nils-herrmann/clean_scirepeval huggingface dataset:
The Incremental Effects of Manual Therapy or Booster Sessions in Addition to Exercise Therapy for Knee Osteoarthritis: A Randomized Clinical Trial.

A factorial randomized controlled trial.



To investigate the addition of manual therapy to exercise therapy for the reduction of pain and increase of physical function in people with knee osteoarthritis (OA), and whether "booster sessions" compared to consecutive sessions may improve outcomes.



The benefits of providing manual therapy in addition to exercise therapy, or of distributing treatment sessions over time using periodic booster sessions, in people with knee OA are not well established.



All participants had knee OA and were provided 12 sessions of multimodal exercise therapy supervised by a physical therapist. Participants were randomly allocated to 1 of 4 groups: exercise therapy in consecutive sessions, exercise therapy distributed over a year using booster sessions, exercise therapy plus manual therapy without booster sessions, and exercise therapy plus manual therapy with booster sessions. The primary outcome measure was the Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC score; 0-240 scale) at 1-year follow-up. Secondary outcome measures were the numeric pain-rating scale and physical performance tests.



Of 75 participants recruited, 66 (88%) were retained at 1-year follow-up. Factorial analysis of covariance of the main effects showed significant benefit from booster sessions (P = .009) and manual therapy (P = .023) over exercise therapy alone. Group analysis showed that exercise therapy with booster sessions (WOMAC score, -46.0 points; 95% confidence interval [CI]: -80.0, -12.0) and exercise therapy plus manual therapy (WOMAC score, -37.5 points; 95% CI: -69.7, -5.5) had superior effects compared with exercise therapy alone. The combined strategy of exercise therapy plus manual therapy with booster sessions was not superior to exercise therapy alone.



Distributing 12 sessions of exercise therapy over a year in the form of booster sessions was more effective than providing 12 consecutive exercise therapy sessions. Providing manual therapy in addition to exercise therapy improved treatment effectiveness compared to providing 12 consecutive exercise therapy sessions alone.
Targeted property-based testing

We introduce targeted property-based testing, an enhanced form of property-based testing that aims to make the input generation component of a property-based testing tool guided by a search strategy rather than being completely random. Thus, this testing technique combines the advantages of both search-based and property-based testing. We demonstrate the technique with the framework we have built, called Target, and show its effectiveness on three case studies. The first of them demonstrates how Target can employ simulated annealing to generate sensor network topologies that form configurations with high energy consumption. The second case study shows how the generation of routing trees for a wireless network equipped with directional antennas can be guided to fulfill different energy metrics. The third case study employs Target to test the noninterference property of information-flow control abstract machine designs, and compares it with a sophisticated hand-written generator for programs of these abstract machines.
Medium- and high-dose omeprazole plus amoxicillin for eradication ofHelicobacter pylori in duodenal ulcer disease

The purpose of the present study was to investigate theHelicobacter pylori eradication potency of combined amoxicillin-omeprazole treatment in patients with duodenal ulcer disease and to compare the efficacy of two omeprazole and amoxicillin doses concerningH. pylori eradication, ulcer healing, pain relief, and safety. Ninety patients with activeH. pylori-positive (culture and/or histology) duodenal ulcer disease were randomly treated with either omeprazole 20 mg twice a day plus amoxicillin 1 g twice a day (group I,N=30), omeprazole 40 mg twice a day plus amoxicillin 1 g twice a day (group II,N=30), or omeprazole 40 mg twice a day plus amoxicillin 1 g three times a day (group III,N=30) over two weeks, followed by ranitidine at bedtime for another four weeks. The overall proportion ofH. pylori eradication was 83% and of ulcer healing 92% without statistically significant differences between the study groups. Complete pain relief occurred after a median of one day in all groups. Six patients complained of side effects during the therapy phase, which led to therapy discontinuation in one female patient. In conclusion, omeprazole plus amoxicillin is a highly effective and well-tolerated therapy regimen to eradicateH. pylori in duodenal ulcer disease. In addition, the results suggest that there is no clear dose-response relation between the dosages of omeprazole and amoxicillin used in this study on the one hand and theH. pylori eradication rates on the other.
Impact that a program to control severe asthma has on the use of Unified Health System resources in Brazil.

To quantify the use of health care resources among patients enrolled in the Bahia State Asthma and Allergic Rhinitis Control Program.



As of January of 2006, 1405 patients had enrolled in the program, which is carried out in four referral centers in the city of Salvador. These patients formed the basis of this retrospective/prospective, observational cohort study. The preliminary analysis involved 269 consecutive patients, all above the age of 12 and diagnosed with severe asthma. After being seen by pulmonologists, nurses, pharmacologists and psychologists, the patients received inhaled asthma medications. Based on patient interviews and charts, the year preceding enrollment in the program was compared with the first year enrolled in the program in terms of the following quantifiable parameters: hospital admissions; emergency room visits; courses of oral corticosteroids; and days of school/work missed due to asthma attacks.



In this sample of patients with severe asthma, enrollment in the program resulted in significant reductions in the number of emergency room visits and hospital admissions (of 85% and 90%, respectively). There were also reductions in the number of school/work days missed due to asthma attacks and in the number of courses of oral corticosteroids (of 86% and 67%, respectively).



A program designed to control severe asthma in referral outpatient clinics and including pharmacological services at no charge can lead to a pronounced reduction in the demand for Unified Health Care System resources.
A randomized controlled trial of a feedback method for improving empathic accuracy in psychotherapy.

To develop and evaluate a feedback method for reducing empathic errors in psychotherapy.



Randomized controlled trial conducted in a university-affiliated out-patient psychiatric clinic.



Sixteen non-psychotic patients treated for Axis I disorders by 12 psychiatry residents were randomly assigned to intervention and control conditions. In both conditions, at the end of each session, patients rated their own functioning on the Global Assessment of Functioning scale, and therapists predicted patients' ratings. Patients predicted their therapist's accuracy and therapists rated their confidence in their own predictions. In the intervention condition, therapists and patients reviewed their respective ratings from the previous session together. In the control condition, ratings were given directly to the investigator without being reviewed by either patients or therapists.



Therapists in the intervention condition showed greater overall accuracy than controls as well as evidence of increasing empathy later in therapy on the Barrett-Lennard empathy subscale. Patients in the control group perceived their therapists as significantly more or less accurate than was warranted according to the accuracy measure (over-/under-idealization). Therapists in the control group were more likely than those in the intervention group to overestimate their own accuracy (overconfidence). Affective responses to the instrument were positive overall and did not differ by condition.



An intervention such as the one tested in this study may be a practical and useful method for improving accuracy of understanding in a variety of training and clinical settings.
Plasma pharmacokinetics of N -[2-(dimethylamino)ethyl]acridine-4-carboxamide in a phase I trial

DACA {N-[2-(dimethylamino)ethyl]acridine-4-carboxamide} is an acridine derivative with high activity against solid tumours in mice and a dual mode of cytotoxic action involving topoisomerases I and II. The plasma pharmacokinetics of DACA were studied in 28 patients with solid tumours in a phase I trial. A single dose was given every 3 weeks, being escalated from a starting dose of 18 mg/m2 (as the dihydrochloride trihydrate salt) to a maximal dose, limited by severe pain in the infusion arm, of 1000 mg/m2. Drug was given by constant intravenous infusion with a target delivery period of 3 h. Blood samples were taken from the contralateral arm before, during and for up to 72 h after the infusion. DACA was separated from plasma by solid-phase extraction and was analysed by reversed-phase high-performance liquid chromatography (C18 column) using fluorescence detection. A two-compartment pharmacokinetic model provided the best fit for the concentration-time profiles obtained for most patients showing clearance of 1.00 ± 0.36 l h−1 kg−1, a volume of distribution of the central compartment of 0.72 ± 0.55 l/kg, an initial half-life of 0.28 ± 0.19 h and a terminal half-life of 2.04 ± 0.94 h. All pharmacokinetic parameters were independent of dose, indicating first-order kinetics. As DACA binds strongly to α1-acid glycoprotein, plasma concentrations of this protein were determined and used to estimate free-drug fractions in plasma. Estimated values for the free fraction varied from 0.9% to 3.3% and were lower than those determined by equilibrium dialysis for mice and rats (15% and 16%, respectively). At the maximum tolerated dose (MTD) of 750 mg/m2, the area under the drug concentration-time curve (AUC) was 46.2 ± 4.4 μM h, exceeding that obtained in mice treated at the MTD (23.4 μM h). On the other hand, the corresponding free-drug AUC was 0.92 ± 0.03 μM h, much lower than the corresponding value (3.5 μM h) determined for mice. These results suggest that free-drug rather than total drug concentrations are more appropriate for interspecies dose comparisons when significant differences exist in the free plasma fraction.
Comparison of laparoscopic radiofrequency ablation versus open resection in the treatment of symptomatic-enlarging hepatic hemangiomas: a prospective study

Radiofrequency ablation (RFA) has been demonstrated to be a promising therapy for symptomatic large hepatic hemangioma. However, there is a lack of studies to demonstrate the benefits and disadvantages of RFA as compared with surgical resection for managing hepatic hemangioma. The aim of this study was to evaluate the outcomes of RFA compared with conventional open resection (ORES) for the treatment of symptomatic-enlarging hepatic hemangiomas. A total of 66 patients with symptomatic-enlarging hepatic hemangiomas (4 cm ≤ diameter < 10 cm) who required surgical treatment were divided into two groups: 32 patients underwent laparoscopic radiofrequency ablation (LRFA) and the other 34 patients underwent ORES. We compared the two groups in terms of radiologic response, clinical response, operative time, estimated blood loss, postoperative pain score and analgesic requirement, length of hospital stay, postoperative complications and hospital cost. The radiologic and clinical responses were comparable between groups. LRFA had significantly shorter operative time (138 vs. 201 min, P < 0.001) and less blood loss (P < 0.001) than ORES. Patients after LRFA experienced significantly less pain and required less analgesia use. Moreover, patients underwent LRFA had significantly shorter length of hospital stay (P < 0.001) and lower hospital cost (P = 0.017). No severe morbidities or mortality was observed, and the overall morbidity rate was similar between groups. As a new minimal invasive treatment option, laparoscopic radiofrequency ablation is as safe and effective a procedure as open resection for patients with symptomatic-enlarging hepatic hemangiomas smaller than 10 cm.
Effect of functional neuromuscular stimulation on postural related orthostatic stress in individuals with acute spinal cord injury.

The purpose of the study was to evaluate the cardiovascular responses of functional neuromuscular stimulation (FNS) on postural-related orthostatic stress in individuals with acute spinal cord injury. Two tetraplegics and three paraplegics participated in this study. A repeated measure design was used in which subjects underwent two graded-tilt table (0 degrees, 15 degrees, 30 degrees, 45 degrees, 60 degrees) orthostatic stress tests with and without FNS (randomized treatment order) of the knee extensors and foot plantar flexors. Successive one-minute digital readings of heart rate (HR) and blood pressure were obtained with an electronic pulse oximeter and automated blood pressure monitor, respectively. Analysis of covariance (ANCOVA) revealed significant test position (tilt angle) and treatment condition (with or without FNS) main effects, but no significant interactions. Between-treatment pairwise contrasts showed that systolic blood pressure was lower without FNS for 15 degrees, 30 degrees, 45 degrees g, and 60 degrees of tilt, while diastolic blood pressure was lower without FNS at 30 degrees and 45 degrees of tilt. In contrast, HR showed a progressive rise with increasing tilt angle. Functional neuromuscular stimulation may be an important treatment adjunct to minimize cardiovascular changes during postural orthostatic stress in individuals with acute spinal cord injury.
Psychometric development of the retinopathy treatment satisfaction questionnaire (RetTSQ).

Objectives were to evaluate the psychometric properties and to determine optimal scoring of the retinopathy treatment satisfaction questionnaire (RetTSQ) in a cross-sectional study of 207 German patients with diabetic retinopathy and a wide range of treatment experience. Forty patients (19%) also had clinically significant macular oedema. Principal components analysis was used to identify factor structures and Cronbach's alpha to assess internal consistency reliabilities. Two highly reliable subscales represented negative versus positive aspects of treatment (both alpha = 0.85). A highly reliable total score can be calculated (alpha = 0.90). Construct validity was examined by testing expected relationships of RetTSQ scores with visual impairment, stage of diabetic retinopathy, additional impact of macular oedema, SF-12 scores and scores of the RetDQoL measure of quality of life in diabetic retinopathy. Worse impairment, worse diabetic retinopathy and macular oedema were associated with less treatment satisfaction. RetTSQ scores correlated moderately with SF-12 scores (r: 0.33-0.53, p < 0.001) and RetDQoL scores (r: 0.43-0.51, p < 0.001).  Repeating the analyses in a subsample with experience of more intense treatment showed very similar results. It can be concluded that the RetTSQ is valid and reliable for people with diabetic retinopathy with or without macular oedema who have experienced different treatments.
DNA Modification Study of Major Depressive Disorder: Beyond Locus-by-Locus Comparisons

Major depressive disorder (MDD) exhibits numerous clinical and molecular features that are consistent with putative epigenetic misregulation. Despite growing interest in epigenetic studies of psychiatric diseases, the methodologies guiding such studies have not been well defined.



We performed DNA modification analysis in white blood cells from monozygotic twins discordant for MDD, in brain prefrontal cortex, and germline (sperm) samples from affected individuals and control subjects (total N = 304) using 8.1K CpG island microarrays and fine mapping. In addition to the traditional locus-by-locus comparisons, we explored the potential of new analytical approaches in epigenomic studies.



In the microarray experiment, we detected a number of nominally significant DNA modification differences in MDD and validated selected targets using bisulfite pyrosequencing. Some MDD epigenetic changes, however, overlapped across brain, blood, and sperm more often than expected by chance. We also demonstrated that stratification for disease severity and age may increase the statistical power of epimutation detection. Finally, a series of new analytical approaches, such as DNA modification networks and machine-learning algorithms using binary and quantitative depression phenotypes, provided additional insights on the epigenetic contributions to MDD.



Mapping epigenetic differences in MDD (and other psychiatric diseases) is a complex task. However, combining traditional and innovative analytical strategies may lead to identification of disease-specific etiopathogenic epimutations.
Does random urine drug testing reduce illicit drug use in chronic pain patients receiving opioids?

Prescription drug abuse and illicit drug use are common in chronic pain patients. Adherence monitoring with screening tests, and urine drug testing, periodic monitoring with prescription monitoring programs, has become a common practice in recent years. Random drug testing for appropriate use of opioids and use of illicit drugs is often used in pain management practices. Thus, it is expected that random urine drug testing will deter use of illicit drugs, and also improve compliance.



To study the prevalence of illicit drug use in patients receiving opioids for chronic pain management and to compare the results of illicit drug use with the results from a previous study.



A prospective, consecutive study.



Interventional pain management practice setting in the United States.



A total of 500 consecutive patients on opioids, considered to be receiving stable doses of opioids supplemental to their interventional techniques, were studied by random drug testing. Testing was performed by rapid drug screen. Results were considered positive if one or more of the monitored illicit drugs including cocaine, marijuana (THC), methamphetamine or amphetamines were present.



Illicit drug use was evident in 80 patients, or 16%, with marijuana in 11%, cocaine in 5%, and methamphetamine and/or amphetamines in 2%. When compared with previous data, the overall illicit drug use was significantly less. Illicit drug use in elderly patients was absent.



The prevalence of illicit drug abuse in patients with chronic pain receiving opioids continues to be a common occurence. This study showed significant reductions in overall illicit drug use with adherence monitoring combined with random urine drug testing.
Efficacy, safety and tolerability of two dosing regimens in adolescent schizophrenia: double-blind study.

Effective treatments for adolescent schizophrenia are needed.



To compare efficacy and safety of two dosing regimens of risperidone.



Double-blind, 8-week study. Patients, 13-17 years, with an acute episode of schizophrenia, randomised 1:1 to risperidone 1.5-6.0 mg/day (regimen A; n=125) or 0.15-0.6 mg/day (regimen B; n=132).



Mean total Positive and Negative Syndrome Scale (PANSS) score improved significantly (P<0.001; effect size=0.49) from baseline to end-point for regimen A (mean=96.4 (s.d.=15.39) to mean=72.8 (s.d.=22.52)) compared with regimen B (mean=93.3 (s.d.=14.14) to mean=80.8 (s.d.=24.33)). Treatment-emergent adverse events occurred in 74% (regimen A) and 65% (regimen B) of patients; 4% of patients overall discontinued for adverse events. Mean change in body weight was 3.2 kg (s.d.=3.49) for regimen A and 1.7 kg (s.d.=3.29) for regimen B.



Adolescent patients in the regimen A group showed greater improvement in total PANSS compared with the regimen B group. Treatment was well tolerated.
Deep breathing heart rate variability is associated with inspiratory muscle weakness in chronic heart failure.

There is a synchronism between the respiratory and cardiac cycles. However, the relationship of inspiratory muscle weakness in chronic heart failure (CHF) on cardiac autonomic modulation is unknown. The purpose of the present investigation was to evaluate the impact of inspiratory muscle strength on the magnitude of respiratory sinus arrhythmia.



Ten CHF (62 ± 7 years--left ventricle eject fraction of 40 ± 5% and New York Heart Association class I-III) and nine matched-age healthy volunteers (64 ± 5 years) participated in this study. Heart rate variability (HRV) was obtained at rest and during deep breathing manoeuvre (DB-M) by electrocardiograph.



CHF patients demonstrated impaired cardiac autonomic modulation at rest and during DB-M when compared with healthy subjects (p < 0.05). Moreover, significant and positive correlations between maximal inspiratory pressure and inspiratory-expiratory differences (r = 0.79), expiratory/inspiratory ratio (r = 0.83), root mean square of the successive differences (r = 0.77), standard deviation of NN intervals (r = 0.77), low frequency (r = 0.77), and high frequency (r = 0.70) were found during DB-M. At rest, significant correlations were found also.



Patients with CHF presented impaired cardiac autonomic modulation at rest. In addition, cardiac autonomic control of heart rate was associated with inspiratory muscle weakness in CHF. Based on this evidence, recommendations for future research applications of respiratory muscle training can bring to light a potentially valuable target for rehabilitation.
Treatment of refractory anterior knee pain using botulinum toxin type A (Dysport) injection to the distal vastus lateralis muscle: a randomised placebo controlled crossover trial

This randomised controlled crossover trial examined the efficacy of botulinum toxin type A (BoNT-A) injection, plus an exercise programme, to remediate chronic anterior knee pain (AKP) associated with quadriceps muscle imbalance.



24 individuals with refractory AKP received either BoNT-A (500 U Dysport) or the same volume saline injection to the vastus lateralis (VL) muscle and performed home exercises focusing on re-training the vastus medialis (VM) muscle. All subjects were offered open-label injection at 12 weeks. Knee-related disability (anterior knee pain scale; AKPS) and activity-induced pain (10 cm visual analogue scale) at 12 weeks were the primary outcomes. Peak isometric extensor force was recorded and normalised VL:VM ratios were derived from simultaneous surface electromyography. Self-reported pain and disability measures were collected at six time points to a mean of 20±8 months.



14 subjects received BoNT-A and 10 placebo injection. Improvement at 12 weeks was significantly greater for BoNT-A compared with placebo-injected subjects for the AKPS (p<0.03), pain on kneeling (p<0.004), squatting (p<0.02) and level walking (p<0.04). At week 12, five placebo subjects crossed over to open-label injection. At 24 weeks, 16 of 19 BoNT-A-injected and two of the remaining five placebo-injected subjects were either satisfied or very satisfied with treatment outcomes. Improvements were maintained in 11 of 14 BoNT-A-injected and two of five placebo subjects available at longer-term follow-up.



BoNT-A injection produced a greater reduction in pain and disability than placebo injection in carefully selected patients with chronic AKP related to quadriceps muscle imbalance.