nils-herrmann/clean_scirepeval huggingface dataset:
Manual therapy and exercise therapy in patients with chronic low back pain: a randomized, controlled trial with 1-year follow-up.

A multicenter, randomized, controlled trial with 1-year follow-up. To compare the effect of manual therapy to exercise therapy in sick-listed patients with chronic low back pain (>8 wks). The effect of exercise therapy and manual therapy on chronic low back pain with respect to pain, function, and sick leave have been investigated in a number of studies. The results are, however, conflicting. Patients with chronic low back pain or radicular pain sick-listed for more than 8 weeks and less than 6 months were included. A total of 49 patients were randomized to either manual therapy (n = 27) or to exercise therapy (n = 22). Sixteen treatments were given over the course of 2 months. Pain intensity, functional disability (Oswestry disability index), general health (Dartmouth COOP function charts), and return to work were recorded before, immediately after, at 4 weeks, 6 months, and 12 months after the treatment period. Spinal range of motion (Schober test) was measured before and immediately after the treatment period only. Although significant improvements were observed in both groups, the manual therapy group showed significantly larger improvements than the exercise therapy group on all outcome variables throughout the entire experimental period. Immediately after the 2-month treatment period, 67% in the manual therapy and 27% in the exercise therapy group had returned to work (P < 0.01), a relative difference that was maintained throughout the follow-up period. Improvements were found in both intervention groups, but manual therapy showed significantly greater improvement than exercise therapy in patients with chronic low back pain. The effects were reflected on all outcome measures, both on short and long-term follow-up. Comment in Manual therapy and exercise therapy in patients with chronic low back pain: a randomized, controlled trial with 1-year follow-up. [Spine (Phila Pa 1976). 2004]
Analysis of baseline by treatment interactions in a drug prevention and health promotion program for high school male athletes.

This paper investigates baseline by treatment interactions (BTI) of a randomized anabolic steroid prevention program delivered to high school football players. Baseline by treatment interactions occur when a participant's score on an outcome variable is associated with both their pretreatment standing on the outcome variable and the treatment itself. The program was delivered to 31 high school football teams (Control=16, Treatment=15) in Oregon and Washington over the course of 3 years (Total N=3207). Although most interactions were nonsignificant, consistent baseline by treatment interactions were obtained for knowledge of the effects of steroid use and intentions to use steroids. Both of these interactions were beneficial in that they increased the effectiveness of the program for participants lower in knowledge and higher in intentions at baseline.
Differences between participants and non-participants in an RCT on physical activity and psychological interventions for older persons.

Volunteer bias in intervention studies on successful aging has been poorly explored. This paper investigated differences between participants and non-participants of the Groningen Intervention Study on Successful Aging (GISSA) over a wide range of demographic, physical, psychological and social subject characteristics.



Subjects were recruited among a longitudinal cohort study (Groningen Longitudinal Aging Study) and included 558 men and 711 women, aged 65-96 years, who were invited to participate in the GISSA. Measures were obtained by questionnaires at the moment of invitation and eight years before invitation. Participants were compared with three groups of non-participants: persons who refused to participate, those who did not respond after a reminder, and those who intended to participate but withdrew before pre-test.



At the moment of invitation, participants were younger, better educated, and functionally and physically more active than the three groups of non-participants. They also had better scores on the physical functioning subscale of the medical outcome scale, better ADL, iADL and vigorous ADL functions and fewer depressive symptoms, and perceived less social support in everyday and problem situations. Participants reported a less strong rate of decline in physical and psychological functioning in the eight years prior to the invitation than did the other groups.



Due to volunteer bias, results of intervention studies on successful aging may have limited generalizability.
Parallel but not equivalent: challenges and solutions for repeated assessment of cognition over time.

Analyses of individual differences in change may be unintentionally biased when versions of a neuropsychological test used at different follow-ups are not of equivalent difficulty. This study's objective was to compare mean, linear, and equipercentile equating methods and demonstrate their utility in longitudinal research.



The Advanced Cognitive Training for Independent and Vital Elderly (ACTIVE, N = 1,401) study is a longitudinal randomized trial of cognitive training. The Alzheimer's Disease Neuroimaging Initiative (ADNI, n = 819) is an observational cohort study. Nonequivalent alternate versions of the Auditory Verbal Learning Test (AVLT) were administered in both studies.



Using visual displays, raw and mean-equated AVLT scores in both studies showed obvious nonlinear trajectories in reference groups that should show minimal change and poor equivalence over time (ps ≤ .001), and raw scores demonstrated poor fits in models of within-person change (root mean square errors of approximation, RMSEAs > 0.12). Linear and equipercentile equating produced more similar means in reference groups (ps ≥ .09) and performed better in growth models (RMSEAs < 0.05).



Equipercentile equating is the preferred equating method because it accommodates tests more difficult than a reference test at different percentiles of performance and performs well in models of within-person trajectory. The method has broad applications in both clinical and research settings to enhance the ability to use nonequivalent test forms.
e-Monitoring of Asthma Therapy to Improve Compliance in children using a real-time medication monitoring system (RTMM): the e-MATIC study protocol

Many children with asthma do not have sufficient asthma control, which leads to increased healthcare costs and productivity loss of parents. One of the causative factors are adherence problems. Effective interventions improving medication adherence may therefore improve asthma control and reduce costs. A promising solution is sending real time text-messages via the mobile phone network, when a medicine is about to be forgotten. As the effect of real time text-messages in children with asthma is unknown, the primary aim of this study is to determine the effect of a Real Time Medication Monitoring system (RTMM) with text-messages on adherence to inhaled corticosteroids (ICS). The secondary objective is to study the effects of RTMM on asthma control, quality of life and cost-effectiveness of treatment.



A multicenter, randomized controlled trial involving 220 children (4-11 years) using ICS for asthma. All children receive an RTMM-device for one year, which registers time and date of ICS doses. Children in the intervention group also receive tailored text-messages, sent only when a dose is at risk of omission. Primary outcome measure is the proportion of ICS dosages taken within the individually predefined time-interval. Secondary outcome measures include asthma control (monthly Asthma Control Tests), asthma exacerbations, healthcare use (collected from hospital records, patient reports and pharmacy record data), and disease-specific quality of life (PAQLQ questionnaire). Parental and children's acceptance of RTMM is evaluated with online focus groups and patient questionnaires. An economic evaluation is performed adopting a societal perspective, including relevant healthcare costs and parental productivity loss. Furthermore, a decision-analytic model is developed in which different levels of adherence are associated with clinical and financial outcomes. Also, sensitivity analyses are carried out on different price levels for RTMM.



If RTMM with tailored text-message reminders proves to be effective, this technique can be used in daily practice, which would support children with suboptimal adherence in their asthma (self)management and in achieving better asthma control and better quality of life.
Rapid high-performance liquid chromatography method for determination of tryptophan in gastric juice.

To develop a rapid, high-performance liquid chromatography (HPLC) method for the determination of tryptophan in gastric juice to help the differentiation between gastric cancer and benign gastric disease.



HPLC was performed on a restricted access material Shiseido Capcell Pak MF SCX SG80 column. Phosphate buffered solution (90mmol/L, pH 3.5)-acetonitrile (ACN; 80/20, V/V) was chosen as the mobile phase. Separation was done at room temperature using a constant flow rate of 1.0mL/min. Fluorescence emission signal intensity at 330nm excited by 288nm ultra violet light was detected and measured.


Thirty-eight gastric juice samples from patients with gastric cancer and 48 gastric juice samples of patients with benign gastric disease were tested. A linear relationship in the range of 0.20-100mg/L was obtained between the concentration of tryptophan and its fluorescence emission signal intensity at 330nm. The limit of detection was 0.05mg/L. The recovery rate was 77.4-90.6%.



An HPLC method based on strong cation-exchange restricted access columns for determination of concentration of tryptophan in gastric juice was developed. The method has excellent precision and stability. It is compatible with the analysis of gastric juice and has the potential to be used for gastric cancer screening.
Improvements in health-related quality of life following a group intervention for coping with AIDS-bereavement among HIV-infected men and women

AIDS-related bereavement is a severe life stressor that may be particularly distressing to persons themselves infected with HIV. Increasing evidence suggests that psychological health is associated with disease progression, HIV-related symptoms, and mortality.  This study assessed change in health-related quality of life among HIV+ persons following a group intervention for coping with AIDS-related loss.  The sample included 235 HIV+ men and women of diverse ethnicities and sexual orientations who had experienced an AIDS-related loss within the previous 2 years. Participants were randomly assigned to a 12-week cognitive-behavioral bereavement coping group intervention or offered individual psychotherapy upon request. Quality of life was assessed at baseline and 2 weeks after the intervention.  Participants in the group intervention demonstrated improvements in general health-related and HIV-specific quality of life, while those in the comparison remained the same or deteriorated. Effect sizes indicated that the majority of change occurred in women.  This bereavement group aimed at improving coping with grief also had a positive impact on health-related quality of life among HIV+ men and women, and suggests that cognitive-behavioral interventions may have a broad impact on both emotional and physical health.
Evaluation of Persistence of Resistant Variants with Ultra-Deep Pyrosequencing in Chronic Hepatitis C Patients Treated with Telaprevir

Telaprevir, a hepatitis C virus NS3/4A protease inhibitor has significantly improved sustained viral response rates when given in combination with pegylated interferon alfa-2a and ribavirin, compared with current standard of care in hepatitis C virus genotype 1 infected patients. In patients with a failed sustained response, the emergence of drug-resistant variants during treatment has been reported. It is unclear to what extent these variants persist in untreated patients. The aim of this study was to assess using ultra-deep pyrosequencing, whether after 4 years follow-up, the frequency of resistant variants is increased compared to pre-treatment frequencies following 14 days of telaprevir treatment.



Fifteen patients from 2 previous telaprevir phase 1 clinical studies (VX04-950-101 and VX05-950-103) were included. These patients all received telaprevir monotherapy for 14 days, and 2 patients subsequently received standard of care. Variants at previously well-characterized NS3 protease positions V36, T54, R155 and A156 were assessed at baseline and after a follow-up of 4±1.2 years by ultra-deep pyrosequencing. The prevalence of resistant variants at follow-up was compared to baseline.



Resistance associated mutations were detectable at low frequency at baseline. In general, prevalence of resistance mutations at follow-up was not increased compared to baseline. Only one patient had a small, but statistically significant, increase in the number of V36M and T54S variants 4 years after telaprevir-dosing.



In patients treated for 14 days with telaprevir monotherapy, ultra-deep pyrosequencing indicates that long-term persistence of resistant variants is rare.
Comparison of therapeutic effects of magnesium sulfate vs. dexamethasone/metoclopramide on alleviating acute migraine headache.

There is controversy about the efficacy of currently used treatment modalities to alleviate migraine headaches.



We aimed to evaluate and compare the effects of magnesium sulfate and combined use of dexamethasone/metoclopramide on relieving acute migraine headache.



We randomly divided 70 patients who had been referred to an emergency department, into two equal treatment groups with the two treatment plans, and analyzed pain severity at baseline using a numeric rating scale (NRS). We gave dexamethasone/metoclopramide to one group and magnesium sulfate to the other group, and evaluated pain severity at 20 min and at 1- and 2-h intervals after infusion. Finally, we used repeated-measure and two-way analysis of variance for intra- and inter-group evaluations of pain severity and complications, respectively.



We found no significant differences in demographic data and pain severity at baseline (8.2 vs. 8.0) between the two groups (p < 0.05). In the dexamethasone/metoclopramide group, pain severity (mean ± standard deviation) was 7.4 ± 1.4 (p = 0.36), 6.0 ± 2.4, and 2.5 ± 2.9 (p < 0.0001) at 20-min, 1-h, and 2-h intervals after treatment, respectively, with statistically significant differences between the baseline values and 1-h and 2-h interval values. Administration of magnesium sulfate was associated with decreased pain severity at the three intervals (5.2 ± 1.7, 2.3 ± 1.9, and 1.3 ± 0.66, respectively), exhibiting significant differences compared to baseline values and the corresponding time intervals in the dexamethasone/metoclopramide group (p < 0.0001).



According to the results, magnesium sulfate was a more effective and fast-acting medication compared to a combination of dexamethasone/metoclopramide for the treatment of acute migraine headaches.
Increased risk of restenosis after placement of gold-coated stents: results of a randomized trial comparing gold-coated with uncoated steel stents in patients with coronary artery disease.

Gold is a highly biocompatible material. Experimental evidence suggests that coating the stent with a gold layer may have a beneficial influence. In this randomized trial, we assessed whether gold-coated stents were associated with a better clinical and angiographic outcome after coronary placement.



Patients with symptomatic coronary artery disease were randomly assigned to receive either a gold-coated Inflow stent (n = 367) or an uncoated Inflow stainless steel stent (n = 364) of identical design. Follow-up angiography was routinely performed at 6 months. The primary end point of the study was the occurrence of any adverse clinical event (death, myocardial infarction, or target-vessel revascularization) during the first year after stenting. At 30 days, there was no significant difference in the combined incidence of adverse events, with 7.9% in the gold-stent group versus 5.8% in the steel-stent group (P = 0.25). The incidence of angiographic restenosis (> or =50% diameter stenosis) was 49.7% in the gold-stent group and 38.1% in the steel-stent group (P = 0.003). One-year survival free of myocardial infarction was 88.6% in the gold-stent group and 91.8% in the steel-stent group (P = 0.14). One-year event-free survival was significantly less favorable in the gold-stent group (62.9% versus 73.9% in the steel-stent group; P = 0.001).



Coating steel stents with gold had no significant influence on the thrombotic events observed during the first 30 days after the intervention. However, gold-coated stents were associated with a considerable increase in the risk of restenosis over the first year after stenting.
Use of drug-eluting versus bare-metal stents after an acute coronary syndrome in Portugal: the EURHOBOP study.

The interventional cardiologist chooses a specific stent type based on the risk-benefit profile for each case. In general, drug-eluting stents should be considered in all clinical conditions, except if there are concerns or contraindications for prolonged dual antiplatelet therapy. The aim of this work was to describe the use of bare-metal vs. drug-eluting stents in patients undergoing percutaneous coronary intervention (PCI) after an acute coronary syndrome in Portuguese hospitals, according to patients' demographic and clinical characteristics and institutional characteristics.



Within the EURopean Hospital Benchmarking Processes (EURHOBOP) study, we retrospectively assessed 3009 consecutive patients in 10 Portuguese hospitals in 2009. Only patients with stents implanted during PCI (n=1194) were analyzed.



A total of 425 patients (36%) received a bare-metal stent and 769 patients (64%) received a drug-eluting stent. A history of previous PCI, current non-ST-elevation myocardial infarction, anterior descending artery as the infarct-related artery and being initially admitted to a hospital with a catheterization laboratory were associated with drug-eluting stent implantation. Age under 45 or over 80, anemia and previous anticoagulation and/or atrial fibrillation were associated with bare-metal stent use.



Approximately two-thirds of patients received drug-eluting stents, which were less frequently implanted in patients with ST-elevation myocardial infarction, aged over 80 years, female, with a previous history of stroke, anticoagulation and/or atrial fibrillation and anemia. Patients who had previously undergone PCI and those with the anterior descending artery as the infarct-related artery were more likely to receive a drug-eluting stent.
The biological evaluation of ADMA/SDMA and eNOS in patients with ACHF.

The aim of this study was to investigate the effects of acute pharmacological treatment on the plasma levels of l-arginine, asymmetrical dimethylarginine (ADMA), and symmetrical dimethylarginine (SDMA). We also investigated the related effects on endothelial nitric oxide synthase (eNOS) expression and activity and cytochrome c oxidase activity in the primary blood mononuclear cells (PBMCs) isolated from patients with acute congestive heart failure (ACHF). Compared to pre-treatment values, ADMA, SDMA, and l-arginine plasma levels were significantly higher after pharmacological treatment (ADMA, 0.82 versus 0.43 µM; SDMA, 1.52 versus 1.12 µM; l-arginine, 1.78 versus 1.29 µM; p < 0.01. In addition, the levels of eNOS expression and activity were decreased after pharmacological treatment, while cytochrome c oxidase activity resulted in higher O2-production. In the PBMCs isolated from patients with acute congestive heart failure (ACHF) and impaired renal function, higher SDMA and ADMA levels were more evident after therapy, as were reduced expression and activity of eNOS. Increased O2- produced after treatment may be involved in impaired recovery of cardiac function associated with higher plasma levels of SDMA.
Long-term clinical and angiographic follow-up after coronary stent placement in native coronary arteries.

Although coronary stents have been proved effective in reducing clinical cardiac events for up to 3 to 5 years, longer term clinical and angiographic outcomes have not yet been fully clarified.



To evaluate longer term (7 to 11 years) outcome, clinical and angiographic follow-up information was analyzed in 405 patients with successful stenting in native coronary arteries. Primary or secondary stabilization, which was defined as freedom from death, coronary artery bypass grafting, and target lesion-percutaneous coronary intervention (TL-PCI) during the 14 months after the initial procedure or after the last TL-PCI, was achieved in 373 patients (92%) overall. Only 7 patients (1.7%) underwent TL-PCI more than twice. After the initial 14-month period, freedom from TL-PCI reached a plateau at 84.9% to 80.7% over 1 to 8 years. However, quantitative angiographic analysis in 179 lesions revealed a triphasic luminal response characterized by an early restenosis phase until 6 months, an intermediate-term regression phase from 6 months to 3 years, and a late renarrowing phase beyond 4 years. Minimal luminal diameter in 131 patients with complete serial data were 2.62+/-0.4 mm immediately after stenting, 2.0+/-0.49 mm at 6 months, 2.19+/-0.49 mm at 3 years, and 1.85+/-0.56 mm beyond 4 years (P<0.0001).



The efficacy and safety of coronary stenting seemed to be clinically sustained at 7 to 11 years of follow-up. However, late luminal renarrowing beyond 4 years was common, which demonstrates the need for further follow-up.
Randomized trial of an intervention to improve mammography utilization among a triracial rural population of women.

Mammography is underused by certain groups of women, in particular poor and minority women. We developed a lay health advisor (LHA) intervention based on behavioral theories and tested whether it improved mammography attendance in Robeson County, NC, a rural, low-income, triracial (white, Native American, African American) population.



A total of 851 women who had not had a mammogram within the past year were randomly assigned to the LHA intervention (n = 433) or to a comparison arm (n = 418) during 1998-2002. Rates of mammography use after 12-14 months (as verified by medical record review) were compared using a chi-square test. Baseline and follow-up (at 12-14 months) surveys were used to obtain information on demographics, risk factors, and barriers, beliefs, and knowledge about mammography. Linear regression, Mantel-Haenszel statistics, and logistic regression were used to compare barriers, beliefs, and knowledge from baseline to follow-up and to identify baseline factors associated with mammography.



At follow-up, 42.5% of the women in the LHA group and 27.3% of those in the comparison group had had a mammogram in the previous 12 months (relative risk = 1.56, 95% confidence interval [CI] = 1.29 to 1.87). Compared with those in the comparison group, women in the LHA group displayed statistically significantly better belief scores (difference = 0.46 points on a 0-10 scale, 95% CI = 0.15 to 0.77) and reduced barriers at follow-up (difference = -0.77 points, 95% CI = -1.02 to -0.53), after adjusting for baseline scores.



LHA interventions can improve mammography utilization. Future studies are needed to assess strategies to disseminate effective LHA interventions to underserved populations.