nils-herrmann/clean_scirepeval huggingface dataset:
Comparison of Calcitriol Treatment with Etidronate–Calcitriol and Calcitonin–Calcitriol Combinations in Turkish Women with Postmenopausal Osteoporosis: A Prospective Study

Calcitriol has been widely used in the management of osteoporosis, but its efficiency is a matter of controversy. It is not known whether combinations of calcitriol and antiresorptive agents such as etidronate and calcitonin are superior to calcitriol alone in the treatment of postmenopausal osteoporosis. To make this determination, 30 Turkish women with postmenopausal osteoporosis between 45 and 68 years of age were randomized to receive either intermittent cyclical etidronate (400 mg/day, for 14 days) followed by 60 days of cyclical calcitriol therapy 0.25 μg twice daily (group 1; n= 10), or calcitriol 0.25 μg twice daily (group 2; n= 10), or calcitriol 0.25 μg/day in combination with 100 IU intranasal salmon calcitonin taken every other day (group 3; n= 10) through a 1-year period. Bone mineral density (BMD) of lumbar spine (L2 to L4) was determined for each patient by dual-photon absorptiometry (153Gd) at baseline, after 6 months, and at the end of the study. There was no significant difference among groups with respect to mean spinal BMD at baseline, after 6, and after 12 months. No significant spinal BMD changes occurred in any group from baseline, after 6 months, and after 12 months. Four patients in groups 1 and 2 and five patients in group 3 developed hypercalcemia at least once during therapy. Hypercalciuria occurred at least once in 9, 10, and 7 patients in groups 1, 2, and 3, respectively. One patient in group 2 developed a renal stone at the end of the study. Mean urine hydroxyproline levels did not change significantly in any group with respect to baseline. The data suggest that one-year treatment with calcitriol, given either alone or in combination with antiresorptive agents, does not improve spinal BMD in Turkish women with postmenopausal osteoporosis, and is associated with a high rate of adverse events.
Differences of two cryoballoon generations: insights from the prospective multicentre, multinational FREEZE Cohort Substudy.

Cryoballoon (CB) ablation with the second-generation cryoballoon (CBG2) seems to be more effective than its predecessor [first-generation cryoballoon (CBG1)], but phrenic nerve palsies were observed more frequently. The aim of this study was to compare the safety and efficacy of CBG1 and CBG2 in a substudy of the prospective multicentre, multinational FREEZE Cohort Study.



Periprocedural data were analysed, and a total of 532 patients with paroxysmal atrial fibrillation (AF) were examined (n = 224 for CBG1 and n = 308 for CBG2). Procedure time decreased significantly from 149 to 130 min when comparing CBG1 with CBG2 (P < 0.0001), and pulmonary vein isolation (PVI) was achieved in 97.8 and 97.6% of PVs with CBG1 and CBG2 (P = 0.77), respectively. The need for dual-balloon usage within a procedure dropped (20.1 vs. 9.0%, P < 0.001), and the fluoroscopy time was reduced when operating the CBG2. Atrial fibrillation recurrence rates until discharge were similar (5.0 vs. 5.8%, P = 0.69). Comparable low rates of major complications were observed with both CBs, and there was a non-significant trend for more phrenic nerve palsies.



Second-generation cryoballoon demonstrated a high rate of acute PVI in a significant faster procedure, which also utilized less radiation exposure and less dual-balloon usage during an average procedure. The safety profile remains favourable with a non-significant trend for more phrenic nerve palsies. If the enhancements lead to a higher clinical benefit has to be determined. The 1-year outcome data from the ongoing FREEZE Cohort Study comparing radiofrequency and CB ablation will shed some light on that issue.


 TRIALS GOV IDENTIFIER
NCT01360008.
A brief intervention designed to increase breast cancer self-screening.

To assess the efficacy of an intervention designed to increase appropriate use of breast self-examination (BSE).



Two-armed randomized clinical trial of cancer-control interventions in women that compared a BSE intervention program to a dietary intervention, which served as the control group. The study was conducted at a large health maintenance organization in Portland, Oregon. Participants were 616 female members of the health maintenance organization who were aged 40 to 70 years. The intervention consisted of a 30- to 45-minute individual counseling session that featured BSE instruction, training and practice with silicone models, identification of barriers to BSE, and problem-solving. This intervention was followed by two brief follow-up telephone calls. The study outcome measure was self-reported BSE practice, which included duration, frequency, and specific elements of exam.



The study had a 90% response rate. At the 1-year follow-up, chi2 analyses showed that significantly more individuals in the BSE intervention (59%) reported adequate BSE performance compared with those in the control group (12.2%; p < .001).



This brief intervention was successful in encouraging women to perform adequate BSEs. Although the role of the BSE in patient care remains controversial, these results show that even brief intervention programs can be effective at encouraging self-screening for cancer. This intervention could easily be modified to target other screening practices (e.g., skin or testicular cancer screening) that are associated with reduced cancer morbidity and mortality.
The Neck Pain Driving Index (NPDI) for chronic whiplash-associated disorders: development, reliability, and validity assessment.

Driving is a functional complaint of many individuals with chronic whiplash-associated disorders (WAD). Current driving scales do not include the most troublesome driving tasks for this group, which suggests that a new tool is required to assess perceived driving difficulty in this population.



To develop a Neck Pain Driving Index (NPDI) to assess the degree of perceived driving difficulty for individuals with chronic WAD and evaluate the reliability and validity of the NPDI.



Descriptive/survey.


PATIENT SAMPLE
An external panel of 15 researchers/clinicians and 87 participants with chronic WAD.



The NPDI and a 0 to 10 numeric rating scale (NRS) of perceived driving difficulty (0, no difficulty and 10, maximum difficulty).



Phase 1 included the construction of a preliminary NPDI and content validity assessment of question items by a 15-member external panel. Comprehension was evaluated by seven participants with chronic WAD. In Phase 2, the final version of the NPDI was developed via descriptive analysis and assessment of internal consistency using responses of 87 participants with chronic WAD. Subsequently, the convergent validity was assessed using NRS scores. Test-retest reliability at 1 month was investigated in 25 of the 87 participants. Psychometric properties of the driving tasks in the final NPDI were categorized by the external panel, based on the hierarchal Michon model of driving task performance levels. An additional symptom section was developed to better understand the reasons for driving difficulties.



The final NPDI included 12 driving tasks, which scored at least 80% on the content validity index (CVI), ensuring content validity. The NPDI demonstrated good internal consistency (α=0.80), convergent validity (ρ=0.51; p<.01), and test-retest reliability (intraclass correlation coefficient, 0.73; p<.01). As a result of the assessment of psychometric properties, driving tasks were categorized into the strategic (n=3), tactical (n=7), and operational (n=2) levels in the Michon model. The content validity of 11 symptoms (CVI ≥80%) was established by the external panel.



The NPDI was developed to assess the degree of perceived driving difficulty in the chronic whiplash population. Reliability and validity of the NPDI were ensured. The NPDI can be the entry point for discussions on driving difficulties between clinicians and patients with chronic WAD.
Threshold retinopathy at threshold of viability: the EpiBel study.

To describe incidence, co-morbidity characteristics, and risk factors associated with threshold retinopathy of prematurity (ROP) in survivors with a gestational age (GA) of < or =26 weeks at birth.



Retrospective analysis of perinatal data of all inborn survivors in all perinatal centres of Belgium in the period 1999-2000 (EpiBel cohort) believed to be between 22 and 26 weeks GA at time of delivery. Data on survivors who did and survivors who did not develop threshold ROP were compared (chi(2), Mann-Whitney U) and logistic regression was performed.



Of 303 admitted infants 175 (58%) were discharged alive. Incidence of major retinopathy (> or =stage 3) and of threshold ROP was 25.5% and 19.8% in survivors. Associated central nervous abnormalities were documented in six (17%) and associated chronic lung disease in 19 (54%) threshold ROP infants. Threshold ROP without additional morbidity characteristics at discharge was documented in 14 (40%) infants. Besides often reported risk factors, renal insufficiency (creatinaemia>1.5 mg/dl) was a risk factor to develop threshold ROP (p<0.0015) (chi(2)). Days of respiratory support (OR 1.02; 95% CI 1.002 to 1.039), number of transfusions (OR 1.118; 95% CI 1.030 to 1.214), and renal insufficiency (OR 3.31; 95% CI 1.344 to 8.196) remained independent risk factors to develop threshold ROP in this cohort in a stepwise logistic regression model (MedCalc).



Incidence of threshold ROP is high at the limits of viability. Renal insufficiency is a risk factor to develop threshold ROP in this cohort.
Trifecta aortic pericardial valve : Results from a global , multicenter , prospective clinical study

From th vania Vanc Medi Depa and D Disclos Receive publi Address vania upenn 0022-52 Copyrig http://dx A C D Background: The St Jude Medical Inc (St Paul, Minn) Trifecta valve is a novel aortic biological prosthesis that incorporates several design features, including a true supra-annular sewing cuff, a stent design that maximizes valve hemodynamics while minimizing leaflet stresses, and an ethanol-based anticalcification technology. This study establishes the safety and early clinical and hemodynamic performance of the Trifecta valve.
Inclusion of Oat in Feeding Can Increase the Potential Probiotic Bifidobacteria in Sow Milk

The objectives of this study were to (i) investigate the impact of feeding oat on the population of bifidobacteria and (ii) evaluate their probiotic potential. In this study, we investigated the effects of supplementing sows' gestation and lactation feed with 15% oat (prebiotic source) on the levels of probiotic population in milk. We found that dietary inclusion of oat during lactation and gestation resulted in increased levels of bifidobacteria compared to lactobacilli in sow milk. Furthermore bifidobacteria within the sow milk samples were further evaluated for probiotic potential based on aggregating properties, and acid- and bile-tolerance after exposure to hydrochloric acid (pH 2.5) and bile salts (0%, 0.25%, 0.50%, 1.0% and 2.0%). All isolates survived under the condition of low pH and bile 2.0%. Autoaggregation ability ranged from 17.5% to 73%. These isolates also showed antimicrobial activity against E. coli O157:H7.Together our results suggest that inclusion of oat in feeding systems could have the potential to improve the intestinal health of piglets by increasing the population of bifidobacteria.
Pedometer-Based Internet-Mediated Intervention For Adults With Chronic Low Back Pain: Randomized Controlled Trial

Chronic pain, especially back pain, is a prevalent condition that is associated with disability, poor health status, anxiety and depression, decreased quality of life, and increased health services use and costs. Current evidence suggests that exercise is an effective strategy for managing chronic pain. However, there are few clinical programs that use generally available tools and a relatively low-cost approach to help patients with chronic back pain initiate and maintain an exercise program.



The objective of the study was to determine whether a pedometer-based, Internet-mediated intervention can reduce chronic back pain-related disability.



A parallel group randomized controlled trial was conducted with 1:1 allocation to the intervention or usual care group. 229 veterans with nonspecific chronic back pain were recruited from one Department of Veterans Affairs (VA) health care system. Participants randomized to the intervention received an uploading pedometer and had access to a website that provided automated walking goals, feedback, motivational messages, and social support through an e-community (n=111). Usual care participants (n=118) also received the uploading pedometer but did not receive the automated feedback or have access to the website. The primary outcome was measured using the Roland Morris Disability Questionnaire (RDQ) at 6 months (secondary) and 12 months (primary) with a difference in mean scores of at least 2 considered clinically meaningful. Both a complete case and all case analysis, using linear mixed effects models, were conducted to assess differences between study groups at both time points.



Baseline mean RDQ scores were greater than 9 in both groups. Primary outcome data were provided by approximately 90% of intervention and usual care participants at both 6 and 12 months. At 6 months, average RDQ scores were 7.2 for intervention participants compared to 9.2 for usual care, an adjusted difference of 1.6 (95% CI 0.3-2.8, P=.02) for the complete case analysis and 1.2 (95% CI -0.09 to 2.5, P=.07) for the all case analysis. A post hoc analysis of patients with baseline RDQ scores ≥4 revealed even larger adjusted differences between groups at 6 months but at 12 months the differences were no longer statistically significant.



Intervention participants, compared with those receiving usual care, reported a greater decrease in back pain-related disability in the 6 months following study enrollment. Between-group differences were especially prominent for patients reporting greater baseline levels of disability but did not persist over 12 months. Primarily, automated interventions may be an efficient way to assist patients with managing chronic back pain; additional support may be needed to ensure continuing improvements.
Towards Improved Healthcare Performance: Examining Technological Possibilities and Patient Satisfaction with Wireless Body Area Networks

This paper investigates the benefits of using less intrusive wireless technologies for heart monitoring. By replacing well established heart monitoring devices (i.e. Holter) with wireless ECG based Body Area Networks (BAN), improved healthcare performance can be achieved, reflected in (1) high quality ECG recordings during physical activities and (2) increased patient satisfaction. A small scale clinical trial was conducted to compare both technologies and the results illustrate that the wireless ECG monitor was able to detect ECG signals intended for arrhythmia diagnostics. Furthermore, from a patient’s perspective, both technologies were evaluated using three dimensions, namely; hygienic aspects, physical activity, and skin reactions. Results demonstrate that the wireless ECG BAN showed better performance, especially regarding the hygienic aspects. It was also favourable for use during physical activities, and the signal quality of the wireless sensor system demonstrated good performance regarding signal noise and artefact disturbances. This paper concludes that wireless cardiac monitoring systems have significant benefits from a patient’s perspective, and further clinical trials should be conducted to further evaluate the new ECG based BAN system, to identify the possibility of widespread adoption and utilisation of wireless technology for arrhythmia diagnostics.
A pilot randomized controlled trial comparing CABG surgery performed with total arterial grafts or without

To date only a few randomized controlled studies have compared grafting strategies in patients with multi-vessel coronary disease. This study represents a pilot RCT designed to test the feasibility of a trial comparing conventional CABG performed with a LIMA-LAD plus saphenous vein grafts (LIMA+SVG) and CABG performed with total arterial grafting (TAG).



Consenting patients undergoing non-redo isolated CABG surgery at a single institution were randomized to TAG or LIMA+SVG groups. Exclusion criteria included prior CABG, emergent procedure, concomitant procedure, varicose veins and renal dysfunction. The primary endpoints were: enrolment >20% and completion of CT coronary angiography at 6 months >80%. Statistical investigation was performed on an intention to treat analysis.



Of 421 eligible patients, 60 were enrolled and 2 withdrew (n = 30 in TAG, n = 28 LIMA+SVG) for 14% enrolment rate. Patient characteristics were similar in each group. No patients died in hospital and adverse events such as MI, stroke and deep sternal wound infection were not significantly different between groups. Clinical follow-up was complete in 100% of patients, with 44/58 (76%) undergoing CT coronary angio at 6 months. Graft occlusion occurred in 2 patients in each group for patency rates of 89% (TAG) and 91% (LIMA+SVG).



We provide evidence that an RCT comparing grafting strategy is possible but also show that achieving recruitment or follow-up CT may be difficult. Given the excellent patency results and little difference between groups, our findings suggest that the sample size required may make it infeasible to compare graft patency at 6 months as a study end-point.


 Few RCT's exist comparing conventional CABG performed with a LIMA-LAD plus saphenous vein grafts (LIMA+SVG) compared to CABG performed with total arterial grafting (TAG). This study is a pilot RCT designed to test the feasibility of such a trial and identify pitfalls.
Safety and Tolerability of CSL112, a Reconstituted, Infusible, Plasma-Derived Apolipoprotein A-I, After Acute Myocardial Infarction

Human or recombinant apolipoprotein A-I (apoA-I) has been shown to increase high-density lipoprotein-mediated cholesterol efflux capacity and to regress atherosclerotic disease in animal and clinical studies. CSL112 is an infusible, plasma-derived apoA-I that has been studied in normal subjects or those with stable coronary artery disease. This study aimed to characterize the safety, tolerability, pharmacokinetics, and pharmacodynamics of CSL112 in patients with a recent acute myocardial infarction.



The AEGIS-I trial (Apo-I Event Reducing in Ischemic Syndromes I) was a multicenter, randomized, double-blind, placebo-controlled, dose-ranging phase 2b trial. Patients with myocardial infarction were stratified by renal function and randomized 1:1:1 to CSL112 (2 g apoA-I per dose) and high-dose CSL112 (6 g apoA-I per dose), or placebo for 4 consecutive weekly infusions. Coprimary safety end points were occurrence of either a hepatic safety event (an increase in alanine transaminase >3 times the upper limit of normal or an increase in total bilirubin >2 times the upper limit of normal) or a renal safety event (an increase in serum creatinine >1.5 times the baseline value or a new requirement for renal replacement therapy).



A total of 1258 patients were randomized, and 91.2% received all 4 infusions. The difference in incidence rates for an increase in alanine transaminase or total bilirubin between both CSL112 arms and placebo was within the protocol-defined noninferiority margin of 4%. Similarly, the difference in incidence rates for an increase in serum creatinine or a new requirement for renal replacement therapy was within the protocol-defined noninferiority margin of 5%. CSL112 was associated with increases in apoA-I and ex vivo cholesterol efflux similar to that achieved in patients with stable coronary artery disease. In regard to the secondary efficacy end point, the risk for the composite of major adverse cardiovascular events among the groups was similar.



Among patients with acute myocardial infarction, 4 weekly infusions of CSL112 are feasible, well tolerated, and not associated with any significant alterations in liver or kidney function or other safety concern. The ability of CSL112 to acutely enhance cholesterol efflux was confirmed. The potential benefit of CSL112 to reduce major adverse cardiovascular events needs to be assessed in an adequately powered phase 3 trial.
Comparison of two pain assessment tools in nonverbal critical care patients.

It is recommended that patient's self-report of pain should be obtained as often as possible as the "gold standard." Unfortunately in critical care, many factors can alter verbal communication with patients, making pain assessment more difficult. Scientific advances in understanding pain mechanisms, multidimensional methods of pain assessment, and analgesic pharmacology have improved pain management strategies. However, pain assessment for nonverbal patients in critical care continues to present a challenge for clinicians and researchers. The purpose of this study was to compare the Pain Assessment in Advanced Dementia (PAINAD) and the Critical-Care Pain Observation Tool (CPOT) scores for assessment in nonverbal critical care patients. A descriptive, comparative, prospective design was used in this study. A convenience sample of 100 critical care, nonverbal, adult patients of varying medical diagnoses who required pain evaluation were assessed with the PAINAD and CPOT scales. Data were collected over a 6-month period in all critical care areas. Observations of pain assessments for nonverbal patients who required pain evaluation were recorded on the PAINAD and the CPOT successively. Internal consistency reliability for the PAINAD was 0.80 and for the CPOT 0.72. Limits of agreement indicated that there was no difference in PAINAD and CPOT scores for assessing pain in nonverbal patients in critical care. Further research in the area of pain assessment for nonverbal patients in critical care is needed.
Differential effects of beta-blockers in patients with heart failure: A prospective, randomized, double-blind comparison of the long-term effects of metoprolol versus carvedilol.

Both metoprolol and carvedilol produce hemodynamic and clinical benefits in patients with chronic heart failure; carvedilol exerts greater antiadrenergic effects than metoprolol, but it is unknown whether this pharmacological difference results in hemodynamic and clinical differences between the 2 drugs.



We randomized 150 patients with heart failure (left ventricular ejection fraction </=0.35) to double-blind treatment with either metoprolol or carvedilol. When compared with metoprolol (124+/-55 mg/d), patients treated with carvedilol (49+/-18 mg/d) showed larger increases in left ventricular ejection fraction at rest (+10.9+/-11.0 versus +7.2+/-7.7 U, P=0.038) and in left ventricular stroke volume and stroke work during exercise (both P<0. 05) after 13 to 15 months of treatment. In addition, carvedilol produced greater decreases in mean pulmonary artery pressure and pulmonary wedge pressure, both at rest and during exercise, than metoprolol (all P<0.05). In contrast, the metoprolol group showed greater increases in maximal exercise capacity than the carvedilol group (P=0.035), but the 2 drugs improved symptoms, submaximal exercise tolerance, and quality of life to a similar degree. After a mean of 23+/-11 months of follow-up, 21 patients in the metoprolol group and 17 patients in the carvedilol group died or underwent urgent transplantation.



The present study demonstrates that during long-term therapy, carvedilol improves cardiac performance to a greater extent than metoprolol when administered to patients with heart failure in the doses shown to be effective in clinical trials. These differences were likely related to a greater antiadrenergic activity of carvedilol.