nils-herrmann/clean_scirepeval huggingface dataset:
Causes of death in patients with acute myocardial infarction treated with angiotensin-converting enzyme inhibitors: findings from the Gruppo Italiano per lo Studio della Sopravvivenza nell'Infarto (GISSI)-3 trial.

The causes of death occurring in clinical trials of myocardial infarction (MI) are scarcely reported in the literature. The present analysis is aimed to describe the inhospital causes of death in patients with acute MI stratified to angiotensin converting enzyme (ACE) inhibitor treatment/no treatment, as described in the GISSI-3 trial. Furthermore, the 5-year survival analysis of GISSI-3 patients is reported.



An independent committee assigned the definition of causes of death of GISSI-3 based on clinical and/or anatomical data. Univariate and multivariable analyses were performed to identify the predictors of early and late deaths. Kaplan-Meier mortality curves were used to describe the effects of ACE-I treatment on mortality on a median follow-up period of 56 months. Patients receiving lisinopril had fewer inhospital cardiac deaths than patients allocated to the no-lisinopril group (4.7% vs 5.3%, P = .052), corresponding to a 12% relative risk reduction. The risk of dying from cardiac rupture was reduced by 39% by lisinopril treatment. The improvement in survival associated with the lisinopril treatment was mainly due to a reduction in cardiac rupture, electromechanical dissociation, and pump failure occurring early (within 4 days) from the onset of MI symptoms. The beneficial effects of lisinopril observed at 6 weeks (8 fewer deaths per 1000 treated patients) were maintained up to nearly 5 years (10 fewer deaths per 1000).



Early administration of ACE inhibitors in unselected patients with acute MI should be considered standard therapy to reduce early deaths, specifically those due to cardiac rupture. The early beneficial effect persisted up to nearly 5 years.
A randomized, controlled effectiveness trial of OROS-methylphenidate compared to usual care with immediate-release methylphenidate in attention deficit-hyperactivity disorder.

The thrice daily dosing regimen of immediate release methylphenidate (IR-MPH) for Attention Deficit/Hyperactivity Disorder (ADHD) requires in-school dosing, leading to issues surrounding dispensing and storage of controlled substances by school personnel and concerns over children?s privacy and the embarrassment associated with taking medication in public at school. OROS-methylphenidate (OROS-MPH) is a once-daily controlled-release formulation of methylphenidate (MPH) developed to overcome some of the limitations associated with IR-MPH and first-generation sustained-release formulations. Randomized, controlled trials (RCTs) that focus on treatment efficacy provide the best evidence for demonstrating whether an intervention works, but under ideal conditions one cannot discount the importance of efficacy study results. However, the most useful information to clinicians comes from an effectiveness study design.



To evaluate the effectiveness and tolerability of OROS-MPH versus usual care with IR-MPH in children aged 6 to 12 years with ADHD.



This 8 week, multicentre, open-label study randomized 147 subjects to either once-daily OROS-MPH or usual care with IR-MPH. Subjects were titrated to a clinically effective dose of either study medication over 4 weeks and maintained on that dose for an additional 4 weeks. The SNAP-IV parent-rating scale was used to assess effectiveness.



OROS-MPH showed statistically significant superiority to IR-MPH in remission rate based on the 18 ADHD symptoms (p=0.0002, X2=13.8, df=1) and severity of ADHD and ODD symptoms (p=0.004, ), as well as on the following secondary assessments: IOWA Conners, Conners Parent Rating Scale (short version), Parent Stress Index, (short version); Visual Analogue Scale for social play; Clinical Global Impression-Severity, Clinical Global Impression-Improvement and Parent Satisfaction with treatment. OROS-MPH and IR-MPH were both well tolerated with a similar side effect profile.



Once-daily OROS-MPH is significantly more effective than usual care with IR-MPH based on multiple outcome measures including remission rate.
Psychological impact of the management of methicillin-resistant staphylococcus aureus (MRSA) in patients with spinal cord injury

Management of MRSA infection includes immediate isolation of the patient. Long periods of isolation are considered to be psychologically detrimental, though little information is available about the impact of isolation as an infection control procedure. The purpose of this study is to examine the psychological well-being of spinal cord injured patients who are isolated as a result of being MRSA positive.  A cross-sectional matched-control study of MRSA positive patients with MRSA negative patients was carried out at the National Spinal Injuries Centre, Stoke Mandeville Hospital, Bucks, England. Sixteen MRSA positive patients, aged 18 to 65, and their matched controls completed a series of questionnaires to measure aspects of psychological impact. The measures used were functional independence, depression, anxiety, and the affective states of anger, vigour, fatigue and confusion.  The MRSA positive spinal cord injured patients were only significantly more angry than the control group, although these isolated patients scored higher in all measures.  In this spinal cord injured group the difference between the psychological well-being of isolated MRSA positive patients and non-isolated MRSA negative patients is not as great as might have been expected. Patients feel that rehabilitation is affected, but the situation may be improved by providing more space and a better view onto the ward.
An effective HIV risk-reduction protocol for drug-using female sex workers.

Female sex workers are especially vulnerable to HIV infection, particularly those who use drugs and engage in street-based sex exchange. This study examines the risk behaviors and HIV serostatus of 806 drug-using female sex workers in Miami and assesses the relative impact of two HIV and hepatitis prevention interventions on changes in risk behavior. Drug-using sex workers were recruited using targeted sampling strategies and were randomly assigned to the NIDA Standard Intervention or an innovative Sex Worker Focused (SWF) Intervention. Outcome analyses indicate that both groups benefited from participation in the intervention trial. However, the SWF Intervention was found to be more efficacious in regard to reductions in unprotected oral sex and sexual violence.
Outcomes of traumatic brain injury in Hong Kong: Validation with the TRISS, CRASH, and IMPACT models

We aimed to test prognostic models (the Trauma Injury Severity Score, International Mission for Prognosis and Analysis of Clinical Trials in Traumatic Brain Injury, and Corticosteroid Randomisation After Significant Head Injury models) for 14-day mortality, 6-month mortality, and 6-month unfavorable outcome in a cohort of trauma patients with traumatic brain injury (TBI) in Hong Kong. We analyzed 661 patients with significant TBI treated in a regional trauma centre in Hong Kong over a 3-year period. The discriminatory power of the models was assessed as the area under the receiver operating characteristic curve. One-sample t-tests were used to compare actual outcomes in the cohort against predicted outcomes. All three prognostic models were shown to have good discriminatory power and no significant systemic over-estimation or under-estimation. In conclusion, all three predictive models are applicable to eligible TBI patients in Hong Kong. These predictive models can be utilized to audit TBI management outcomes for trauma service development in the future.
3D quantitative evaluation of atherosclerotic plaque based on rotational angiography.

Atherosclerosis is a systemic disease that has been shown to cause various cardiovascular diseases and stroke. However, technologies to evaluate the volume of atherosclerotic plaque are limited. We present a method for determination of 3D plaque volume based on RA.



3DRA images obtained from patients were used to evaluate the plaque. Six patients who were diagnosed with atherosclerotic lesions were included. The PR model developed for 3DRA was applied to analyze the geometry of the vessel and calculate the plaque volume. To validate the present method, we tested computer-generated phantoms with different degrees of stenosis.



Application of PR to clinical cases allowed the estimation of plaque morphology and quantification of plaque volume. Technique validation showed that on average, PR can rebuild 92% of the plaque and provide satisfactory determination of plaque volume.



A new approach to obtain plaque volume based on 3DRA is presented. The initial tests in 6 clinical cases and validation with different phantoms showed that this method is feasible. Further validation in a larger clinical series is required to assess the ultimate value of the present technique.
Clinical potential role of circulating microRNAs in early diagnosis of colorectal cancer patients.

Current procedures for diagnosis and biomarker examination of colorectal cancer (CRC) are invasive and unpleasant. There is a great need to identify sensitive and specific biomarkers for early diagnosis of CRC. Circulating microRNAs (miRNAs) are promising molecular markers for CRC prediction. We performed a comprehensive meta-analysis to integrate an evaluation index for diagnostic accuracy of circulating miRNAs in diagnosing CRC patients. Furthermore, we conducted an independent validation set of 49 CRC patients and 49 healthy controls. In our meta-analysis, we found that miR-21 yielded a pooled area under ROC curve (AUC) of 0.867 (sensitivity: 76%, specificity: 82%) in discriminating CRC from controls, and miR-92a yielded a summary AUC of 0.803 (sensitivity: 77%, specificity: 68%); miR-21 had a higher diagnostic efficiency than miR-92a. In the further validation, plasma miR-21 levels in CRC patients were significantly higher than levels observed in healthy subjects. A ROC curve analysis showed a consistent result. However, this phenotype was not present in miR-92a. Moreover, the expression trend of miR-21 in plasma samples was in line with that of tissue samples, along with the cellular level. Current evidences suggest that plasma miR-21 could be a reliable and non-invasive biomarker for CRC diagnosis. Studies with larger cohorts that include the diagnostic value of plasma miR-21 for CRC are warranted.
Effect of canagliflozin on serum uric acid in patients with type 2 diabetes mellitus

Hyperuricaemia is associated with an increased risk of gout, kidney stones and cardiovascular disease. The present post hoc analysis of pooled data from four placebo-controlled phase III studies assessed the effect of canagliflozin, a sodium-glucose co-transporter 2 inhibitor, on serum uric acid levels in patients with type 2 diabetes mellitus (T2DM) and in a subset of patients with hyperuricaemia [defined as baseline serum uric acid ≥475 µmol/l (∼8 mg/dl)]. At week 26, canagliflozin 100 and 300 mg were associated with a ∼13% reduction in serum uric acid compared with placebo. In the subset of patients with hyperuricaemia, placebo-subtracted percent reductions in serum uric acid were similar to those in the overall cohort. More patients in the hyperuricaemic group achieved a serum uric acid level of <360 µmol/l (∼6 mg/dl) with both canagliflozin 100 mg (23.5%) and 300 mg (32.4%) compared with placebo (3.1%). Incidences of gout and kidney stones were low and similar across groups. In conclusion, canagliflozin treatment decreased serum uric acid in patients with T2DM, including those with baseline hyperuricaemia.
Highly refractory acute myeloid leukemia

In this study we evaluated 103 patients suffering from acute myeloid leukemia (AML) who did not respond to induction chemotherapy and defined a subgroup of patients with highly refractory disease characterized by a persistence of more than 1G/L blast cells in the peripheral blood between days 12 and 16 of the first induction cycle. Only seven patients (one female, six males) met these criteria. Their median age was 65 years (range 41–82 years). Four had de novo AML and three secondary AML. Cytogenetic analysis was performed in six patients: complex aberrations were detected in four patients and, unexpectedly, normal karyotypes were found in the other two. Analysis of multidrug-resistance factors revealed high co-expression of P-glycoprotein (P-gp) and lung resistance protein (LRP) in all four patients with highly refractory disease tested a finding in only 6% of patients with refractory disease and 3% of patients who achieved complete remission (CR) of disease. Furthermore, patients with highly refractory AML had substantially higher leukocyte counts than patients with refractory AML or CR, although this was not significant statistically. Overall, patients with highly refractory AML are characterized by a high incidence of complex cytogenetic aberrations and marked expression of drug transporters.
Preventing facial pressure ulcers in patients under non-invasive mechanical ventilation: a randomised control trial.

To comparatively assess the efficacy of four different therapeutic strategies to prevent the development of facial pressure ulcers (FPUs) related to the use of non-invasive mechanical ventilation (NIV) with oro-nasal masks in critically ill hospitalised patients.



This randomised control trial was performed at the high dependency unit in the University General Hospital Gregorio Marañón in Madrid, Spain. Overall, 152 patients with acute respiratory failure were recruited. All patients were hospitalised and received NIV through oro-nasal masks. The Norton tool was used to evaluate the general risk of developing pressure ulcers (PUs). Subjects were divided into four groups, each of them receiving a different treatment. Tissue assessment and preventive care were performed by a member of the research team.



The incidence of FPUs was significantly lower in the group receiving a solution of hyperoxygenated fatty acids (HOFA) when compared with each of the other therapeutic strategies: direct mask (p=0.055), adhesive thin dressing (p=0.03) and adhesive foam dressing (p<0.001).



The application of HOFA on the facial skin in contact with the oro-nasal masks showed the highest efficacy in the prevention of NIV-related FPUs.
Improving management and effectiveness of home blood pressure monitoring: a qualitative UK primary care study.

Self-monitoring blood pressure (SMBP) is becoming an increasingly prevalent practice in UK primary care, yet there remains little conceptual understanding of why patients with hypertension engage in self-monitoring.



To identify psychological factors or processes prompting the decision to self-monitor blood pressure.



A qualitative study of patients previously participating in a survey study about SMBP from four general practices in the West Midlands.



Taped and transcribed in-depth interviews with 16 patients (6 currently monitoring, 2 used to self-monitor, and 8 had never self-monitored). Thematic analysis was undertaken.



Three main themes emerged: 'self' and 'living with hypertension' described the emotional element of living with an asymptomatic condition; 'self-monitoring behaviour and medication' described overall views about self-monitoring, current practice, reasons for monitoring, and the impact on medication adherence; and 'the GP-patient transaction' described the power relations affecting decisions to self-monitor. Self-monitoring was performed by some as a protective tool against the fears of a silent but serious condition, whereas others self-monitor simply out of curiosity. People who self-monitored tended not to discuss this with their nurse or GP, partly due to perceiving minimal or no interest from their clinician about home monitoring, and partly due to fear of being prescribed additional medication.



The decision to self-monitor appeared often to be an individual choice with no schedule or systems to integrate it with other medical care. Better recognition by clinicians that patients are self-monitoring, perhaps utilising the results in shared decision-making, might help integrate it into daily practice.
Safety of abrupt discontinuation of fluoxetine: a randomized, placebo-controlled study.

Selective serotonin reuptake inhibitors may be associated with new adverse events after abrupt discontinuation. Hypothesizing that the long half-life of fluoxetine would be protective, this study analyzed the effects of abrupt fluoxetine discontinuation during a randomized, double-blind, placebo-controlled study of depression maintenance treatment. After 12 weeks of fluoxetine treatment (20 mg/day), 395 responders were abruptly randomized to placebo (N = 96) or to continued fluoxetine (N = 299). Patients were seen at weeks 1, 2, 4, and 6 after randomization. Reports of new or worsened adverse events were similar for both groups at each visit after randomization. Patient discontinuations related to adverse events were also similar in both groups. Mild, self-limited lightheadedness or dizziness occurred in a small percentage of patients who discontinued fluoxetine treatment but was of little clinical significance. No cluster of symptoms suggestive of a discontinuation syndrome was observed. Abrupt discontinuation of fluoxetine treatment was well tolerated and did not seem to be associated with significant clinical risk. Fluoxetine may offer a potential safety advantage over shorter-acting agents with respect to treatment interruption and/or discontinuation and may be a better choice for those patients who are likely to miss doses because of travel or forgetfulness.
The correlation between asthma control and health status: the GOAL study.

The present study examined the association between guideline-derived asthma control and health-related quality of life, assessed using the Asthma Quality of Life Questionnaire (AQLQ), in patients with uncontrolled asthma whose treatment was directed towards achieving the highest possible level of control. The present randomised, double-blind, parallel-group study compared the efficacy of fluticasone propionate (FP) and salmeterol/fluticasone propionate combination (SFC) in achieving two composite, guideline-derived measures of control: total control (TC) and well-controlled (WC) asthma. Not achieving these levels was classed as not well-controlled (NWC). Doses were augmented until patients achieved TC or reached the maximum dose. This dose was maintained for the remainder of the study. AQLQ was assessed at baseline and at each clinic visit. AQLQ scores improved throughout the study, reaching near-maximal levels in patients achieving TC and WC, and 52-week mean scores in the three control groups were statistically significantly different. Clinically meaningful improvements (mean change from baseline) were: TC group (SFC 1.9, FP 1.8), WC (SFC 1.5, FP 1.5) and NWC (SFC 1.0, FP 0.9). In conclusion, the treatment aimed at controlling asthma improves the health-related quality of life to levels approaching normal. The difference in Asthma Quality of Life Questionnaire scores between total control and well-controlled confirms that patients distinguish even between these high levels of control.
A protocol for the 0.9% saline versus Plasma-Lyte 148 for intensive care fluid therapy (SPLIT) study.

0.9% saline is the most commonly used intravenous (IV) fluid in the world. However, recent data raise the possibility that, compared with buffered crystalloid fluids such as Plasma-Lyte 148, the administration of 0.9% saline to intensive care unit patients might increase their risk of acute kidney injury (AKI).



To describe the protocol for the 0.9% Saline v Plasma-Lyte 148 for ICU Fluid Therapy (SPLIT) study.



This is a multicentre, cluster-randomised, double crossover feasibility study to be conducted in four New Zealand tertiary ICUs over a 28-week period and will enroll about 2300 participants. All ICU patients who need crystalloid IV fluid therapy (except those with established renal failure needing dialysis and those admitted to the ICU for palliative care) will be enrolled. Participating ICUs will be randomly assigned to 0.9% saline or Plasma-Lyte 148 as the routine crystalloid IV fluid, in a blinded fashion, in four alternating 7-week blocks.



The primary outcome will be the proportion of patients who develop AKI in the ICU. Secondary outcomes will include the difference between the most recent serum creatinine level measured before study enrollment and the peak serum creatinine level in the ICU; use of renal replacement therapy; and ICU and in hospital mortality. All analyses will be conducted on an intention-to-treat basis.



The SPLIT study started on 1 April 2014 and will provide preliminary data on the comparative effectiveness of using 0.9% saline v Plasma- Lyte 148 as the routine IV fluid therapy in ICU patients.
Efficacy and safety of retreatment in patients with rheumatoid arthritis with previous inadequate response to tumor necrosis factor inhibitors: results from the SUNRISE trial.

To assess the efficacy and safety of 1 versus 2 courses of rituximab over 48 weeks in patients with rheumatoid arthritis (RA).



Adult patients taking methotrexate with a previous inadequate response to > or = 1 tumor necrosis factor inhibitor received 1 course of open-label rituximab (2 x 1000 mg IV) at baseline. From Week 24, patients were randomized to receive an additional course of retreatment with rituximab or placebo. Efficacy responses at Week 48 relative to baseline were assessed.



Of 559 patients who received the open-label first course of rituximab, 475 patients were randomized to a second course (rituximab retreatment: n = 318, placebo retreatment: n = 157). Relative to baseline, patients who took rituximab during retreatment had significantly improved efficacy at Week 48 compared to patients who took a placebo during retreatment [American College of Rheumatology (ACR20) criteria, 54% vs 45%, p = 0.02; change in Disease Activity Score-28 mean -1.9 vs -1.5, p = 0.006]. Differences in efficacy between groups were first observed following Weeks 28-32. Worsening of most components of the ACR core set occurred in the placebo-retreated patients with relative maintenance of these measures in rituximab-retreated patients. Randomized patients who had achieved week 24 ACR responses following the first course had greater odds of losing response if retreated with placebo (odds ratios for ACR20, ACR50, ACR70: 2.09, 2.03, and 4.09, respectively). Following retreatment, the proportion of patients experiencing any adverse events (AE), serious AE, infections, and serious infections were comparable between the rituximab and placebo retreatment groups.



Two courses of rituximab about 6 months apart resulted in improved and sustained efficacy at 1 year, compared with 1 course, with a similar safety profile.