nils-herrmann/clean_scirepeval huggingface dataset:
[Comparing the activity of multiple sclerosis (MS) at the minute and at 20 minutes of gadolinium application in magnetic resonance imaging (MRI) of the brain?]

The aim was to compare active disease in patients diagnosed with multiple sclerosis, brain by MRI after gadolinium application at one minute and 20 minutes. A longitudinal, prospective, observational, analytical and comparative study was conducted in 18 patients over 18 years of age diagnosed with multiple sclerosis (MS). An analysis was made for each patient, watching for inflammatory activity in MS lesions, comparing the results to one minute and 20 minutes after the application of gadolinium. For the descriptive analysis, absolute frequencies and percentages were used, as well as means and standard deviations or medians with ranges for the inferential analysis comparing the presence or absence of enhancement in lesions at one minute and 20 minutes; the exact probability test used was Fisher. Finally, the results were analyzed, looking at the gender distribution: 14 (77.8%) were female. The average age was 36.2 ± 9.5 years, with a minimum age of 18 years and a maximum of 55 years; four patients (22.2%) presented further highlight active lesions at 20 minutes, and two patients (11.1%) presented enhancement at one minute. Concluding that MRI in the diagnosis of MS is very important for the detection of activity in lesions caused by the disease, it is evident that the optimum time for evaluation of postcontrast sequences is 20 minutes.
Chronic insomnia: Effects of tryptophan, flurazepam, secobarbital, and placebo

This study compared the effects of l-tryptophan (1 g), secobarbital (100 mg), flurazepam (30 mg), and placebo on sleep in 96 serious insomniacs. Each treatment was given nightly for 7 nights in a separate-group design. Outcome measures were subjective estimates by subjects of a number of sleep parameters during the week of treatment and for 1 week after, and an overall evaluation made by subjects and investigators at the end of the 2 weeks. During the treatment week, flurazepam produced significant improvement on several sleep measures compared to placebo, while tryptophan and secobarbital did not. Flurazepam and secobarbital produced withdrawal symptoms during the post-treatment week, while tryptophan and placebo did not. Sleep latency was not significantly improved by tryptophan during the treatment week, but continued to improve during the post-treatment week, resulting in a significant difference between tryptophan and baseline in week 2.
Maraviroc Clinical Test (MCT) as an alternative tool to decide CCR5-antagonists prescription in naïve HIV-infected patients.

Our aim was to analyze the virological response to a combined antiretroviral therapy started after Maraviroc Clinical Test (MCT) in naïve HIV-infected patients. Forty-one patients were exposed to MCT, based on an 8-day MVC monotherapy. If undetectability or a viral load reduction >1 log10 HIV-RNA copies/ml was achieved, a MVC-containing cART was prescribed. Forty patients showed a positive MCT; undetectability after 48weeks on cART was achieved in 34/41 (82.9%) patients. The result of MCT was compared with a genotypic tropism method and with Trofile®, showing 10.7% and 18.75% discordance rates, respectively. MCT is a reliable tool to decide CCR5-antagonists prescription, also in the naïve scenario where most patients show a virological response to MVC independently the tropism result reported by genotypic or phenotypic methods.
Effects of antiplatelet components of tomato extract on platelet function in vitro and ex vivo: a time-course cannulation study in healthy humans.

Natural antithrombotic agents that influence platelet function are of potential interest for primary prevention of cardiovascular disease. Previous reports showed that tomato extracts inhibit platelet aggregation in vitro, but little is known of the active components, their mode of action, or their efficacy in vivo.



The objectives of the study were to examine the antiplatelet activity of specific tomato components by in vitro experimentation and to establish their ex vivo efficacy in healthy humans.



The mechanisms of action of antiplatelet components isolated from tomato extracts were examined in vitro. A 7-h time-course study was carried out in cannulated human subjects (n = 23) to determine the ex vivo efficacy of a supplement drink containing tomato extract and the onset and duration of antiplatelet effects.



The inhibition of ADP-, collagen-, thrombin-, and arachidonate-mediated platelet aggregation by tomato extract components appears to be linked to the inhibition of glycoprotein IIb/IIIa and platelet secretory mechanisms. We found a significant inhibition of baseline platelet function, from 2.9 +/- 1.4% (optimal ADP concentrations; P = 0.03) to 20.0 +/- 4.9% (suboptimal ADP concentrations; P < 0.001), 3 h after supplementation with a dose of tomato extract equivalent to 6 tomatoes. The observed effects persisted for >12 h. Coagulation variables were not affected.



The ingestion of tomato components with in vitro antiplatelet activity significantly affects ex vivo platelet function. The reported cardioprotective effects of tomatoes are potentially linked to a modulation of platelet function.
Retention of ECG interpretation skills How can we improve teaching of ECG interpretation skills ? Findings from a prospective randomised trial

1 Health Behaviour Research Centre, University College London, UK 2 Department of Cardiology and Pneumology, University Medical Centre Göttingen, Germany 3 Department of Internal Medicine, University Medical Centre Hamburg-Eppendorf, Germany 4 Department of Legal Medicine, University Medical Centre Hamburg-Eppendorf, Germany 5 Department of Haematology and Oncology, University Medical Centre Göttingen, Germany
LICAVAL: combination therapy in acute and maintenance treatment of bipolar disorder

The challenge of Bipolar Disorder (BD) treatment is due to the complexity of the disease. Current guidelines represent an effort to help clinicians in their everyday practice but still have limitations, specially concerning to long term treatment. LICAVAL (efficacy and tolerability of the combination of LIthium and CArbamazepine compared to lithium and VALproic acid in the treatment of young bipolar patients) study aim to evaluate acute and maintenance phase of BD treatment with two combined drugs.



LICAVAL is a single site, parallel group, randomized, outcome assessor blinded trial. BD I patients according to the DSM-IV-TR, in depressive, manic,/hypomanic or mixed episode, aged 18 to 35 years are eligible. After the diagnostic assessments, the patients are allocated for one of the groups of treatment (lithium + valproic acid or lithium + carbamazepine). Patients will be followed up for 8 weeks in phase I (acute treatment), 6 months in phase II (continuation treatment) and 12 months in phase III (maintenance treatment). Outcome assessors are blind to the treatment. The main outcome is the evaluation of changes in mean scores on CGI-BP-M between baseline and endpoint at the end of each phase of the study.



LICAVAL is currently in progress, with patients in phase I, II or III. It will extended until august 2012.



Trials comparing specific treatments efficacy in BD (head to head) can show relevant information in clinical practice. Long term treatment is an issue of great important and should be evaluated carefully in more studies as long as BD is a chronic disease.
Lack of renoprotective effects of dopamine and furosemide during cardiac surgery.

Because development of acute renal failure is one of the most potent predictors of outcome in cardiac surgery patients, the prevention of renal dysfunction is of utmost importance in perioperative care. In a double-blind randomized controlled trial, the effectiveness of dopamine or furosemide in prevention of renal impairment after cardiac surgery was evaluated. A total of 126 patients with preoperatively normal renal function undergoing elective cardiac surgery received a continuous infusion of either "renal-dose" dopamine (2 microg/kg per min) (group D), furosemide (0.5 microg/kg per min) (group F), or isotonic sodium chloride as placebo (group P), starting at the beginning of surgery and continuing for 48 h or until discharge from the intensive care unit, whichever came first. Renal function parameters and the maximal increase of serum creatinine above baseline value within 48 h (deltaCrea(max)) were determined. The increase in plasma creatinine was twice as high in group F as in groups D and P (P < 0.01). Acute renal injury (defined as deltaCreamax) >0.5 mg/dl) occurred more frequently in group F (six of 41 patients) than in group D (one of 42) and group P (zero of 40) (P < 0.01). (The difference between group D and group P was not significant.) Creatinine clearance was lower in group F (P < 0.05). Two patients in group F required renal replacement therapy. The mean volume of infused fluids, blood urea nitrogen, serum sodium, serum potassium, and osmolar- and free-water clearance was similar in all groups. It was shown that continuous infusion of dopamine for renal protection was ineffective and was not superior to placebo in preventing postoperative dysfunction after cardiac surgery. In contrast, continuous infusion of furosemide was associated with the highest rate of renal impairment. Thus, renaldose dopamine is ineffective and furosemide is even detrimental in the protection of renal dysfunction after cardiac surgery.
A phase I trial of bortezomib in combination with epirubicin, carboplatin and capecitabine (ECarboX) in advanced oesophagogastric adenocarcinoma

The protease inhibitor bortezomib attenuates the action of NF-κB and has shown preclinical activity alone and in combination with chemotherapy.  A Phase I dose-escalation study was performed administering bortezomib (0.7, 1.0, 1.3 and 1.6 mg m−2 on days 1 and 8 from cycle 2 onwards) in combination with Epirubicin 50 mg m−2 intravenously on day 1, Carboplatin AUC 5 day 1 and Capecitabine 625 mg m−2 BD days 1–21 every 21 days (VECarboX regimen), in patients with advanced oesophagogastric adenocarcinoma. The primary objective was to define the maximum tolerated dose (MTD) of Bortezomib when combined with ECarboX. Results 18 patients received bortezomib 0.7 (n = 6), 1.0 (n = 3), 1.3 (n = 6) and 1.6 mg m−2 (n = 3) and a protocol amendment reducing the capecitabine dose to 500 mg m−2 BD was enacted due to myelotoxicity. Common treatment-related non-haematological adverse events of any grade were fatigue (83.3 %), anorexia (55.6 %), constipation (55.6 %) and nausea (55.6 %). Common Grade 3/4 haematological toxicities were neutropenia (77.8 %) and thrombocytopenia (44.4 %). Objective responses were achieved in 6 patients (33.3 %) and a further 5 patients (27.8 %) had stable disease for >8 weeks.  The addition of Bortezomib to ECarboX is well tolerated and response rates are comparable with standard chemotherapy.
B-type natriuretic peptide as a marker for cardiac dysfunction in anthracycline-treated children.

Anthracyclines (AC) are useful antineoplastic agents, whose utility is limited by progressive cardiotoxicity. Our purpose was to evaluate plasma B-type natriuretic peptide (BNP), as a screening test for detecting late cardiac dysfunction in AC-treated children and to determine the prevalence of late cardiac dysfunction at low cumulative AC doses.



This was a prospective study in which patients who had completed AC therapy at least 1 year earlier, underwent a detailed echocardiogram and a simultaneous BNP level. Cardiac dysfunction was defined as any one of the following: shortening fraction (FS) <29%, rate corrected velocity of circumferential fiber shortening (VCFc) <0.9 c x sec(-1), end systolic wall stress (ESWS) >60 g x cm(-2), abnormal VCFc: ESWS ratio or decreased mitral inflow velocity (E/A) ratios, compared to age-specific norms.



The cohort (n = 63) included 37 males with a median age of 13.1 years (range, 6.5-26.5 years). Cardiac dysfunction was found in 26 (41%) patients and in 40% of patients who received cumulative doses <150 mg x m(-2). ESWS was the most common abnormality. Mean BNP levels in the subset with abnormal function were significantly higher than the normal group (23.4 +/- 25.3 vs. 14.2 +/- 8.9 pg x ml(-1), P = 0.02).



Plasma BNP was significantly elevated in AC-treated patients with late cardiac dysfunction, although there was considerable overlap of levels between groups with and without cardiac dysfunction. BNP may need further evaluation as a serial index of cardiac function in this population. Cardiac dysfunction was observed in a significant proportion of patients, even at low cumulative AC doses.
Cryopreserved mobilized autologous blood progenitors stored for more than 2 years successfully support blood count recovery after high-dose chemotherapy.

The ability of hematopoietic progenitor cells-apheresis (HPC-A) that have been stored for many years after cryopreservation to reconstitute hematopoiesis following high-dose chemo/radiotherapy has not been well-documented.



In this retrospective study, eight Canadian centers contributed data from 53 autologous stem cell transplants (ASCT) performed using HPC-A that had undergone long-term storage (>2 years, range 2-7 years) and 120 ASCT using HPC-A stored for <6 months (short-term storage).



The doses of nucleated and CD34(+) cells per kilogram recipient weight were similar between the short- (mean ± SD, 4.7 ± 4.9 × 10(8) and 6.8 ± 4.3 × 10(6), respectively) and long- (4.0 ± 4.9 × 10(8) and 6.1 ± 3.4 × 10(6), respectively) term storage groups. The median days to neutrophils (absolute neutrophil count; ANC) >0.5 × 10(9)/L (median 11 days for both short- and long-term storage) and platelets >20 × 10(9)/L (median 12 and 11 for short- and long-term storage, respectively) post-ASCT were not significantly different between the two groups. When ASCT performed with <5 × 10(6)/kg CD34(+) cells was compared there was also no difference in ANC or platelet recovery (median 12 days for both after short-term storage, and 12 and 11 days, respectively, after long-term storage). Fourteen HPC-A products stored for >5 years also showed similar count recoveries as the entire long-term storage group (median 11 days for both ANC and platelets).



Cryopreserved HPC-A can be stored for at least 5 years with no apparent loss in their ability to support hematopoietic reconstitution after high-dose chemotherapy.
Ratio of Systolic Blood Pressure to Right Atrial Pressure, a Novel Marker to Predict Morbidity and Mortality in Acute Systolic Heart Failure.

Congestion is the main contributor to heart failure (HF) morbidity and mortality. We assessed the combined role of congestion and decreased forward flow in predicting morbidity and mortality in acute systolic HF. The Evaluation Study of Congestive Heart Failure and Pulmonary Artery Catheterization Effectiveness trial data set was used to determine if the ratio of simultaneously measured systolic blood pressure (SBP)/right atrial pressure (RAP) on admission predicted HF rehospitalization and 6-month mortality. One hundred ninety-five patients (mean age 56.5 years, 75% men) who received pulmonary artery catheterization were studied. The RAP, SBP, and SBP/RAP had an area under the curve (AUC) of 0.593 (p = 0.0205), 0.585 (p = 0.0359), and 0.621 (p = 0.0026), respectively, in predicting HF rehospitalization. The SBP/RAP was a superior marker of HF rehospitalization compared with RAP alone (difference in AUC 0.0289, p = 0.0385). The optimal criterion of SBP/RAP <11 provided the highest combined sensitivity (77.1%) and specificity (50.9%) in predicting HF rehospitalization. The SBP/RAP had an AUC 0.622, p = 0.0108, and a cut-off value of SBP/RAP <8 had a sensitivity of 61.9% and specificity 64.1% in predicting mortality. Multivariate analysis showed that an SBP/RAP <11 independently predicted rehospitalization for HF (estimated odds ratio 3.318, 95% confidence interval 1.692 to 6.506, p = 0.0005) and an SBP/RAP <8 independently predicted mortality (estimated hazard ratio 2.025, 95% confidence interval 1.069 to 3.833, p = 0.030). In conclusion, SBP/RAP ratio is a marker that identifies a spectrum of complications after hospitalization of patients with decompensated systolic HF, starting with increased incidence of HF rehospitalization at SBP/RAP <11 to increased mortality with SBP/RAP <8.
Linaclotide for Irritable Bowel Syndrome With Constipation: A 26-Week, Randomized, Double-blind, Placebo-Controlled Trial to Evaluate Efficacy and Safety

Linaclotide is a minimally absorbed peptide guanylate cyclase-C agonist. The objective of this trial was to determine the efficacy and safety of linaclotide treatment in patients with irritable bowel syndrome with constipation (IBS-C) over 26 weeks.This phase 3, double-blind, parallel-group, placebo-controlled trial randomized IBS-C patients to placebo or 290 μg of oral linaclotide once daily for a 26-week treatment period. The primary and the secondary efficacy assessments were evaluated over the first 12 weeks of treatment. Primary end points included the Food and Drug Administration's (FDA's) end point for IBS-C (responder: a patient who reported (i) improvement of ≥30% from baseline in average daily worst abdominal pain score and (ii) increase of ≥1 complete spontaneous bowel movement (CSBM) from baseline, both in the same week for ≥6/12 weeks) and three other primary end points, based on improvements in abdominal pain and CSBMs for 9/12 weeks. Adverse events (AEs) were monitored.In all, 804 patients (mean age=44 years, female=90%, white=78%) were evaluated; 33.7% of linaclotide-treated patients were FDA end point responders, vs. 13.9% of placebo-treated patients (P<0.0001) (number needed to treat=5.1, 95% confidence interval (CI): 3.9, 7.1). The pain responder criterion of the FDA end point was met by 48.9% of linaclotide-treated patients vs. 34.5% of placebo-treated patients (number needed to treat=7.0, 95% CI: 4.7, 13.1), and the CSBM responder criterion was met by 47.6% of linaclotide-treated patients, vs. 22.6% of placebo patients (number needed to treat=4.0, 95% CI: 3.2, 5.4). Remaining primary end points (P<0.0001) and all secondary end points (P<0.001), including abdominal pain, abdominal bloating, and bowel symptoms (SBM and CSBM rates, Bristol Stool Form Scale (BSFS) score, and straining), were also statistically significantly improved with linaclotide vs. placebo. Statistically significant differences from placebo were observed for responder and continuous end points over 26 weeks of treatment. AE incidence was similar between treatment groups, except for diarrhea, which caused discontinuation in 4.5% of linaclotide patients vs. 0.2% of placebo patients.Linaclotide 290 μg once daily significantly improved abdominal and bowel symptoms associated with IBS-C over 26 weeks of treatment.
Effects of proportional assist ventilation on exercise tolerance in COPD patients with chronic hypercapnia.

This study investigates the impact of proportional assist ventilation (PAV), a new mode of partial ventilatory support, on exercise tolerance and breathlessness in severe hypercapnic chronic obstructive pulmonary disease (COPD) patients. We also examined the effects of continuous positive airway pressure (CPAP) and pressure support ventilation (PSV). On two consecutive days, 15 stable hypercapnic COPD patients underwent four endurance tests on a cycle ergometer at 80% of their maximal workrate, receiving, via a nasal mask in random order, either: 1) sham ventilation (CPAP: 1 cmH2O); 2) CPAP (6 cmH2O); 3) PSV (inspiratory pressure support: 12-16 cmH2O; expiratory positive airway pressure (EPAP): 1 cmH2O); or 4) PAV (8.6+/-3.6 cmH2O x L(-1) and 3+/-1.3 cmH2O x L(-1)x s(-1) of volume and flow assistance, respectively plus EPAP: 1 cmH2O). Oxygen supply was standardized to maintain an arterial oxygen saturation (Sa,O2) of 92-93%. Breathing pattern and minute ventilation (by respiratory inductive plethysmography), pulse oximetry, end tidal partial pressure of CO2, cardiac frequency and sensations of dyspnoea and leg discomfort (by Borg scale) were monitored. In comparison to sham ventilation, PAV, PSV and CPAP were able to increase the endurance time (from 7.2+/-4.4 to 12+/-5.6, 10+/-5.2 and 9.6+/-4.6 min, respectively) and to reduce dyspnoea and oxygen flow to the nasal mask. However, the greatest improvement was observed with PAV. We conclude that PAV delivered by nasal mask can im-prove exercise tolerance and dyspnoea in stable hypercapnic COPD patients and hence this mode of ventilatory support may be useful in respiratory rehabilitation programmes.
Subjects with essential hypertension are more sensitive to the inhibition of 11 β-HSD by liquorice

In this intervention study, we have investigated if hypertensive patients are more sensitive to liquorice-induced inhibition of 11 β-hydroxysteroid dehydrogenase (11 β-HSD) type 2 than normotensive (NT) subjects and if the response depends on gender. Healthy volunteers and patients with essential hypertension (HT), consumed 100 g of liquorice daily, for 4 weeks, corresponding to a daily intake of 150 mg glycyrrhetinic acid. Office, 24-h ambulatory blood pressure (BP) and blood samples were measured before, during and after liquorice consumption. Effect on cortisol metabolism was evaluated by determining the urinary total cortisol metabolites and urinary free cortisol/free cortisone quotient (Q). The mean rise in systolic BP with office measurements after 4 weeks of liquorice consumption was 3.5 mmHg (p<0.06) in NT and 15.3 mmHg (p=0.003) in hypertensive subjects, the response being different (p=0.004). The mean rise in diastolic BP was 3.6 mmHg (p=0.01) in NT and 9.3 mmHg (p<0.001) in hypertensive subjects, the response also being different (p=0.03). Liquorice induced more pronounced clinical symptoms in women than in men (p=0.0008), although the difference in the effect on the BP was not significant. The increase in Q was prominent (p<0.0001) and correlated to the rise in BP (p=0.02). The rise in BP was not dependant on age, the change in plasma renin activity or weight. We conclude that patients with essential HT are more sensitive to the inhibition of 11 β-HSD by liquorice than NT subjects, and that this inhibition causes more clinical symptoms in women than in men.
Mindfulness-based stress reduction for family caregivers: a randomized controlled trial.

Caring for a family member with dementia is associated with chronic stress, which can have significant deleterious effects on caregivers. The purpose of the Balance Study was to compare a mindfulness-based stress reduction (MBSR) intervention to a community caregiver education and support (CCES) intervention for family caregivers of people with dementia.



We randomly assigned 78 family caregivers to an MBSR or a CCES intervention, matched for time and attention. Study participants attended 8 weekly intervention sessions and participated in home-based practice. Surveys were completed at baseline, postintervention, and at 6 months. Participants were 32- to 82-year-old predominately non-Hispanic White women caring for a parent with dementia.



MBSR was more effective at improving overall mental health, reducing stress, and decreasing depression than CCES. Both interventions improved caregiver mental health and were similarly effective at improving anxiety, social support, and burden.



MBSR could reduce stress and improve mental health in caregivers of family members with dementia residing in the community.