nils-herrmann/clean_scirepeval huggingface dataset:
The effectiveness of pulsed electrical stimulation (E-PES) in the management of osteoarthritis of the knee: a protocol for a randomised controlled trial

Osteoarthritis (OA) of the knee is one of the main causes of musculoskeletal disability in the western world. Current available management options provide symptomatic relief (exercise and self-management, medication and surgery) but do not, in general, address the disease process itself. Moreover, adverse effects and complications with some of these interventions (medication and surgery) and the presence of co-morbidities commonly restrict their use. There is clearly a need to investigate treatments that are more widely applicable for symptom management and which may also directly address the disease process itself. In two randomised controlled trials of four and 12 weeks duration, pulsed electrical stimulation was shown to be effective in managing the symptoms of OA of the knee. Laboratory and animal studies demonstrate the capacity of externally applied electric and electromagnetic fields to positively affect chondrocyte proliferation and extracellular matrix protein production. This latter evidence provides strong theoretical support for the use of electrical stimulation to maintain and repair cartilage in the clinical setting and highlights its potential as a disease-modifying modality.



A double-blind, randomised, placebo-controlled, repeated measures trial to examine the effectiveness of pulsed electrical stimulation in providing symptomatic relief for people with OA of the knee over 26 weeks. Seventy people will be recruited and information regarding age, gender, body mass index and medication use will be recorded. The population will be stratified for age, gender and baseline pain levels. Outcome measures will include pain (100 mm VAS and WOMAC 3.1), function (WOMAC 3.1), stiffness (WOMAC 3.1), patient global assessment (100 mm VAS) and quality of life (SF-36). These outcomes will be measured at baseline, four, 16 and 26 weeks. Activity levels will be measured at baseline and 16 weeks using accelerometers and the Human Activity Profile questionnaire. A patient global perceived effect scale (11-point Likert) will be completed at 16 and 26 weeks.



This paper describes the protocol for a randomised, double-blind, placebo-controlled trial that will contribute to the evidence regarding the use of sub-sensory pulsed electrical stimulation in the management of OA of the knee.
Illicit drug exposure in patients evaluated for alleged child abuse and neglect.

Substantiation of drug exposure in cases with alleged maltreatment is important to provide proper treatment and services to these children and their families. A study performed at University of Iowa Hospitals and Clinics showed that 30% of pediatric patients with burn injuries, which were due to child maltreatment, were also exposed to illicit drugs.



The children presenting to the University of Iowa Hospitals and Clinics with alleged maltreatment have been tested for illicit substances since 2004. The objective of this study was to analyze the presence of illicit drug exposure in the pediatric subpopulation admitted to pediatric inpatient and outpatient units for an evaluation for abuse/neglect.



The study design is a retrospective chart review. Using hospital databases, every pediatric chart with a child abuse/neglect allegation was retrieved. The association between risk factors and clinical presentation and illicit drug test result was assessed. Excel and SAS were used for statistical analysis. Institutional review board approval was obtained to conduct this study.



Six hundred sixty-five charts met study inclusion criteria for child abuse/neglect allegation. Of those, 232 cases were tested for illicit drugs between 2004 and 2008 per the testing protocol. Thirty-four cases (14.7%) tested positive on a drug test. Positive test rates based on clinical presentation were 28.6% (18/63) in neglect cases, 16.1% (5/31) in cases with soft tissue injuries, 14.3% (4/28) in burn injuries, 10.0% (2/20) in cases with sexual abuse, 7.1% (2/28) in cases with fractures, and 4.8% (3/62) in abusive head trauma cases. There were long-term abuse findings in 129 children (55.6%). Logistic regression analysis revealed that positive drug testing was most significantly associated with clinical symptoms suggesting physical abuse or neglect versus sexual abuse (odds ratio [OR] = 6.70; 95% confidence interval [CI], 1.26-35.49; P = 0.026), no or public health insurance versus those with private insurance (OR = 4.49; 95% CI, 1.47-13.66; P = 0.008), history of parental drug abuse versus those without parental history of drug abuse (OR = 3.42; 95% CI, 1.38-8.46; P = 0.008), and history of domestic violence versus those without a history of domestic violence (OR = 2.81; 95% CI, 1.08-7.30; P = 0.034).



The results of this study showed that an illicit drug screening protocol used in the assessment of children evaluated for child abuse identified almost 15% of the population of allegedly abused and neglected children who were tested according to a protocol being exposed to illicit drugs. Thus, routine drug testing of at least children assessed for neglect and nonaccidental burn and soft tissue injuries, children with a history of either parental drug use or domestic violence is recommended.
Mechanisms for an effect of acetylcysteine on renal function after exposure to radio-graphic contrast material: study protocol

Contrast-induced nephropathy is a common complication of contrast administration in patients with chronic kidney disease and diabetes. Its pathophysiology is not well understood; similarly the role of intravenous or oral acetylcysteine is unclear. Randomized controlled trials to date have been conducted without detailed knowledge of the effect of acetylcysteine on renal function. We are conducting a detailed mechanistic study of acetylcysteine on normal and impaired kidneys, both with and without contrast. This information would guide the choice of dose, route, and appropriate outcome measure for future clinical trials in patients with chronic kidney disease.



We designed a 4-part study. We have set up randomised controlled cross-over studies to assess the effect of intravenous (50 mg/kg/hr for 2 hrs before contrast exposure, then 20 mg/kg/hr for 5 hrs) or oral acetylcysteine (1200 mg twice daily for 2 days, starting the day before contrast exposure) on renal function in normal and diseased kidneys, and normal kidneys exposed to contrast. We have also set up a parallel-group randomized controlled trial to assess the effect of intravenous or oral acetylcysteine on patients with chronic kidney disease stage III undergoing elective coronary angiography. The primary outcome is change in renal blood flow; secondary outcomes include change in glomerular filtration rate, tubular function, urinary proteins, and oxidative balance.



Contrast-induced nephropathy represents a significant source of hospital morbidity and mortality. Over the last ten years, acetylcysteine has been administered prior to contrast to reduce the risk of contrast-induced nephropathy. Randomized controlled trials, however, have not reliably demonstrated renoprotection; a recent large randomized controlled trial assessing a dose of oral acetylcysteine selected without mechanistic insight did not reduce the incidence of contrast-induced nephropathy. Our study should reveal the mechanism of effect of acetylcysteine on renal function and identify an appropriate route for future dose response studies and in time randomized controlled trials.
Combining Attention Training with Internet-Based Cognitive-Behavioural Self-Help for Social Anxiety: A Randomised Controlled Trial

Guided Internet-based cognitive-behavioural self-help (ICBT) has been proven to be effective for social anxiety disorder (SAD) by several independent research groups. However, as the proportion of clinical significant change has room for improvement, new treatments should be developed and investigated. A novel treatment is attention bias modification (ABM). This study aimed at evaluating the combination of ABM and ICBT. We compared two groups, one group receiving ICBT and ABM targeting attentional avoidance and the other group receiving ICBT and control training. ABM and control training tasks were both based on the dot-probe paradigm. A total of 133 participants, diagnosed with SAD, were randomised to these two groups. The attention training group (N = 66) received 2 weeks of daily attention training followed by 9 weeks of ICBT. The control group (N = 67) received 2 weeks of daily control training, also followed by 9 weeks of ICBT. Social anxiety measures as well as the attention bias were assessed at pre-assessment, at week 2, and at post-treatment. Results showed no significant differences between the attention training group and the control group. Both groups improved substantially on social anxiety symptoms from pre- to post-assessment (dwithin = 1.39-1.41), but showed no change in attention processes (dwithin = 0.10-0.17). In this trial, the attention modification training failed to induce differential change in attention bias. Results demonstrate that the applied ABM procedure with its focus on the reduction of attentional avoidance was ineffective in the Internet-based setting. The results do not suggest that adding ABM targeting attentional avoidance to ICBT results in better outcomes than ICBT alone.
Probabilistic model of the human protein-protein interaction network

A catalog of all human protein-protein interactions would provide scientists with a framework to study protein deregulation in complex diseases such as cancer. Here we demonstrate that a probabilistic analysis integrating model organism interactome data, protein domain data, genome-wide gene expression data and functional annotation data predicts nearly 40,000 protein-protein interactions in humans—a result comparable to those obtained with experimental and computational approaches in model organisms. We validated the accuracy of the predictive model on an independent test set of known interactions and also experimentally confirmed two predicted interactions relevant to human cancer, implicating uncharacterized proteins into definitive pathways. We also applied the human interactome network to cancer genomics data and identified several interaction subnetworks activated in cancer. This integrative analysis provides a comprehensive framework for exploring the human protein interaction network.
Haemodialysis catheters increase mortality as compared to arteriovenous accesses especially in elderly patients.

Catheter use has been associated with an increased mortality risk in haemodialysis patients. However, differences in the all-cause and cause-specific mortality risk between catheter use and arteriovenous access use in young and elderly haemodialysis patients have not yet been investigated.



In this prospective cohort study of 1109 incident haemodialysis patients from 38 centres in the Netherlands, hazard ratios (HRs) with 95% confidence intervals (95% CIs) were calculated for 2-year all-cause, infection-related and cardiovascular mortality in patients with a catheter as compared to patients with an arteriovenous access stratified for age (< 65 years and ≥ 65 years).



Of the 1109 patients, 919 had an arteriovenous access and 190 had a catheter. The mortality rate was 76 per 1000 person-years in young patients with an arteriovenous access, 129 per 1000 person-years in young patients with a catheter, 222 per 1000 person-years in elderly patients with an arteriovenous access and 427 per 1000 person-years in elderly patients with a catheter. The adjusted HR was 3.15 (95% CI: 2.09-4.75) for elderly patients with a catheter as compared to young patients with an arteriovenous access. The adjusted HRs in elderly patients with a catheter as compared to elderly patients with an arteriovenous access were 1.54 (95% CI: 1.13-2.12) for all-cause mortality, 1.60 (95%: CI 0.62-4.19) for infection-related mortality and 1.67 (95% CI: 1.04-2.68) for cardiovascular mortality.



Especially, elderly haemodialysis patients with a catheter have an increased all-cause, infection-related and cardiovascular mortality risk as compared to patients with an arteriovenous access.
Validity and applicability of a new recording method for hypertension.

Blood pressure measurement methods and conditions are determinants of hypertension diagnosis. A recent British guideline recommends systematic 24-h ambulatory blood pressure monitoring. However, these devices are not available at all health centers and they can only be used by 1 patient per day. The aim of this study was to test a new blood pressure recording method to see if it gave the same diagnostic results as 24-h blood pressure monitoring.



One-hour blood pressure monitoring under routine clinical practice conditions was compared with standard method of day time recording by analyzing the coefficient of correlation and Bland-Altman plots. The Kappa index was used to calculate degree of agreement. Method sensitivity and specificity were also analyzed.



Of the 102 participants, 89 (87.3%) obtained the same diagnosis regardless of method, with high between-method agreement (κ= 0.81; 95% confidence interval, 0.71-0.91). We observed robust correlations between diastolic (r=0.85) and systolic blood pressure (r=0.76) readings. Sensitivity and specificity for the new method for diagnosing white coat hypertension were 85.2% (95% confidence interval 67.5%-94.1%) and 92% (95% confidence interval, 83.6%-96.3%), respectively.



One-hour blood pressure monitoring is a valid and reliable method for diagnosing hypertension and for classifying hypertension subpopulations, especially in white coat hypertension and refractory hypertension. This also leads to a more productive use of monitoring instruments.
Exploratory clinical studies of a synthetic HIV-1 Tat epitope vaccine in asymptomatic treatment-naïve and antiretroviral-controlled HIV-1 infected subjects plus healthy uninfected subjects.

TUTI-16 is a synthetic universal HIV-1 Tat epitope vaccine, designed to induce anti-Tat antibodies that block the function of circulating Tat, an HIV encoded protein secreted by HIV-1 infected cells. Circulating Tat activates CD4 T cells, permitting HIV replication and sustained viremia. Safety, immunogenicity and antiretroviral potential of TUTI-16 were explored in a randomized double-blind dose-escalating study in asymptomatic treatment-naïve HIV-1 infected subjects. TUTI-16 was safe, with mild local and systemic injection-related adverse reactions, but the antibody response was barely detectable. Surprisingly, a highly statistically significant reduction of HIV-1 viral load was found in the lowest 30 μg vaccine dose group (p < 0.01) but not at the higher doses. We posited that an anti-Tat antibody response below the limit of detection inhibited HIV viral load at this dose, an effect nullified at higher vaccine doses by activating cytokines induced by adjuvant components in TUTI-16. To clarify this immunogenicity/activation conundrum open label immunogenicity studies were performed in healthy HIV uninfected and aviremic ART-controlled HIV-infected subjects. These established that (1) healthy HIV negative subjects had robust antibody responses, maximal with 1 mg TUTI-16, (2) ART-controlled aviremic HIV infected subjects had similarly robust antibody responses, and (3) adjuvant-induced increases of HIV viral load did not occur in the presence of ART. These studies provided us a basis for the design of a protocol to explore the therapeutic potential of TUTI-16 vaccination to provide drug free control of HIV-1 viremia.
Development of a community health inclusion index: an evaluation tool for improving inclusion of people with disabilities in community health initiatives

Community health initiatives often do not provide enough supports for people with disabilities to fully participate in healthy, active living opportunities. The purpose of this study was to design an instrument that focused on integrating disability-related items into a multi-level survey tool that assessed healthy, active living initiatives.



The development and testing of the Community Health Inclusion Index (CHII) involved four components: (a) literature review of studies that examined barriers and facilitators to healthy, active living; (b) focus groups with persons with disabilities and professionals living in geographically diverse settings; (c) expert panel to establish a final set of critical items; and (d) field testing the CHII in 164 sites across 15 communities in 5 states to assess the instrument's reliability.



Results from initial analysis of these data indicated that the CHII has good reliability. Depending on the subscale, Cronbach's alpha ranged from 0.700 to 0.965. The CHII's inter-rater agreement showed that 14 of the 15 venues for physical activity or healthy eating throughout a community had strong agreement (0.81 - 1.00), while one venue had substantial agreement (0.61 - 0.80).



The CHII is the first instrument to operationalize community health inclusion into a comprehensive assessment tool that can be used by public health professionals and community coalitions to examine the critical supports needed for improving healthy, active living among people with disabilities.
Equations, Contractions, and Unique Solutions

One of the most studied behavioural equivalences is bisimilarity. Its success is much due to the associated bisimulation proof method, which can be further enhanced by means of “bisimulation up-to” techniques such as “up-to context.”
 A different proof method is discussed, based on a unique solution of special forms of inequations called contractions and inspired by Milner’s theorem on unique solution of equations. The method is as powerful as the bisimulation proof method and its “up-to context” enhancements. The definition of contraction can be transferred onto other behavioural equivalences, possibly contextual and non-coinductive. This enables a coinductive reasoning style on such equivalences, either by applying the method based on unique solution of contractions or by injecting appropriate contraction preorders into the bisimulation game.
 The techniques are illustrated in CCS-like languages; an example dealing with higher-order languages is also shown.
A Subgroup Analysis of Chinese Patients Switched to Paliperidone Palmitate One-Month Injectable by Prior Oral Antipsychotic Treatment.

Safely tapering current antipsychotic medication, while balancing efficacy and tolerability, is an important consideration when switching patients from their antipsychotic therapy to a new treatment. The efficacy and tolerability of paliperidone palmitate one-month (PP1M) in Chinese patients switched from previous antipsychotic treatments were examined in order to develop effective switching and dosing strategies.



A 13-week open-label, single arm, prospective, interventional study was conducted in Chinese patients (n = 610) with acute schizophrenia to examine their response, by previous treatment group, when switched to PP1M (75-150 mg eq).



Among 610 patients with ≥ 30% reduction in PANSS total score were 191/263 (72.6%) risperidone/paliperidone extended-release patients, 36/52 (69.2%) olanzapine patients, and 214/293 (73.0%) other antipsychotic patients. Patient functioning and adherence were significantly (p ≤ 0.05) improved for all subgroups.



Patients on higher doses of prior antipsychotics generally took longer to withdraw from their current medication. Most patients were administered the 100 mg eq dose, and all subgroups received a similar mean dose (114-119 mg eq) of PP1M. Recommendations for transitioning patients to PP1M from each subgroup are discussed.
The oncologic outcome and immediate surgical complications of lipofilling in breast cancer patients: a multicenter study--Milan-Paris-Lyon experience of 646 lipofilling procedures.

Lipofilling is now performed to improve the breast contour, after both breast-conserving surgery and breast reconstruction. However, injection of fat into a previous tumor site may create a new environment for cancer and adjacent cells. There is also no international agreement regarding lipofilling after breast cancer treatment.



The authors included three institutions specializing in both breast cancer treatment and breast reconstruction (European Institute of Oncology, Milan, Italy; Paris Breast Center, Paris, France; and Leon Berard Centre, Lyon, France) for a multicenter study. A collective chart review of all lipofilling procedures after breast cancer treatment was performed.



From 2000 to 2010, the authors reviewed 646 lipofilling procedures from 513 patients. There were 370 mastectomy patients and 143 breast-conserving surgery patients. There were 405 patients (78.9 percent) with invasive carcinoma and 108 (21.1 percent) with carcinoma in situ. The average interval between oncologic surgical interventions and lipofilling was 39.7 months. Average follow-up after lipofilling was 19.2 months. The authors observed a complication rate of 2.8 percent (liponecrosis, 2.0 percent). Twelve radiologic images appeared after lipofilling in 119 breast-conserving surgery cases (10.1 percent). The overall oncologic event rate was 5.6 percent (3.6 percent per year). The locoregional event rate was 2.4 percent (1.5 percent per year).



Lipofilling after breast cancer treatment leads to a low complication rate and does not affect radiologic follow-up after breast-conserving surgery. A prospective clinical registry including high-volume multicenter data with a long follow-up is warranted to demonstrate the oncologic safety. Until then, lipofilling should be performed in experienced hands, and a cautious oncologic follow-up protocol is advised.



Therapeutic, IV [corrected].
Neonatal neurobehavior effects following buprenorphine versus methadone exposure.

To determine the effects of in utero exposure to methadone or buprenorphine on infant neurobehavior.



Three sites from the Maternal Opioid Treatment: Human Experimental Research (MOTHER) study, a double-blind, double-dummy, randomized clinical trial participated in this substudy.



Medical Centers that provided comprehensive maternal care to opioid-dependent pregnant women in Baltimore, MD, Providence, RI and Vienna, Austria.



Thirty-nine full-term infants.



The Neonatal Intensive Care Unit (NICU) Network Neurobehavioral Scale (NNNS) was administered to a subgroup of infants on postpartum days 3, 5, 7, 10, 14-15 and 28-30.



While neurobehavior improved for both medication conditions over time, infants exposed in utero to buprenorphine exhibited fewer stress-abstinence signs (P < 0.001), were less excitable (P < 0.001) and less over-aroused (P < 0.01), exhibited less hypertonia (P < 0.007), had better self-regulation (P < 0.04) and required less handling (P < 0.001) to maintain a quiet alert state relative to in utero methadone-exposed infants. Infants who were older when they began morphine treatment for withdrawal had higher self-regulation scores (P < 0.01), and demonstrated the least amount of excitability (P < 0.02) and hypertonia (P < 0.02) on average. Quality of movement was correlated negatively with peak NAS score (P < 0.01), number of days treated with morphine for NAS (P < 0.01) and total amount of morphine received (P < 0.03). Excitability scores were related positively to total morphine dose (P < 0.03).



While neurobehavior improves during the first month of postnatal life for in utero agonist medication-exposed neonates, buprenorphine exposure results in superior neurobehavioral scores and less severe withdrawal than does methadone exposure.