nils-herrmann/clean_scirepeval huggingface dataset:
The effect of imaginal exposure length on outcome of treatment for PTSD.

The effects of prolonged imaginal exposure sessions (60 minutes; n=60) were compared with those of shorter exposure sessions (30 minutes, n=32) for patients with chronic posttraumatic stress disorder (PTSD). Consistent with the authors' hypothesis, patients who received 30-minute imaginal exposure sessions showed less within-session habituation than patients who received 60-minute exposure sessions. However, no differences between patients who received 60-minute and 30-minute exposure sessions emerged on improvement in PTSD-symptoms, state anxiety, depression, and end-state functioning, both at posttreatment and at 1-month follow-up. No group differences were found with regard to between-sessions habituation, number of sessions, and dropout rate. Results suggest that 30-minute imaginal exposure sessions are as effective as 60-minute exposure sessions and that within-session habituation may not be a necessary condition for successful treatment of PTSD. Future research is needed to replicate these findings and extend them to other clinical populations.
Mindfulness-Based Stress Reduction for Posttraumatic Stress Disorder Among Veterans: A Randomized Clinical Trial.

Mindfulness-based interventions may be acceptable to veterans who have poor adherence to existing evidence-based treatments for posttraumatic stress disorder (PTSD).



To compare mindfulness-based stress reduction with present-centered group therapy for treatment of PTSD.



Randomized clinical trial of 116 veterans with PTSD recruited at the Minneapolis Veterans Affairs Medical Center from March 2012 to December 2013. Outcomes were assessed before, during, and after treatment and at 2-month follow-up. Data collection was completed on April 22, 2014.



Participants were randomly assigned to receive mindfulness-based stress reduction therapy (n = 58), consisting of 9 sessions (8 weekly 2.5-hour group sessions and a daylong retreat) focused on teaching patients to attend to the present moment in a nonjudgmental, accepting manner; or present-centered group therapy (n = 58), an active-control condition consisting of 9 weekly 1.5-hour group sessions focused on current life problems.



The primary outcome, change in PTSD symptom severity over time, was assessed using the PTSD Checklist (range, 17-85; higher scores indicate greater severity; reduction of 10 or more considered a minimal clinically important difference) at baseline and weeks 3, 6, 9, and 17. Secondary outcomes included PTSD diagnosis and symptom severity assessed by independent evaluators using the Clinician-Administered PTSD Scale along with improvements in depressive symptoms, quality of life, and mindfulness.



Participants in the mindfulness-based stress reduction group demonstrated greater improvement in self-reported PTSD symptom severity during treatment (change in mean PTSD Checklist scores from 63.6 to 55.7 vs 58.8 to 55.8 with present-centered group therapy; between-group difference, 4.95; 95% CI, 1.92-7.99; P=.002) and at 2-month follow-up (change in mean scores from 63.6 to 54.4 vs 58.8 to 56.0, respectively; difference, 6.44; 95% CI, 3.34-9.53, P < .001). Although participants in the mindfulness-based stress reduction group were more likely to show clinically significant improvement in self-reported PTSD symptom severity (48.9% vs 28.1% with present-centered group therapy; difference, 20.9%; 95% CI, 2.2%-39.5%; P = .03) at 2-month follow-up, they were no more likely to have loss of PTSD diagnosis (53.3% vs 47.3%, respectively; difference, 6.0%; 95% CI, -14.1% to 26.2%; P = .55).



Among veterans with PTSD, mindfulness-based stress reduction therapy, compared with present-centered group therapy, resulted in a greater decrease in PTSD symptom severity. However, the magnitude of the average improvement suggests a modest effect.
Accuracy of urea breath tests tablets after 10 minutes compared with standard 30 minutes to diagnose and monitoring Helicobacter pylori infection: a randomized controlled trial.

REFERENCES 1. Prasad KK, Thapa BR, Nain CK, et al. Assessment of the diagnostic value of duodenal bulb histology in patients with celiac disease, using multiple biopsy sites.  is a multiple duodenal biopsy strategy appropriate? Endoscopy.  Duodenal bulb biopsies in celiac disease: a multicenter study. J Pediatr Gastroenterol Nutr. 2008;47:618–622.
Efficacy and Safety of Rosuvastatin 5 mg in Combination with Fenofibric Acid 135 mg in Patients with Mixed Dyslipidemia – A Phase 3 Study

Patients with mixed dyslipidemia characterized by elevated low-density lipoprotein cholesterol (LDL-C), elevated triglycerides (TG), and reduced high-density lipoprotein cholesterol (HDL-C) often require combination therapy to improve multiple lipid and nonlipid parameters. This phase 3, multicenter, randomized, double-blind study evaluated the efficacy and safety of rosuvastatin 5 mg coadministered with fenofibric acid 135 mg in patients with mixed dyslipidemia. A total of 760 patients with TG ≥ 150 mg/dL, HDL-C <40 mg/dL (<50 mg/dL for women), and LDL-C ≥ 130 mg/dL were randomized for a 12-week treatment period to rosuvastatin 5 mg, fenofibric acid 135 mg, or rosuvastatin 5 mg + fenofibric acid 135 mg. The primary efficacy comparisons were mean percentage changes in HDL-C and TG (rosuvastatin + fenofibric acid vs. rosuvastatin monotherapy), and LDL-C (rosuvastatin + fenofibric acid vs. fenofibric acid monotherapy). Treatment with rosuvastatin + fenofibric acid resulted in statistically significant greater improvements in HDL-C (23.0% vs. 12.4%; P < 0.001) and TG (–40.3% vs. –17.5%; P < 0.001), compared with rosuvastatin monotherapy; and LDL-C (–28.7% vs. –4.1%; P < 0.001), compared with fenofibric acid monotherapy. All secondary efficacy variables improved with combination therapy. Combination therapy was generally well tolerated with a safety profile consistent with individual monotherapies. No unexpected muscle, hepatic, or renal safety signals were identified with combination therapy versus individual monotherapies. In conclusion, rosuvastatin 5 mg + fenofibric acid 135 mg resulted in comprehensive improvements in the lipid profile of patients with mixed dyslipidemia without unanticipated adverse events.
A Methodology for Creating User Views in Database Design

The View Creation System (VCS) is an expert system that engages a user in a dialogue about the information requirements for some application, develops an Entity-Relationship model for the user's database view, and then converts the E-R model to a set of Fourth Normal Form relations. This paper describes the knowledge base of VCS. That is, it presents a formal methodology, capable of mechanization as a computer program, for accepting requirements from a user, identifying and resolving inconsistencies, redundancies, and ambiguities, and ultimately producing a normalized relational representation. Key aspects of the methodology are illustrated by applying VCS's knowledge base to an actual database design task.
The ankle-foot orthosis improves balance and reduces fall risk of chronic spastic hemiparetic patients.

Ankle foot orthoses (AFO) are commonly used orthotic device in order to restore the ankle foot function and to improve the balance and gait in post-stroke hemiparetic patients. However, there remain some discussions about their effectiveness on long term hemiparetic patients who had mild to moderate spasticity.



To investigate the relative effect of prefabricated thermoplastic posterior leaf spring AFO (PLS-AFO) on balance and fall risk.



A cross-over interventional study



The Department of PMR of a tertiary hospital.



Twenty-five chronic post-stroke long duration hemiparetic patients who had Ashworth grade 1-2 spasticity at affected calf muscles and lower limb Brunnstrom stage 2-3 and also able to walk independently without an assistive device.



Berg Balance Scale (BERG), and the postural stability test (PST) and the fall risk test (FRT) of Biodex balance systems were used for the assessments. All of the patients were assessed with AFO and without AFO. All assessments were made with footwear.



The mean post-stroke duration was 20,32±7,46 months. The BERG scores were 42,12±9,05 without AFO and 47,52±7,77 with AFO; the overall stability scores of FRT were 3,35±1,97 without AFO and 2,69±1,65 with AFO (P<0,001).



It was found that the prefabricated thermoplastic PLS-AFO improve balance and provide fall risk reduction in chronic post-stroke ambulatory hemiparetic patients who had mild to moderate spasticity on their affected lower limb.



These results encourage the usage of AFO on long duration hemiparetic patients in order to provide better balance and lesser fall risk.
Pharmacokinetic and pharmacodynamic comparison of fluoropyrimidine derivatives, capecitabine and 5′-deoxy-5-fluorouridine (5′-DFUR)

Capecitabine is a three-step prodrug that was rationally designed to be a more effective and safer alternative to its intermediate metabolite, 5′-deoxy-5-fluorouridine (5′-DFUR). We compared the pharmacokinetics/pharmacodynamics of these drugs in metastatic breast cancer patients. Six patients received oral capecitabine at 1657 mg/m2 twice daily and 17 received 5′-DFUR at 400 mg three times daily. Both drugs were administered for 21 days followed by a 7-day rest. Median daily 5′-DFUR AUC was significantly higher for capecitabine than for 5′-DFUR (81.1 vs 32.6 mmol h/l; P=0.01). Following treatment with 5′-DFUR, the median AUC and Cmax of 5′-DFUR tended to be higher in patients with a partial response (3.83 μg h/ml and 4.88 μg/ml) and stable disease (6.46 μg h/ml and 4.96 μg/ml) than in those with disease progression (2.53 μg h/ml and 1.36 μg/ml). The AUC and Cmax of 5′-DFUR was significantly related to overall survival. These results support the superiority of capecitabine over 5′-DFUR.
Genetic association of the CCR5 region with lipid levels in at-risk cardiovascular patients.

There is mounting evidence to suggest that chemokine receptor 5 (CCR5) plays an important role in the development and progression of atherosclerosis. A naturally occurring variant of the CCR5 gene CCR532, exists at allele frequencies of typically 10% in European populations and results in a nonfunctional CCR5 receptor.



The CCR5Delta32 deletion and 26 other variants within the chemokine receptor 2-CCR5-chemokine receptor-like protein 2 (CCRL2) gene cluster spanning 59 kilobases of chromosome 3 were genotyped in 5748 subjects from the Treating to New Targets atorvastatin trial to determine whether genetic associations could be identified with circulating lipid values and cardiovascular disease. Our results demonstrate an association between the CCR5Delta32 deletion and increased plasma high-density lipoprotein cholesterol and decreased plasma triglycerides, both of which are beneficial from a cardiovascular perspective. Three single-nucleotide polymorphisms (rs1154428, rs6808835, and rs6791599) in CCRL2 in linkage disequilibrium (r(2)> or =0.65) with CCR5Delta32 and located up to 45 kilobases distal to it were associated with high-density lipoprotein cholesterol. The high-density lipoprotein cholesterol and triglycerides findings were replicated in an additional set of >6000 individuals from the Incremental Decrease in Endpoints through Aggressive Lipid Lowering atorvastatin trial.



Our study provides evidence that a locus within the region of the genome encompassing the CCR5-CCRL2 region is associated with lipid levels and suggests that chemokine activity influences lipid levels in populations with preexisting cardiovascular disease.
Multicenter randomized controlled trial of an outreach nursing support program for recently discharged stroke patients.

Many stroke patients and informal carers experience a decreased quality of life after discharge home and are dissatisfied with the care received. We assessed the effectiveness of an outreach nursing care program.



In a multicenter trial, 536 stroke patients were randomized at discharge to standard care (n=273) or standard care plus outreach care (n=263). The outreach care consisted of 3 telephone calls and 1 home visit within 5 months after discharge by 1 of 13 stroke nurses. Patients were masked for the trial objectives. Six months after discharge, they assessed the 2 primary outcomes: quality of life (Short Form 36 [SF-36]) and dissatisfaction with care. Secondary measures of outcome were disability, handicap, depression, anxiety, and use of health care services and secondary prevention drugs. Informal carers assessed strain, and social support. Analysis was by intention to treat.



Twelve patients died before follow-up, 38 declined outcome assessment, and 486 completed the primary outcome assessments. Outreach care patients had better scores on the SF-36 domain "Role Emotional" than controls (mean difference 7.9 [95% confidence limit, 0.1 to 15.7]). No statistically significant differences were found on the other primary outcome measures. For secondary outcomes, no statistically significant differences were found, except that intervention patients used fewer rehabilitation services (relative risk, 0.66 [0.44 to 1.00]) and had lower anxiety scores (median difference 1 [0.19 to 2.79]).



This outreach nursing stroke care was not effective in improving quality of life and dissatisfaction with care of recently discharged patients.
C-reactive protein as a prognostic factor in patients with chordoma of lumbar spine and sacrum—a single center pilot study

This is a retrospective, diagnostic study, level IV.



It appears to be necessary to identify prognostic markers for individual risk estimation for progression and survival in patients with chordoma, a rare disease. Are pre-operative serum levels of C-reactive protein (CRP) associated with disease progression and survival?



Survival rates of 24 patients (18 males, 6 females) (mean age 67 years (SD ± 16; range 20-85 years); minimum follow-up 2 years, mean follow-up 5 years (SD ± 5; range 2-19 years)) with chordoma of the lower spine and sacrum were assessed with a focus on pre-operative CRP levels.



The survival rate of patients with pre-operative CRP level of >1.0 mg/dl was lower than that of patients with a CRP level <1.0 mg/dl (p = 0.01). The estimated 10-year survival of patients with pre-operative CRP values <1.0 and >1.0 mg/dl was 76 and 25%, respectively. CRP remained as an independent survival factor (p = 0.025; CI 95% 1.0-2.6) in multivariable analysis.



Pre-operative CRP levels appear to be a biomarker for disease-specific survival in patients with chordoma of the lumbar spine and sacrum. A validation of our finding with larger cohorts and integration of putative risk factor would further elucidate CRP a surrogate for tumor progression.
The impact of dry versus moist heat on peripheral IV catheter insertion in a hematology-oncology outpatient population.

To determine whether dry versus moist heat application to the upper extremity improves IV insertion rates.



Two-group, randomized, controlled clinical design.



An academic cancer infusion center in the western United States.


SAMPLE
136 hematologic outpatients with cancer or other malignancies.



Participants were randomly assigned to dry or moist heat with warmed towels wrapped around each patient's arm for seven minutes prior to IV insertion. Skin and room temperatures were monitored pre- and postwarming. Two experienced chemotherapy infusion nurses performed the venipunctures according to protocol. Outcomes were examined using variance analysis, with 34 patients for each combination of nurse and heat type.



Number of IV insertion attempts, time to achieve IV insertion postheating, patient anxiety levels pre- and postheating, and patient comfort.



Dry heat was 2.7 times more likely than moist heat to result in successful IV insertion on the first attempt, had significantly lower insertion times, and was more comfortable. Heat type had no effect on patient anxiety.



Dry heat application decreases the likelihood of multiple IV insertion attempts and procedure time and is comfortable, safe, and economical to use in an outpatient oncology setting.
A prospective, randomized evaluation of a novel everolimus-eluting coronary stent: the PLATINUM (a Prospective, Randomized, Multicenter Trial to Assess an Everolimus-Eluting Coronary Stent System [PROMUS Element] for the Treatment of Up to Two de Novo Coronary Artery Lesions) trial.

We sought to evaluate the clinical outcomes with a novel platinum chromium everolimus-eluting stent (PtCr-EES) compared with a predicate cobalt chromium everolimus-eluting stent (CoCr-EES) in patients undergoing percutaneous coronary intervention (PCI).



Randomized trials have demonstrated an excellent safety and efficacy profile for the CoCr-EES. The PtCr-EES uses the identical antiproliferative agent and polymer but with a novel platinum chromium scaffold designed for enhanced deliverability, vessel conformability, side-branch access, radiopacity, radial strength, and fracture resistance.



A total of 1,530 patients undergoing PCI of 1 or 2 de novo native lesions were randomized at 132 worldwide sites to CoCr-EES (n = 762) or PtCr-EES (n = 768). The primary endpoint was the 12-month rate of target lesion failure (TLF), the composite of target vessel-related cardiac death, target vessel-related myocardial infarction (MI), or ischemia-driven target lesion revascularization (TLR) in the per-protocol population (patients who received ≥1 assigned study stent), powered for noninferiority.



The 12-month rate of TLF in the per-protocol population occurred in 2.9% versus 3.4% of patients assigned to CoCr-EES versus PtCr-EES, respectively (difference: 0.5%, 95% confidence interval: -1.3% to 2.3%, p(noninferiority) = 0.001, p(superiority) = 0.60). By intention-to-treat, there were no significant differences between CoCr-EES and PtCr-EES in the 12-month rates of TLF (3.2% vs. 3.5%, p = 0.72), cardiac death or MI (2.5% vs. 2.0%, p = 0.56), TLR (1.9% vs. 1.9%, p = 0.96), or Academic Research Consortium definite or probable stent thrombosis (0.4% vs. 0.4%, p = 1.00).



In this large-scale, prospective, single-blind randomized trial, a novel PtCr-EES was noninferior to the predicate CoCr-EES for TLF, with nonsignificant differences in measures of safety and efficacy through 12-month follow-up after PCI.
Absorption of calcium and magnesium in patients with intestinal resections treated with medium chain fatty acids.

Steatorrhoea is associated with increased faecal loss of calcium and magnesium. Medium chain C8-C10 triglycerides (MCTs) improve fat absorption in patients with small bowel resections but the effects on intestinal absorption of divalent cations are not clear.



To assess the effect of dietary replacement of long chain triglycerides (LCTs) with MCTs on calcium and magnesium absorption in patients with small bowel resections.



Nineteen adult patients with a remaining small intestine averaging 171 cm (range 50-300).



In a crossover design, patients were randomised to two high fat diets (10 MJ/day, 50% as fat) for four days each separated by one day of washout. Diets were prepared in duplicate and were based on either LCT (LCT period) or equal quantities of LCT and MCT (L/MCT period). Metabolic balances were calculated during the last three days of each period.



Mean stool volume increased significantly with the L/MCT diet and was 336 ml more than that with the LCT diet (95% confidence interval of mean difference, 26-649 ml). There was no significant change in the net absorption of calcium and magnesium between the two diets. On average, percentage calcium absorption was 8.6% with the LCT diet and 12.5% with the L/MCT diet. Mean percentage magnesium absorption was 5.4% with the LCT diet and 2.9% with the L/MCT diet.



Dietary replacement of 50% long chain triglycerides with medium chain triglycerides in small bowel resected patients increased faecal volume significantly. No changes in the intestinal net absorption of calcium and magnesium were demonstrated.
Influenza A(H1N1)pdm09 vaccine effectiveness and other characteristics associated with hospitalization in chronic liver disease patients

To date, few studies have investigated the clinical effectiveness of influenza vaccine in chronic liver disease patients. The aim of this study was to examine the effectiveness of monovalent inactivated influenza A(H1N1)pdm09 vaccine and other characteristics associated with hospitalization in patients with chronic hepatitis C.



We conducted a hospital-based cohort study during influenza A(H1N1)pdm09 pandemic. A total of 408 patients (132 vaccinated, 276 unvaccinated) with detectable HCV-RNA were followed up with respect to any hospitalization using a weekly postal questionnaire. Reported hospitalizations were verified by medical records.



During the epidemic period, 28 hospitalizations (6 vaccinated, 22 unvaccinated) were observed. After adjustment for potential confounders, vaccination decreased the odds ratio (OR) for hospitalization with marginal significance (OR = 0.43, 95%CI = 0.16-1.17). Besides, positive association with hospitalization was observed in patients with albumin levels <3.5 g/dl (OR = 8.40, 3.66-19.3) and steroid users (OR = 5.58, 0.98-31.7).



Among patients with chronic hepatitis C, A(H1N1)pdm09 vaccine appeared to have a protective effect against hospitalization. Those patients with a higher risk for hospitalization should be carefully followed during the influenza season, even when vaccinated.
What proportion of patients with myocardial infarction are suitable for thrombolysis?

Four hundred and three patients were considered for entry into a trial of intravenous streptokinase in suspected myocardial infarction. Three hundred and sixty seven (91%) were excluded. Two hundred and sixty (65%) did not meet the inclusion criteria and 45 of the remaining 143 (35%) patients had contraindications to thrombolysis. This left 98 (24%) patients who were suitable for thrombolysis and 42 of them were over 70 years, the upper age limit. Thus according to this trial protocol 56 (14%) patients were eligible for recruitment; 36 (9%) patients were finally randomised. These data suggest that treatment with intravenous streptokinase may be applicable to only a small proportion of patients with myocardial infarction.
Phase I study of oral CP-4126, a gemcitabine derivative, in patients with advanced solid tumors

CP-4126 is a gemcitabine (2′,2′-difluorodeoxycytidine; dFdC) 5′ elaidic acid ester. The purpose of this dose-escalating study was to assess safety, pharmacokinetics (PK) and preliminary antitumor activity of the oral formulation and to determine the recommended dose (RD) for phase II studies. The study had a two-step design: a non-randomized dose-escalating step I with oral CP-4126 alone, followed by a randomized, cross-over step II that compared oral CP-4126 with dFdC i.v.. CP-4126 was given on days 1,8,15 in a 4-week schedule with increasing doses until the RD was established. 26 patients with different solid tumours were enrolled in step I at seven dose levels (100–3,000 mg/day). The most frequent drug-related AEs were fatigue and dysgeusia, the majority being grade 1–2. One patient experienced a dose limiting toxicity after one dose of CP-4126 at 1,300 mg/day (ASAT grade 3). PK of CP-4126 could not be determined. The metabolites dFdC and dFdU obeyed dose-dependent pharmacokinetics. Exposures to dFdC were about ten-fold lower compared to exposures after comparable doses of dFdC i.v.. Nine patients reached stable disease as best response, whereby in one patient with vaginal carcinoma a 25 % reduction of tumor volume was reached. This study demonstrates that CP-4126 can be safely administered orally to patients up to 3,000 mg/day in a d1,8,15 q4w schedule with a tolerable safety profile. CP-4126 acts as a prodrug for dFdC when given orally, but because of the poor absorption and the rapid pre-systemic metabolism the study was terminated early and no RD could be determined.