nils-herrmann/clean_scirepeval huggingface dataset:
A cluster-randomized controlled trial evaluating the effect of culturally-appropriate hypertension education among Afro-Surinamese and Ghanaian patients in Dutch general practice: study protocol

Individuals of African descent living in western countries have increased rates of hypertension and hypertension-related complications. Poor adherence to hypertension treatment (medication and lifestyle changes) has been identified as one of the most important modifiable causes for the observed disparities in hypertension related complications, with patient education being recommended to improve adherence. Despite evidence that culturally-appropriate patient education may improve the overall quality of care for ethnic minority patients, few studies have focused on how hypertensive individuals of African descent respond to this approach. This paper describes the design of a study that compares the effectiveness of culturally-appropriate hypertension education with that of the standard approach among Surinamese and Ghanaian hypertensive patients with an elevated blood pressure in Dutch primary care practices.



A cluster-randomized controlled trial will be conducted in four primary care practices in Amsterdam, all offering hypertension care according to Dutch clinical guidelines. After randomization, patients in the usual care sites (n = 2) will receive standard hypertension education. Patients in the intervention sites (n = 2) will receive three culturally-appropriate hypertension education sessions, culturally-specific educational materials and targeted lifestyle support. The primary outcome will be the proportion of patients with a reduction in systolic blood pressure >or= 10 mmHg at eight months after the start of the trial. The secondary outcomes will be the proportion of patients with self-reported adherence to (i) medication and (ii) lifestyle recommendations at eight months after the start of the trial. The study will enrol 148 patients (74 per condition, 37 per site).  current diagnosis of hypertension, self-identified Afro-Surinamese or Ghanaian, >or= 20 years, and baseline blood pressure >or= 140/90 mmHg. Primary and secondary outcomes will be measured at baseline and at 3 1/2, 6 1/2, and eight months. Other measurements will be performed at baseline and eight months.



The findings will provide new knowledge on how to improve blood pressure control and patient adherence in ethnic minority persons with a high risk of negative hypertension-related health outcomes.
Reliability and Validity of the Korean Version of the Penn State Worry Questionnaire in Primary School Children

Worry is a generalized psychological phenomenon seen among most people. When worry is excessive and nearly uncontrollable, people usually suffer psychological pain. The Penn State Worry Questionnaire for Children (PSWQ-C) was developed to measure worry objectively. It comprises 14 items for measuring excessive, generalized, and uncontrollable worry in children. This study, conducted with a large group of elementary children (3rd through 6th graders, ages 8-12 yr; N=973), investigated the reliability and validity of the Korean version of the Penn State Worry Questionnaire for Children (PSWQ-CK). The PSWQ-CK showed high reliability by test-retest and also excellent internal consistency results. To examine the validity of the PSWQ-CK, we calculated its correlation with the Revised Children's Manifest Anxiety Scale (RCMAS). The PSWQ-CK had a higher correlation with the worry/oversensitivity factor than with other subscales of the RCMAS, and it showed no correlation with the lie factor. When 3 reversed PSWQ-CK items were eliminated, the instrument showed higher internal consistency. However, this did not improve its correlation with other anxiety-measuring tools. In conclusion, the PSWQ-CK's reliability and validity were satisfactory, and it is a useful tool for objectively measuring the worry of Korean children of this age group.
Patient referral is influenced by dialysis centre structure in the Diamant Alpin Dialysis cohort study.

Late referral (LR) to the nephrologist of patients with progressing chronic kidney disease (CKD) has numerous deleterious effects and is observed in many countries. The contributing factors associated with LR are controversial and poorly defined. We hypothesized that these factors might be better identified by analysing patients starting dialysis in three distinct European countries within the same area.



The referral and progression of kidney failure patterns were analysed with demographic, clinical and biological data in 279 non-selected consecutive patients starting dialysis in eight centres of three adjacent regions in France, Italy and Switzerland.



Early referral (>6 months before the start of dialysis) was seen in 200 patients (71.6%), intermediate referral (1-6 months) in 42 (15.1%) and LR (<1 month) in 37 (13.3%). However inter-centre variations were between 2 and 19% for LR and 6-50% for combined late and intermediate referral. There were no differences at the national levels, but LR was more frequent in the large city centres than in the private or regional structures, with 31 out of 169 (18.3%), two out of 55 (5.4%) and four out of 55 (7.3%), respectively, of their patients (P<0.01). By multivariate analysis, it appears that, besides the presence of an active cancer and the CKD progression rate, the centre structure and the referring physician (primary care physicians and nephrologists are less responsible for LR than other medical specialists) play a significant role in the practice of LR.



Within a dialysis cohort spread over adjacent regions of three countries, LR has the same global distribution pattern, indicating that different health and social security systems do not play a major role in inducing or preventing this practice. The contributing factors for LR that were identified are the type of the referring physician and the structure of the dialysis unit. Both factors are potential targets for an educational and collaborative approach.
The cost-effectiveness and public health benefit of nalmefene added to psychosocial support for the reduction of alcohol consumption in alcohol-dependent patients with high/very high drinking risk levels: a Markov model

To determine whether nalmefene combined with psychosocial support is cost-effective compared with psychosocial support alone for reducing alcohol consumption in alcohol-dependent patients with high/very high drinking risk levels (DRLs) as defined by the WHO, and to evaluate the public health benefit of reducing harmful alcohol-attributable diseases, injuries and deaths.



Decision modelling using Markov chains compared costs and effects over 5 years.



The analysis was from the perspective of the National Health Service (NHS) in England and Wales.



The model considered the licensed population for nalmefene, specifically adults with both alcohol dependence and high/very high DRLs, who do not require immediate detoxification and who continue to have high/very high DRLs after initial assessment.



We modelled treatment effect using data from three clinical trials for nalmefene (ESENSE 1 (NCT00811720), ESENSE 2 (NCT00812461) and SENSE (NCT00811941)). Baseline characteristics of the model population, treatment resource utilisation and utilities were from these trials. We estimated the number of alcohol-attributable events occurring at different levels of alcohol consumption based on published epidemiological risk-relation studies. Health-related costs were from UK sources.



We measured incremental cost per quality-adjusted life year (QALY) gained and number of alcohol-attributable harmful events avoided.



Nalmefene in combination with psychosocial support had an incremental cost-effectiveness ratio (ICER) of £5204 per QALY gained, and was therefore cost-effective at the £20,000 per QALY gained decision threshold. Sensitivity analyses showed that the conclusion was robust. Nalmefene plus psychosocial support led to the avoidance of 7179 alcohol-attributable diseases/injuries and 309 deaths per 100,000 patients compared to psychosocial support alone over the course of 5 years.



Nalmefene can be seen as a cost-effective treatment for alcohol dependence, with substantial public health benefits.
Feasibility and acceptability of a Tai Chi Chih randomized controlled trial in senior female cancer survivors.

The purpose of this randomized controlled trial (RCT) was to examine the feasibility and acceptability of a Tai Chi Chih (TCC) intervention in senior female cancer survivors with physical functioning limitations, and its effects on health-related quality of life (QOL).



This was a two-armed, parallel group, RCT with 12-weeks of Tai Chi Chih or Health Education Control.



Sixty-three senior (M age = 67 years, SD = 7.15) female cancer survivors (83% breast cancer, stages I-III) with physical functioning limitations (SF-12 Health Survey role-physical & physical functioning subscales) were randomized to 12-weeks of TCC or Health Education control (HEC). Primary outcomes were feasibility and acceptability. Secondary outcomes included health-related QOL (SF-36 Health Survey), and participants' qualitative feedback on the intervention.



Retention (TCC = 91%; HEC = 81%) and class attendance (TCC = 79%; HEC = 83%) rates, and satisfaction levels for both study arms were high, but did not significantly differ from one another. At one-week post-intervention, none of the SF-36 scores differed between the TCC and HEC groups. Within-group analyses revealed significant improvements in the mental component summary score in TCC (p = 0.01), but not in HEC. Qualitative analyses indicated that the TCC group felt they received mental and physical benefits, whereas HEC group reported on social support benefits and information received.



The TCC intervention was found to be a feasible and acceptable modality for senior female cancer survivors. Future, larger definitive trials are needed to clarify TCC dosage effects on QOL in this vulnerable population.
An extensively hydrolysed cow's milk formula improves clinical symptoms of gastroesophageal reflux and reduces the gastric emptying time in infants.

About 20 % of infants fed with breast-milk substitutes suffer from Gastro Esophageal Reflux (GER) and 1/3 of them also show Cow's Milk Allergy (CMA) symptoms.



We planned this study to assess by dynamic echography the usefulness of an Extensively Hydrolysed Cow's Milk Formula (eHF) in infants suffering from GER. Ten infants showing GER symptoms and 10 normal babies, all fed with breast-milk substitutes, were enrolled. Clinical symptom scores related to GER were assessed for one week. The Gastric Emptying Time (GET) was determined by means of dynamic echography after feeding with cow's milk-derived formulae and again after a week feeding with eHF in subjects previously showing GER symptoms.



All infants with a clinical diagnosis for GER showed an abnormally high average GET in comparison to normal subjects (205 vs 124 min, p = 0.000). Switching to the eHF led to a significant clinical improvement (p = 0.0039) especially in babies skin-test and RAST positive to cow's milk, and to a significant decrease toward the normal value of the GET (167 min, p < 0.001).



The eHF tested improves GER symptoms in infants suffering from this disease. Our experience confirms and supports the use of dynamic echography as a reliable, simple, and non-invasive diagnostic method for infants with an increased GET associated with clinical symptoms of GER.
L-Tryptophan administered to chronic sleep-onset insomniacs: Late-appearing reduction of sleep latency

The effects of 3 g l-tryptophan on sleep, performance, arousal threshold, and brain electrical activity during sleep were assessed in 20 male, chronic sleep-onset insomniacs (mean age 20.3±2.4 years). Following a sleep laboratory screening night, all subjects received placebo for 3 consecutive nights (single-blind), ten subjects received l-tryptophan, and ten received placebo for 6 nights (double-blind). All subjects received placebo on 2 withdrawal nights (single-blind). There was no effect of l-tryptophan on sleep latency during the first 3 nights of administration. On nights 4–6 of administration, sleep latency was significantly reduced. Unlike benzodiazepine hypnotics, l-tryptophan did not alter sleep stages, impair performance, elevate arousal threshold, or alter brain electrical activity during sleep.
Comparison of Epidemiology, Emergency Care, and Outcomes of Acute Ischemic Stroke between Young Adults and Elderly in Korean Population: A Multicenter Observational Study

Stroke in young adults has been known to show a lower incidence and a better prognosis. Only a few studies have examined the epidemiology and outcomes of ischemic stroke in young adults and compared them with the elderly in Korean population. All consecutive patients with ischemic stroke visiting 29 participating emergency departments were enrolled from November 2007 to October 2009. Patients with less than 15 yr of age and unknown information on age and confirmed diagnosis were excluded. We categorized the patients into young adults (15 to 45 yr) and elderly (46 yr and older) groups. Of 39,156 enrolled all stroke patients, 25,818 with ischemic stroke were included and analyzed (young adult; n=1,431, 5.5%). Young adult patients showed lower prevalence of most chronic diseases but significantly higher prevalence in exercise, current smoking, and alcohol consumption. Hospital mortality was significantly lower in young adults than elderly (1.1% vs. 3.1%, P<0.001). Higher number of patients in elderly group (68.1%) showed worsening change of modified Rankin Scale than young adults (65.2%). Young adults ischemic stroke showed favorable hospital outcomes than the elderly in Korean population.
Double-pulse magnetic brain stem stimulation: mimicking successive descending volleys.

Magnetic stimulation with a double-cone-coil over the back of the head activates the motor tracts at the level of pyramidal decussation (brain stem stimulation [BST]). However, single-pulse BST (single BST) sometimes cannot elicit motor-evoked potentials (MEPs) in patients with corticospinal tract involvement. We developed a technique using double-pulse BST (double BST) to elicit MEPs even in patients whose threshold is abnormally elevated. Subjects were 11 healthy volunteers and 12 patients with corticospinal tract involvement in whom single BST evoked no discernible MEP. Double BST was performed at the intensities of resting and active motor threshold for single BST; MEPs were recorded from the first dorsal interosseous muscle. Interstimulus intervals (ISIs) between two pulses were 1.5, 2, 3, 5, and 10 ms in healthy subjects. Double BST enlarged MEPs at ISIs of 1.5-5 ms with a peak at 2 ms in the relaxed condition, but not in the active condition. At an ISI of 2 ms in the relaxed condition, the MEP amplitude was 15 times as large as that to single BST in relaxed muscles. The onset latency of the enlarged MEP from the second pulse in relaxed muscles was the same as that by single BST in active muscles. Double BST at a 2-ms interval elicited MEPs in eight patients. Double BST can enhance MEPs probably by temporal summations of excitatory postsynaptic potentials at the spinal motoneurons. Using this new technique, we can obtain more information about the central motor conduction even when single BST fails to elicit any MEP.
Molecular restoration of archived transcriptional profiles by complementary-template reverse-transcription (CT-RT)

Gene expression profiling of formalin-fixed and paraffin-embedded (FFPE) specimens, banked from completed clinical trials and routine clinical care, has the potential to yield valuable information implicating and linking genes with clinical parameters. In order to prepare high-quality cDNA from highly fragmented FFPE-RNA, previously precluded from high-throughput analyses, we have designed a novel strategy based on the nucleic acid restoration of incomplete cDNA sequences prior to T7 in vitro transcription (IVT) amplification. We describe this strategy as complementary-template reverse-transcription (CT-RT) because short single-stranded T7-oligo-dT24-VN-DNA sequences, obtained from FFPE-RNA, are used as primers for the RT of complementary RNA templates contained in a sense-RNA library. We validated our assay by determining the correlation between expression profiles of a matched 10-year-old frozen and FFPE breast cancer sample. We show that T7 IVT-amplification of cDNA transcripts restored by CT-RT is a specific and reliable process that allows recovery of transcriptional features undetectable by direct T7 IVT-amplification of FFPE-RNA. Furthermore, CT-RT restored 35-41% of the transcripts from archived breast and cervical specimens when compared to matched frozen tissue; and profiles included tissue-specific transcripts. Our results indicate that CT-RT allows microarray profiling of severely degraded RNA that could not be analyzed by previous methods.
Visual evoked potentials after photostress in newly diagnosed insulin-dependent diabetes patients

The study was performed in order to ascertain whether electrophysiological abnormalities in visual function exist in newly diagnosed diabetic patients.  Visual evoked potentials (VEPs) were assessed under basal conditions and after photostress in normal control subjects and in newly diagnosed diabetic patients free of any fluorescein angiography signs of retinopathy. •  In basal conditions VEP P100 latency was significantly increased in the diabetic patients compared to controls (P<0.01), while N75-P100 amplitude was similar in both groups. After photostress N75-P100 amplitude (mean percentage decrement) was significantly higher in diabetic patients (P<0.01), while P100 latency (mean increment) and recovery time (time at which VEPs were superimposable on basal condition) were similar in the two groups.  The impaired basal VEPs suggest an early involvement of conduction in the optic nerve. In contrast, the preserved recovery time after photostress indicates that a short duration of disease does not induce physiopathological changes in macular function.
No effect of 6-month intake of glucosamine sulfate on Modic changes or high intensity zones in the lumbar spine: sub-group analysis of a randomized controlled trial

The underlying pathology and natural course of Modic changes (MC) in the vertebral body marrow and high intensity zones (HIZs) in the annulus fibrosus is not completely clarified. These findings on magnetic resonance imaging (MRI) have initiated different treatments with little or unclear effect. In a randomized trial (n = 250), glucosamine sulfate (GS) had no effect on low back pain related disability. GS could still have an effect on MC and HIZ. In this sub-study, 45 patients from the trial who had MC and/or HIZ at pre-treatment underwent follow-up MRI. The aim was to examine the course of MC and HIZ and to compare this course between groups treated with 6-month intake of oral GS versus placebo. Of 141 pre-treatment MC in 42 (of 45) patients, 29 (20.6%) MC in 18 patients had altered type and 14 MC in 9 patients had altered size (decreased for 1 MC) 6-18 months later: odds ratio (OR) for type vs. size alterations 4.0; 95% confidence interval (CI) 1.2-17.7. No MC resolved. HIZ vanished from 3 of 23 discs in 3 of 21 patients with pre-treatment HIZ. Ten new MC (all type I or I/II) occurred in 8 patients and 2 new HIZs in 2 patients. The GS group (n = 19) and placebo group (n = 26) did not differ in proportions of MC with decreased (OR 1.6; 95% CI 0.4-6.1) or increased type I dominance at follow-up (OR placebo:GS 2.4; 95% CI 0.6-9.7), or with increased size (OR 1.0; 95% CI 0.2-4.7). HIZ vanished from 1 of 8 discs in 1 of 8 patients in the GS group vs. 2 of 15 discs in 2 of 13 patients in the placebo group (OR 0.8; 95% CI 0.02-12.2). In this sub-group analysis of a placebo-controlled trial, the effect of GS on MC and HIZs was no different from the effect of the placebo intervention. MC and HIZs remained mostly unchanged during the 6-18 months study period. Some short term changes did occur and MC more often altered type than size. NCT00404079 at http://www.clinicaltrial.gov .
The telehealth satisfaction scale: reliability, validity, and satisfaction with telehealth in a rural memory clinic population.

Patient satisfaction is a key aspect of quality of care and can inform continuous quality improvement. Of the few studies that have reported on patient satisfaction with telehealth in programs aimed at individuals with memory problems, none has reported on the psychometric properties of the user satisfaction scales used.



We evaluated the construct validity and internal consistency reliability of the Telehealth Satisfaction Scale (TeSS), a 10-item scale adapted for use in a rural and remote memory clinic (RRMC). The RRMC is a one-stop interprofessional clinic for rural and remote seniors with suspected dementia, located in a tertiary-care hospital. Telehealth videoconferencing is used for preclinic assessment and for follow-up. Patients and caregivers completed the TeSS after each telehealth appointment. With data from 223 patients, exploratory factor analysis was conducted using the principal components analysis extraction method.



The eigenvalue for the first factor (5.2) was greater than 1 and much larger than the second eigenvalue (0.92), supporting a one-factor solution that was confirmed by the scree plot. The total variance explained by factor 1 was 52.1%. Factor loadings (range, 0.54-0.84) were above recommended cutoffs. The TeSS items demonstrated high internal consistency reliability (Cronbach's alpha=0.90). Satisfaction scores on the TeSS items ranged from 3.43 to 3.72 on a 4-point Likert scale, indicating high satisfaction with telehealth.



The study findings demonstrate high user satisfaction with telehealth in a rural memory clinic and the sound psychometric properties of the TeSS in this population.
Does dissociation moderate treatment outcomes of narrative exposure therapy for PTSD? A secondary analysis from a randomized controlled clinical trial.

Dissociative symptoms, especially depersonalisation and derealisation, are often perceived as a contraindication for exposure-based treatments of posttraumatic stress disorder (PTSD) despite limited empirical evidence. The present paper examines whether derealisation and depersonalisation influence the treatment outcomes of narrative exposure therapy (NET) and treatment as usual (TaU) among severely traumatised asylum seekers and refugees. We performed a secondary analysis of a recently published randomized controlled multicentre trial comparing NET and TaU for the treatment of PTSD in asylum seekers and refugees. In order to investigate whether depersonalisation and derealisation moderate treatment outcomes, a number of moderated multiple, blockwise regression analyses were conducted. Missing data were handled with multiple imputation. The main finding from intention-to-treat analyses is that derealisation and depersonalisation overall do not moderate the treatment outcomes of either NET or TaU. The treatment condition was the most stable predictor of residual gain scores across outcome measures, with NET being associated with lower residual gain scores indicating better treatment outcomes. The present study substantiates and extends previous research indicating that dissociative symptoms such as derealisation and depersonalisation do not moderate the treatment outcome of exposure-based treatments for PTSD.


CLINICALTRIALSGOV IDENTIFIER
NCT00218959.