 3 months, assessed by intention-to-treat analysis; secondary outcomes were global function at 3 months after injury using the Glasgow outcome scale (GOS) and the GOS-extended pediatrics, and the occurrence of serious adverse events. Investigators assessing outcomes were masked to treatment. 
The study was terminated early for futility after an interim data analysis on data for 77 patients (enrolled between Nov 1, 2007, and Feb 28, 2011): 39 in the hypothermia group and 38 in the normothermia group. We detected no between-group difference in mortality 3 months after injury (6 [15%] of 39 patients in the hypothermia group vs two [5%] of 38 patients in the normothermia group; p=0·15). Poor outcomes did not differ between groups (in the hypothermia group, 16 [42%] patients had a poor outcome by GOS and 18 [47%] had a poor outcome by GOS-extended paediatrics; in the normothermia group, 16 [42%] patients had a poor outcome by GOS and 19 [51%] of 37 patients had a poor outcome by GOS-extended paediatrics). We recorded no between-group differences in the occurrence of adverse events or serious adverse events.



Hypothermia for 48 h with slow rewarming does not reduce mortality of improve global functional outcome after paediatric severe traumatic brain injury.



National Institute of Neurological Disorders and Stroke and National Institutes of Health.
Validity and Reliability of the Bahasa Melayu Version of the Migraine Disability Assessment Questionnaire

The study was designed to determine the validity and reliability of the Bahasa Melayu version (MIDAS-M) of the Migraine Disability Assessment (MIDAS) questionnaire.



Patients having migraine for more than six months attending the Neurology Clinic, Hospital Universiti Sains Malaysia, Kubang Kerian, Kelantan, Malaysia, were recruited. Standard forward and back translation procedures were used to translate and adapt the MIDAS questionnaire to produce the Bahasa Melayu version. The translated Malay version was tested for face and content validity. Validity and reliability testing were further conducted with 100 migraine patients (1st administration) followed by a retesting session 21 days later (2nd administration).



A total of 100 patients between 15 and 60 years of age were recruited. The majority of the patients were single (66%) and students (46%). Cronbach's alpha values were 0.84 (1st administration) and 0.80 (2nd administration). The test-retest reliability for the total MIDAS score was 0.73, indicating that the MIDAS-M questionnaire is stable; for the five disability questions, the test-retest values ranged from 0.77 to 0.87.



The MIDAS-M questionnaire is comparable with the original English version in terms of validity and reliability and may be used for the assessment of migraine in clinical settings.
[QT interval dispersion analysis in acute myocardial infarction patients: coronary reperfusion effect].

To study the effect of early reperfusion of infarct-related artery on QT(DeltaQT) dispersion interval, as well as how valuable it is as a marker for coronary reperfusion and ventricular arrhythmias.



One hundred and six patients with reperfusion (WR) and 48 without reperfusion (WtR) who have received thrombolytic therapy in the acute phase of infarction were studied. ECG carried out on admission as well as on day 4 of patients course were analyzed. DeltaQT - defined as the difference between maximum and minimum QT interval - was measured by 12-lead ECG.



The reperfusion group showed significant DeltaQT reduction - from 89.66+/-20.47ms down to 70.95+/-21.65ms (p<0.001). On the other hand, the group without reperfusion showed DeltaQT significant increase - from 81.27+/-20.52ms up to 91.85+/-24.66ms (p<0.001). Logistic regression analysis showed that reduction magnitude between pre- and post-thrombolysis DeltaQT was the independent factor to most effectively identify coronary reperfusion (OR 1.045, p<0.0001; CI 95%). No significant difference was found in dispersion measures when patients with ventricular arrhythmias were compared with those with no arrhythmias in the course of the first 48 hours.



The study shows that DeltaQT is significantly reduced in patients with acute myocardial infarction submitted to successful thrombolysis, and is increased in infarcted patients with closed artery. DeltaQT reduction between the pre- and post-thrombolysis condition was a predictor for coronary reperfusion of those patients, and did not show correlation to ventricular arrhythmias.
Genetic influences on prefrontal activation during a verbal fluency task in adults: A twin study based on multichannel near-infrared spectroscopy

Near-infrared spectroscopy (NIRS) studies have reported that prefrontal hemodynamic dysfunction during executive function tasks may be a promising biomarker of psychiatric disorders, because its portability and noninvasiveness allow easy measurements in clinical settings. Here, we investigated the degree to which prefrontal NIRS signals are genetically determined. Using a 52-channel NIRS system, we monitored the oxy-hemoglobin (oxy-Hb) signal changes in 38 adult pairs of right-handed monozygotic (MZ) twins and 13 pairs of same-sex right-handed dizygotic (DZ) twins during a letter version of the verbal fluency task. Heritability was estimated based on a classical twin paradigm using structured equation modeling. Significant genetic influences were estimated in the right dorsolateral prefrontal cortex and left frontal pole. The degrees of heritability were 66% and 75% in the variances, respectively. This implies that the prefrontal hemodynamic dysfunction observed during an executive function task measured by NIRS may be an efficient endophenotype for large-scale imaging genetic studies in psychiatric disorders.
Anticoagulation in childhood-onset arterial ischemic stroke with non-moyamoya arteriopathy: findings from the Colorado and German (COAG) collaboration.

Childhood arterial ischemic stroke treatment guidelines recommend extended anticoagulation in cardioembolism and dissection. We sought to investigate the safety of extended anticoagulation in childhood arterial ischemic stroke with nonmoyamoya arteriopathy, for which the risk of recurrent stroke is high.



Thirty-seven patients with childhood-onset arterial ischemic stroke with acute arteriopathy (excluding moyamoya) were diagnosed between 1999 and 2007 and treated with anticoagulation for at least 4 weeks. Patients were followed in hospital-based cohort studies at 2 centers and systematically assessed for bleeding episodes and recurrent events.



Over a cumulative anticoagulation duration of 1329 patient-months, there were no major bleeding episodes and 2 clinically relevant bleeding episodes. Cumulative probability of recurrent arterial ischemic stroke at 1 year was 14%.



Anticoagulation can be used safely for secondary arterial ischemic stroke prevention in children with acute nonmoyamoya arteriopathy. Anticoagulation is worthy of evaluation in future randomized, controlled treatment trials in this disease.
Virological factors associated with outcome of dual maraviroc/raltegravir therapy (ANRS-157 trial).

ROCnRAL ANRS-157 was a single-arm study designed to evaluate a switch to a maraviroc (300 mg twice a day) plus raltegravir (400 mg twice a day) regimen in virologically suppressed HIV-1-infected patients (ClinicalTrials.gov: NCT01420523). The aim of this work was to investigate the factors associated with virological failure (VF) (5/44 patients) or virological rebound defined as one viral load (VL) >50 copies/mL or VL >1 copy/mL.



At baseline (BL), ultradeep sequencing (UDS) of DNA gp120 V3 and integrase regions and quantification of HIV DNA were performed in PBMCs. Tropism, VL, BL ultrasensitive HIV RNA VL, BL HIV DNA VL, subtype, age, ethnicity, transmission group, AIDS status, nadir CD4 and BL CD4 cell count, time since HIV diagnosis, duration of ART and suppressed viraemia, VL zenith, CD4/CD8 ratio and BL CD8 cell count were investigated as potential factors associated with virological rebound.



The proportion of patients with VL <1 copy/mL did not evolve over time. Among the 44 included patients, 3 had minority X4-tropic viruses determined by UDS at BL and one of them presented VF. Minority resistant variants in the integrase gene were detected at BL at two positions (E138 and G140) for three patients who did not have VF. Among all studied factors, none was associated with virological rebound.



Maraviroc plus raltegravir failed to maintain virological suppression in virologically suppressed HIV-1-infected patients. However, neither minority viral variants nor ultrasensitive viraemia was found to be a predictive factor of VF or virological rebound in this context.
Knowledge of human papillomavirus (HPV) infection, cervical cancer, and HPV vaccine and its correlates among medical students in Southwest China: a multi-center cross-sectional survey.

Since cervical cancer can be prevented and controlled through human papillomavirus (HPV) vaccination, it is important to train health care providers and provide them with appropriate knowledge. This study aimed to understand the level of HPV related knowledge among medical students and correlates in Southwest China in order to address any potential gap in their knowledge base.



We conducted a cross-sectional survey among medical students in six selected universities across Southwest China based on a pretested questionnaire regarding HPV infection, cervical cancer, and HPV vaccines.



We successfully surveyed 1, 878 medical students, of whom 32.1% were males and 67.9% were females. Their mean age was 20.8 (standard deviation: 1.3) years. 91.8% of them were ethnic Han Chinese, and 43.8% were students in clinical medicine. While 76.5% had heard of HPV only 48.8% knew that the prevention of cervical cancer was possible through HPV vaccination. Only 42.9% of the male and 49.2% of the female students correctly answered over 10 out of 22 questions on HPV related knowledge. Female students appeared to know more about HPV and HPV vaccination (OR: 1.39; 95% CI: 1.11-1.75). In addition, the student knowledge improved with the grade (p<0.001). University courses were the most selected source of knowledge about HPV vaccination (66.4%). 83.6% of males and 91.4% of females were willing to have more HPV related education by experts (p<0.001). Only 10.1% of the students acknowledged that people had asked for their advice regarding HPV vaccination.



Our survey indicates that medical students from Southwest China have poor knowledge of HPV and HPV vaccination, but are willing to receive more relevant information. Targeted education should be incorporated into school courses to inform these future health care providers and ensure success of programs for cervical cancer control and prevention.
Influence of atorvastatin on blood pressure control in treated hypertensive, normolipemic patients - An open, pilot study.

The aim of the study was to determine whether a high dose of atorvastatin lowers blood pressure (BP) in normolipemic patients with well controlled primary arterial hypertension and if this effect is associated with alteration of biomarkers of endothelial function and oxidative stress. In this open-label study, normolipemic patients (n=56) were randomized in the proportion of 2:1 to receive atorvastatin 80 mg daily for 3 months (statin-treated, ST n=39), or to previous therapy (statin-free, SF). BP was measured using a 24-h ambulatory BP measurement device. Plasma levels of 6-keto-PGF(1alpha) (prostacyclin metabolite), serum nitric oxide (NO) and levels of autoantibodies immunoglobulin G against oxidatively modified low-density lipoprotein (ox-LDL) were measured.



The mean change in systolic BP and diastolic BP for ST was - 5.7 mmHg (95% CI -4.1 to -7.2 mmHg) and -3.9 mmHg (95% CI -2.7 to -5.0 mmHg), respectively. Hypotensive statin effect was independent of lipid lowering. No change of BP in SF patients was observed. In ST, prostacyclin metabolites and NO concentrations were not significantly increased and autoantibodies against ox-LDL concentrations did not change. In ST, the decrease in BP correlated with increase in NO and decrease in autoantibodies against ox-LDL.



High-dose atorvastatin resulted in reduction of BP independently of lipid-lowering effect, changes in endothelial function and oxidative stress, but it was related to the increase in NO and decrease in autoantibodies against ox-LDL. However, because of the open design of the study, these results should be carefully debated.