nils-herrmann/clean_scirepeval huggingface dataset:
Analysis of knee functional flexion axis in navigated TKA: identification and repeatability before and after implant positioning

Providing correct rotational alignment of femoral component in total knee arthroplasty (TKA) is mandatory to achieve correct kinematics, good ligament balance and patellar tracking. The purpose of this study was to evaluate potential clinical applications of functional flexion axis (FFA) by analysing the differences between pre- and post-implant placement. This evaluation was supported by the analysis of repeatability, assessing the robustness of the proposed method. Anatomical acquisitions and passive kinematics were acquired on 87 patients undergoing TKA using a commercial navigation system. Knee FFA was estimated, before and after implant positioning, from three flexion–extension movements between 0 and 120°. The angle between FFA and transepicondylar axis was analysed in frontal and axial planes. Repeatability coefficient and intraclass correlation coefficient (ICC) were used to analyse the reliability and the agreement in identifying the axis. The analysed angle presented differences between pre- and post-operative conditions only in the frontal plane (from −8.3 ± 5.5° to −2.8 ± 5.3°) (p < 0.0001). There was good intraobserver reliability and agreement. Repeatability coefficient ranged between 4.4° (3.7–4.9°) and 3.4° (2.9–3.8°), the ICC between 0.87 (0.83–0.91) and 0.93 (0.90–0.95) and the standard deviation ranged between 1.3 and 1.0°. The present study demonstrated that TKA affected the estimation of FFA only in the frontal plane. This method reported good repeatability, demonstrating its usefulness for clinical purposes particularly to evaluate rotational positioning of the femoral component in the axial plane. Case series,
Clinical pharmacokinetics of lofexidine, the alpha 2-adrenergic receptor agonist, in opiate addicts plasma using a highly sensitive liquid chromatography tandem mass spectrometric analysis.

The objective of this investigation was to characterize the pharmacokinetic profile of lofexidine. Lofexidine is an orally bioavailable alpha 2-adrenergic receptor agonist analogue of clonidine that acts centrally to suppress opiate withdrawal symptoms.



During the detoxification period of a phase 3 placebo-controlled, randomized, double-blind trial, six subjects were entered in this preliminary pharmacokinetic study.



Pharmacokinetic analysis of plasma samples collected during study day 7 indicated that C(max) was 3242 +/- 917 ng/L. The mean trough levels between the study days were not significantly different (p > .05), suggesting that the subjects were at steady-state.



Although preliminary due to the limited number of subjects, these findings are the first to document lofexidine clinical pharmacokinetics in opiate addicts using a highly sensitive liquid chromatography tandem mass spectrometric analysis.
The role of interventional radiology for pediatric blunt renal trauma

This study aimed to appraise the role of interventional radiology in children with blunt renal trauma.



The clinical data, injury severity score, days of hospital stay, outcomes and complications of pediatric renal trauma were recorded and evaluated. The two groups: the transcatheter arterial embolization (TAE) group and the non-TAE group were compared for clinical features and laboratory data.



Eighteen pediatric patients (12 boys, 6 girls with average age 12.4 ± 4.7 years) with blunt renal injury were included in the study. Six patients underwent angiography because of contrast medium extravasations in the kidney found on computed tomography of which four subsequently underwent a TAE. The clinical features and laboratory data of patients in the TAE and non-TAE groups were not significantly different. All patients were managed successfully by conservative treatment without complications except one in the non-TAE group who required nephrectomy due to renal arterial hypertension directly related to trauma. Both groups had relatively good results and all patients had normal renal function at follow-up.



TAE is an alternative therapeutic modality for blunt renal injury in children who have contrast medium extravasations in the kidney on angiography.
Immunoscintigraphy of septic loosening of knee endoprosthesis: a retrospective evaluation of the antigranulocyte antibody BW 250/183

Immunoscintigraphy with the use of the antigranulocyte antibody BW 250/183 is a reliable method for detecting infection, especially in septic loosening of hip prostheses, for which purpose quantitative interpretation of the time-activity course is employed. Therefore, we retrospectively studied whether similar results could be achieved in knee prostheses. We verified 28 scintigraphic examinations in 26 patients by histology. Scintigraphy was performed during an early (4–6 h post injection) and a late phase (23–25 h post injection). Infection was diagnosed when activity around the knee prosthesis increased by more than 10% compared with bone marrow. We found a sensitivity and a negative predictive value of 100%, a specificity of 80%, a positive predictive value of 81% and an accuracy of 89%. Specificity and accuracy are lower than in the evaluation of hip prostheses; however, in comparison to other scintigraphic modalities, scintigraphy with the antigranulocyte antibody BW 250/183 is superior in excluding infection and has better specificity and accuracy. Therefore, as in the case of hip prostheses, the described methodology appears to be the scintigraphic modality of choice for knee prostheses.
Acamprosate calcium as augmentation therapy for anxiety disorders.

Glutamate is a major excitatory neurotransmitter, while γ-aminobutyric acid (GABA) is a predominant inhibitory neurotransmitter in the central nervous system. This GABA-glutamate imbalance is thought to play a role in the development of anxiety. Acamprosate calcium is thought to restore this chemical imbalance in alcohol withdrawal.



To examine acamprosate calcium as augmentation therapy for treatment of anxiety.



This 8-week, open-label study was designed to evaluate patients with anxiety who were stable on current medications (selective serotonin-reuptake inhibitors and serotonin-norepinephrine-reuptake inhibitors) but still symptomatic. Acamprosate was dosed at 1998 mg/day. Assessments included the Hamilton Rating Scale for Anxiety (HAM-A) and the Hospital Anxiety and Depression Scale.



Thirteen patients enrolled in the study and received study medication. Acamprosate reduced anxiety symptoms (mean HAM-A score reduction to 8.87 from a baseline of 20). Sixty-two percent of patients receiving acamprosate achieved remission (HAM-A score ≤ 7). Modal dose was 1998 mg/day (range 999-1998). The most commonly reported adverse events were nausea (n = 1), gastrointestinal upset (n = 1), and increased dream activity (n = 1).



Acamprosate calcium may be effective augmentation therapy in patients with treatment-resistant anxiety.
Low vision depression prevention trial in age-related macular degeneration: a randomized clinical trial.

To compare the efficacy of behavior activation (BA) + low vision rehabilitation (LVR) with supportive therapy (ST) + LVR to prevent depressive disorders in patients with age-related macular degeneration (AMD).



Single-masked, attention-controlled, randomized, clinical trial with outcome assessment at 4 months.



Patients with AMD and subsyndromal depressive symptoms attending retina practices (n = 188).



Before randomization, all subjects had 2 outpatient LVR visits, and were then randomized to in-home BA+LVR or ST+LVR. Behavior activation is a structured behavioral treatment that aims to increase adaptive behaviors and achieve valued goals. Supportive therapy is a nondirective, psychological treatment that provides emotional support and controls for attention.



The Diagnostic and Statistical Manual IV defined depressive disorder based on the Patient Health Questionnaire-9 (primary outcome), Activities Inventory, National Eye Institute Vision Function Questionnaire-25 plus Supplement (NEI-VFQ), and NEI-VFQ quality of life (secondary outcomes).



At 4 months, 11 BA+LVR subjects (12.6%) and 18 ST+LVR subjects (23.4%) developed a depressive disorder (relative risk [RR], 0.54; 95% CI, 0.27-1.06; P = 0.067). In planned adjusted analyses the RR was 0.51 (95% CI, 0.27-0.98; P = 0.04). A mediational analysis suggested that BA+LVR prevented depression to the extent that it enabled subjects to remain socially engaged. In addition, BA+LVR was associated with greater improvements in functional vision than ST+LVR, although there was no significant between-group difference. There was no significant change or between-group difference in quality of life.



An integrated mental health and low vision intervention halved the incidence of depressive disorders relative to standard outpatient LVR in patients with AMD. As the population ages, the number of persons with AMD and the adverse effects of comorbid depression will increase. Promoting interactions between ophthalmology, optometry, rehabilitation, psychiatry, and behavioral psychology may prevent depression in this population.
Contralaterally controlled neuromuscular electrical stimulation for recovery of ankle dorsiflexion: a pilot randomized controlled trial in patients with chronic post-stroke hemiplegia.

The aim of this study was to compare the effects of contralaterally controlled neuromuscular electrical stimulation (CCNMES) vs. cyclic neuromuscular electrical stimulation (NMES) on lower extremity impairment, functional ambulation, and gait characteristics.



Twenty-six survivors of stroke with chronic (≥6 mos) foot drop during ambulation were randomly assigned to 6 wks of CCNMES or cyclic NMES. Both groups had ten sessions per week of self-administered home application of either CCNMES or cyclic NMES plus two sessions per week of gait training with a physical therapist. Primary outcomes included lower extremity Fugl-Meyer score, modified Emory Functional Ambulation Profile, and gait velocity. Assessments were made at pretreatment and posttreatment and at 1 and 3 mos after treatment.



There were no significant differences between the groups in the outcome trajectories for any of the measures. With data from both groups pooled, there were significant but modest and sustained improvements in the Fugl-Meyer score and the modified Emory Functional Ambulation Profile but not in gait velocity.



The results support the hypothesis that gait training combined with either CCNMES or cyclic NMES reduces lower extremity impairment and functional ambulation but do not support the hypothesis that CCNMES is more effective than cyclic NMES in patients with chronic post-stroke hemiplegia.
Impaired visuospatial associative memory and attention in obsessive compulsive disorder but no evidence for differential dopaminergic modulation

Patients with obsessive compulsive disorder (OCD) demonstrate impaired cognition in some selected domains. Although serotoninergic dysfunction has been implicated in OCD, recent evidence suggests that dopamine may play a role as well. The aim of the study was to evaluate learning and working memory in OCD and to determine the effects of dopaminergic manipulations on these capacities. Visuospatial associative memory and spatial and verbal working memory were examined in 18 nondepressed patients with OCD and 18 matched healthy controls. The study further investigated whether acute administration of dopamine D2/D3 receptor agonist and antagonist would differentially modulate cognition in OCD. Each participant underwent the cognitive battery three times in a randomized double-blind, placebo-controlled crossover design. Significant impairments in patients compared with controls were noted on the Cambridge Neuropsychological Test Automated Battery (CANTAB) paired associates learning (PAL) and a measure of sustained attention (rapid visual information processing, RVIP) that persisted across all sessions, with deficient strategy in the CANTAB spatial working memory task in the first session alone. Although the dopamine D2/D3 agonist, pramipexole, led to poorer performance on the PAL and RVIP tasks, no differential effects were noted between the two groups. No significant effects were noted for the D2/D3 antagonist, amisulpride. The results are consistent with a specific associative memory deficit in OCD that remained robust despite possible practice effects and compensatory strategies and point to abnormal medial temporal lobe involvement in OCD in addition to the previously implicated frontostriatal loops, with no clear evidence of D2 receptor mediation.
Unmedicated, remitted patients with major depression have decreased serum immunoglobulin A

Patents with major depression have evidence of a proinflammatory state with consistent elevations in acute phase proteins and in the levels of inflammatory mediators such as interleukin-6 and tumor necrosis factor-α. We report here a study of the serum levels of immunoglobulin A (IgA) in medication-free patients with major depression in the remitted state (ruMDD). Selective IgA deficiency is the most common form of immunoglobulin abnormality, and is often associated with a higher than expected incidence of proinflammatory and autoimmune phenomena. We measured serum IgG, IgM, and IgA in 28 ruMDD patients and 27 healthy subjects (Ctrl) at 0 (pretreatment), 7, and 24h following sham depletion and tryptophan (TrpD) depletion conducted at least 8 days apart under balanced, randomized, blinded conditions. Immunoglobulins were measured by automated immunonephelometry. Data were analyzed by repeated measures ANOVA with diagnosis as a fixed effect and drug (TrpD vs. sham), and time as repeated measures factors. Serum IgA was consistently lower in ruMDD patients vs. Ctrl at all time points examined (p<0.04 for main effect of diagnosis). Serum IgG and IgM levels did not show significant differences by diagnosis. Medication-free patients with major depression in the remitted state have a significant reduction in serum IgA levels measured on multiple occasions. In the light of the fact that IgA serves many immunomodulatory, anti-inflammatory roles, this finding supports the concept that major depressive illness represents a proinflammatory state.
Walking faster: distilling a complex prescription for type 2 diabetes management through pedometry.

W ith the growth of pedometry, physical activity recommendations have been distilled to a simple focus on ambulatory volume (i.e., 10,000 steps/day). Although energy balance may be most affected by volume, the concomitant lack of focus on physical activity intensity may undermine realization of intensity-dependent outcomes for those with type 2 diabetes, particularly cardiorespiratory fitness because of its inverse association with HbA1c (A1C) (1) and its predictive power for cardiovascular mortality and morbidity in this population (2–4). Historically, a multicomponent framework, commonly known as FITT (frequency, intensity, time, and type) was used to prescribe how often (frequency per week), at what intensity (typically as indicated by heart rate), for how long (duration or time), and what type of activity (typically aerobic) one should pursue for health or performance outcomes. At a population level, there has been a secular trend in the emphasis on the interrelated factors of FITT. For example, in 1975, physical activity recommendations promoted aerobic exercise (type) at 3–5 days/ week (frequency) at 70–90% of heart rate reserve (intensity) for 20–45 min (time). By 2000, recommendations had evolved to promote aerobic activity 7 days/week at an intensity of 40–85% of heart rate reserve for 20 min (5). The variables that compose this framework for prescription are contained within the clinical practice guidelines from both the American Diabetes Association and the Canadian Diabetes Association (5,6). Regardless of the details of the framework underlying these recommendations, however, the challenge remains how to 1) feasibly translate all FITT factors outside of the exercise physiology laboratory and 2) motivate lifelong physical activity in the type 2 diabetic population. Pedometers may help meet both these challenges. We recently reported that individuals with type 2 diabetes naturally walk at a speed (intensity) that is slower than that associated with the minimal intensity (i.e., moderate) required to derive health benefit, despite increasing their number of steps taken per day (8). Hence, we evaluated a simple educational framework designed to help individuals with type 2 diabetes called Pick up the Pace (PUP; i.e., increasing the intensity by increasing the speed of walking), which recommends 30 min/day on at least 3 days/week within the context of a pedometer-based program. We hypothesized that increased walking speed would result in an improved metabolic risk profile among people with established type 2 diabetes, specifically targeting glycemia and cardiorespiratory fitness.
Followup of cocaine-dependent men and women with antisocial personality disorder.

Long-term outcomes following drug treatment were examined for cocaine-dependent men (N = 453) and women (N = 254) with and without antisocial personality disorder (ASP). In-depth assessments were conducted at treatment intake in 1991-93 and at 1 and 5 years following treatment discharge. Overall, 47.2% of the males and 34.3% of females were diagnosed with ASP using DSM-III-R criteria derived from the Diagnostic Interview Schedule. All groups reduced their cocaine, marijuana, and alcohol use; reduced their levels of psychological distress; and improved in functioning (e.g., employment, arrests, residential status). At Year 5 ASP was associated with an increased likelihood of heavy alcohol use and additional substance abuse treatment among men, whereas women with ASP were more likely to report psychological problems and to receive mental health treatment and other services than either women without ASP or men with ASP. The findings suggest the need to address the specific treatment needs of male and female cocaine abusers with ASP.
A prospective randomized study to evaluate the renoprotective action of beating heart coronary surgery in low risk patients q

Cardiopulmonary bypass (CPB) is widely regarded as an important contributor to renal failure, a well recognized complication following coronary artery surgery (coronary artery bypass grafting (CABG)). Anecdotally off-pump coronary surgery (OPCAB) is considered renoprotective. We examine the extent of renal glomerular and tubular injury in low-risk patients undergoing either OPCAB or on-pump coronary artery bypass (ONCAB).  Forty low-risk patients with normal preoperative cardiac and renal functions awaiting elective CABG were prospectively randomized into those undergoing OPCAB (n 1⁄4 20) and ONCAB (n 1⁄4 20). Glomerular and tubular injury were measured respectively by urinary excretion of microalbumin and retinol binding protein (RBP) indexed to creatinine (Cr). Daily measurements were taken from admission to postoperative day 5. Fluid balance, serum Cr and blood urea were also monitored.  No mortality or renal complication were observed. Both groups had similar demographic makeup, Parsonnet score, functional status and extent of coronary revascularization (2.1 ^ 1.0 vs. 2.5 ^ 0.7 grafts; P 1⁄4 0:08). Serum Cr and blood urea remained normal in both groups throughout the study. A significant and similar rise in urinary RBP:Cr occurred in both groups peaking on day 1 (3183 ^ 2534 vs. 4035 ^ 4079; P 1⁄4 0:43) before reapproximating baseline levels. These trends were also observed with urinary microalbumin:Cr (5.05 ^ 2.66 vs. 6.77 ^ 5.76; P 1⁄4 0:22). Group B patients had a significantly more negative fluid balance on postoperative day 2 (2183 ^ 1118 vs. 637 ^ 847 ml; P 1⁄4 0:03).  Although renal complication or serum markers of kidney dysfunction were absent, sensitive indicators revealed significant and similar injury to renal tubules and glomeruli following either OPCAB or ONCAB. These results suggest that avoidance of CPB does not offer additional renoprotection to patients at low risk of perioperative renal insult during CABG. q 2002 Elsevier Science B.V. All rights reserved.
Combined alpha- and beta-adrenoceptor blockade with labetalol in hypertension.

The antihypertensive effect of labetalol, a new alpha- and beta-adrenoceptor inhibiting agent, was studied in 20 patients in a double-blind crossover trial. A dose of 300 mg daily reduced blood pressure only moderately in the supine position, though in the sitting and standing positions the effect was more pronounced. A dose of 600 mg daily produced statistically significant and clinically relevant reductions in blood pressure in all positions studied. The effect on heart rate was small and of significance only in reducing the heart rate increment due to a change in posture. Side effects were mild: only one patient complained of postural dizziness with the higher dose. We conclude that labetalol is useful in the treatment of mild and moderately severe hypertension.
A phase I study of decitabine and rapamycin in relapsed/refractory AML.

A phase I study utilizing decitabine (DAC) followed by the mammalian target of rapamycin (mTOR) inhibitor, rapamycin, in patients with relapsed/refractory adult AML was undertaken to assess safety and feasibility. Patients received DAC 20mg/m(2) intravenously daily for 5 days followed by rapamycin from day 6 to day 25 at doses of 2 mg, 4 mg, and 6 mg/day in a standard 3+3 dose escalation design. Twelve patients completed treatment for safety evaluation. Maximum tolerated dose (MTD) was not reached, and except for grade 3 mucositis in 4 patients, no other significant unexpected non-hematologic toxicities have occurred indicating safety of this regimen.
A randomised controlled trial of a patient based Diabetes recall and Management system: the DREAM trial: A study protocol [ISRCTN32042030]

Whilst there is broad agreement on what constitutes high quality health care for people with diabetes, there is little consensus on the most efficient way of delivering it. Structured recall systems can improve the quality of care but the systems evaluated to date have been of limited sophistication and the evaluations have been carried out in small numbers of relatively unrepresentative settings. Hartlepool, Easington and Stockton currently operate a computerised diabetes register which has to date produced improvements in the quality of care but performance has now plateaued leaving substantial scope for further improvement. This study will evaluate the effectiveness and efficiency of an area wide 'extended' system incorporating a full structured recall and management system, actively involving patients and including clinical management prompts to primary care clinicians based on locally-adapted evidence based guidelines.



The study design is a two-armed cluster randomised controlled trial of 61 practices incorporating evaluations of the effectiveness of the system, its economic impact and its impact on patient wellbeing and functioning.