nils-herrmann/clean_scirepeval huggingface dataset:
Randomised controlled trial of the effectiveness of a respiratory health worker in reducing impairment, disability, and handicap due to chronic airflow limitation.

A randomised controlled trial was undertaken to determine whether a respiratory health worker was effective in reducing the respiratory impairment, disability, and handicap experienced by patients with chronic airflow limitation attending a respiratory outpatient department. The 152 adults (aged 30-75 years) who participated had a prebronchodilator forced expiratory volume in one second (FEV1) below 60% predicted and no other disease. They were randomised to receive the care of a respiratory health worker or the normal services provided by the outpatient department. The respiratory health worker provided health education and symptom and treatment monitoring in liaison with primary care services. After one year there was little difference between the two groups in spirometric values (FEV1 and forced vital capacity before and after salbutamol 200 micrograms), disability (six minute walking distance and paced step test), and handicap (sickness impact profile, hospital anxiety and depression scale). Patients not looked after by the respiratory health worker were more likely to die (relative risk 2.9 (95% confidence limits 0.8, 10.2); when age and FEV1 were controlled for this risk increased to 5.5 (95% confidence limits 1.2, 24.5). Patients looked after by the respiratory health worker attended their general practitioner more frequently and were prescribed a greater range of drugs. This is the third study to have found limited measurable benefit in terms of morbidity from the intervention of a respiratory health worker. This may be due to the ability of such workers to keep frail patients alive.
Protocol for the Cognitive Interventions and Nutritional Supplements (CINS) trial: A randomized controlled multicenter trial of a brief intervention (BI) versus a BI plus cognitive behavioral treatment (CBT) versus nutritional supplements for patients with long-lasting muscle and back pain

Brief intervention programs are clinically beneficial, and cost efficient treatments for low back pain, when offered at 8-12 weeks, compared with treatment as usual. However, about 30% of the patients do not return to work. The European Guidelines for treatment of chronic low back pain recommends Cognitive Behavioral Therapy (CBT), but conclude that further research is needed to evaluate the effectiveness of CBT for chronic low back pain.



The aim of the multicenter CINS trial (Cognitive Interventions and Nutritional Supplements) is to compare the effectiveness of 4 different interventions; Brief Intervention, Brief Intervention and CBT, Brief Intervention and nutritional supplements of seal oil, and Brief Intervention and nutritional supplements of soy oil. All participants will be randomly assigned to the interventions. The nutritional supplements will be tested in a double blind design. 400 patients will be recruited from a population of chronic low back pain patients that have been sick listed for 2-10 months. Four outpatient clinics, located in different parts of Norway, will participate in recruitment and treatment of the patients.The Brief Intervention is a one session cognitive, clinical examination program based on a non-injury model, where return to normal activity and work is the main goal, and is followed by two booster sessions. The CBT is a tailored treatment involving 7 sessions, following a detailed manual. The nutritional supplements consist of a dosage of 10 grams of either soy or seal oil (capsules) per day for 3 months, administered in a double blind design. All patients will be followed up with questionnaires after 3, 6 and 12 months, while sick leave data will be collected up to at least 24 months after randomization. The primary outcome of the study is sick leave and will be based on register data from the National Insurance Administration. Secondary outcomes include self-reported data on disability, pain, and psychological variables.



To our knowledge, the CINS trial will be the largest, randomized trial of psychological and nutritional interventions for chronic low back pain patients to date. It will provide important information regarding the effectiveness of CBT and seal oil for chronic low back pain patients.
Differential effects of leflunomide and methotrexate on cytokine production in rheumatoid arthritis.

T cells have a pivotal role in RA. Leflunomide inhibits pyrimidine biosynthesis, to which T cells are especially susceptible, and therefore may have a different cytokine profile than methotrexate.



Serum samples of 100 patients with RA, treated with leflunomide (n = 50) or methotrexate (n = 50), were collected at baseline, after 16 weeks and after 1 year's treatment. Serum levels of interleukin 6 (IL6), and interferon (IFN) gamma were determined by ELISA. Additionally, peripheral blood mononuclear cells (PBMC) of five healthy volunteers and three patients with RA were isolated and the effects of the active metabolite of leflunomide (A77-1726, 0-200 mmol/l) on cell proliferation and on IL6 and IFNgamma production were determined by ELISA. In peripheral blood lymphocytes (PBL) and monocytes (PBM) from two healthy volunteers the effects of A77-1726 on IL6 production were measured by ELISA and PCR.



Mean (SEM) serum levels of IFNgamma were significantly reduced after leflunomide treatment (baseline 43 (10) pg/ml; 1 year 29 (7) (p = 0.015), but there was no change in IL6 levels (baseline 158 (41), 1 year 151 (48)). Both IFNgamma and IL6 levels were significantly reduced after methotrexate treatment. This observation was supported by in vitro experiments. The production of IFNgamma by PBL was inhibited by A77-1726, but IL6 production by PBM was not inhibited.



The differential effect on IFNgamma and IL6 production supports the hypothesis that activated T cells are preferentially inhibited by leflunomide. An explanation may be either inhibition of uridine synthesis or effects on signal transduction pathways.
Factors influencing the beliefs of patients with rheumatoid arthritis regarding disease-modifying medication.

To investigate factors influencing the beliefs of patients with rheumatoid arthritis (RA) regarding disease-modifying medication.



Twenty-nine patients with RA either starting a disease-modifying anti-rheumatic drug (DMARD) for the first time or changing DMARD were recruited. Semi-structured interviews, activity diaries and focus groups were conducted over 9 months. A coding framework was developed and data analysed using the constant comparative method to identify key themes.



DMARDs were perceived as central to the management of RA but strong concerns were expressed about potential long-term effects. Beliefs about DMARDs were informed by material from a wide range of sources. Judgements of efficacy were influenced by symptom relief, occurrence of side-effects and perception of alternative treatment options. Perception, reporting and tolerance of side-effects differed widely between individuals. The emotional impact of starting and being withdrawn from medication appeared stronger in people with more experience of DMARD use.



Patients have complex and evolving belief systems relating to DMARDs. Understanding these systems will facilitate the provision of appropriate information and effective support not only in decision-making about treatment but also in relation to discontinuing treatment.
Atomoxetine Effects on Executive Function as Measured by the BRIEF-A in Young Adults with ADHD: A Randomized, Double-Blind, Placebo-Controlled Study

To evaluate the effect of atomoxetine treatment on executive functions in young adults with attention-deficit/hyperactivity disorder (ADHD).



In this Phase 4, multi-center, double-blind, placebo-controlled trial, young adults (18-30 years) with ADHD were randomized to receive atomoxetine (20-50 mg BID, N = 220) or placebo (N = 225) for 12 weeks. The Behavior Rating Inventory of Executive Function-Adult (BRIEF-A) consists of 75 self-report items within 9 nonoverlapping clinical scales measuring various aspects of executive functioning. Mean changes from baseline to 12-week endpoint on the BRIEF-A were analyzed using an ANCOVA model (terms: baseline score, treatment, and investigator).



At baseline, there were no significant treatment group differences in the percentage of patients with BRIEF-A composite or index T-scores ≥60 (p>.5), with over 92% of patients having composite scores ≥60 (≥60 deemed clinically meaningful for these analyses). At endpoint, statistically significantly greater mean reductions were seen in the atomoxetine versus placebo group for the BRIEF-A Global Executive Composite (GEC), Behavioral Regulation Index (BRI), and Metacognitive Index (MI) scores, as well as the Inhibit, Self-Monitor, Working Memory, Plan/Organize and Task Monitor subscale scores (p<.05), with decreases in scores signifying improvements in executive functioning. Changes in the BRIEF-A Initiate (p = .051), Organization of Materials (p = .051), Shift (p = .090), and Emotional Control (p = .219) subscale scores were not statistically significant. In addition, the validity scales: Inconsistency (p = .644), Infrequency (p = .097), and Negativity (p = .456) were not statistically significant, showing scale validity.



Statistically significantly greater improvement in executive function was observed in young adults with ADHD in the atomoxetine versus placebo group as measured by changes in the BRIEF-A scales.
Public and professional education on urgent therapy for acute ischemic stroke: a community-based intervention in Changsha

Excessive delay of presentation for stroke in China is reported. In this study, an intervention trial was conducted to promote urgent therapy for acute ischemic stroke. Two communities in Changsha were selected as either intervention or control community from November 2007 to December 2011. Public and professional education was regularly implemented in the intervention community. Publics’ knowledge about early identification and urgent therapy of ischemic stroke was surveyed before and after intervention in the two communities. During the intervention period, first-ever ischemic stroke cases occurring in the intervention community (intervention group) and that in the control community (control group) were collected and followed for 90 days. After intervention, the publics’ knowledge levels in the intervention community improved significantly. Intervention group’ average presentation time was shorter than control group (8.3 ± 5.8 vs. 10.5 ± 6.5 h, P = 0.018). Percentage of presentation time within 3 h (48.0 %), the rate of ambulance use (59.0 %), and thrombolytic therapy (9.3 %) in the intervention group was all obviously higher than that in the control group (21.5, 41.3, and 4.5, respectively). When admitted, the intervention group had lower mean systolic blood pressure (160.8 ± 26.7 vs. 164.7 ± 26.8 mmHg, P = 0.000) than control group. Survivors in the intervention group were more likely to be in higher Barthel index scoring groups than that in the control group at day 90 [(75, 50–100) vs. (65, 35–90), P = 0.035]. Public and professional education may promote prompt presentation and urgent therapy for ischemic stroke, which may be helpful for patients’ prognosis.
Intravitreal bevacizumab in acute central/hemicentral retinal vein occlusions: three-year results of a prospective clinical study.

To prospectively evaluate the effects of intravitreal bevacizumab (IVB, Avastin; Genentech, Inc., San Francisco, CA) injections in patients with acute central/hemicentral retinal vein occlusions (C/HCRVOs) (≤1 month after the occlusion was diagnosed) over the course of 3 years.



The study included 57 patients with unilateral acute C/HCRVOs. Initially, the treatment for acute C/HCRVO patients consisted of 4 consecutive IVB injections administered off-label at a dose of 2.5 mg per injection, with each injection spaced ∼45 days apart. Thereafter, IVB therapy was flexible, and subsequent injections were administered during scheduled visits whenever a best corrected visual acuity (BCVA) loss of ≥5 Early Treatment Diabetic Retinopathy Study (ETDRS) letters occurred and/or iris/angle neovascularization appeared (regardless of the intraocular pressure level). Changes in the BCVA and foveal thickness (FT), number of IVB injections administered, and incidence of neovascular glaucoma (NVG) were estimated.



The increase in the BCVA score at month 36 was 17.15 (ETDRS letters) (P<0.0001) in cases of nonischemic and 26.81 (ETDRS letters) (P<0.01) in cases of ischemic occlusions. At the end of the follow-up, the proportion of BCVA score improvements greater than 15 ETDRS letters was similar in patients with both forms of occlusions (measured in 45.5% of nonischemic and 45.8% of ischemic patients) (P=0.977). There were significant reductions in FT from baseline values to 230±40.50 μm (P=0.0001) in patients with nonischemic occlusions and 270±40.50 μm (P=0.0001) in patients with ischemic forms. There was a significant difference (P<0.03) in the number of IVB injections administered in patients with nonischemic C/HCRVOs (8.7±1.58) compared to patients with ischemic occlusions (9.7±1.78). NVG occurred in 2 cases of ischemic occlusions.



The 3-year IVB therapy provided sustained vision and FT gains in most phakic patients with acute C/HCRVOs, making this treatment option a rational and viable therapeutic strategy. Bevacizumab was more effective in patients with ischemic occlusions who required a significantly higher number of injections.
Randomized clinical trial of standard dietary treatment versus a low-carbohydrate/high-protein diet or the LighterLife Programme in the management of obesity*.

With the current obesity epidemic, the search for effective weight loss approaches is required. In the present study, changes in weight, body composition and cardiovascular (CV) risk in response to a low-fat, reduced-energy diet (LFRE), a low-carbohydrate/high-protein diet (LCHP), or a commercially available very low-calorie diet (LighterLife; LL) were assessed.



One hundred and twenty obese patients (body mass index ≥35 kg/m² ) underwent a screening period of 3 months on the LFRE. Those who lost >5% of their body weight were maintained on this approach for an additional 3 months, whereas those who lost >10% at this time were maintained for 1 year. Patients failing to achieve these targets were randomly allocated to either the LCHP (n = 38) or LL (n = 34) for a period of 9 months.



Significantly greater weight loss was seen for patients on the LL than the LCHP at 3 (mean (± SD) -11.6 ± 12.9 vs -2.8 ± 4.5 kg, respectively; P < 0.0001) and 9 months (-15.1 ± 21.1 vs -1.9 ± 5.0 kg, respectively; P < 0.0001) after screening. Significantly greater improvement in total cholesterol, low-density lipoprotein-cholesterol, fasting glucose, and diastolic blood pressure was seen at 3 months in patients on the LL compared with the LCHP (P < 0.05). These differences were no longer significant at 9 months, with the exception of fasting glucose. The attrition rate was elevated in the LCHP group, but did not differ significantly from the LL group.



Greater weight loss and improved CV risk were achieved with the LL, which mostly reflects the patient support provided for each dietary treatment.
Predictors of pain and disability outcomes in one thousand, one hundred and eight patients who underwent lumbar discectomy surgery

A key component toward improving surgical outcomes is proper patient selection. Improved selection can occur through exploration of prognostic studies that identify variables which are associated with good or poorer outcomes with a specific intervention, such as lumbar discectomy. To date there are no guidelines identifying key prognostic variables that assist surgeons in proper patient selection for lumbar discectomy. The purpose of this study was to identify baseline characteristics that were related to poor or favourable outcomes for patients who undergo lumbar discectomy. In particular, we were interested in prognostic factors that were unique to those commonly reported in the musculoskeletal literature, regardless of intervention type. This retrospective study analysed data from 1,108 patients who underwent lumbar discectomy and had one year outcomes for pain and disability. All patient data was part of a multicentre, multi-national spine repository. Ten relatively commonly captured data variables were used as predictors for the study: (1) age, (2) body mass index, (3) gender, (4) previous back surgery history, (5) baseline disability, unique baseline scores for pain for both (6) low back and (7) leg pain, (8) baseline SF-12 Physical Component Summary (PCS) scores, (9) baseline SF-12 Mental Component Summary (MCS) scores, and (10) leg pain greater than back pain. Univariate and multivariate logistic regression analyses were run against one year outcome variables of pain and disability. For the multivariate analyses associated with the outcome of pain, older patients, those with higher baseline back pain, those with lesser reported disability and higher SF-12 MCS quality of life scores were associated with improved outcomes. For the multivariate analyses associated with the outcome of disability, presence of leg pain greater than back pain and no previous surgery suggested a better outcome. For this study, several predictive variables were either unique or conflicted with those advocated in general prognostic literature, suggesting they may have value for clinical decision making for lumbar discectomy surgery. In particular, leg pain greater than back pain and older age may yield promising value. Other significant findings such as quality of life scores and prior surgery may yield less value since these findings are similar to those that are considered to be prognostic regardless of intervention type.
Epratuzumab, a humanized anti-CD22 antibody, in aggressive non-Hodgkin's lymphoma: phase I/II clinical trial results.

We conducted a single-center, dose-escalation study evaluating the safety, pharmacokinetics, and efficacy of epratuzumab, an anti-CD22 humanized monoclonal antibody, in patients with aggressive non-Hodgkin's lymphoma.



Epratuzumab was administered once weekly for 4 weeks at 120-1000-mg/m2 doses to 56 patients [most (n = 35) with diffuse large B-cell lymphoma].



Patients were heavily pretreated (median, 4 prior therapies), 25% received prior high-dose chemotherapy with stem cell transplant, and 84% had bulky disease (> or =5 cm). Epratuzumab was well tolerated, with no dose-limiting toxicity. Most (95%) infusions were completed within 1 h. The mean serum half-life was 23.9 days. Across all dose levels and histologies, objective responses (ORs) were observed in five patients (10%; 95% confidence interval, 3-21%), including three complete responses. In patients with diffuse large B-cell lymphoma, 15% had ORs. Overall, 11 (20%) patients experienced some tumor mass reduction. Median duration of OR was 26.3 weeks, and median time to progression for responders was 35 weeks. Two responses are ongoing at > or =34 months, including one rituximab-refractory patient.



These data demonstrate that epratuzumab has a good safety profile and exerts antitumor activity in aggressive non-Hodgkin's lymphoma at doses of > or =240 mg/m2, thus warranting further evaluation in this clinical setting.
Trajectories of change in emotion regulation and social anxiety during cognitive-behavioral therapy for social anxiety disorder.

Cognitive-behavioral therapy (CBT) for social anxiety disorder (SAD) may decrease social anxiety by training emotion regulation skills. This randomized controlled trial of CBT for SAD examined changes in weekly frequency and success of cognitive reappraisal and expressive suppression, as well as weekly intensity of social anxiety among patients receiving 16 weekly sessions of individual CBT. We expected these variables to (1) differ from pre-to-post-CBT vs. Waitlist, (2) have differential trajectories during CBT, and (3) covary during CBT. We also expected that weekly changes in emotion regulation would predict (4) subsequent weekly changes in social anxiety, and (5) changes in social anxiety both during and post-CBT. Compared to Waitlist, CBT increased cognitive reappraisal frequency and success, decreased social anxiety, but had no impact on expressive suppression. During CBT, weekly cognitive reappraisal frequency and success increased, whereas weekly expressive suppression frequency and social anxiety decreased. Weekly decreases in social anxiety were associated with concurrent increases in reappraisal success and decreases in suppression frequency. Granger causality analysis showed that only reappraisal success increases predicted decreases in subsequent social anxiety during CBT. Reappraisal success increases pre-to-post-CBT predicted reductions in social anxiety symptom severity post-CBT. The trajectory of weekly changes in emotion regulation strategies may help clinicians understand whether CBT is effective and predict decreases in social anxiety.


CLINICALTRIALSGOV IDENTIFIER
NCT00380731; http://www.clinicaltrials.gov/ct2/show/NCT00380731?term=social+anxiety+cognitive+behavioral+therapy+Stanford&rank=1.
Sodium bicarbonate vs sodium chloride for the prevention of contrast medium-induced nephropathy in patients undergoing coronary angiography: a randomized trial.

Sodium bicarbonate has been suggested as a possible strategy for prevention of contrast medium-induced nephropathy, a common cause of renal failure associated with prolonged hospitalization, increased health care costs, and substantial morbidity and mortality.



To determine if sodium bicarbonate is superior to sodium chloride for preventing contrast medium-induced nephropathy in patients with moderate to severe chronic kidney dysfunction who are undergoing coronary angiography.



Randomized, controlled, single-blind study conducted between January 2, 2006, and January 31, 2007, and enrolling 353 patients with stable renal disease who were undergoing coronary angiography at a single US center. Included patients were 18 years or older and had an estimated glomerular filtration rate of 60 mL/min per 1.73 m(2) or less and 1 or more of diabetes mellitus, history of congestive heart failure, hypertension, or age older than 75 years.



Patients were randomized to receive either sodium chloride (n = 178) or sodium bicarbonate (n = 175) administered at the same rate (3 mL/kg for 1 hour before coronary angiography, decreased to 1.5 mL/kg per hour during the procedure and for 4 hours after the completion of the procedure).



The primary end point was a 25% or greater decrease in the estimated glomerular filtration rate on days 1 through 4 after contrast exposure.



Median patient age was 71 (interquartile range, 65-76) years, and 45% had diabetes mellitus. The groups were well matched for baseline characteristics. The primary end point was met in 13.3% of the sodium bicarbonate group and 14.6% of the sodium chloride group (relative risk, 0.94; 95% confidence interval, 0.55-1.60; P = .82). In patients randomized to receive sodium bicarbonate vs sodium chloride, the rates of death, dialysis, myocardial infarction, and cerebrovascular events did not differ significantly at 30 days (1.7% vs 1.7%, 0.6% vs 1.1%, 0.6% vs 0%, and 0% vs 2.2%, respectively) or at 30 days to 6 months (0.6% vs 2.3%, 0.6% vs 1.1%, 0.6% vs 2.3%, and 0.6% vs 1.7%, respectively) (P > .10 for all).



The results of this study do not suggest that hydration with sodium bicarbonate is superior to hydration with sodium chloride for the prevention of contrast medium-induced nephropathy in patients with moderate to severe chronic kidney disease who are undergoing coronary angiography.