nils-herrmann/clean_scirepeval huggingface dataset:
CPAP versus oxygen in obstructive sleep apnea.

Obstructive sleep apnea is associated with hypertension, inflammation, and increased cardiovascular risk. Continuous positive airway pressure (CPAP) reduces blood pressure, but adherence is often suboptimal, and the benefit beyond management of conventional risk factors is uncertain. Since intermittent hypoxemia may underlie cardiovascular sequelae of sleep apnea, we evaluated the effects of nocturnal supplemental oxygen and CPAP on markers of cardiovascular risk.



We conducted a randomized, controlled trial in which patients with cardiovascular disease or multiple cardiovascular risk factors were recruited from cardiology practices. Patients were screened for obstructive sleep apnea with the use of the Berlin questionnaire, and home sleep testing was used to establish the diagnosis. Participants with an apnea-hypopnea index of 15 to 50 events per hour were randomly assigned to receive education on sleep hygiene and healthy lifestyle alone (the control group) or, in addition to education, either CPAP or nocturnal supplemental oxygen. Cardiovascular risk was assessed at baseline and after 12 weeks of the study treatment. The primary outcome was 24-hour mean arterial pressure.



Of 318 patients who underwent randomization, 281 (88%) could be evaluated for ambulatory blood pressure at both baseline and follow-up. On average, the 24-hour mean arterial pressure at 12 weeks was lower in the group receiving CPAP than in the control group (-2.4 mm Hg; 95% confidence interval [CI], -4.7 to -0.1; P=0.04) or the group receiving supplemental oxygen (-2.8 mm Hg; 95% CI, -5.1 to -0.5; P=0.02). There was no significant difference in the 24-hour mean arterial pressure between the control group and the group receiving oxygen. A sensitivity analysis performed with the use of multiple imputation approaches to assess the effect of missing data did not change the results of the primary analysis.



In patients with cardiovascular disease or multiple cardiovascular risk factors, the treatment of obstructive sleep apnea with CPAP, but not nocturnal supplemental oxygen, resulted in a significant reduction in blood pressure. (Funded by the National Heart, Lung, and Blood Institute and others; HeartBEAT ClinicalTrials.gov number, NCT01086800 .).
[Efficacy and safety of a single intra-articular injection of 2% hyaluronic acid plus mannitol in knee osteoarthritis over a 6-month period].

To evaluate the safety and efficacy of a single intra-articular injection of 2% hyaluronic acid (HA)+mannitol in symptomatic knee osteoarthritis (KOA).



Pilot, multicentre, open, non-comparative study performed in eighty patients with painful KOA, of whom 79 completed the study. They received one injection of 2ml of 2% HA+0.5% mannitol (Day 0) and were followed-up for 6 months. On Days 0, 15, 30, 60, 90, 120, 150 and 180, pain and joint function were assessed using a visual analogue scale (VAS) and WOMAC index. Efficacy and safety by investigator and patient, and rescue medication, as an indirect measure of pain, were also recorded.



A significant reduction in joint pain, stiffness and functional disability compared with baseline was observed at every follow-up visit (P<.001). Joint function improved by 38.7% on Day 30, reaching 47.5% on Day 180. Rescue medication use decreased from 58.2% at baseline to 2.5% on Day 90, increasing in the last visits. Efficacy and safety were positively evaluated by investigators and patients. No serious adverse events were observed. Mild side effects were reported in 4 patients (local pain and swelling in the infiltration area).



There is evidence that repeated intra-articular injections of HA improve symptoms in KOA. However, studies with a single injection of HA have shown mixed results. This study demonstrates that one single intra-articular injection of non-cross-linked HA reduces joint pain and increases function in patients with KOA over a period of at least 6 months.
Phase 1 b Study of Pegylated Interferon Lambda 1 With or Without Ribavirin in Patients with Chronic Genotype 1 Hepatitis C Virus Infection

Interferon lambda 1 (IFN-k1) is a type III IFN that produces intracellular responses similar to those of IFN-a but in fewer cell types because of differences in the receptor distribution pattern, and this could potentially result in an improved safety profile. This was an open-label three-part study of patients with chronic hepatitis C virus (HCV) genotype 1 infection. Part 1 evaluated single-agent pegylated interferon lambda (PEG-IFN-k) at 1.5 or 3.0 lg/kg administered every 2 weeks or weekly for 4 weeks in patients who had relapsed after previous IFN-a-based treatment. Part 2 evaluated weekly doses of PEGIFN-k ranging from 0.5 to 2.25 lg/kg in combination with ribavirin (RBV) for 4 weeks in treatment-relapse patients. Part 3 evaluated weekly PEG-IFN-k at 1.5 lg/kg in combination with RBV for 4 weeks in treatment-naive patients. Fifty-six patients were enrolled: 24 patients in part 1, 25 patients in part 2, and 7 patients in part 3. Antiviral activity was observed at all PEG-IFN-k dose levels (from 0.5 to 3.0 lg/kg). Two of seven treatmentnaive patients (29%) achieved rapid virological response. Treatment was well tolerated with minimal flu-like symptoms and no significant hematologic changes other than RBV-associated decreases in hemoglobin. The most common adverse events were fatigue (29%), nausea (12%), and myalgia (11%). Six patients experienced increases in aminotransferases that met protocol-defined criteria for dose-limiting toxicity (DLT) or temporarily holding therapy with PEG-IFN-k. Most DLT occurred in patients with high PEGIFN-k exposure.  Weekly PEG-IFN-k with or without daily RBV for 4 weeks is well tolerated with minimal adverse events and hematologic effects and is associated with clear antiviral activity across a broad range of doses in patients with chronic HCV. (HEPATOLOGY 2010;00:000-000)
Development and validation of a short form of the Fugl-Meyer motor scale in patients with stroke.

The 50-item Fugl-Meyer motor scale (FM) is commonly used in outcome studies. However, the lengthy administration time of the FM keeps it from being widely accepted for routine clinical use. We aimed to develop a short form of the FM (the S-FM) with sound psychometric properties for stroke patients.



The FM was administered to 279 patients. It was then simplified based on expert opinions and the results of Rasch analysis. The psychometric properties (including Rasch reliability, concurrent validity, predictive validity, and responsiveness) of the S-FM were examined and were compared with those of the FM. The concurrent validity and responsiveness of the S-FM were further validated in a sample from the Netherlands.



We selected 6 items for each subscale to construct a 12-item S-FM. The S-FM demonstrated high Rasch reliability, high concurrent validity with the original scale, moderate responsiveness, and moderate predictive validity with the comprehensive activities of daily living function. The S-FM also showed sufficient concurrent validity and responsiveness on the Dutch sample.



Our results provide strong evidence that the psychometric properties of the S-FM are comparable with those of the FM. The S-FM contains only 12 items, making it a very efficient measure for assessing the motor function of stroke patients in both clinical and research settings.
Handling categorical variables in effort estimation

Accurate effort estimation is the basis of the software development project management. The linear regression model is one of the widely-used methods for the purpose. A dataset used to build a model often includes categorical variables denoting such as programming languages. Categorical variables are usually handled with two methods: the stratification and dummy variables. Those methods have a positive effect on accuracy but have shortcomings. The other handing method, the interaction and the hierarchical linear model (HLM), might be able to compensate for them. However, the two methods have not been examined in the research area.  giving useful suggestions for handling categorical variables with the stratification, transforming dummy variables, the interaction, or HLM, when building an estimation model.  We built estimation models with the four handling methods on ISBSG, NASA, and Desharnais datasets, and compared accuracy of the methods with each other.  The most effective method was different for datasets, and the difference was statistically significant on both mean balanced relative error (MBRE) and mean magnitude of relative error (MMRE). The interaction and HLM were effective in a certain case.  The stratification and transforming dummy variables should be tried at least, for obtaining an accurate model. In addition, we suggest that the application of the interaction and HLM should be considered when building the estimation model.
A controlled trial of nebulized salbutamol and adrenaline in acute severe asthma

To compare efficacy and safety of nebulisation of adrenaline (2 mg over 10 min) and salbutamol (5 mg over 10 min) in acute severe asthma. Prospective randomized and double blind study. Intensive care unit of a University teaching hospital. 22 asthmatic patients presenting to the emergency room with acute severe asthma. Patients were randomly assigned to receive either adrenaline (n=11) or salbutamol (n=11) via a nebulizer. Additional treatment comprised hydrocortisone hemisuccinate (100 mg) and supplemental oxygen (7l/min). The efficacy and safety of both drugs were evaluated at 20 and 40 min. A statistically significant increase in the Peak Expiratory Flow (PEF) was achieved at the 20th min in both groups (from 85±38 l/min to 120±45 l/min;p<0.001; and from 107±28 l/min to 145±19 l/min;p<0.001; in adrenaline group and salbutamol group respectively). With both drugs, PEF further increased at 40 min to a level that was statistically significant when compared to the 20 min evaluation. The magnitude of the absolute variation in PEF was similar with both drugs. Both drugs induced a significant decrease in heart rate, respiratory frequency and PaCO2 while the increase of PaO2/FIO2 ratio was not significant. The decrease of respiratory frequency at 40 min was more important with salbutamol (p=0.03). No side effects were recorded in both groups. After a single dose, nebulized adrenaline (2 mg) proved as effective and safe as salbutamol (5 mg) in acute severe asthma.
Psychometric properties of KIDSCREEN-27 among childhood cancer survivors and age matched peers: a Rasch analysis

There is a growing population of children and adolescents that have survived their cancer diagnosis. Therefore, it is of great importance to perform follow-up studies with relevant, valid and sensitive measures. It is of interest both to follow changes over time and to compare results from childhood cancer survivors with those from persons without this experience, to fully understand the impact and complexity of childhood cancer in regard to different aspects of quality of life. The aim of this study was to evaluate the psychometric properties of KIDCSREEN-27 for use with survivors of childhood cancer.



KIDSCREEN-27 consists of five dimensions measuring health-related quality of life (HRQoL) in children and adolescents; 63 survivors, (4-6 years post- diagnosis) aged 12-22 and 257 from a comparison group were assessed. KIDSCREEN-27 was evaluated using a Rasch Partial Credit Model (PCM). The aspects studied were the properties of the rating scale including threshold values, internal scale validity, unidimensionality, person response validity, and differential item functioning (DIF) comparing the survivors with peers.



The rating scales revealed almost expected patterns of responses, and the threshold ordering for two of three rating scales displayed acceptable results. The items demonstrated acceptable goodness-of-fit MnSq values in 23 of 27 items (85.2%). The explained variance within each dimension was above the set criterion (50%) for all dimensions except Autonomy & Parent Relations (39.8%). Person goodness-of-fit showed acceptable results in four of five dimensions. No DIF was detected with regard to cancer experience (survivors/comparison group).



Based on the performed Rasch analysis, KIDSCREEN-27 is recommended, with the exception of Autonomy & Parent Relations, due to non-satisfactory unidimensionality, for use among adolescents and young adults who have survived childhood cancer. Still, it is recommended that future research should include a larger sample of childhood cancer survivors in order to monitor some items more thoroughly and explore different levels and patterns of HRQoL in KIDSCREEN-27.
Prehospital triage to primary stroke centers and rate of stroke thrombolysis.

Implementation of prehospital stroke triage is a public policy intervention that can have an immediate impact on acute stroke care in a region.  To evaluate the impact that a citywide policy recommending prehospital triage of patients with suspected stroke to the nearest primary stroke center had on intravenous tissue plasminogen activator (tPA) use in Chicago, Illinois.



Retrospective multicenter cohort study from September 1, 2010, to August 31, 2011 (6 months before and after intervention that began March 1, 2011).



Ten primary stroke center hospitals in Chicago.



All admitted patients with stroke and transient ischemic attack.  Prehospital triage policy of patients with stroke to primary stroke centers.



Intravenous tPA use (measured as a fraction of patients with ischemic strokes arriving through the emergency department).  There were 1075 stroke and transient ischemic attack admissions in the pretriage period and 1172 in the posttriage period. Patient demographic characteristics including age, sex, and risk factors were similar between the 2 periods (mean age, 65 years; 53% female). Compared with the pretriage period, use of emergency medical services increased from 30.2% to 38.1% (P < .001) and emergency medical services prenotification increased from 65.5% to 76.5% (P = .001) after implementation. Rates of intravenous tPA use were 3.8% and 10.1% (P < .001) and onset-to-treatment times decreased from 171.7 to 145.7 minutes (P = .03) in the pretriage and posttriage periods, respectively. Stroke unit admission, symptomatic intracranial hemorrhage rates, and in-hospital mortality were not significantly different between periods. Adjusting for mode of arrival, prehospital notification, and onset-to-arrival time, the posttriage period was independently associated with increased tPA use for patients with ischemic stroke presenting through the emergency department (adjusted odds ratio = 2.21; 95% CI, 1.34-3.64).



Implementation of a prehospital stroke triage policy in Chicago resulted in significant improvements in emergency medical services use and prenotification and more than doubled intravenous tPA use at primary stroke centers.
Effects of a preoperative simplified home rehabilitation education program on length of stay of total knee arthroplasty patients.

In patients with severe knee osteoarthritis (OA), total knee arthroplasty (TKA) is performed for both symptom relief and to achieve better function in daily life. Implementation of efficient TKA rehabilitation programs with shorter length of stay (LOS) and reduced medical expenditures is an important issue in clinical practice. However, the effectiveness of preoperative rehabilitation programs is still under debate. Most preoperative rehabilitation programs last many weeks and may be more expensive than TKA. The purpose of this study was to investigate the effects of a simplified, easy-to-learn, and less time-consuming preoperative rehabilitation education program on TKA patients.



In this randomized controlled study, we allocated all the patients into study and control group according to chart number. The study group, which comprised 126 patients, participated in a 40-min preoperative home rehabilitation education program 4 weeks prior to TKA. One hundred seventeen patients in the control group did not participate in this preoperative program.



The study group required a shorter hospital LOS (mean: 7.12 days; P=0.027) and had less hospitalization-related medical expenditures (mean: 123726 New Taiwan dollars [NTD], equivalent to 4266.4 United States dollars [USD] or 3022.1 [Euros]), (P=0.001) than the control group. However, the study group showed no significant improvement in function when compared to the control group.



Our study demonstrates that a simplified preoperative rehabilitation program can reduce LOS and increase cost savings. This program was recommended as a routine protocol for OA patients before admission for TKA.
Linking gene expression data with patient survival times using partial least squares

There is an increasing need to link the large amount of genotypic data, gathered using microarrays for example, with various phenotypic data from patients. The classification problem in which gene expression data serve as predictors and a class label phenotype as the binary outcome variable has been examined extensively, but there has been less emphasis in dealing with other types of phenotypic data. In particular, patient survival times with censoring are often not used directly as a response variable due to the complications that arise from censoring. We show that the issues involving censored data can be circumvented by reformulating the problem as a standard Poisson regression problem. The procedure for solving the transformed problem is a combination of two approaches: partial least squares, a regression technique that is especially effective when there is severe collinearity due to a large number of predictors, and generalized linear regression, which extends standard linear regression to deal with various types of response variables. The linear combinations of the original variables identified by the method are highly correlated with the patient survival times and at the same time account for the variability in the covariates. The algorithm is fast, as it does not involve any matrix decompositions in the iterations. We apply our method to data sets from lung carcinoma and diffuse large B-cell lymphoma studies to verify its effectiveness.
Monoclonal antibody-purged bone marrow transplantation therapy for multiple myeloma.

Forty patients with plasma cell dyscrasias underwent high-dose chemoradiotherapy and either anti-B-cell monoclonal antibody (MoAb)-treated autologous, anti-T-cell MoAb-treated HLA-matched sibling allogeneic or syngeneic bone marrow transplantation (BMT). The majority of patients had advanced Durie-Salmon stage myeloma at diagnosis, all were pretreated with chemotherapy, and 17 had received prior radiotherapy. At the time of BMT, all patients demonstrated good performance status with Karnofsky score of 80% or greater and had less than 10% marrow tumor cells; 34 patients had residual monoclonal marrow plasma cells and 38 patients had paraprotein. Following high-dose chemoradiotherapy, there were 18 complete responses (CR), 18 partial responses, one non-responder, and three toxic deaths. Granulocytes greater than 500/microL and untransfused platelets greater than 20,000/microL were noted at a median of 23 (range, 12 to 46) and 25 (range, 10 to 175) days posttransplant (PT), respectively, in 24 of the 26 patients who underwent autografting. In the 14 patients who received allogeneic or syngeneic grafts, granulocytes greater than 500/microL and untransfused platelets greater than 20,000/microL were noted at a median of 19 (range, 12 to 24) and 16 (range, 5 to 32) days PT, respectively. With 24 months median follow-up for survival after autologous BMT, 16 of 26 patients are alive free from progression at 2+ to 55+ months PT; of these, 5 patients remain in CR at 6+ to 55+ months PT. With 24 months median follow-up for survival after allogeneic and syngeneic BMT, 8 of 14 patients are alive free from progression at 8+ to 34+ months PT; of these, 5 patients remain in CR at 8+ to 34+ months PT. This therapy has achieved high response rates and prolonged progression-free survival in some patients and proven to have acceptable toxicity. However, relapses post-BMT, coupled with slow engraftment post-BMT in heavily pretreated patients, suggest that such treatment strategies should be used earlier in the disease course. To define the role of BMT in the treatment of myeloma, its efficacy should be compared with that of conventional chemotherapy in a randomized trial.
Naltrexone reduces the relative reinforcing value of nicotine in a cigarette smoking choice paradigm

Human behavioral pharmacology studies can examine how medications that target different neurotransmitter systems influence different aspects of smoking. Naltrexone and bupropion have been shown to alter ad lib smoking behavior; however, medication effects on nicotine reward in a cigarette choice paradigm have yet to be investigated. This study explored the effects of an acute dose of naltrexone, bupropion, or placebo on the relative reinforcing value of nicotine from cigarette smoking using new nicotine and de-nicotinized (Quest, 0.6 and 0.05 mg = “denicotinized”) cigarettes. In a double-blind, within-subjects design, 26 dependent smokers participated in three experimental cigarette smoking sessions following pretreatment with either naltrexone (50 mg), bupropion (300 mg), or placebo. After medication administration and 2 h of monitored deprivation from cigarettes and food, participants rated their responses to the initial exposure to the cigarettes and then participated in four choice sessions over a 2-h period during which they could take four puffs from either cigarette. The relative reinforcing value of nicotine, as measured by the number of nicotine puffs chosen out of 16, was significantly lower following naltrexone compared to placebo. There were no effects of an acute dose of bupropion on nicotine choices. These results suggest that naltrexone may reduce the relative reinforcing effects of nicotine via cigarette smoking and support ongoing investigation of opioid antagonists as potential smoking cessation pharmacotherapies.
Alcohol-facilitated ankylosis of the distal intertarsal and tarsometatarsal joints in horses with osteoarthritis.

To assess the safety and efficacy of alcohol-facilitated ankylosis of the distal intertarsal (DIT) and tarsometatarsal (TMT) joints in horses with osteoarthritis (bone spavin).



Prospective clinical trial.



21 horses with DIT or TMT joint-associated hind limb lameness and 5 nonlame horses.


PROCEDURES
11 horses (group 1) underwent lameness, force-plate, and radiographic examinations; following intra-articular analgesia, lameness and force-plate examinations were repeated. Nonlame horses were used for force-plate data acquisition only. Following localization of lameness to the DIT and TMT joints, contrast arthrographic evaluation was performed; when communication with the tibiotarsal joint was not evident or suspected, 70% ethyl alcohol (3 mL) was injected. Group 1 horses underwent lameness, force-plate, and radiographic examinations every 3 months for 1 year. Ten other horses (group 2) underwent lameness and radiographic examinations followed by joint injection with alcohol; follow-up information was obtained from owners or via clinical examination.



Significant postinjection reduction in lameness (after 3 days to 3 months) was evident for all treated horses. Twelve months after injection, 10 of 11 group 1 horses were not lame; lameness grade was 0.5 in 1 horse. Follow-up information was available for 9 of 10 group 2 horses; 7 were not lame, and 2 remained mildly lame (1 had a concurrent problem in the injected limb, and the other had DIT joint collapse that precluded needle entry).



Intra-articular alcohol injection in horses with bone spavin resulted in a rapid (usually within 3 months) reduction in lameness and joint space collapse.