nils-herrmann/clean_scirepeval huggingface dataset:
Rotational laxity after anatomical ACL reconstruction measured by 3-D motion analysis: a prospective randomized clinical trial comparing anatomic and nonanatomic ACL reconstruction techniques

To compare the ability of three different anterior cruciate ligament (ACL) reconstruction techniques to normalize rotational knee stability 1 year after ACL reconstruction. Two of these techniques are so-called anatomic techniques. Three different ACL reconstruction techniques were tested for their ability to normalize rotational knee stability in a prospective randomized study. Forty-seven ACL-deficient (ACLD) patients were randomized to transtibial single-bundle (SB), anatomic SB, and double-bundle ACL reconstruction. Three-dimensional motion analysis was performed preoperatively and at 1-year follow-up to evaluate tibial rotation and rotational stiffness. Motion data were captured using an eight-camera motion analysis system. Tibial rotation was determined during walking, running, and a pivoting task. Other outcome parameters were KT-1000 knee laxity measurements and the subjective outcome scores KOOS and IKDC. Three-dimensional motion analysis demonstrated that the tibial internal rotation and the rotational stiffness did not differ between the ACL reconstruction techniques during walking, running, and pivoting at 1-year follow-up. Objective knee stability and subjective outcome scores did not differ between the reconstruction groups. No significant difference in rotational stability walking, running, and pivoting was seen between anatomic and nonanatomic ACL reconstruction techniques at 1-year follow-up. Therapeutic study,
Zonisamide monotherapy in a multi-group clinic

Reports on zonisamide monotherapy are limited despite favourable preliminary data, and typically restricted to tertiary referral centres. The goal of this study is to report clinical experience with zonisamide monotherapy in a large, multi-group clinic setting.



We reviewed the charts of patients treated with zonisamide monotherapy in the Neurology Department of the Kelsey-Seybold Clinic (Houston, Texas) during an 18-month period. We analysed subgroups of patients who were naive to antiepileptic drug (AED) therapy (Group 1) and those who had previous exposure to AEDs (Group 2).



The study included 54 paediatric and adult patients with a variety of seizure types: 15 patients in Group 1 and 39 patients in Group 2. Mean maintenance zonisamide dosages in the two groups were similar (193 mg/day in Group 1 vs. 218 mg/day in Group 2). Thirty-eight patients (70.4%) continued zonisamide monotherapy, with 7 patients (13.0%) adding a second AED and 9 patients (16.7%) switching to a different drug. Of the 24 patients who became seizure free on zonisamide monotherapy, 11 were on the 100-mg initial dosage. Zonisamide monotherapy was well tolerated.



Zonisamide monotherapy is safe and effective for a variety of seizure types and may be appropriate as first-line therapy in some cases.
Health outcomes of continuous positive airway pressure versus oral appliance treatment for obstructive sleep apnea: a randomized controlled trial.

Continuous positive airway pressure (CPAP) and mandibular advancement device (MAD) therapy are commonly used to treat obstructive sleep apnea (OSA). Differences in efficacy and compliance of these treatments are likely to influence improvements in health outcomes.



To compare health effects after 1 month of optimal CPAP and MAD therapy in OSA.



In this randomized crossover trial, we compared the effects of 1 month each of CPAP and MAD treatment on cardiovascular and neurobehavioral outcomes.



Cardiovascular (24-h blood pressure, arterial stiffness), neurobehavioral (subjective sleepiness, driving simulator performance), and quality of life (Functional Outcomes of Sleep Questionnaire, Short Form-36) were compared between treatments. Our primary outcome was 24-hour mean arterial pressure. A total of 126 patients with moderate-severe OSA (apnea hypopnea index [AHI], 25.6 [SD 12.3]) were randomly assigned to a treatment order and 108 completed the trial with both devices. CPAP was more efficacious than MAD in reducing AHI (CPAP AHI, 4.5 ± 6.6/h; MAD AHI, 11.1 ± 12.1/h; P < 0.01) but reported compliance was higher on MAD (MAD, 6.50 ± 1.3 h per night vs. CPAP, 5.20 ± 2 h per night; P < 0.00001). The 24-hour mean arterial pressure was not inferior on treatment with MAD compared with CPAP (CPAP-MAD difference, 0.2 mm Hg [95% confidence interval, -0.7 to 1.1]); however, overall, neither treatment improved blood pressure. In contrast, sleepiness, driving simulator performance, and disease-specific quality of life improved on both treatments by similar amounts, although MAD was superior to CPAP for improving four general quality-of-life domains.



Important health outcomes were similar after 1 month of optimal MAD and CPAP treatment in patients with moderate-severe OSA. The results may be explained by greater efficacy of CPAP being offset by inferior compliance relative to MAD, resulting in similar effectiveness.
Deep wound infections after spinal fusion in children with cerebral palsy: a prospective cohort study.

Prospective cohort.



To (1) calculate the rate of deep wound infection in children with cerebral palsy (CP) after spinal fusion surgery; (2) identify factors (patient, laboratory, and surgical) associated with deep wound infection development; and (3) report causative organisms.



Wound infection after spine fusion for CP is more common than after spine fusion for most other diagnoses.



We prospectively gathered data on 204 consecutive pediatric patients with CP who underwent surgery at 7 institutions. Univariate and multivariate regression analysis was performed to analyze patient, laboratory, and surgical characteristics to identify factors that were significantly associated with infection development. Statistical significance was set at a value of P less than 0.05.



Deep wound infection developed in 13 (6.4%) children. The mean time to infection development was 34.2 ± 60.2 days. On univariate analysis, older age, larger curve size, presence of gastrostomy/gastrojejunostomy tube, higher preoperative serum white blood cell count, and longer operative time were significantly associated with deep wound infection. On multivariate analysis, only the presence of a gastrostomy/gastrojejunostomy tube remained significant (1.9-fold risk of deep wound infection compared with patients without tubes). Escherichia coli was the most common organism cultured from the wound sites (5 patients). Other infective agents were: Pseudomonas aeruginosa (2), methicillin-susceptible Staphylococcus aureus (1), Proteus mirabilis (1), and polymicrobial organisms (4).



Deep wound infection occurred in 6.4% of children with CP after spinal fusion. The presence of a gastrostomy/gastrojejunostomy tube was a significant predictor of infection. Gram-negative organisms were the most common causative agents. Surgeons should be cognizant of these factors when treating children with CP and may consider Gram-negative antibiotic prophylaxis.
A drug use survey among clients of harm reduction sites across British Columbia, Canada, 2012

In British Columbia (BC), understanding of high-risk drug use trends is largely based on survey and cohort study data from two major cities, which may not be representative of persons who use drugs in other regions. Harm reduction stakeholders, representing each of the five geographic health regions in BC, identified a need for data on drug use to inform local and regional harm reduction activities across the province. The aims of this project were to (1) develop a drug use survey that could be feasibly administered at harm reduction (HR) sites across all health regions and (2) assess the data for differences in reported drug use frequencies by region.



A pilot survey focusing on current drug use was developed with stakeholders and administered among clients at 28 HR supply distribution sites across the province by existing staff and peers. Data were collated and analysed using univariate and bivariate descriptive statistics to assess differences in reported drug use frequencies by geography. A post-survey evaluation was conducted to assess acceptability and feasibility of the survey process for participating sites.



Crack cocaine, heroin, and morphine were the most frequently reported drugs with notable regional differences. Polysubstance use was common among respondents (70%) with one region having 81% polysubstance use. Respondents surveyed in or near their region's major centre were more likely to report having used crack cocaine (p < 0.0001) and heroin (p < 0.0001) in the past week as compared to those residing >50 km from the major centre. Participants accessing services >50 km from the regional centre were more likely to have used morphine (p < 0.0001). There was no difference in powder cocaine use by client/site proximity to the regional centre. Participating sites found the survey process acceptable, feasible to administer annually, and useful for responding to client needs.



The survey was a feasible way for harm reduction sites across BC to obtain drug use data from clients who actively use drugs. Drug use frequencies differed substantially by region and community proximity to the regional centre, underlining the need for locally collected data to inform service planning.
The Know & Go! program improves knowledge for patients with coronary heart disease in pilot testing.

To determine if patients hospitalized for angioplasty could learn about symptoms, risk factors, and care-seeking behaviors before and after discharge and to assess patient acceptability of the intervention.



Thirty-two women and 32 men were randomly assigned to groups and completed an intervention pretest. The experimental group viewed the Know & Go! slide presentation at baseline and 2 and 4 months after discharge. A satisfaction survey was mailed to patients in the experimental group.



There were no significant differences between groups in clinical or sociodemographic characteristics. The experimental group scored significantly higher on an intervention posttest at study completion (F = 15.21; P < .001). Patients were highly satisfied with the program and computer technology (range 0-12, M = 9.57 ± 1.83).



The Know & Go! intervention was safe, effective, and acceptable to patients in pilot testing. Results support refinement and further testing of the intervention for patients diagnosed with coronary heart disease.
The MRI-detected osteophyte score is a predictor for undergoing joint replacement in patients with end-stage knee osteoarthritis.

The aim of this prospective cohort study was to examine whether MRI-detected osteoarthritis (OA)-structural changes at baseline could predict knee OA patients who would undergo total knee arthroplasty (TKA).



In total, 128 end-stage medial-type knee OA patients were enrolled and followed up for 6 months. MRI using the whole-organ MRI scoring (WORMS) method, radiographic findings, visual analog scale (VAS) for pain and a patient-oriented outcome measure, and the Japanese Knee Osteoarthritis Measure (JKOM) were recorded at baseline. The area under the curve (AUC) was estimated to determine the discriminative value of the prediction models.



While 74 patients (57.8%) did not undergo TKA, the remaining 54 patients (42.2%) underwent TKA during this period. The AUCs of the receiver operating characteristic (ROC) curve for the activities of daily living (ADL) score evaluated by the JKOM ADL score [0.70 (95% CI: 0.60-0.79)] and osteophyte score [0.72 (0.64-0.81)] were 0.70 or greater. The JKOM ADL score (17/40) and the osteophyte score (30/98) showed relative risks (RR) of 2.61 (1.32-5.15) and 3.01 (1.39-6.52) for undergoing TKA, respectively.



The osteophyte score detected by MRI, in addition to ADL score, was found to be an important factor in determining whether the patient should undergo TKA.
Control of 24-hour intragastric acidity with morning dosing of immediate-release and delayed-release proton pump inhibitors in patients with GERD.

GOALS
To compare the effects of immediate-release omeprazole and 2 different delayed-release proton pump inhibitors on 24-hour intragastric acidity in gastroesophageal reflux disease patients.



Because of its unique pharmacokinetic properties, immediate-release omeprazole does not need to be dosed before a meal to control intragastric acidity. Previous studies showed effectiveness of immediate-release omeprazole in controlling nocturnal intragastric acidity with bedtime dosing. This is the first study to compare the effects of prebreakfast dosing of immediate-release omeprazole and delayed-release lansoprazole and pantoprazole on 24-hour intragastric acidity.



To compare the effects of prebreakfast dosing of immediate-release omeprazole 40 mg capsules, lansoprazole 30 mg capsules, and pantoprazole 40 mg tablets on 24-hour intragastric acidity.



Fifty-five patients with gastroesophageal reflux disease received 7 consecutive once-daily morning doses of each drug in this open-label, randomized, 3-period crossover study. On day 7, intragastric pH was recorded for 24 hours.



After 7 days, the percentage of time with intragastric pH >4 over 24 hours was 59.7% (14.3 hours) with immediate-release omeprazole, 48.8% (11.7 hours) with lansoprazole (P=0.005), and 41.8% (10.0 hours) with pantoprazole (P<0.001). Median intragastric pH was significantly higher with immediate-release omeprazole than with lansoprazole (P=0.003) or pantoprazole (P<0.001). All drugs were well tolerated.



When dosed in the morning, immediate-release omeprazole provided significantly better control of 24-hour intragastric acidity than lansoprazole and pantoprazole.
The Effects of a Graded Activity Intervention for Low Back Pain in Occupational Health on Sick Leave, Functional Status and Pain: 12-Month Results of a Randomized Controlled Trial

Behaviorally oriented graded activity interventions have been suggested for sick-listed workers with low back pain on return to work, but have not been extensively evaluated.  One hundred and thirty-four workers were randomly assigned to either a graded activity intervention (n = 67) or usual care (n = 67) and followed-up for 12 months.  The graded activity group returned back to work faster with a median of 54 days compared to 67 days in the usual care group. The graded activity intervention was more effective after approximately 50 days post-randomization (HRR = 1.9, CI = 1.2–3.1, p = 0.01). Differences between the groups in number of recurrent episodes, total number of days of sick leave due to low back pain, and total number of days of sick leave due to all diagnoses, were in favor of the graded activity group, although not statistically significant. No effects of the graded activity intervention were found for functional status or pain.  Graded activity intervention is a valuable strategy to enhance short-term return to work outcomes.
Effectiveness of a Peer Support Programme versus Usual Care in Disease Management of Diabetes Mellitus Type 2 regarding Improvement of Metabolic Control: A Cluster-Randomised Controlled Trial

Testing the effectiveness of peer support additionally to a disease management programme (DMP) for type 2 diabetes patients.



Unblinded cluster-randomised controlled trial (RCT) involving 49 general practices, province of Salzburg, Austria. All patients enrolled in the DMP were eligible, n = 337 participated (intervention: 148 in 19 clusters; control: 189 in 20 clusters). The peer support intervention ran over 24 months and consisted of peer supporter recruitment and training, and group meetings weekly for physical exercise and monthly for discussion of diabetes related topics.



At two-year follow-up, adjusted analysis revealed a nonsignificant difference in HbA1c change of 0.14% (21.97 mmol/mol) in favour of the intervention (95% CI -0.08 to 0.36%, p = 0.22). Baseline values were 7.02 ± 1.25% in the intervention and 7.08 ± 1.25 in the control group. None of the secondary outcome measures showed significant differences except for improved quality of life (EQ-5D-VAS) in controls (4.3 points on a scale of 100; 95% CI 0.08 to 8.53, p = 0.046) compared to the intervention group.



Our peer support intervention as an additional DMP component showed no significant effect on HbA1c and secondary outcome measures. Further RTCs with a longer follow-up are needed to reveal whether peer support will have clinically relevant effects.
Psychometric evaluation of the Serbian version of the Quality of Life in Epilepsy Inventory-31 (QOLIE-31)

To evaluate the psychometric properties of the Serbian-language version of the Quality of Life in Epilepsy Inventory-31 (QOLIE-31).



After undergoing a translation and cultural adaptation of its items in order to create a Serbian-language version of QOLIE-31, we assessed its psychometric properties-reliability, construct validity and criterion validity. The sample consisted of 203 adults with epilepsy. Reliability was tested both by assessing the internal consistency and by the test-retest method. Construct validity was assessed by factor analysis, multitrait-scaling analysis and method of known-groups validation. This was achieved by assessing the relationship between scales and external measures (socio-demographic characteristics, seizure severity and etiology of epilepsy). Criterion validity was assessed by correlation analysis between QOLIE-31 and Short form 36 health survey (SF-36) and Neurotoxicity scale-II.



The domains showed high internal consistency (Cronbach's α 0.94). Test-retest reliability for Overall test score was 0.83 (Pearson's coefficient) indicating temporal stability. Seizure severity and etiology of epilepsy significantly influenced all QOLIE-31 domains except the Medication effect domain, with lowest scores in high seizure severity and symptomatic etiology groups. Employment status significantly influenced Overall quality of life, Emotional well-being, Social function and Overall score. Educational level was related to the Emotional well-being domain, with highest scores for students. The QOLIE-31 was highly positively correlated with SF-36 (rho=0.898) and strongly negatively correlated with Neurotoxicity scale-II (rho=-0.783).



Serbian adaptation of the QOLIE-31 questionnaire is reliable and valid for assessing the quality of life in patients with epilepsy.
Prevention of fatal pulmonary embolism and mortality in surgical patients: a randomized double-blind comparison of LMWH with unfractionated heparin.

The incidences of fatal pulmonary embolism and death in surgical patients receiving low-molecular-weight heparin thromboprophylaxis have not been previously determined in large, adequately designed clinical trials and information on the relative efficacy and safety of unfractionated and low-molecular-weight heparin in preventing these clinical endpoints is not available. In a double-blind study, 23078 surgical patients randomly received the low-molecular-weight heparin, certoparin (3000 anti Xa IU) subcutaneously once-daily, or unfractionated heparin (5000 IU) subcutaneously three-times daily, for a minimum of 5 days. The primary outcome measure, autopsy-proven fatal pulmonary embolism recorded up to 14 days after the end of prophylaxis, occurred in 0.152% (95% confidence interval (CI) 0.10, 0.20%; 35 of 23078 patients) of cases, with no significant difference between the certoparin-treated patients (0.147% (95% CI 0.077, 0.217%; 17 of 11542 patients) and patients treated with unfractionated heparin (0.156% (95% CI 0.084, 0.228%; 18 of 11,536 patients, P=0.868). The autopsy rate was 70.2%. Comparing mortality, there was no significant difference between the groups (1 .44% [166 of 11542 certoparin patients] versus 1.27% [146 of 11536 unfractionated heparin patients]; P=0.279). The safety profiles of both treatment groups were similar. Once-daily certoparin and three-times daily unfractionated heparin are equally effective and safe in reducing fatal pulmonary embolism and death to low levels in surgical patients and mirror the findings of comparative efficacy studies using surrogate endpoints.
A novel ensemble machine learning for robust microarray data classification

Microarray data analysis and classification has demonstrated convincingly that it provides an effective methodology for the effective diagnosis of diseases and cancers. Although much research has been performed on applying machine learning techniques for microarray data classification during the past years, it has been shown that conventional machine learning techniques have intrinsic drawbacks in achieving accurate and robust classifications. This paper presents a novel ensemble machine learning approach for the development of robust microarray data classification. Different from the conventional ensemble learning techniques, the approach presented begins with generating a pool of candidate base classifiers based on the gene sub-sampling and then the selection of a sub-set of appropriate base classifiers to construct the classification committee based on classifier clustering. Experimental results have demonstrated that the classifiers constructed by the proposed method outperforms not only the classifiers generated by the conventional machine learning but also the classifiers generated by two widely used conventional ensemble learning methods (bagging and boosting).
Citalopram for the Treatment of Agitation in Alzheimer Dementia: Genetic Influences.

To assess potential genetic influences on citalopram treatment efficacy for agitation in individuals with Alzheimer dementia (AD). Six functional genetic variants were studied in the following genes: serotonin receptor 2A (HTR2A-T102C), serotonin receptor 2C (HTR2C-Cys23Ser), serotonin transporter (5HTT-LPR), brain-derived neurotropic factor (BDNF-Val66Met), apolipoprotein E (ε2, ε3, ε4 variants), and cytochrome P450 (CYP2C19). Treatment response by genotype was measured by (1) the agitation domain of the Neurobehavioral Rating Scale, (2) the modified Alzheimer Disease Cooperative Study-Clinical Global Impression of Change scale (mADCS-CGIC), (3) the agitation domain of the Neuropsychiatric Inventory (NPI), and (4) the Cohen-Mansfield Agitation Inventory.



We utilized data from the Citalopram for Agitation in Alzheimer's Disease (CitAD) database. CitAD was a 9-week randomized, double-blind, placebo-controlled multicenter clinical trial showing significant improvement in agitation and caregiver distress in patients treated with citalopram. Proportional odds logistic regression and mixed effects models were used to examine the above-mentioned outcome measures.



Significant interactions were noted on the NPI agitation domain for HTR2A (likelihood ratio [LR] = 6.19, df = 2, P = .04) and the mADCS-CGIC for HTR2C (LR = 4.33, df = 2, P = .02) over 9 weeks.



Treatment outcomes in CitAD showed modest, although statistically significant, influence of genetic variation at HTR2A and HTR2C loci. Future studies should continue to examine the interaction of known genetic variants with antidepressant treatment in patients with AD having agitation.