nils-herrmann/clean_scirepeval huggingface dataset:
Influence of DDD rate response pacing with integrated double sensors on physical efficiency and quality of life.

The aim of this study was to evaluate whether the use of a double sensor gives additional benefits for patients in improving physical efficiency as well as quality of life (QoL) as compared to the accelerometer sensor alone.



The presented research is a prospective, randomized, single-blind clinical trial. Double-sensor (accelerometer and minute-ventilation) pacemakers (Guidant, Pulsar Max DR) were implanted in 20 patients with sinus node dysfunction (SND) and chronotropic incompetence. After randomization, patients were placed in one of two groups: 1, only the accelerometer sensor was activated; 2, both sensors were activated. After a 3-month follow-up, an initial cardio-pulmonary exercise test was performed, after which the patients were placed in the opposite group for a further 3 months. Finally, the second tests were performed. In 75% of the patients an improvement in QoL was observed in the double-sensor group (P = 0.0242) when compared with the single-sensor group. The addition of a ventilating sensor had no influence on the duration of exercise test . The parameters of cardio-pulmonary exercise tests recorded in situations A and B before exertion, and 6 minutes after exertion were not statistically different.



The use of double-sensor pacemakers does not improve physical efficiency; however, it does improve QoL.
Cluster analysis and its application to healthcare claims data: a study of end-stage renal disease patients who initiated hemodialysis

Cluster analysis (CA) is a frequently used applied statistical technique that helps to reveal hidden structures and "clusters" found in large data sets. However, this method has not been widely used in large healthcare claims databases where the distribution of expenditure data is commonly severely skewed. The purpose of this study was to identify cost change patterns of patients with end-stage renal disease (ESRD) who initiated hemodialysis (HD) by applying different clustering methods.



A retrospective, cross-sectional, observational study was conducted using the Truven Health MarketScan® Research Databases. Patients aged ≥18 years with ≥2 ESRD diagnoses who initiated HD between 2008 and 2010 were included. The K-means CA method and hierarchical CA with various linkage methods were applied to all-cause costs within baseline (12-months pre-HD) and follow-up periods (12-months post-HD) to identify clusters. Demographic, clinical, and cost information was extracted from both periods, and then examined by cluster.



A total of 18,380 patients were identified. Meaningful all-cause cost clusters were generated using K-means CA and hierarchical CA with either flexible beta or Ward's methods. Based on cluster sample sizes and change of cost patterns, the K-means CA method and 4 clusters were selected: Cluster 1: Average to High (n = 113); Cluster 2: Very High to High (n = 89); Cluster 3: Average to Average (n = 16,624); or Cluster 4: Increasing Costs, High at Both Points (n = 1554). Median cost changes in the 12-month pre-HD and post-HD periods increased from $185,070 to $884,605 for Cluster 1 (Average to High), decreased from $910,930 to $157,997 for Cluster 2 (Very High to High), were relatively stable and remained low from $15,168 to $13,026 for Cluster 3 (Average to Average), and increased from $57,909 to $193,140 for Cluster 4 (Increasing Costs, High at Both Points). Relatively stable costs after starting HD were associated with more stable scores on comorbidity index scores from the pre-and post-HD periods, while increasing costs were associated with more sharply increasing comorbidity scores.



The K-means CA method appeared to be the most appropriate in healthcare claims data with highly skewed cost information when taking into account both change of cost patterns and sample size in the smallest cluster.
Plasma lipoproteins and apolipoproteins as predictors of cardiovascular risk and treatment benefit in the PROspective Study of Pravastatin in the Elderly at Risk (PROSPER).

Statins are important in vascular disease prevention in the elderly. However, the best method of selecting older patients for treatment is uncertain. We assessed the role of plasma lipoproteins as predictors of risk and of treatment benefit in the PROspective Study of Pravastatin in the Elderly at Risk (PROSPER).



The association of LDLc and HDLc with risk was examined in the 5804 70- to 82-year-old subjects of PROSPER. Baseline LDLc showed no relation to risk of the primary end point in the placebo group (P=0.27), nor did on-treatment LDLc in the pravastatin group (P=0.12). HDLc was inversely associated with risk in subjects on placebo (P=0.0019) but not in those on pravastatin (P=0.24). Risk reduction on pravastatin treatment was unrelated to baseline LDLc (P=0.38) but exhibited a significant interaction with HDLc (P=0.012). Subjects in the lowest 2 quintiles of HDLc (<1.15 mmol/L) had a risk reduction of 33% (hazard ratio, 0.67; 95% confidence limits, 0.55, 0.81; P<0.0001), whereas those with higher HDLc showed no benefit (RR, 1.06; 95% confidence limits, 0.88, 1.27; P=0.53). During follow-up, there was no relation between achieved level of LDLc or HDLc and risk. However, the change in the LDLc/HDLc ratio on statin treatment appeared to account for the effects of therapy.



In people >70 years old, HDLc appears to be a key predictor of risk and of treatment benefit. Findings in PROSPER suggest that statin therapy could usefully be targeted to those with HDLc <1.15 mmol/L or an LDLc/HDLc ratio >3.3.
Use of matched historical controls to evaluate the anti-fracture efficacy of once-a-week risedronate

Placebo controls are essential to assess anti-fracture efficacy of new osteoporosis therapies, but inclusion of a placebo arm in a subsequent clinical trial may be limited by practical or ethical considerations; in these cases, use of an historical control may be appropriate. A recent active-controlled study of risedronate 35 mg once a week demonstrated that this regimen produces increases in bone mineral density (BMD) that are comparable to those seen with the risedronate 5 mg daily dose, which has proven anti-fracture efficacy. To assess the anti-fracture efficacy of this new regimen, we have analyzed the fracture data collected in an active controlled study of risedronate dosing regimens (the Once-a-Week study) using matched historical control data from previous placebo-controlled trials. Women in the Once-a-Week study were matched for age, years since menopause, BMD, and prevalent vertebral fracture status, with placebo patients in the Vertebral Efficacy of Risedronate Therapy (VERT) trials forming an historical placebo group. We also constructed an historical active treatment group from the 5 mg daily arm of the VERT trials for comparison with the 5 mg daily and 35 mg once weekly treatment groups in the Once-a-Week study. Data were obtained from the risedronate 5 mg daily group (n=480) and 35 mg once-a-week group (n=485) in the Once-a-Week study and historical control groups representing daily placebo patients (n=114, matched from 993) and risedronate 5 mg daily patients (n=120; matched from 990) in the VERT studies. Patients received calcium supplementation (1000 mg daily); vitamin D was given if baseline serum 25-hydroxyvitamin D levels were low. Over 1 year, new vertebral fracture risk in the 35 mg once-a-week group was reduced by 77% relative to the historical placebo group (1.2% versus 5.0%; RR 0.23; 95% CI, 0.54 to 0.91, P=0.018), similar to the 1-year risk reduction observed in the VERT trials of risedronate 5 mg daily (61–65%). The incidence of new vertebral fractures in the three active treatment groups was similar: 1.7% in the historical risedronate 5 mg group, 1.5% in the risedronate 5 mg daily group from the Once-a-Week study, and 1.2% in the 35 mg once-a-week group. Risedronate 35 mg once a week appears as effective as the 5 mg daily dose in reducing the risk of new vertebral fractures in the first year of treatment. The use of appropriate historical control data provides an approach to the assessment of fracture effects in osteoporosis trials for which placebo-controlled data are not available.
German adaptation of the Resources for Enhancing Alzheimer’s Caregiver Health II: study protocol of a single-centred, randomised controlled trial

Caring for a family member with dementia is extremely stressful, and contributes to psychiatric and physical illness among caregivers. Therefore, a comprehensive programme called Resources for Enhancing Alzheimer's Caregiver Health II (REACH II) was developed in the United States to enhance the health of Alzheimer's caregivers. REACH II causes a clear reduction of the stress and burdens faced by informal caregivers at home. The aim of this protocol is to adapt, apply, and evaluate this proven intervention programme in a German-speaking area for the first time. This newly adapted intervention is called Deutsche Adaption der Resources for Enhancing Alzheimer's Caregiver Health (DeREACH).



A total of 138 informal caregivers at home are recruited in a single-centred, randomised controlled trial. The intervention (DeREACH) consists of nine home visits and three telephone contacts over six months, all of which focus on safety, psychological well-being and self-care, social support, problem behaviour and preventive health-related behaviours. A complex intervention assessment on effectiveness will be adopted when the primary outcome - namely, the reduction of caregiver burden - and other secondary outcomes, including changes with regard to anxiety and depression, somatisation, health-related quality of life, and perceived social support, are measured at baseline, as well as immediately and three months after the intervention. The change from baseline to post-intervention assessment with regard to the primary outcome will be compared between treatment and control group using t-tests for independent samples.



It is anticipated that this study will show that DeREACH effectively reduces caregiver burden and therefore works under the conditions of a local German health-care system. If successful, this programme will provide an effective intervention programme in the German-speaking area to identify and develop the personal capabilities of informal caregivers to cope with the burdens of caring for people with dementia.
Neural complications in the surgical treatment of adolescent idiopathic scoliosis.

Multicenter, prospective, consecutive clinical series.



To report on neural complications in a prospective cohort study of 1301 children undergoing spinal fusion and instrumentation for adolescent idiopathic scoliosis (AIS).



The incidence of neural complications for spinal deformity surgery has been reported to be 0.26% to 17%. However, most studies have relied on retrospective voluntary reporting of nonconsecutive cases.



A review of 1301 consecutive surgical cases was conducted using the Prospective Pediatric Scoliosis Study database, which is maintained by the Spinal Deformity Study Group.



There were 9 neural complications. There were 3 thecal penetrations, none of which required repair, and none of which demonstrated intraoperative neural monitoring changes or postoperative clinical sequelae. There were 2 nerve root injuries. In 1 nerve root injury, a positional compression femoral neurapraxia resolved over 6 months. The other was an L4 neurapraxia despite lowest instrumented vertebra L1, and resolved spontaneously by 3 months' follow-up. There were 4 spinal cord injuries. One required removal of implants and fusion in situ, 1 required relaxation of correction and in situ fusion with instrumentation, while the other 2 were observed after fusion and instrumentation with reduction. All resolved spontaneously within 3 months after operation.



The neural complication rate was 0.69%. Two thecal penetrations were due to medial placement of pedicle screws, and 1 was due to dissection during spine exposure. If these are eliminated, as they imply intraspinal entry but not direct neural injury, together with 1 positional neurapraxia, which is remote from the surgical field, our complication rate is 0.38%. This is consistent with other studies in the North American Literature, including multiple reports from the Scoliosis Research Society. Common themes are significant curve correction producing neural stretch and the use of sublaminar wires. None of the neural injuries was permanent. These results reaffirm that surgical treatment of adolescent idiopathic scoliosis has a low but real neural complication rate.
Sirolimus-eluting stent or paclitaxel-eluting stent vs balloon angioplasty for prevention of recurrences in patients with coronary in-stent restenosis: a randomized controlled trial.

In patients with de novo coronary lesions, drug-eluting stents have drastically reduced restenosis risk compared with bare metal stents and conventional balloon angioplasty. It is less clear whether drug-eluting stents are superior to conventional balloon angioplasty for the treatment of patients with in-stent restenosis.



To assess if drug-eluting stents are a more effective treatment of in-stent restenosis than conventional balloon angioplasty, and to assess the relative merits of 2 drug-eluting stents, a sirolimus-eluting stent and a paclitaxel-eluting stent.



Randomized, open-label, active-controlled trial conducted among 300 patients with angiographically significant in-stent restenosis in 2 tertiary German centers from June 1, 2003, to October 20, 2003.



After pretreatment with 600 mg of clopidogrel for at least 2 hours before intervention, all patients were randomly assigned to 1 of 3 treatment groups: sirolimus stent, paclitaxel stent, or balloon angioplasty (100 patients in each group).



Primary end point: angiographic restenosis (diameter stenosis > or =50%) at 6-month follow-up angiography based on "in-segment" analysis. Primary analysis was comparison between stent groups and balloon angioplasty groups; a secondary analysis compared sirolimus and paclitaxel stents.



Follow-up angiography was performed in 275 (92%) of 300 patients. The incidence of angiographic restenosis was 44.6% (41/92) in the balloon angioplasty group, 14.3% (13/91) in the sirolimus stent group (P<.001 vs balloon angioplasty), and 21.7% (20/92) in the paclitaxel stent group (P = .001 vs balloon angioplasty). When compared with balloon angioplasty, receiving a sirolimus stent had a relative risk (RR) of angiographic restenosis of 0.32 (95% confidence interval [CI], 0.18-0.56); a paclitaxel stent had an RR of 0.49 (95% CI, 0.31-0.76). The incidence of target vessel revascularization was 33.0% (33/100) in the balloon angioplasty group, 8.0% (8/100) in the sirolimus stent group (P<.001 vs balloon angioplasty), and 19.0% (19/100) in the paclitaxel stent group (P = .02 vs balloon angioplasty). The secondary analysis showed a trend toward a lower rate of angiographic restenosis (P = .19) and a significantly lower rate of target vessel revascularization (P = .02) among sirolimus stent patients compared with paclitaxel stent patients.



In patients with in-stent restenosis, a strategy based on sirolimus- or paclitaxel-eluting stents is superior to conventional balloon angioplasty for the prevention of recurrent restenosis. Sirolimus-eluting stents may be superior to paclitaxel-eluting stents for treatment of this disorder.
Calcium dobesilate for prevention of gentamicin-induced nephrotoxicity in rats.

Calcium dobesilate is an antioxidant drug and this study is aimed to investigate the effects of calcium dobesilate on gentamicin-induced nephrotoxicity.



This experimental study was conducted on 40 male Sprague-Dawley rats. The rats were randomly divided into the following 5 groups: control, sham, gentamicin (100 mg/kg/d, intraperitoneal), gentamicin and calcium dobesilate (50 mg/kg body weight), gentamicin and calcium dobesilate (50 mg/kg body weight). Treatment was provided once a day in a 7-day period. At the end of the 7th day, plasma and urine samples were taken and the concentrations of creatinine, urea nitrogen, sodium, potassium, and osmolarity were measured in both samples. The level of oxidative stress in the left kidney tissue samples was also assessed by measuring malondialdehyde and ferric reducing antioxidant power.



Calcium dobesilate intake with both doses led to a significant decrease in the elevated concentration of creatinine, urea nitrogen, and fractional excretion of sodium by gentamicin, and an increase in creatinine clearance and absolute excretion of potassium as compared to the gentamicin group. Furthermore, calcium dobesilate decreased tissue malondialdehyde and increased tissue ferric reducing antioxidant power at both doses, in comparison to those in the gentamicin group.



Calcium dobesilate is capable of protecting rats against gentamicin-induced nephrotoxicity. This protective effect of calcium dobesilate is probably dependent on its antioxidant properties.
Two Doses of Candidate TB Vaccine MVA85A in Antiretroviral Therapy (ART) Naïve Subjects Gives Comparable Immunogenicity to One Dose in ART+ Subjects

Tuberculosis (TB) is a global public health problem exacerbated by the HIV epidemic. Here we evaluate a candidate TB vaccine, MVA85A, in a Phase I study in HIV-infected adults in Senegal. 24 patients were enrolled: Group 1∶12, antiretroviral therapy (ART) naïve, adults, with CD4 counts >300 and HIV RNA load <100,000 copies/ml. Group 2∶12 adults, stable on ART, with CD4 counts >300, and an undetectable HIV RNA load. Safety was evaluated by occurrence of local and systemic adverse events (AEs) and by monitoring of CD4 count, HIV RNA load, haematology and biochemistry. Immunogenicity was evaluated by ex-vivo interferon-gamma ELISpot assay. 87.7% of AEs were mild; 11.6% were moderate; and 0.7% were severe. 29.2% of AEs were systemic; 70.8% were expected local AEs. There were no vaccine-related Serious Adverse Events (SAEs) or clinically significant effects on HIV RNA load or CD4 count. In ART naive subjects, the first MVA85A immunisation induced a significant immune response at 1 and 4 weeks post-immunisation, which contracted to baseline by 12 weeks. Durability of immunogenicity in subjects on ART persisted out to 24 weeks post-vaccination. A second dose of MVA85A at 12 months enhanced immunogenicity in ART naïve subjects. Subjects on ART had higher responses after the first vaccination compared with ART naïve subjects; responses were comparable after 2 immunisations. In conclusion, MVA85A is well-tolerated and immunogenic in HIV-infected subjects in Senegal. A two dose regimen in ART naïve subjects is comparable in immunogenicity to a single dose in subjects on ART.
Short-term outcomes following laparoscopic resection for colon cancer

Laparoscopic resection for colon cancer has been proven to have a similar oncological efficacy compared to open resection. Despite this, it is performed by a minority of colorectal surgeons. The aim of our study was to evaluate the short-term clinical, oncological and survival outcomes in all patients undergoing laparoscopic resection for colon cancer. From July 2005 to December 2008, 202 consecutive patients underwent laparoscopic resection for colon cancer. Surgery was analysed on an intention to treat basis. The mean follow-up was 24.3 months. Two hundred twenty-two patients underwent resection for colon cancer. Two hundred two underwent laparoscopic resection (91%). One hundred sixteen were male patients. Mean age was 65.9 years (range = 24–91). The median length of stay was 6.6 days (mean = 7.1 days). One hundred eighty-eight of 202 (93.1%) were completed laparoscopically. Fourteen (6.9%) were converted. The overall morbidity rate was 15.8%. There were three clinically apparent anastomotic leaks. The 30-day mortality was 1 (0.5%). The mean nodal yield was 13.4 (range = 8–37) nodes. There were no positive margins detected. Overall survival in laparoscopically treated colon cancer was 88.1%. In those patients with non-metastatic disease, the overall survival was 90.7% (165/182). Laparoscopic resection for colon cancer is achievable in 85% (188/222) of patients. This facilitates adequate oncological clearance. It is associated with a low morbidity rate and favourable short-term survival outcomes. This data reflects the potential outcomes dedicated MIS colorectal units will have to offer colon cancer patients once laparoscopic colorectal surgery becomes the de facto surgical approach.
Site factors may be more important than participant factors in explaining HIV test acceptance in the prevention of mother-to-child HIV transmission programme in Kenya, 2005.

To determine the role of participant factors on the acceptance of a Prevention-of-Mother-to-Child (PMTCT) HIV test programme in a situation with an opt-out testing strategy.



We analysed antenatal clinic (ANC) HIV sentinel surveillance data. All 43 sites in the 2005 round of Kenya's ANC surveillance offered opt-out PMTCT services and recorded if women were offered PMTCT HIV testing and whether they accepted or refused. Logistic regression was used to determine the role of participant-level factors on PMTCT acceptance.



During the period of sentinel surveillance, 13,026 women attended ANC and testing was offered to 12,030 women. Of those offered testing, 9690 (80.5%) accepted, with a large variation in the percent of acceptors by site. Age, residence and educational status were significant determinants of PMTCT acceptance. However, after adjusting for site none of the participant-level factors were significant determinants of PMTCT acceptance.



Participant level factors were not significant determinants of PMTCT HIV test acceptance after adjusting for sites. PMTCT programmes should collect and evaluate the role of site-level (provider and testing service) factors on PMTCT acceptance. Improvement of site-level factors could improve PMTCT uptake.
Shortening a survey and using alternative forms of prenotification: Impact on response rate and quality

Evidence suggests that survey response rates are decreasing and that the level of survey response can be influenced by questionnaire length and the use of pre-notification. The goal of the present investigation was determine the effect of questionnaire length and pre-notification type (letter vs. postcard) on measures of survey quality, including response rates, response times (days to return the survey), and item nonresponse.



In July 2008, the authors randomized 900 residents of Olmsted County, Minnesota aged 25-65 years to one of two versions of the Talley Bowel Disease Questionnaire, a survey designed to assess the prevalence of functional gastrointestinal disorders (FGID). One version was two pages long and the other 4 pages. Using a 2 x 2 factorial design, respondents were randomized to survey length and one of two pre-notification types, letter or postcard; 780 residents ultimately received a survey, after excluding those who had moved outside the county or passed away.



Overall, the response rates (RR) did not vary by length of survey (RR = 44.6% for the 2-page survey and 48.4% for the 4-page) or pre-notification type (RR = 46.3% for the letter and 46.8% for the postcard). Differences in response rates by questionnaire length were seen among younger adults who were more likely to respond to the 4-page than the 2-page questionnaire (RR = 39.0% compared to 21.8% for individuals in their 20s and RR = 49.0% compared to 32.3% for those in their 30s). There were no differences across conditions with respect to item non-response or time (days after mailing) to survey response.



This study suggests that the shortest survey does not necessarily provide the best option for increased response rates and survey quality. Pre-notification type (letter or postcard) did not impact response rate suggesting that postcards may be more beneficial due to the lower associated costs of this method of contact.