nils-herrmann/clean_scirepeval huggingface dataset:
A Randomized Trial of Cinacalcet versus Vitamin D Analogs as Monotherapy in Secondary Hyperparathyroidism (PARADIGM).

Direct comparison of cinacalcet and vitamin D analogs as monotherapies to lower parathyroid hormone (PTH) levels has not been undertaken.



This was a prospective, multicenter, phase 4, randomized, open-label study that enrolled participants from 2010 to 2012. Adult participants (n=312) on hemodialysis with PTH >450 pg/ml were randomized 1:1 to 12 months of treatment with either cinacalcet (n=155) or vitamin D analogs (n=157) to evaluate the mean percentage change in plasma PTH level (primary end point) and the proportion of participants achieving plasma PTH <300 pg/ml or a ≥30% decrease in PTH (secondary end points). A preplanned analysis to determine whether there were important region-by-treatment interactions was also undertaken.



Baseline mean PTH was 846 pg/ml (n=155) for cinacalcet and 816 pg/ml (n=157) for vitamin D analog therapy. The mean (95% confidence interval) percentage change from baseline in PTH was -12.1% (-20.0% to -4.1%) in the cinacalcet arm and -7.0% (-14.9% to 0.8%) in the vitamin D analog arm, a difference of -5.0% (-15.4% to 5.4%) (P=0.35). Similarly, there was no difference in achievement of secondary efficacy end points between arms (19.4% and 15.3% of participants with PTH≤300 pg/ml and 42.6% and 33.8% of participants had a PTH reduction >30% in the cinacalcet and vitamin D analog arms, respectively). A prespecified analysis revealed a large treatment-by-region interaction, with nominally greater response to cinacalcet compared with vitamin D analogs in non-United States participants (US versus non-US participants, P<0.001). Hypocalcemia was more common in the cinacalcet arm, whereas hypercalcemia and hyperphosphatemia occurred more often in the vitamin D analog arm.



Participants had similar modest reductions in PTH with either cinacalcet or vitamin D analog monotherapy over 52 weeks of treatment, but effects varied by region. Treatments differed with regard to effect on calcium and phosphorus levels.
Dietary phosphorus is associated with a significant increase in left ventricular mass

Dietary phosphorus consumption has risen steadily in the United States. Oral phosphorus loading alters key regulatory hormones and impairs vascular endothelial function, which may lead to an increase in left ventricular mass (LVM). We investigated the association of dietary phosphorus with LVM in 4494 participants from the Multi-Ethnic Study of Atherosclerosis, a community-based study of individuals who were free of known cardiovascular disease. The intake of dietary phosphorus was estimated using a 120-item food frequency questionnaire and the LVM was measured using magnetic resonance imaging. Regression models were used to determine associations of estimated dietary phosphorus with LVM and left ventricular hypertrophy (LVH). Mean estimated dietary phosphorus intake was 1167 mg/day in men and 1017 mg/day in women. After adjustment for demographics, dietary sodium, total calories, lifestyle factors, comorbidities, and established LVH risk factors, each quintile increase in the estimated dietary phosphate intake was associated with an estimated 1.1 g greater LVM. The highest gender-specific dietary phosphorus quintile was associated with an estimated 6.1 g greater LVM compared with the lowest quintile. Higher dietary phosphorus intake was associated with greater odds of LVH among women, but not men. These associations require confirmation in other studies.
Heart rate and use of β-blockers in Mexican stable outpatients with coronary artery disease.

To evaluate the use of β-blockers and to monitor heart rate in Mexican patients with coronary artery disease.



CLARIFY is an outpatients registry with stable CAD. A total of 33,283 patients from 45 countries were enrolled between November 2009 and July 2010 from which 1342 were Mexican patients.



The mean HR pulse was 70 bpm (beats per minute). Patients in Mexico were compared with the remaining global CLARIFY population. Patients in Mexico had a higher incidence of acute myocardial infarction and percutaneous coronary intervention, and lower incidence of revascularization surgery compared with the remaining CLARIFY population. More often, Mexican patients presented with diabetes, but less often hypertension and stroke. These patients were split into three mutually exclusive groups of HR ≤ 60 (N=263), HR 61-69 (N=356) and HR ≥ 70 (N=722). Patients with elevated HR had a higher incidence of diabetes and higher diastolic blood pressure on average than those with controlled HR. Regarding the use of β-blockers, they were used in 63.3% of patients, 2.7% showed intolerance or contraindication to treatment to monitor heart rate, and ivabradine was used in 2.3%. Out of approximately 849 patients receiving treatment of β-blockers, 52.1% had ≥ 70 bpm HR.



In a large proportion of Mexican patients with stable coronary disease the HR remain elevated, > 70 bpm, even with the use of β-blockers; this requires further attention.
Interpretation of heart rate variability via detrended fluctuation analysis and alphabeta filter.

Detrended fluctuation analysis (DFA), suitable for the analysis of nonstationary time series, has confirmed the existence of persistent long-range correlations in healthy heart rate variability data. In this paper, we present the incorporation of the alphabeta filter to DFA to determine patterns in the power-law behavior that can be found in these correlations. Well-known simulated scenarios and real data involving normal and pathological circumstances were used to evaluate this process. The results presented here suggest the existence of evolving patterns, not always following a uniform power-law behavior, that cannot be described by scaling exponents estimated using a linear procedure over two predefined ranges. Instead, the power law is observed to have a continuous variation with segment length. We also show that the study of these patterns, avoiding initial assumptions about the nature of the data, may confer advantages to DFA by revealing more clearly abnormal physiological conditions detected in congestive heart failure patients related to the existence of dominant characteristic scales.
[Effects of Self-management Program applying Dongsasub Training on Self-efficacy, Self-esteem, Self-management Behavior and Blood Pressure in Older Adults with Hypertension].

The purpose of this study was to develop a self-management program applying Dongsasub training based on self-efficacy theory, and to verify the program effectiveness on self-esteem as well as self-efficacy, self-management behaviors, and blood pressure.



The study design was a non-equivalent, pre-post controlled quasi-experiment study. Thirty-eight patients aged 65 and older from a senior welfare center in Seoul participated in this study (20 patients in the experimental group and 18 patients in the control group). The self-management program applying Dongsasub training consisted of eight sessions. After development was complete the program was used with the experimental group. Outcome variables included self-efficacy, self-esteem, self-management behaviors measured by questionnaires, and blood pressure measured by electronic manometer.



Self-efficacy (t=2.42, p=.021), self-esteem (t=2.57, p=.014) and self-management behaviors (t=2.21, p=.034) were significantly higher and systolic blood pressure (t=-2.14, p=.040) was significantly lower in the experimental group compared to the control group. However, diastolic blood pressure (t=-.85, p=.400) was not significantly different between the two groups.



The results indicate that the self-management program applying Dongsasub training can be used as a nursing intervention in community settings for improving self-management behaviors for older adults with hypertension.
Early course of nicotine dependence in adolescent smokers.

The goal was to characterize the early course of nicotine dependence.



Data were collected from 1246 sixth-graders in a 4-year (2002-2006) prospective study using 11 individual interviews. Subjects were monitored for 10 symptoms of dependence by using the Hooked on Nicotine Checklist. The bidirectional prospective relationship between the intensity of dependence (number of symptoms) and smoking frequency was examined by using cross-lagged analyses.



Of the 370 subjects who had inhaled from a cigarette, 62% smoked at least once per month, 53% experienced dependence symptoms, and 40% experienced escalation to daily smoking. Smoking frequency predicted the number of dependence symptoms at the next interview, and the number of symptoms predicted reciprocally the observed escalation in smoking frequency. Monthly smoking was a strong risk factor for the development of symptoms (adjusted hazard ratio: 9.9 [95% confidence interval: 6.6-14.8]). A strong desire to smoke was the most common presenting symptom, typically followed by the appearance of symptoms of nicotine withdrawal, escalation to daily smoking, and then reports of feeling addicted or difficulty controlling smoking. The appearance of any dependence symptom increased the risk for daily smoking (hazard ratio: 6.81 [95% confidence interval: 4.4-10.5]).



Nondaily tobacco use triggers the emergence of nicotine dependence. Early dependence symptoms promote escalation in smoking frequency and, reciprocally, more-frequent smoking accelerates the appearance of additional symptoms of dependence. As this positive feedback progresses, the symptoms of nicotine dependence present in a typical sequence, with some individual variation.
Distal pancreatectomy with celiac axis resection: what are the added risks?

Reported series of a distal pancreatectomy with celiac axis resection (DP-CAR) are either small or not adequately controlled. The aim of this analysis was to report a multicentre series of modified Appleby procedures with a comparison group to determine the relative operative risk.



Data were gathered through the American College of Surgeons-National Surgical Quality Improvement Program (ACS-NSQIP) Pancreatectomy Demonstration Project. Over 14 months, 822 patients underwent a distal pancreatectomy at 43 institutions. Twenty of these patients (2.4%) also underwent a celiac axis resection. DP-CAR patients were matched by age, gender, BMI, serum albumin, ASA class, gland texture, duct size and pathology to 172 patients undergoing DP alone.



The majority of DP and DP-CAR patients had adenocarcinomas (61% and 60%). The median operative time for a DP alone was shorter than for a DP-CAR (207 versus 276 min, P < 0.01). Post-operative acute kidney injury (1% versus 10%, P < 0.03) and 30-day mortality were higher after a DP-CAR (1% versus 10%, P < 0.03).



A distal pancreatectomy with celiac axis resection is associated with increased operative time, post-operative acute kidney injury and a 10% operative mortality. The decision to offer a modified Appleby procedure for a body of pancreas tumour should be made with full disclosure of the increased risks.
Tight glycemic control does not affect asymmetric-dimethylarginine in septic patients

We investigated whether preventing hyperglycemia in septic patients affected the plasma concentration of asymmetric-dimethylarginine and if this was associated with clinical benefit. A prospective, multicenter, randomized, controlled, clinical study. Intensive care units (ICU) in three university hospitals. A total of 72 patients admitted for severe sepsis or septic shock, who stayed at least 3 days in the ICU. At admission the patients were assigned to receive either tight or conventional glycemic control. Determination of circulating levels of asymmetric-dimethylarginine, arginine, interleukin-6, C-reactive-protein and tumor-necrosis-factor-α. Blood was sampled at admission (no differences between groups), and on the 3rd, 6th, 9th, and 12th (T12) days. Sequential organ failure assessment was scored at each sampling time. All the data were analyzed on an intention-to-treat basis. The control and treatment groups received the same energy intake, glycemia (110.4 ± 17.3 vs. 163.0 ± 28.9 mg/dL, P < 0.001) and insulin (P = 0.02) supply differed. No differences were found in high plasma levels of asymmetric-dimethylarginine (P = 0.812) at any time during the ICU stay. The clinical course, as indicated by markers of inflammation, average and maximum organ failure score, ICU stay and ICU and 90-day mortality, was the same. Intensive insulin treatment, while achieving glucose control, did not reduce asymmetric-dimethylarginine in high-risk septic patients fed with no more than 25 kcal/kg per day to limit ventilatory demand and to simplify glucose control. 45 (SIRS/sepsis: clinical studies).
Effect of the humidification device on the work of breathing during noninvasive ventilation

Heat and moisture exchangers (HME) increase circuitry deadspace compared to heated humidifiers (HH). This study compared the effect of HH and HME during noninvasive ventilation (NIV) on arterial blood gases and patient's effort assessed by respiratory muscles pressure-time product and by work of breathing (WOB).  Randomized cross-over study in a medical intensive care unit.  Nine patients receiving NIV for moderate to severe acute hypercapnic respiratory failure. Measurements. HME was randomly compared to HH during periods of 20 min. Each device was studied without (ZEEP) and with a PEEP of 5 cmH2O. At the end of each period arterial blood gases, ventilatory parameters, oesophageal and gastric pressures were recorded and indexes of patient's effort calculated.  Minute ventilation was significantly higher with HME than with HH (ZEEP: 15.8±3.7 vs. 12.8±3.6 l/min) despite a similar PaCO2 (60±16 vs. 57±16 mmHg). HME was associated with a greater increase in WOB (ZEEP: 15.5±7.7 vs. 8.4±4.5 J/min and PEEP: 11.3±5.7 vs. 7.3±3.8 J/min) and indexes of patient effort. NIV with HME failed to decrease WOB compared to baseline. Addition of PEEP reduced the level of effort, but similar differences between HME and HH were observed.  In patients receiving NIV for moderate to severe acute hypercapnic respiratory failure, the use of HME lessens the efficacy of NIV in reducing effort compared to HH.
Do psychological factors and general health influence the short-term efficacy of resilient appliance therapy in patients with temporomandibular disorder pain?

To study how sense of coherence (SOC), grade of depression and non-specific physical symptoms and general health influence the efficacy of intraoral appliance therapy in patients with temporomandibular disorder (TMD) pain. A second objective was to study the association between SOC, grade of depression, grade of non-specific physical symptoms and general health.



A total of 73 TMD pain patients participated; 36 were treated with a resilient appliance and 37 with a non-occluding control appliance in a randomized controlled trial for a period of 10 weeks. All patients had at least one pain diagnosis according to the research diagnostic criteria for TMD, including both the Symptom Checklist-90-Revised (Axis II) measuring grade of depression and non-specific physical symptoms, and general health (physical characteristics). Patients also filled in the 29-item SOC questionnaire.



A low grade of SOC was found in eight of the patients in the treatment group and in 17 of the control group at baseline, with a statistically significant difference between the groups. Logistic regression analyses revealed that, after correcting for the background variables, the resilient appliance did not differ from the non-occluding control appliance in terms of treatment outcome. No statistically significant differences were found when correlating mean SOC with grade of depression, grade of non-specific physical symptoms and general health.



These findings indicate that none of the studied background variables (age, gender, SOC, depression, non-specific physical symptoms or general health) seemed to influence the short-term efficacy of intraoral appliances. No association was found between SOC and depression, non-specific physical symptoms or general health in TMD pain patients.
BCR-ABL messenger RNA levels continue to decline in patients with chronic phase chronic myeloid leukemia treated with imatinib for more than 5 years and approximately half of all first-line treated patients have stable undetectable BCR-ABL using strict sensitivity criteria.

In the first years of imatinib treatment, BCR-ABL remained detectable in all but a small minority of patients with chronic myeloid leukemia. We determined whether BCR-ABL continues to decline with longer imatinib exposure and the incidence and consequence of undetectable BCR-ABL.



BCR-ABL levels were measured in a subset of 53 imatinib-treated IRIS trial patients for up to 7 years (29 first-line, 24 second-line). Levels were deemed undetectable using strict PCR sensitivity criteria.



By 18 months, the majority achieved a 3-log reduction [major molecular response (MMR)]. BCR-ABL continued to decline but at a slower rate (median time to 4-log reduction and undetectable BCR-ABL of 45 and 66 months for first-line). The probability of undetectable BCR-ABL increased considerably from 36 to 81 months of first-line imatinib {7% [95% confidence interval (95% CI), 0-17%] versus 52% (95% CI, 32-72%)}. Undetectable BCR-ABL was achieved in 18 of 53 patients and none of these 18 lost MMR after a median follow-up of 33 months. Conversely, MMR was lost in 6 of 22 (27%) patients with sustained detectable BCR-ABL and was associated with BCR-ABL mutations in 3 of 6. Loss of MMR was recently defined as suboptimal imatinib response. There was no difference in the probability of achieving molecular responses between first- and second-line patients but first-line had a significantly higher probability of maintaining MMR [P = 0.03; 96% (95% CI, 88-100%) versus 71% (95% CI, 48-93%)].



With prolonged therapy, BCR-ABL continued to decline in most patients and undetectable BCR-ABL was no longer a rare event. Loss of MMR was only observed in patients with sustained detectable BCR-ABL.
Effect of Radial Shock Wave Therapy on Spasticity of the Upper Limb in Patients With Chronic Stroke

Recently, studies have reported that extracorporeal shock wave therapy (ESWT) is a safe, noninvasive, alternative treatment for spasticity. However, the effect of ESWT on spasticity cannot be determined, because most studies to date have enrolled small patient numbers and have lacked placebo-controlled groups and/or long-term follow-up. In addition, whether varying the number of ESWT sessions would affect the duration of the therapeutic effect has not been investigated in a single study. Hence, we performed a prospective, randomized, single blind, placebo-controlled study to investigate the long-term effect of radial ESWT (rESWT) in patients with poststroke spasticity and surveyed the outcome of functional activity.Sixty patients were randomized into 3 groups. Group A patients received 1 session of rESWT per week for 3 consecutive weeks; group B patients received a single session of rESWT; group C patients received one session of sham rESWT per week for 3 consecutive weeks. The primary outcome was Modified Ashworth Scale of hand and wrist, whereas the secondary outcomes were Fugl-Meyer Assessment of hand function and wrist control. Evaluations were performed before the first rESWT treatment and immediately 1, 4, 8, 12, and 16 weeks after the last session of rESWT.Compared to the control group, the significant reduction in spasticity of hand and wrist lasted at least 16 and 8 weeks in group A and B, respectively. Three sessions of rESWT had a longer-lasting effect than one session. Furthermore, the reduction in spasticity after 3 sessions of rESWT may be beneficial for hand function and wrist control and the effect was maintained for 16 and 12 weeks, respectively.rESWT may be valuable in decreasing spasticity of the hand and wrist with accompanying enhancement of wrist control and hand function in chronic stroke patients.
Brachial artery elastic mechanics in patients with heart failure.

Studies of arterial elasticity in patients with heart failure (HF) have produced varying results. In addition, the direct effects of smooth muscle relaxation on arterial wall mechanics in these patients have not been well characterized. Nineteen patients with New York Heart Association class II to IV HF and 17 age- and size-matched normal subjects were studied by using a recently validated technique for measuring brachial arterial wall mechanics over a wide pressure range. The left brachial artery was imaged through a water-filled blood pressure cuff by use of an ultrasound wall-tracking system at baseline and after 0.4 mg sublingual nitroglycerin (NTG). Simultaneous radial artery pressure waveforms were recorded by tonometry. Transmural pressure (TP) was reduced by increasing water pressure in the cuff. Baseline area, compliance, and pulse wave velocity versus TP curves were similar in the normal subjects and the patients with HF. The incremental elastic modulus versus TP curve tended to be lower in the patients with HF. The wall-to-lumen ratio was increased in HF (P=0.05). NTG significantly shifted the area versus TP (P<0.001) and compliance versus TP (P<0.05) curves upward and the pulse wave velocity versus TP (P<0.05) curve downward in both groups. NTG also significantly (P<0.001) shifted the stress versus strain curve to the right in both groups but did not alter the incremental elastic modulus versus TP curve. We conclude that the brachial arterial wall-to-lumen ratio is increased in HF. This finding occurs together with a trend toward reduced arterial stiffness such that overall mechanical behavior of the brachial artery is preserved. Smooth muscle relaxation with NTG produces similar improvements in brachial arterial wall mechanics in normal subjects and in patients with HF.
Effect of Therapeutic Hyperoxia on Maximal Oxygen Consumption and Perioperative Risk Stratification in Chronic Obstructive Pulmonary Disease

Maximal consumption of oxygen $$ (\dot{V} $$ O2max) during exercise is used in patients with chronic obstructive pulmonary disease (COPD) to stratify perioperative risk. However, the impact of therapeutic hyperoxia (i.e., use of supplemental oxygen to prevent hypoxemia during exercise) on $$ \dot{V} $$ O2max and other ventilatory parameters during maximal exercise in the resting normoxic COPD population is poorly defined. A randomized, double-blind crossover study was performed in which resting normoxic subjects (n = 16) with COPD underwent two standard symptom-limited, ramped-protocol bicycle ergometry cardiopulmonary exercise tests >5 days apart with FiO2 of 0.21 (control) and ~0.28 (therapeutic hyperoxia). $$ \dot{V} $$ O2max and other ventilatory parameters were compared using a paired two-sample t-test. Therapeutic hyperoxia significantly increased $$ \dot{V} $$ O2max (12.2 ± 2.9 vs. 13.6 ± 3.8 ml/kg/min, P = 0.03), partial pressure of end-tidal carbon dioxide, and oxygen saturation and significantly decreased $$ \dot{V} $$ E– $$ \dot{V} $$ CO2 slope, but it did not affect exercise time, maximum watts achieved, maximum minute ventilation, or change in end-expiratory lung volume. Three of four subjects with $$ \dot{V} $$ O2max <10 ml/kg/min without supplemental oxygen increased $$ \dot{V} $$ O2max to ≥10 ml/kg/min on therapeutic hyperoxia and potentially changed perioperative risk category. Therapeutic hyperoxia in a resting normoxic COPD population significantly improves $$ \dot{V} $$ O2max and may change perioperative risk stratification by conventional criteria. Further studies are needed to determine if this change in stratification is appropriate.