nils-herrmann/clean_scirepeval huggingface dataset:
Effect of spironolactone on diastolic function and exercise capacity in patients with heart failure with preserved ejection fraction: the Aldo-DHF randomized controlled trial.

Diastolic heart failure (ie, heart failure with preserved ejection fraction) is a common condition without established therapy, and aldosterone stimulation may contribute to its progression.



To assess the efficacy and safety of long-term aldosterone receptor blockade in heart failure with preserved ejection fraction. The primary objective was to determine whether spironolactone is superior to placebo in improving diastolic function and maximal exercise capacity in patients with heart failure with preserved ejection fraction.



The Aldo-DHF trial, a multicenter, prospective, randomized, double-blind, placebo-controlled trial conducted between March 2007 and April 2012 at 10 sites in Germany and Austria that included 422 ambulatory patients (mean age, 67 [SD, 8] years; 52% female) with chronic New York Heart Association class II or III heart failure, preserved left ventricular ejection fraction of 50% or greater, and evidence of diastolic dysfunction.



Patients were randomly assigned to receive 25 mg of spironolactone once daily (n=213) or matching placebo (n=209) with 12 months of follow-up.



The equally ranked co-primary end points were changes in diastolic function (E/e') on echocardiography and maximal exercise capacity (peak VO2) on cardiopulmonary exercise testing, both measured at 12 months.



Diastolic function (E/e') decreased from 12.7 (SD, 3.6) to 12.1 (SD, 3.7) with spironolactone and increased from 12.8 (SD, 4.4) to 13.6 (SD, 4.3) with placebo (adjusted mean difference, -1.5; 95% CI, -2.0 to -0.9; P < .001). Peak VO2 did not significantly change with spironolactone vs placebo (from 16.3 [SD, 3.6] mL/min/kg to 16.8 [SD, 4.6] mL/min/kg and from 16.4 [SD, 3.5] mL/min/kg to 16.9 [SD, 4.4] mL/min/kg, respectively; adjusted mean difference, +0.1 mL/min/kg; 95% CI, -0.6 to +0.8 mL/min/kg; P = .81). Spironolactone induced reverse remodeling (left ventricular mass index declined; difference, -6 g/m2; 95% CI, -10 to-1 g/m2; P = .009) and improved neuroendocrine activation (N-terminal pro-brain-type natriuretic peptide geometric mean ratio, 0.86; 95% CI, 0.75-0.99; P = .03) but did not improve heart failure symptoms or quality of life and slightly reduced 6-minute walking distance (-15 m; 95% CI, -27 to -2 m; P = .03). Spironolactone also modestly increased serum potassium levels (+0.2 mmol/L; 95% CI, +0.1 to +0.3; P < .001) and decreased estimated glomerular filtration rate (-5 mL/min/1.73 m2; 95% CI, -8 to -3 mL/min/1.73 m2; P < .001) without affecting hospitalizations.



In this randomized controlled trial, long-term aldosterone receptor blockade improved left ventricular diastolic function but did not affect maximal exercise capacity, patient symptoms, or quality of life in patients with heart failure with preserved ejection fraction. Whether the improved left ventricular function observed in the Aldo-DHF trial is of clinical significance requires further investigation in larger populations.
Epidemiology and symptom profile of gastroesophageal reflux in the Indian population: report of the Indian Society of Gastroenterology Task Force.

Gastroesophageal reflux disease (GERD) and its complications are thought to be infrequent in India; there are no data from India on the prevalence of and risk factors for GERD. The Indian Society of Gastroenterology formed a task force aiming to study: (a) the frequency and profile of GERD in India, (b) factors including diet associated with GERD.



In this prospective, multi-center (12 centers) study, data were obtained using a questionnaire from 3224 subjects regarding the frequency, severity and duration of heartburn, regurgitation and other symptoms of GERD. Data were also obtained regarding their dietary habits, addictions, and lifestyle, and whether any of these were related or had been altered because of symptoms. Data were analyzed using univariate and multivariate methods.



Two hundred and forty-five (7.6%) of 3224 subjects had heartburn and/or regurgitation at least once a week. On univariate analysis, older age (OR 1.012; 95% CI 1.003-1.021), consumption of non-vegetarian and fried foods, aerated drinks, tea/coffee were associated with GERD. Frequency of smoking was similar among subjects with or without GERD. Body mass index (BMI) was similar in subjects with and without GERD. On multivariate analysis, consumption of non-vegetarian food was independently associated with GERD symptoms. Overlap with symptoms of irritable bowel syndrome was not uncommon; 21% reported difficulty in passage of stool and 9% had mucus in stools. About 25% of patients had consulted a doctor previously for their gastrointestinal symptoms.



7.6% of Indian subjects have significant GERD symptoms. Consumption of non-vegetarian foods was an independent predictor of GERD. BMI was comparable among subjects with or without GERD.
The National Trauma Registry as a Canadian spine trauma database: a validation study using an institutional clinical database.

Miscoding is a common source of error in population-based registries. Given this, we performed a validation study comparing the Canadian National Trauma Registry (NTR) data based on the 10th Revision of the International Classification of Diseases coding with clinical data from an institutional database.



All patients with acute spine trauma who were admitted to Toronto Western Hospital from May 2003 to April 2007 were included. Accuracy, sensitivity and specificity were estimated having chart data abstraction as the gold standard.



There were 92 patients with spine trauma (50 males, 42 females; ages from 16 to 102 years). The use of the NTR as a spine trauma database has an accuracy of 87%, sensitivity of 89.8% and specificity of 25%. If the same database is considered as a spinal cord injury (complete motor injury) database, there will be a decrease in the precision with an accuracy of 32.6%, sensitivity of 81.3% and specificity of 6.7%.



Our results indicate that the NTR may be relatively more precise when used as a database of spine trauma in comparison with its use as a spinal cord injury database. However, the low specificity suggests that the NTR should be comprehensively validated using data from the other institutions that contribute with data collection for the NTR.
Pre-treatment drug resistance among patients initiating antiretroviral therapy (ART) in Zimbabwe: 2008–2010

Zimbabwe set up 12 sentinel sites to monitor HIV drug resistance (HIVDR) following the international standards for prevention of HIVDR from 2008 to 2010. Participants were consecutively enrolled. Blood was collected and used for CD4 count, viral load (VL) and pre-treatment DR (PDR) tests besides routine baseline tests. We analyzed the characteristics of participants enrolled into the survey and estimated the point prevalence of PDR and its associated factors among ART initiators in a cross-sectional analysis using the baseline data collected from a prospective cohort in 12 purposefully selected sentinel sites. A total of 1728 participants (96 % response rate) were enrolled and 1610 had complete data. Of the 1610 there were more females (68.7 %) than males (31.3 %). The median CD4 count was 168 cells/mm3 with males having lower values (P = 0.003). Ninety-six percent of participants had a VL ≥ 1000 copies/ml and the median VL was 128,000. Previous exposure to antiretroviral drugs (ARVs) was mainly through PMTCT (5 % of the participants). Overall, PDR mutations were detected in 6.3 % (95 % CI 5.2–7.7) of the 1480 successfully genotyped participants. However, the prevalence of PDR mutations was double for those with previous exposure (12.1 %) to ARVs compared with those without previous exposure (5.7 %, P = 0.002). The results show a moderate level of PDR prevalence among ART initiators. To maintain the efficacy of the current first-line regimens, there is need to strengthen all HIVDR prevention efforts and to conduct further studies to investigate optimal strategies that can prolong the efficacy of first-line ARV regimens in the country.
A phase I/II study of XELIRI plus bevacizumab as second-line chemotherapy for Japanese patients with metastatic colorectal cancer (BIX study).

Capecitabine is used mainly with oxaliplatin to treat metastatic colorectal cancer (mCRC). Results from capecitabine plus irinotecan (XELIRI) with or without bevacizumab (BV) have been reported in Europe but not in Japan. Consequently, the safety and efficacy of XELIRI plus BV in Japanese patients with mCRC were assessed in a single-arm phase II study.



Eligible patients had had prior chemotherapy containing BV for mCRC and wild-type or heterozygous UGT1A1. Therapy in each 21-day treatment cycle consisted of capecitabine (800 mg/m(2) twice daily on days 1-15), irinotecan (200 mg/m(2) on day 1), and BV (7.5 mg/kg on day 1). The primary endpoint was dose-limiting toxicity in phase I and progression-free survival (PFS) in phase II.



A total of 34 patients (6 in phase I, 28 in phase II) were enrolled from May 2010 to June 2011. Baseline characteristics included a median age of 60 years (range: 22-74 years) for 24 men and 10 women. No dose-limiting toxicities appeared in phase I. Median PFS was 240 days (95% confidence interval: 179-311 days). Overall response rate was 18.1%, and the disease-control rate was 90.9%. The incidence of adverse events frequently associated with irinotecan and capecitabine were neutropenia (any grade, 55.9%; grade 3 or 4, 11.8%), diarrhea (any grade, 50%; grade 3 or 4, 5.9%), and hand-foot syndrome (any grade, 61.8%; grade 3 or 4, 5.9%).



Our results suggest that XELIRI plus BV is well tolerated and effective as a second-line treatment for mCRC in Japanese patients. This regimen could be especially appropriate for patients resistant to oxaliplatin-based regimens.
Influence of early enteral nutrition (EEN) on insulin resistance in gastric cancer patients after surgery.

To evaluate the benefits of reducing insulin resistance by early enteral nutrition (EEN) in gastric cancer patients after surgery.



Gastric cancer patients were managed to randomly accept traditional total parenteral nutrition (group A) or EEN (group B) after surgical treatment. The patients in group B were fed by tubes with 250-500 mL 5% sodium chloride and glucose injection at 24 h post-surgery, and were fed enteral nutritional emulsion with constant infusion by pump slowly increasing from 20 mL/h to 100 mL/h from 48 h, and then transiting to total enteral nutrition. Insulin sensitivity of patients was detected by Quicki method before operation and at 24 h, 48 h, 72 h, 120 h and 168 h post-surgery.



A total of 77 patients were enrolled, with 42 patients in group A, and 35 patients in group B. Baseline characteristics, biochemical indexes and operational characteristics were well balanced between two groups. The time-insulin sensitivity curves of the two groups indicated that IR was present early (day 1 to day 7) in gastric cancer patients and was significantly different between patients who had undergone surgical treatment and those who had not. Insulin sensitivity (SI) of patients in group B were higher than patients in group A with adjusting BMI, age and SI preoperative at 72 h, 120 h and 168 h post-surgery.



The management of EEN can alleviate insulin resistance in gastric cancer patients with surgical treatment.
Blood pressure goal achievement with olmesartan medoxomil-based treatment: additional analysis of the OLMEBEST study

Guidelines recommend blood pressure (BP) in hypertensive patients should be <140 systolic BP (SBP) and <90 diastolic BP (DBP) mmHg. This analysis assessed goal rate achievement in hypertensive patients receiving olmesartan-based treatment in the OLMEBEST study.



Patients with essential hypertension (DBP > or = 90 mmHg and <110 mmHg) received open-label olmesartan medoxomil 20 mg/day (n = 2306). After 8 weeks, patients with DBP > or = 90 mmHg (n = 627) were randomized to 4 weeks' double-blind treatment with olmesartan 40 mg/day monotherapy or olmesartan 20 mg/day plus hydrochlorothiazide (HCTZ) 12.5 mg/day. For this analysis, the numbers and proportions of patients who achieved SBP < 140 mmHg and/or DBP < 90 mmHg at the end of the 4 weeks were calculated.



In patients who achieved DBP normalization (<90 mmHg) at week 8 (n = 1546) and continued open-label olmesartan 20 mg/day, 66.7% achieved SBP/DBP < 140/90 mmHg at Week 12. In patients who did not achieve DBP normalization at Week 8, 26.8% of those randomized to olmesartan 40 mg/day and 42.5% of those randomized to olmesartan 20 mg/day plus HCTZ 12.5 mg/day achieved a SBP/DBP < 140/90 mmHg at Week 12.



Olmesartan 40 mg/day and olmesartan 20 mg/day plus HCTZ 12.5 mg/day allow substantial proportions of patients to achieve BP goals.
A double-blind, randomized, multicenter, Italian study of frovatriptan versus rizatriptan for the acute treatment of migraine

The objective of this study was to assess patient satisfaction with acute treatment of migraine with frovatriptan or rizatriptan by preference questionnaire. 148 subjects with a history of migraine with or without aura (IHS 2004 criteria), with at least one migraine attack per month in the preceding 6 months, were enrolled and randomized to frovatriptan 2.5 mg or rizatriptan 10 mg treating 1–3 attacks. The study had a multicenter, randomized, double-blind, cross-over design, with treatment periods lasting <3 months. At the end of the study, patients assigned preference to one of the treatments using a questionnaire with a score from 0 to 5 (primary endpoint). Secondary endpoints were pain-free and pain relief episodes at 2 h, and recurrent and sustained pain-free episodes within 48 h. 104 of the 125 patients (83%, intention-to-treat population) expressed a preference for a triptan. The average preference score was not significantly different between frovatriptan (2.9 ± 1.3) and rizatriptan (3.2 ± 1.1). The rates of pain-free (33% frovatriptan vs. 39% rizatriptan) and pain relief (55 vs. 62%) episodes at 2 h were not significantly different between the two treatments. The rate of recurrent episodes was significantly (p < 0.001) lower under frovatriptan (21 vs. 43% rizatriptan). No significant differences were observed in sustained pain-free episodes (26% frovatriptan vs. 22% rizatriptan). The number of patients with adverse events was not significantly different between rizatriptan (34) and frovatriptan (25, p = NS). The results suggest that frovatriptan has a similar efficacy to rizatriptan, but a more prolonged duration of action.
Emergency Portacaval Shunt Versus Rescue Portacaval Shunt in a Randomized Controlled Trial of Emergency Treatment of Acutely Bleeding Esophageal Varices in Cirrhosis—Part 3

Emergency treatment of bleeding esophageal varices in cirrhosis is of singular importance because of the high mortality rate. Emergency portacaval shunt is rarely used today because of the belief, unsubstantiated by long-term randomized trials, that it causes frequent portal-systemic encephalopathy and liver failure. Consequently, portacaval shunt has been relegated solely to salvage therapy when endoscopic and pharmacologic therapies have failed.  Is the regimen of endoscopic sclerotherapy with rescue portacaval shunt for failure to control bleeding varices superior to emergency portacaval shunt? A unique opportunity to answer this question was provided by a randomized controlled trial of endoscopic sclerotherapy versus emergency portacaval shunt conducted from 1988 to 2005. Unselected consecutive cirrhotic patients with acute bleeding esophageal varices were randomized to endoscopic sclerotherapy (n = 106) or emergency portacaval shunt (n = 105). Diagnostic workup was completed and treatment was initiated within 8 h. Failure of endoscopic sclerotherapy was defined by strict criteria and treated by rescue portacaval shunt (n = 50) whenever possible. Ninety-six percent of patients had more than 10 years of follow-up or until death. Comparison of emergency portacaval shunt and endoscopic sclerotherapy followed by rescue portacaval shunt showed the following differences in measurements of outcomes: (1) survival after 5 years (72% versus 22%), 10 years (46% versus 16%), and 15 years (46% versus 0%); (2) median post-shunt survival (6.18 versus 1.99 years); (3) mean requirements of packed red blood cell units (17.85 versus 27.80); (4) incidence of recurrent portal-systemic encephalopathy (15% versus 43%); (5) 5-year change in Child’s class showing improvement (59% versus 19%) or worsening (8% versus 44%); (6) mean quality of life points in which lower is better (13.89 versus 27.89); and (7) mean cost of care per year ($39,200 versus $216,700). These differences were highly significant in favor of emergency portacaval shunt (all p < 0.001). Emergency portacaval shunt was strikingly superior to endoscopic sclerotherapy as well as to the combination of endoscopic sclerotherapy and rescue portacaval shunt in regard to all outcome measures, specifically bleeding control, survival, incidence of portal-systemic encephalopathy, improvement in liver function, quality of life, and cost of care. These results strongly support the use of emergency portacaval shunt as the first line of emergency treatment of bleeding esophageal varices in cirrhosis.
One-year follow-up evaluation of Project Towards No Drug Abuse (TND-4).

This paper describes the one-year outcomes of the fourth experimental trial of Project Towards No Drug Abuse. Two theoretical content components of the program were examined to increase our understanding of the relative contribution of each to the effectiveness of the program.



High schools in Southern California (n=18) were randomly assigned to one of three conditions: cognitive perception information curriculum, cognitive perception information+behavioral skills curriculum, or standard care (control). The curricula were delivered to high school students (n=2734) by project health educators and regular classroom teachers. Program effectiveness was assessed with both dichotomous and continuous measures of 30-day substance use at baseline and one-year follow-up.



Across all program schools, the two different curricula failed to significantly reduce dichotomous measures of substance use (cigarette, alcohol, marijuana, and hard drugs) at one-year follow-up. Both curricula exerted an effect only on the continuous measure of hard drug use, indicating a 42% (p=0.02) reduction in the number of times hard drugs were used in the last 30 days in the program groups relative to the control.



The lack of main effects of the program on dichotomous outcomes was contrary to previous studies. An effect on an ordinal count measure of hard drug use among both intervention conditions replicates previous work and suggests that this program effect may have been due to changes in cognitive misperception of drug use rather than behavioral skill.
Significance of antibodies to cardiolipin in unselected patients with systemic lupus erythematosus: clinical and laboratory associations

In a multicentre study anticardiolipin antibodies of the IgG and IgM isotypes were measured by a solid phase enzyme immunoassay in 368 patients with systemic lupus erythematosus (SLE) who were not selected on the basis of features of antiphospholipid syndrome. Clinical and laboratory associations of increased levels of anticardiolipin antibodies were evaluated. IgG and IgM antibodies to cardiolipin were documented in 224 (60.9%) and 128 (34.8%) patients, respectively. Regarding the symptoms of antiphospholipid syndrome, elevated amounts of anticardiolipin IgG were significantly associated with spontaneous abortion (P<0.001), thrombocytopenia (P<0.01), livedo reticularis (P<0.01) and a positive direct Coombs test (P<0.05), but not with thrombosis or central nervous system diseases such as epilepsy and psychosis. IgM antibodies to cardiolipin were associated with a positive direct Coombs test (P<0.01), but with no other symptom of antiphospholipid syndrome. The predictive values of anticardiolipin antibody determinations in unselected SLE patients were poor for all features of antiphospholipid syndrome because of high proportions of false-positive and false-negative results. As for other manifestations of SLE, positive correlations between raised antibodies to double-stranded DNA and the occurrence of anticardiolipin antibodies of the IgG isotype were observed, and anticardiolipin IgM was negatively associated with nephritis.
Independent external validation of the status epilepticus severity score.

A clinical scoring system for patients with status epilepticus was developed for predicting outcome, planning the level of monitoring needed, and guiding treatment. The aim was to confirm the external validity and transportability of the Status Epilepticus Severity Score prediction functions for outcome in adult patients with status epilepticus.



Observational cohort study.



Tertiary academic medical care center.



Consecutive adult ICU patients with status epilepticus.



None.



History of seizures, age, seizure type, and level of consciousness were determined at status epilepticus onset, in order to calculate the Status Epilepticus Severity Score. The main outcome measure was the ability to accurately predict the outcome of status epilepticus by measures of discrimination and calibration. Among 171 status epilepticus patients with a mean age of 64.1 years (± 16.3), mortality was 18%. The receiver operating characteristic curve for prediction of death by the Status Epilepticus Severity Score had an area under the curve of 0.744 with an optimal cutoff point greater than or equal to 4. Hosmer-Lemeshow statistics revealed good calibration of the Status Epilepticus Severity Score (chi-square goodness-of-fit test = 1.39; p = 0.845).



This study is the first independent external validation of the predictive accuracy of the Status Epilepticus Severity Score and its transportability to ICU patients with status epilepticus. Measures of discrimination and calibration indicated that Status Epilepticus Severity Score performed reasonably well on our cohort of ICU patients with status epilepticus. However, the specific optimal cutoff point for survival versus death in our cohort was different than proposed.
Use of complementary and alternative medicine in paediatric oncology patients in Singapore.

Use of Complementary and Alternative Medicine in Paediatric Oncology Patients in Singapore Joeanne Lim,1MBBS, Manzhi Wong,1MBBS, Mei Yoke Chan,2MBBS, MMed (Paeds), MRCP (UK), Ah Moy Tan,2MBBS, MMed (Paeds), FAMS, Vasanthi Rajalingam,2MBBS, MMed (Paeds), FAMS, Lillian PN Lim,2MBBS, MMed (Paeds), MRCP (Lond), June Lou,2MBBS, MMed (Paeds), FRACP (Paeds), Cheng Lim Tan,2MBBS, MMed (Paeds), FRCP (Paeds) (Edin)