nils-herrmann/clean_scirepeval huggingface dataset:
Discrepancy between clinic and ambulatory blood pressure measurement in the evaluation of two antihypertensive agents.

Discrepancies between clinic and ambulatory BP measurements may be important in the assessment of antihypertensive drug efficacy. Trimazosin (50-200 mg twice daily) and propranolol (40-160 mg twice daily) were compared in 22 hypertensive subjects in a randomised double-blind cross-over study. Daytime ambulatory BP was measured with a non-invasive portable recorder (Remler M2000). Clinic BP measurements were made with a random zero sphygmomanometer. While both drugs reduced clinic supine BP (trimazosin by 16/10 mmHg, P less than 0.01/P less than 0.001; propranolol by 25/14 mmHg, P less than 0.001/P less than 0.001), equivalent decreases on ambulatory measurement occurred with propranolol (28/11 mm/Hg, P less than 0.001/P less than 0.001) but not trimazosin (8/3 mmHg, P less than 0.05/NS). This difference in drug efficacy persisted throughout the 12-hour dosing interval. We conclude that clinic BP measurements alone cannot be relied upon to reflect accurately changes in BP induced by antihypertensive drugs. Moreover this study confirms the necessity for ambulatory BP measurement in the evaluation of antihypertensive drugs.
Effects of a short term supplementation of a fermented papaya preparation on biomarkers of diabetes mellitus in a randomized Mauritian population.

Clinical evidence and cellular models have shown an inverse relationship between the intakes of plant and fruit based diets and oxidative stress, suggesting the suitability of natural antioxidants in the management of diabetes mellitus and its complications.



A randomized controlled clinical trial was conducted at the Cardiac Centre, SSRN Hospital, Pamplemousses, (Mauritius) to determine the effect of a short term supplementation of a fermented papaya preparation (FPP®) on biomarkers of diabetes and antioxidant status in a multi-ethnical neo-diabetic population from November 2010 to March 2011.



Supplementation of 6g FPP®/day for a period of 14 weeks could improve the general health status of several organs targeted by oxidative stress during diabetes. When comparing experimental to control groups with independent samples t-test, C-reactive protein levels significantly decreased (P=0.018), LDL/HDL ratio was considerably changed (P=0.042), and uric acid levels were significantly improved (P=0.001). ANOVA results also validated the same findings with significant differences in C-reactive protein, LDL/HDL ratio, uric acid and in serum ferritin levels.



FPP® may present a novel, economically feasible nutraceutical supplement for the management of diabetes and for those at risk for cardiovascular disease, neurological disease and other conditions worsened by overt inflammation and oxidative stress.
High Acceptability of HIV Pre-exposure Prophylaxis but Challenges in Adherence and Use: Qualitative Insights from a Phase I Trial of Intermittent and Daily PrEP in At-Risk Populations in Kenya

This paper used qualitative methods to explore experiences of men who have sex with men and female sex workers in Nairobi and Mtwapa, Kenya, who used oral pre-exposure prophylaxis (PrEP) for HIV prevention as part of a four-month trial of safety, acceptability and adherence. Fifty-one of 72 volunteers who took part in a randomized, placebo-controlled, blinded trial that compared daily and intermittent dosage of PrEP underwent qualitative assessments after completing the trial. Analyses identified three themes: (i) acceptability of PrEP was high, i.e. side effects were experienced early in the study but diminished over time, however characteristics of pills could improve comfort and use; (ii) social impacts such as stigma, rumors, and relationship difficulties due to being perceived as HIV positive were prevalent; (iii) adherence was challenged by complexities of daily life, in particular post-coital dosing adherence suffered from alcohol use around time of sex, mobile populations, and transactional sex work. These themes resonated across dosing regimens and gender, and while most participants favored the intermittent dosing schedule, those in the intermittent group noted particular challenges in adhering to the post-coital dose. Culturally appropriate and consistent counseling addressing these issues may be critical for PrEP effectiveness.
Psychological contributions to functional independence: a longitudinal investigation of spinal cord injury rehabilitation.

To investigate the contribution of prerehabilitation appraisals of spinal cord injury (SCI) and patient's coping strategies to the variance in functional independence postdischarge.



Longitudinal, cohort study. Patients aged 16 and older and sustaining an SCI were recruited from English- and German-speaking specialist spinal injuries centers. Measures of appraisals, coping strategies, mood, and functional independence were administered on commencing active rehabilitation (12-weeks postinjury) and following hospital discharge (1-y postinjury).



Specialist SCI rehabilitation centers in England, Germany, Switzerland, and Ireland.



Patients (N=127) completed questionnaires at both time points. Sample age ranged between 17.5 and 64.5 years with a mean age of 39.3 years. Demographic and injury characteristics were similar to those reported in international statistics databases.



Not applicable.



FIM (motor subscale).



Injury characteristics, age, sex, current depression, and the utilization of the coping strategy, social reliance, at 12-weeks postinjury explained 33.5% of the variance in motor FIM at 1-year postinjury. Strong relationships were found between appraisals, coping styles, mood, and functional outcomes.



The coping strategy, social reliance, was found to contribute significantly when explaining the variance in functional outcomes. Suggestions were made to assess appraisals and coping strategies early in rehabilitation in order to provide effective interventions and additional support to those scoring highly on negative coping styles. Further research is recommended to provide support for the relationship between dependent coping strategies and functional outcomes.
Improvement of aggressive behavior and quality of life impairment following <ce:italic>S</ce:italic>-Adenosyl-Methionine (SAM-e) augmentation in schizophrenia

S-adenosyl-methionine (SAM-e), functions as a primary methyl group donor for several metabolic compounds. Since SAM-e is involved in several metabolic processes, its administration may have a role in the amelioration of several disorders. In addition, SAM-e increases catechol-O-methyltransferase (COMT) enzyme activity, which may ameliorate aggressive symptoms in certain patients. We have therefore investigated the efficacy of SAM-e in managing schizophrenia symptomatology in patients with the low activity COMT polymorphism. Eighteen patients with chronic schizophrenia were randomly assigned to receive either SAM-e (800 mg) or placebo for 8 weeks in double-blind fashion. Results indicated some reduction in aggressive behavior and improved quality of life following SAM-e administration. Female patients showed improvement of depressive symptoms. Clinical improvement did not correlate with serum SAM-e levels. Two patients receiving SAM-e exhibited some exacerbation of irritability. This preliminary pilot short-term study cautiously supports SAM-e as an adjunct in management of aggressive behavior and quality of life impairment in schizophrenia.
The popliteal fibular ligament in acute knee trauma: patterns of injury on MR imaging

To describe the patterns of injury associated with injury to the popliteofibular ligament injury. A retrospective review was performed of 180 MRI scans undertaken for acute knee trauma. Scans were excluded if the time of injury was over 4 weeks from the time of the scan, or if there was a history of septic arthritis, inflammatory arthropathy, previous knee surgery, or significant artefact. An agreed criterion for assessing the structures of the posterolateral ligamentous complex was defined and in each scan, the popliteofibular ligament (PFL) was scored as normal or injured. The menisci, ligaments, and tendons of each knee were also assessed. The mean age was 25.7 years (range, 9–65 years) and 72.2 % (n = 130) patients were male. The PFL was injured in 36 cases (20 %). There is a significant association between PFL injury and ACL rupture (p = 0.0001), ITB injury (p = 0.0001), PCL injury (p = 0.0373), in addition to associations with injury to other posterolateral corner structures including the lateral collateral ligament (p = 0.0001), biceps femoris tendon (p = 0.0014), and popliteus tendon (p = 0.0014). Of our series of PFL injuries, nine cases (25 %) were associated with further injuries of posterolateral corner structures and in 27 cases (75 %) the PFL was the only posterolateral corner structure torn. PFL injury is not uncommon in acute knee trauma and is associated with significant internal derangement of the knee, especially anterior cruciate ligament rupture, ITB sprain, and injury to other structures within the posterolateral corner.
Prognostic significance of admission levels of cardiac indicators in patients with acute ischaemic stroke: prospective observational study.

The performance of cardiac indicators as determinants of stroke outcomes remains debatable, therefore the present study focused on the short-term prognostic value of cardiac indicators in patients who had experienced acute ischaemic stroke.



Consecutive patients with acute ischaemic stroke were enrolled in a prospective stroke registry. Data on demographics, clinical characteristics and cardiac indicator levels (including troponin I, creatine kinase-MB, myoglobin and brain natriuretic peptide) were prospectively collected. Receiver operating characteristic curves and binary logistic regression models were used to examine the performance of variables in predicting poor functional outcomes (modified Rankin Scale score 2-6).



Out of 337 patients with acute ischaemic stroke, myoglobin had the greatest power for predicting poor outcomes among the cardiac indicators. Forward stepwise multivariate logistic regression analysis revealed that myoglobin could independently predict short-term outcomes. Spearman's rank correlation tests indicated a positive correlation between myoglobin levels and stroke severity.



Among cardiac indicators, myoglobin may be an independent predictor of short-term outcomes in patients with acute ischaemic stroke.
Immediate outcome after sutureless versus transcatheter aortic valve replacement

The aim of this study was to compare the immediate outcome of patients undergoing transcatheter (TAVI) versus surgical aortic valve replacement with the sutureless Perceval bioprosthesis (SU-AVR). This is a retrospective multicenter analysis of 773 patients who underwent either TAVI (394 patients, mean age, 80.8 ± 5.5 years, mean EuroSCORE II 5.6 ± 4.9 %) or SU-AVR (379 patients, 77.4 ± 5.4 years, mean EuroSCORE II 4.0 ± 3.9 %) with or without concomitant myocardial revascularization. Data on SU-AVRs were provided by six European institutions (Belgium, Finland, Germany, Italy and Sweden) and data on TAVIs were provided by a single institution (Catania, Italy). In-hospital mortality was 2.6 % after SU-AVR and 5.3 % after TAVI (p = 0.057). TAVI was associated with a significantly high rate of mild (44.0 vs. 2.1 %) and moderate–severe paravalvular regurgitation (14.1 vs. 0.3 %, p < 0.0001) as well as the need for permanent pacemaker implantation (17.3 vs. 9.8 %, p = 0.003) compared with SU-AVR. The analysis of patients within the 25th and 75th percentiles interval of EuroSCORE II, i.e., 2.1–5.8 %, confirmed the findings of the overall series. One-to-one propensity score-matched analysis resulted in 144 pairs with similar baseline characteristics and operative risk. Among these matched pairs, in-hospital mortality (6.9 vs. 1.4 %, p = 0.035) was significantly higher after TAVI. SU-AVR with the Perceval prosthesis in intermediate-risk patients is associated with excellent immediate survival and is a valid alternative to TAVI in these patients.
A Simple Clinical Measure of Quadriceps Muscle Strength Identifies Responders to Pulmonary Rehabilitation

The aim was to determine if baseline measures can predict response to pulmonary rehabilitation in terms of six-minute walk distance (6MWD) or quality of life. Participants with COPD who attended pulmonary rehabilitation between 2010 and 2012 were recruited. Baseline measures evaluated included physical activity, quadriceps strength, comorbidities, inflammatory markers, and self-efficacy. Participants were classified as a responder with improvement in 6MWD (criteria of ≥25 m or ≥2SD) and Chronic Respiratory Questionnaire (CRQ; ≥0.5 points/question). Eighty-five participants with a mean (SD) age of 67(9) years and a mean forced expiratory volume in one second of 55(22)% were studied. Forty-nine and 19 participants were responders when using the 6MWD criteria of ≥25 m and ≥61.9 m, respectively, with forty-four participants improving in CRQ. In a regression model, responders in 6MWD (≥25 m criteria) had lower baseline quadriceps strength (P = 0.028) and higher baseline self-efficacy scores (P = 0.045). Independent predictors of 6MWD response (≥61.9 m criteria) were participants with metabolic disease (P = 0.007) and lower baseline quadriceps strength (P = 0.016). Lower baseline CRQ was the only independent predictor of CRQ response. A participant with relatively lower baseline quadriceps strength was the strongest independent predictor of 6MWD response. Metabolic disease may predict 6MWD response, but predictors of CRQ response remain unclear.
Effects of pharmacologic treatment based on airflow limitation and breathlessness on daily physical activity in patients with chronic obstructive pulmonary disease

Improvement in the daily physical activity (PA) is important for the management of chronic obstructive pulmonary disease (COPD). However, the effects of pharmacologic treatment on PA are not well understood. We evaluated the effects of additional medications, including bronchodilator with or without inhaled corticosteroid, based on airflow limitation and breathlessness on the PA in COPD patients and the factors that could predict or affect the improvement in PA.



A prospective non-randomized observational study was employed. Twenty-one COPD subjects without any other diseases that might reduce PA were recruited. The PA was measured with a triaxial accelerometer for 2 weeks, and pulmonary function tests and incremental shuttle walking tests were administered before and after 4-week treatment with an additional medication.



Bronchodilation was obtained by additional medication. The mean values of PA evaluated by metabolic equivalents (METs) at ≥3.0 METs and the duration of PA at ≥3.0 METs and ≥3.5 METs were improved by medication. The % change in the duration of PA at ≥3.5 METs was significantly correlated with the baseline functional residual capacity (FRC), residual volume, and inspiratory capacity/total lung capacity. However, the % change in the duration of PA at any intensity was not correlated with the % changes of any values of the pulmonary function tests or incremental shuttle walking test except the PA at ≥2.5 METs with FRC.



Medication could improve the PA in patients with COPD, especially at a relatively high intensity of activity when medication was administered based on airflow limitation and breathlessness. The improvement was seen in the patients with better baseline lung volume, but was not correlated with the improvements in the pulmonary function tests or exercise capacity.
Liquid formulation of pentoxifylline is a poorly tolerated treatment for duchenne dystrophy.

In this study we performed an open-label, pilot study of an orally administered liquid formulation of immediate-release pentoxifylline (PTX) on patients with Duchenne muscular dystrophy (DMD). Treatment efficacy, safety, and tolerability were assessed.



The tolerability and safety of PTX and measures of muscle strength and function were evaluated during 12 months of treatment.



Seventeen boys with DMD, between 4 and 8 years of age, were enrolled at one of five Cooperative International Neuromuscular Research Group (CINRG) centers. Only 9 were able to complete the 12-month PTX treatment phase; the primary reason for discontinuation was adverse events. Intolerable gastrointestinal side effects were experienced by 65% of participants. Two participants had severe leukopenia that resolved with medication withdrawal.



Open-label treatment with a liquid formulation of immediate-release PTX resulted in a high incidence of adverse events in boys with DMD. Poor tolerability of this PTX formulation precluded adequate assessment of efficacy.
Electronic monitoring of adherence, treatment of hypertension, and blood pressure control.

Although it is generally acknowledged that electronic monitoring of adherence to treatment improves blood pressure (BP) control by increasing patients' awareness to their treatment, little information is available on the long-term effect of this intervention.



In this observational study among a total of 470 patients with mild-to-moderate hypertension, adherence was measured in 228 patients by means of both the Medication Event Monitoring System (MEMS) and pill count (intervention group), and in 242 patients by means of pill count alone (control group). During a follow-up period of 1 year consisting of seven visits to the physician's office, BP measurements were performed and medication adjusted based on the achieved BP. In addition, at each visit adherence to treatment was assessed.



On the basis of pill counts, median adherence to treatment did not differ between the intervention group and the control group (96.1% vs. 94.2%; P = 0.97). In both groups, systolic and diastolic BP decreased similarly: 23/13 vs. 22/12 mm Hg in the intervention and control group respectively. Drug changes and the number of drugs used were associated with BP at the start of study, but not with electronic monitoring.



In this study, electronic monitoring of adherence to treatment by means of MEMS did not lead to better long-term BP control nor did it result in less drug changes and drug use.
The Rutgers Arm, a Rehabilitation System in Virtual Reality: A Pilot Study

Stroke is one of the leading causes of death and disability worldwide. Its prevalence calls for innovative rehabilitation methods. The Rutgers Arm is a novel upper extremity rehabilitation system consisting of a low-friction table, three-dimensional (3D) tracker, custom forearm support, PC workstation, library of Java 3D virtual reality (VR) exercises, clinical database module, and a tele-rehabilitation extension. The system was tested on a chronic stroke subject, under local and tele-rehabilitation conditions, over 5 weeks of training. Results show improvements in arm motor control and shoulder range of motion, corresponding to improved Fugl-Meyer test scores. Exercise duration, level of difficulty, and patient motivation were maintained under tele-rehabilitaion. A 1-week retention trial showed that gains were maintained.
Brain morphology in Klinefelter syndrome: extra X chromosome and testosterone supplementation.

This study focuses on variation in brain morphology associated with supernumerary X chromosome and Klinefelter syndrome (KS). Using an unselected birth cohort of KS subjects and high-resolution MRI, the authors investigated the neuroanatomic consequences of the 47,XXY karyotype in the presence and absence of exogenous testosterone supplementation.



Regional brain volumes were measured in 10 subjects with KS and 10 age-matched control men. Five of the KS subjects had received testosterone supplementation since puberty (KS+T) and five had not (KS-T).



KS subjects showed significant (p < 0.01) reduction in left temporal lobe gray matter volumes compared with normal control subjects. Differences in left temporal gray volumes were also significant between the KS+T and KS-T groups (p < 0.01). Verbal fluency scores were significantly different between the KS+T and KS-T groups as well.



Supernumerary X chromosome material in men is associated with a reduction in left temporal lobe gray matter, a finding that is consistent with the verbal and language deficits associated with KS. Also, relative preservation of gray matter in the left temporal region is associated with exposure to exogenous androgen during development. A history of testosterone supplementation also appears to be associated with increased verbal fluency scores in KS patients.
Novel and recurrent FERMT1 gene mutations in Kindler syndrome.

Kindler syndrome (OMIM 173650) is an autosomal recessive condition characterized by skin blistering, skin atrophy, photosensitivity, colonic inflammation and mucosal stenosis. Fewer than 100 cases have been described in the literature. First reported in 1954, the molecular basis of Kindler syndrome was elucidated in 2003 with the discovery of FERMT1 (KIND1) loss-of-function mutations in affected individuals. The FERMT1 gene encodes kindlin-1 (also known as fermitin family homologue 1), a 77 kDa protein that localizes at focal adhesions, where it plays an important role in integrin signalling. In the current study, we describe five novel and three recurrent loss-of-function FERMT1 mutations in eight individuals with Kindler syndrome, and provide an overview of genotype-phenotype correlation in this disorder.
Structured self-management education maintained over two years in insufficiently controlled type 2 diabetes patients: the ERMIES randomised trial in Reunion Island

Self-management education programs can reduce the complications and mortality in type 2 diabetes. The need to structure these programs for outpatient and community care with a vision for long-term maintenance has been recognised. In Reunion Island, an area affected by epidemiological and nutritional transition, diabetes affects 18% of the adult population over 30 years, with major social disparities, poor glycaemic control and frequent cardiovascular complications.



ERMIES is a randomised controlled trial designed to test the efficacy of a long-term (2 years) structured group self management educational intervention in improving blood glucose in non-recent, insufficiently controlled diabetes. After an initial structured educational cycle carried out blind for the intervention arm, patients will be randomised in two parallel group arms of 120 subjects: structured on-going group with educational intervention maintained over two years, versus only initial education. Education sessions are organised through a regional diabetes management network, and performed by trained registered nurses at close quarters. The educational approach is theoretically based (socio-constructivism, social contextualisation, empowerment, action planning) and reproducible, thanks to curricula and handouts for educators and learners. The subjects will be recruited from five hospital outpatient settings all over Reunion Island. The main eligibility criteria include: age ≥18 years, type 2 diabetes treated for more than one year, HbA1c ≥ 7.5% for ≥3 months, without any severe evolving complication (ischaemic or proliferative retinopathy, severe renal insufficiency, coronaropathy or evolving foot lesion), and absence of any major physical or cognitive handicap. The primary outcome measure is HbA1c evolution between inclusion and 2 years. The secondary outcome measures include anthropometric indicators, blood pressure, lipids, antidiabetic medications, level of physical activity, food ingestion, quality of life, social support, anxiety, depression levels and self-efficacy. An associated nested qualitative study will be conducted with 30 to 40 subjects in order to analyse the learning and adaptation processes during the education cycles, and throughout the study.



This research will help to address the necessary but difficult issue of structuring therapeutic education in type 2 diabetes based on: efficacy and potential interest of organising on-going empowerment group-sessions, at close quarters, over the long term, in a heterogeneous socioeconomic environment.