nils-herrmann/clean_scirepeval huggingface dataset:
Test-based exclusion diets in gastro-esophageal reflux disease patients: a randomized controlled pilot trial.

To investigate the clinical response of gastro-esophageal reflux disease (GERD) symptoms to exclusion diets based on food intolerance tests.



A double blind, randomized, controlled pilot trial was performed in 38 GERD patients partially or completely non-responders to proton pump inhibitors (PPI) treatment. Fasting blood samples from each patients were obtained; leukocytotoxic test was performed by incubating the blood with a panel of 60 food items to be tested. The reaction of leukocytes (rounding, vacuolization, lack of movement, flattening, fragmentation or disintegration of cell wall) was then evaluated by optical microscopy and rated as follows: level 0 = negative, level 1 = slightly positive, level 2 = moderately positive, and level 3 = highly positive. A "true" diet excluding food items inducing moderate-severe reactions, and a "control" diet including them was developed for each patient. Then, twenty patients received the "true" diet and 18 the "control" diet; after one month (T1) symptoms severity was scored by the GERD impact scale (GIS). Hence, patients in the "control" group were switched to the "true" diet, and symptom severity was re-assessed after three months (T2).



At baseline (T0) the mean GIS global score was 6.68 (range: 5-12) with no difference between "true" and control group (6.6 ± 1.19 vs 6.7 ± 1.7). All patients reacted moderately/severely to at least 1 food (range: 5-19), with a significantly greater number of food substances inducing reaction in controls compared with the "true" diet group (11.6 vs 7.0, P < 0.001). Food items more frequently involved were milk, lettuce, brewer's yeast, pork, coffee, rice, sole asparagus, and tuna, followed by eggs, tomato, grain, shrimps, and chemical yeast. At T1 both groups displayed a reduction of GIS score ("true" group 3.3 ± 1.7, -50%, P = 0.001; control group 4.9 ± 2.8, -26.9%, P = 0.02), although the GIS score was significantly lower in "true" vs "control" group (P = 0.04). At T2, after the diet switch, the "control" group showed a further reduction in GIS score (2.7 ± 1.9, -44.9%, P = 0.01), while the "true" group did not (2.6 ± 1.8, -21.3%, P = 0.19), so that the GIS scores didn't differ between the two groups.



Our results suggest that food intolerance may play a role in GERD symptoms development, and leucocytotoxic test-based exclusion diets may be a possible therapeutic approach when PPI are not effective or indicated.
Efficacy of zoledronic acid for chronic low back pain associated with Modic changes in magnetic resonance imaging

Modic changes (MC) are associated with low back pain (LBP), but effective treatments are lacking. The aim of this randomized, placebo-controlled, double-blinded trial was to evaluate the efficacy of zoledronic acid (ZA) for chronic LBP among patients with MC in magnetic resonance imaging (MRI).



Inclusion criteria were LBP lasting ≥3 months, with an intensity of ≥6 on a 10-cm VAS or an Oswestry Disability Index (ODI) of ≥30%, and MC in MRI. Patients were randomized into single intravenous infusion of ZA 5 mg (n = 20), or placebo (n = 20) groups. The primary outcome was LBP intensity, secondary outcomes leg pain intensity, ODI, health-related quality of life (RAND-36), lumbar flexibility, sick leaves and use of pain medication. The treatment differences at one month and one year were analysed using ANCOVA with adjustment for the baseline score.



The mean difference (MD) between the groups in the primary outcome, intensity of LBP, was 1.4 (95% confidence intervals (CI) 0.01 to 2.9) in favour of ZA at one month. We observed no significant between-group difference in the intensity of LBP at one year (MD 0.7; 95% CI -1.0 to 2.4) or in secondary outcomes at any time point except that 20% of patients in the ZA group used non-steroidal anti-inflammatory drugs at one year compared to 60% in the placebo group (P = 0.022). Acute phase reactions (fever, flu-like symptoms, arthralgia) emerged in 95% of the patients in the ZA group, compared to 35% in the placebo group.



ZA was effective in reducing the intensity of LBP in the short term and in reducing the use of NSAIDs within the time span of one year among patients with chronic LBP and MC confirmed in MRI. Although the results seem encouraging, larger studies are required to analyse the effectiveness and safety of ZA for patients with MC.
[Prognostic value of cytokines and neurohormones in severe heart failure].

The screening of candidates for heart transplantation continues to present difficulties. High plasma levels of cytokines and neurohormones have been associated with a poor prognosis in heart failure but their usefulness for identifying candidates for heart transplantation is still not established.



In 83 patients (59 11 years old), with systolic left ventricular dysfunction and New York Heart Association functional class III-IV, we assessed levels of aldosterone, atrial natriuretic peptide, plasma renin activity, angiotensin II, norepinephrine, endothelin, interleukin-6 and tumor necrosis factor-alpha.



Over the following year, 13 patients died and 26 received heart transplantation. Mean ejection fraction was 23 6%, end-diastolic and end-systolic diameters were 73 10 and 60 10 mm, respectively. Univariate analysis identified the following variables to be associated with poor prognosis: angiotensin II (p = 0.001), norepinephrine (p = 0.003), plasma renin activity (p = 0.02), systolic blood pressure (p = 0.006), end-diastolic diameter (p = 0.02) and end-systolic diameter (p = 0.04). Multivariate regression analysis identified the following variables to be independent predictors of death or need for heart transplantation: a low cardiac index (p = 0.007), plasma angiotensin II (p = 0.001) and pulmonary capillary wedge pressure (p = 0.04) The sensitivity and specificity of angiotensin II for predicting poor outcome was only moderate according to interpretation of the receiver operating curves.



Although plasma angiotensin II was the best neurohormone for identifying patients with severe heart failure and the worst prognosis, its sensitivity and specificity for predicting death or the need for heart transplantation was limited. The decision to transplant should continue to be based on clinical and hemodynamic parameters.
Artichoke leaf juice contains antihypertensive effect in patients with mild hypertension.

Lifestyle modifications are effective for the management and prevention of hypertension. We conducted a randomized, placebo-controlled trial to evaluate the efficacy of an oral concentrated leaf juice of artichoke (Cynara scolymus L.; CS) in patients with mild hypertension (systolic blood pressure [SBP]/diastolic blood pressure [DBP], 140-159/90-99 mmHg). Subjects were randomized into a placebo and two drug groups that received 50 and 100 mg of artichoke juice concentrate. After 12 weeks, SBP significantly reduced as compared with the baseline data in case groups and DBP was significantly lower from the baseline as compared with the placebo group. It is concluded that the use of artichoke juice concentrate may have a blood pressure-lowering effect in mild hypertension.
Endurance and strength training in patients with COPD.

The purpose of this study was to compare the effects of endurance training only to endurance plus strength (combined) training in a randomized trial of patients with COPD.



Twenty-four patients completed the study: 11 patients in the combined training group (FEV(1) 45 +/- 5% predicted), and 13 patients in the endurance training group (FEV(1) 40 +/- 4% predicted) [mean +/- SE]. Muscle strength, quality of life, exercise performance, and quadriceps fatigability were measured before and after rehabilitation.



Combined training led to significant improvements in quadriceps (23.6%), hamstring (26.7), pectoralis major (17.5%), and latissimus dorsi (20%) muscle strength. Endurance training alone did not produce significant improvements in muscle strength: quadriceps (1.1% decrease), hamstring (12.2% increase), pectoralis major (7.8% increase), and latissimus dorsi (2.8% decrease). The increase in strength after training was significantly greater in the combined group compared to the endurance group for the quadriceps and latissimus dorsi muscles but not for the hamstring and pectoralis major muscles. Six-minute walk distance, endurance exercise time, and quality of life (as measured by the Chronic Respiratory Questionnaire) significantly increased in both groups after rehabilitation with no significant differences in the extent of improvement between groups. The extent of improvement in quadriceps fatigability after training (assessed by quadriceps twitch force before and after exercise) was not significantly different between groups.



Strength training can lead to significant improvement in muscle strength in elderly patients with COPD. However, this improvement in muscle strength does not translate into additional improvement in quality of life, exercise performance or quadriceps fatigability compared to that achieved by endurance exercise alone.
Adrenergic activity and peripheral hemodynamics in relation to sodium sensitivity in patients with essential hypertension.

In 25 outpatients with essential hypertension, sodium sensitivity, defined as the difference in mean arterial pressure (delta MAP) between 2 weeks of high-sodium (300 mmol per day) and 2 weeks of low-sodium (LS) intake (50-100 mmol per day), was studied in relation to the plasma norepinephrine (NE) level, NE release, and pressor response to intravenous NE. In addition, forearm blood flow (FBF) was measured by plethysmography. There were two control periods of regular sodium intake, one of 4 weeks' duration at the beginning of the study and one of 2 weeks' duration at the end. The delta MAP ranged from +18 to -8 mm Hg. The eight patients in whom delta MAP was greater than 10 mm Hg were regarded as salt-sensitive. When compared with salt-insensitive subjects, salt-sensitive patients had higher plasma NE levels in the control period (p less than 0.05) and after 2 weeks of HS intake (p less than 0.01). Sodium sensitivity was directly related to the change in plasma NE between the HS and LS periods (p less than 0.001). The NE release decreased in salt-insensitive subjects whereas it increased in salt-sensitive patients between the LS and HS periods. Changes in NE release were directly related to sodium sensitivity (p less than 0.05). The pressor response to NE was not significantly influenced by changes in sodium intake. The FBF fell in salt-sensitive patients and increased in salt-insensitive subjects between the LS and HS periods. Sodium sensitivity was directly related to the change in forearm vascular resistance (p less than 0.01).(ABSTRACT TRUNCATED AT 250 WORDS)
Illustration of a measure to combine viral suppression and viral rebound in studies of HIV therapy.

Viral load is an important tool for assessing antiretroviral treatment efficacy. However, the most common viral load end point, virologic failure, may be flawed. We illustrate an alternative end point that estimates the average time patients spent suppressed before rebound in the AIDS Clinical Trials Group A5095 trial. Patients averaged 644 days suppressed in the 3-drug arm and 686 days suppressed in the 4-drug arm, for a difference of 42 days in favor of the 4-drug regimen (95% confidence interval: -11 to 96). These results agree with results using virologic failure as the end point but better emphasize the separate suppression and rebound processes.
Dabigatran versus warfarin major bleeding in practice: an observational comparison of patient characteristics, management and outcomes in atrial fibrillation patients

Data comparing the patient characteristics, management and outcomes for dabigatran versus warfarin major bleeding in the practice setting are limited. We performed a retrospective single health system study of atrial fibrillation patients with dabigatran or warfarin major bleeding from October 2010 through September 2012. Patient identification occurred through both an internal adverse event reporting system and a structured stepwise data filtering approach using the International Classification of Diseases diagnosis codes. Thirty-five dabigatran major bleeding patients were identified and compared to 70 warfarin major bleeding patients. Intracranial bleed occurred in 4.3 % of warfarin patients and 8.6 % of dabigatran patients. Dabigatran patients tended to be older (79.9 vs. 76 years) and were more likely to have a creatinine clearance of 15–30 mL/min (40 vs. 18.6 %, p = 0.02). Over one-third of dabigatran patients had an excessive dose based on renal function. More dabigatran patients required a procedure for bleed management (37.1 vs. 17.1 %, p = 0.03) and received a hemostatic agent for reversal (11.4 vs. 1.4 %, p = 0.04). Dabigatran patients were twice as likely to spend time in an ICU (45.7 vs. 27.1 %, p = 0.06), be placed in hospice/comfort care (14.3 vs. 7.1 %, p = 0.24), expire during hospitalization (14.3 vs. 7.1 %, p = 0.24), and expire within 30-days (22.9 vs. 11.4 %, p = 0.28). In a single hospital center practice setting, as compared to warfarin, patients with dabigatran major bleeding were more likely to be older, have renal impairment, require a procedure for bleed management and receive a hemostatic agent. Patients with dabigatran major bleeding had an excessive dose for renal function in more than one-third of cases.
Mucosal integrity and sensitivity to acid in the proximal esophagus in patients with gastroesophageal reflux disease.

Acid reflux episodes that extend to the proximal esophagus are more likely to be perceived. This suggests that the proximal esophagus is more sensitive to acid than the distal esophagus, which could be caused by impaired mucosal integrity in the proximal esophagus. Our aim was to explore sensitivity to acid and mucosal integrity in different segments of the esophagus. We used a prospective observational study, including 12 patients with gastroesophageal reflux disease (GERD). After stopping acid secretion-inhibiting medication, two procedures were performed: an acid perfusion test and an upper endoscopy with electrical tissue impedance spectroscopy and esophageal biopsies. Proximal and distal sensitivity to acid and tissue impedance were measured in vivo, and mucosal permeability and epithelial intercellular spaces at different esophageal levels were measured in vitro. Mean lag time to heartburn perception was much shorter after proximal acid perfusion (0.8 min) than after distal acid perfusion (3.9 min) (P = 0.02). Median in vivo tissue impedance was significantly lower in the distal esophagus (4,563 Ω·m) compared with the proximal esophagus (8,170 Ω·m) (P = 0.002). Transepithelial permeability, as measured by the median fluorescein flux was significantly higher in the distal (2,051 nmol·cm(-2)·h(-1)) than in the proximal segment (368 nmol·cm(-2)·h(-1)) (P = 0.033). Intercellular space ratio and maximum heartburn intensity were not significantly different between the proximal and distal esophagus. In GERD patients off acid secretion-inhibiting medication, acid exposure in the proximal segment of the esophagus provokes symptoms earlier than acid exposure in the distal esophagus, whereas mucosal integrity is impaired more in the distal esophagus. These findings indicate that the enhanced sensitivity to proximal reflux episodes is not explained by increased mucosal permeability.
Cystoscopic diagnosis of bladder cancer by intravesical instillation of 5-aminolevulinic acid induced porphyrin fluorescence--the Singapore experience.

1) To determine whether fluorescence cystoscopy after intravesical administration of 5-aminolevulinic acid (5-ALA) is more sensitive in detection of dysplasia and bladder cancer when compared with conventional cystoscopy. 2) To determine the safety of using 5-ALA.



A 3% 5-ALA solution was instilled intravesically before cystoscopy in 41 patients. The 5-ALA-induced porphyrin fluorescence was excited by violet light from a xenon arc lamp (lambda 375-440 mm).



Among the 175 biopsies obtained, the sensitivity of the fluorescence cystoscopy was greater than that of conventional cystoscopy (89.1% versus 65.6%, P < 0.05). Specificity was at 64.8% and 83.8% respectively with P < 0.05. Duration of ALA instillation did not seem to affect the sensitivity and specificity of photodynamic diagnosis. The procedures were well tolerated by all patients with no additional complication.



Fluorescence-guided biopsies are more sensitive than random biopsies in detecting dysplasia or bladder cancer without additional risk or complication. The duration of ALA instillation did not seem to affect the accuracy of photodynamic diagnosis.
In a randomized, double-blind clinical trial, adjuvant atorvastatin improved symptoms of depression and blood lipid values in patients suffering from severe major depressive disorder.

The administration of statins seems to be a promising new avenue in the treatment of patients suffering from major depressive disorder (MDD), though patients suffering from severe MDD remain unstudied in this respect. The aim of the present study was therefore to investigate, in a randomized double-blind clinical trial, the influence of adjuvant atorvastatin on symptoms of depression in patients with MDD.



A total of 60 patients suffering from MDD (mean age: 32.25 years; 53% males) received a standard medication of 40 mg/d citalopram. Next, patients were randomly assigned either to the atorvastatin group (20 mg/d) or to the placebo group. Blood lipid values were assessed at baseline and on completion of the study 12 weeks later. Experts rated depressive symptoms via Hamilton Depression Rating Scales (HDRS) at baseline and 3, 6 and 12 weeks later.



HDRS scores decreased over time; the significant Time by Group interaction showed that symptoms of depression decreased more in the atorvastatin than in the placebo group. Compared to the placebo group, in the atorvastatin group cholesterol, triglyceride, and Low Density Lipids (LDL) significantly decreased, and High Density Lipids (HDL) significantly increased over time. HDRS scores and blood lipid values were generally not associated.



The pattern of results suggests that adjuvant atorvastatin favorably influences symptoms of depression among patients with severe MDD. Given that after 12 weeks of monotherapy and adjuvant atorvastatin patients were still moderately to severely depressed, more powerful treatment algorithms such as augmentation and change of medication are highly recommended.
Mother-infant pair clinic and SMS messaging as innovative strategies for improving access to and retention in eMTCT care and Option B+ in Malawi: a cluster randomized control trial (the PRIME study).

UNAIDS has set a goal of achieving the elimination of mother-to-child transmission (eMTCT) of HIV by 2015 and keeping HIV-positive (HIV+) mothers alive. In pursuit of this goal, in 2011, the Malawi Ministry of Health (MoH) adopted the Option B+ strategy, which entails lifelong antiretroviral treatment for all HIV+ mothers, irrespective of severity of HIV infection. Poor mother-child pair retention is one of the major challenges against achieving this goal. To improve retention of mother-infant pairs in the eMTCT continuum of care, the Promoting Retention among Infants and Mothers Effectively (PRIME) study is evaluating the effectiveness of 3 models of health care delivery namely, mother-infant pair clinics, which deliver integrated HIV and non-HIV services, mother-infant pair clinics plus electronic text message (SMS) reminders for mother-infant pairs who miss scheduled eMTCT follow-up clinics, and current standard of care. The primary outcome is "the proportion of HIV+ mothers and/or HIV-exposed infants (HEI) retained in eMTCT care at 12 months postpartum and received recommended HIV and non-HIV services during preceding scheduled visits." This 3-arm cluster randomized intervention study is being implemented in 30 primary health facilities (10 facilities per arm) in Mangochi and Salima districts, Malawi. At each clinic, a total of 41 HIV+ mothers attending maternal and child health services are being recruited and followed up for 18 months postpartum. This article describes the study methodology and interventions, successes and challenges experienced during the first 12 months of study implementation and relevance of study results to Malawi and other countries adopting the Option B+ strategy.
Development and validation of a web-based neuropsychological test protocol for sports-related return-to-play decision-making.

The Concussion Resolution Index (CRI) is an online assessment tool designed to track resolution of symptoms following sports-related concussion. The CRI is composed of six subtests measuring reaction time, visual recognition, and speed of information processing. Three factors are derived from the subtests: Simple Reaction Time (SRT), Complex Reaction Time (CRT), and Processing Speed (PS). Multiple alternate forms within subtests afford simple, reliable, assessment of change, relative to a baseline test completed by an athlete. The test also assesses self-reported neurophysiological symptoms at the time of injury and tracks resolution of these symptoms. The data demonstrate the CRI is a valid and reliable measure of cognitive performance in a relatively heterogeneous group of athletes aged 13-35. Two methods of statistical analysis for assessing change from baseline were compared to establish a psychometric basis for return-to-play decision-making: the Reliable Change Index (RCI) and multiple regression. Multiple regression was more accurate than the RCI in determining a decline in performance relative to the baseline.
Cardiorespiratory fitness changes in patients receiving comprehensive outpatient cardiac rehabilitation in the UK: a multicentre study.

To cite: Sandercock GRH, Cardoso F, Almodhy M, et al. Heart 2013;99: 785–790.  Exercise training is a key component of cardiac rehabilitation but there is a discrepancy between the high volume of exercise prescribed in trials comprising the evidence base and the lower volume prescribed to UK patients.  To quantify prescribed exercise volume and changes in cardiorespiratory fitness in UK cardiac rehabilitation patients.  We accessed n=950 patients who completed cardiac rehabilitation at four UK centres and extracted clinical data and details of cardiorespiratory fitness testing preand post-rehabilitation. We calculated mean and effect size (d) for change in fitness at each centre and converted values to metabolic equivalent (METs). We calculated a fixed-effects estimate of change in fitness expressed as METs and d.  Patients completed 6 to 16 (median 8) supervised exercise sessions. Effect sizes for changes in fitness were d=0.34–0.99 in test-specific raw units and d=0.34–0.96 expressed as METs. The pooled fixed effect estimate for change in fitness was 0.52 METs (95% CI 0.51 to 0.53); or an effect size of d=0.59 (95% CI 0.58 to 0.60).  Gains in fitness varied by centre and fitness assessment protocol but the overall increase in fitness (0.52 METs) was only a third the mean estimate reported in a recent systematic review (1.55 METs). The starkest difference in clinical practice in the UK centres we sampled and the trials which comprise the evidencebase for cardiac rehabilitation was the small volume of exercise completed by UK patients. The exercise training volume prescribed was also only a third that reported in most international studies. If representative of UK services, these low training volumes and small increases in cardiorespiratory fitness may partially explain the reported inefficacy of UK cardiac rehabilitation to reduce patient mortality and morbidity.