nils-herrmann/clean_scirepeval huggingface dataset:
Effectiveness of the Dader Method for pharmaceutical care in patients with bipolar I disorder: EMDADER-TAB: study protocol for a randomized controlled trial

Bipolar I disorder (BD-I) is a chronic mental illness characterized by the presence of one or more manic episodes, or both depressive and manic episodes, usually separated by asymptomatic intervals. Pharmacists can contribute to the management of BD-I, mainly with the use of effective and safe drugs, and improve the patient's life quality through pharmaceutical care. Some studies have shown the effect of pharmaceutical care in the achievement of therapeutic goals in different illnesses; however, to our knowledge, there is a lack of randomized controlled trials designed to assess the effect of pharmacist intervention in patients with BD. The aim of this study is to assess the effectiveness of the Dader Method for pharmaceutical care in patients with BD-I.



Randomized, controlled, prospective, single-center clinical trial with duration of 12 months will be performed to compare the effect of Dader Method of pharmaceutical care with the usual care process of patients in a psychiatric clinic. Patients diagnosed with BD-I aged between 18 and 65 years who have been discharged or referred from outpatients service of the San Juan de Dios Clinic (Antioquia, Colombia) will be included. Patients will be randomized into the intervention group who will receive pharmaceutical care provided by pharmacists working in collaboration with psychiatrists, or into the control group who will receive usual care and verbal-written counseling regarding BD. Study outcomes will be assessed at baseline and at 3, 6, 9, and 12 months after randomization. The primary outcome will be to measure the number of hospitalizations, emergency service consultations, and unscheduled outpatient visits. Effectiveness, safety, adherence, and quality of life will be assessed as secondary outcomes. Statistical analyses will be performed using two-tailed McNemar tests, Pearson chi-square tests, and Student's t-tests; a P value <0.05 will be considered as statistically significant.



As far as we know, this is the first randomized controlled trial to assess the effect of the Dader Method for pharmaceutical care in patients with BD-I and it could generate valuable information and recommendations about the role of pharmacists in the improvement of therapeutic goals, solution of drug-related problems, and adherence.


 First patient randomized on 24 November 2011.
Modeling DCE-MRI at low temporal resolution: a case study on rheumatoid arthritis.

To identify the optimal tracer-kinetic modeling strategy for dynamic contrast-enhanced magnetic resonance imaging (DCE-MRI) data acquired at low temporal resolution.



DCE-MRI was performed on 13 patients with rheumatoid arthritis of the hand before and after anti-tumor necrosis factor alpha (TNFα) therapy, using a 3D sequence with a temporal resolution of 13 seconds, imaging for 4 minutes postcontrast injection. Concentration-time curves were extracted from regions of interest (ROIs) in enhancing synovium and fitted to the 3-parameter modified Tofts model (MT) and the 4-parameter two-compartment exchange model (2CXM). To assist the interpretation of the data, the same analysis was applied to simulated data with similar characteristics.



Both models fitted the data closely, and showed similar therapy effects. The MT plasma volume was significantly lower than with 2CXM, but the differences in permeability and interstitial volume were not significant. 2CXM was less precise than MT, with larger standard deviations relative to the mean in most parameters. The additional perfusion parameter determined with 2CXM did not provide a statistically significant trend due to low precision.



The standard MT model is the optimal modeling strategy at low temporal resolution. Advanced models improve the accuracy and generate an additional parameter, but these benefits are offset by low precision.
Genetic and environmental influences on pro-inflammatory monocytes in bipolar disorder: a twin study.

A monocyte pro-inflammatory state has previously been reported in bipolar disorder (BD).



To determine the contribution of genetic and environmental influences on the association between monocyte pro-inflammatory state and BD.



A quantitative polymerase chain reaction case-control study of monocytes in bipolar twins. Determination of the influence of additive genetic, common, and unique environmental factors by structural equation modeling (ACE).



Dutch academic research center.



Eighteen monozygotic BD twin pairs, 23 dizygotic BD twin pairs, and 18 monozygotic and 16 dizygotic healthy twin pairs.



Expression levels of monocytes in the previously reported coherent set of 19 genes (signature) reflecting the pro-inflammatory state.



The familial occurrence of the association between the monocyte pro-inflammatory gene-expression signature and BD found in the within-trait/cross-twin correlations (twin correlations) was due to shared environmental factors (ie, both monozygotic and dizygotic ratios in twin correlations approximated 1; ACE modeling data: 94% [95% confidence interval, 53%-99%] explained by common [shared] environmental factors). Although most individual signature genes followed this pattern, there was a small subcluster of genes in which genetic influences could dominate.



The association of the monocyte pro-inflammatory state with BD is primarily the result of a common shared environmental factor.
Quality of life after adjuvant intra-arterial chemotherapy and radiotherapy versus surgery alone in resectable pancreatic and periampullary cancer: a prospective randomized controlled study.

Adjuvant therapies for pancreatic and periampullary cancer reportedly achieve only a marginal survival benefit. In this randomized controlled trial, 120 patients with resected pancreatic or periampullary cancer received either adjuvant celiac axis infusion chemotherapy combined with radiotherapy (CAI/RT) or no adjuvant treatment. The objective of the study was to compare the quality of life (QoL) in patients who received CAI/RT after pancreatoduodenectomy with the QoL in patients who did not receive adjuvant treatment.



During and after CAI/RT, QoL was assessed using the European Organization for Research and Treatment of Cancer QoL Questionnaire C30 every 3 months during the first 24 months after randomization.



Eighty-six percent of patients (n = 103) completed 1 or more questionnaires. In total, 355 questionnaires were completed. The results indicated that CAI/RT did not impair physical, emotional, or social functioning. During and after CAI/RT, patients had significantly less pain (P = .02) and less nausea and vomiting (P = .01). Overall QoL (global functioning) tended to be better (P = .08) after CAI/RT.



Over a period of 24 months, CAI/RT improved QoL compared with observation alone in patients with resected pancreatic and periampullary cancer. This beneficial effect of CAI/RT was most prominent in the latter half of the follow-up.
Magnesium sulphate at 30 to 34 weeks’ gestational age: neuroprotection trial (MAGENTA) - study protocol

Magnesium sulphate is currently recommended for neuroprotection of preterm infants for women at risk of preterm birth at less than 30 weeks' gestation, based on high quality evidence of benefit. However there remains uncertainty as to whether these benefits apply at higher gestational ages.The aim of this randomised controlled trial is to assess whether giving magnesium sulphate compared with placebo to women immediately prior to preterm birth between 30 and 34 weeks' gestation reduces the risk of death or cerebral palsy in their children at two years' corrected age.



Randomised, multicentre, placebo controlled trial.



Women, giving informed consent, at risk of preterm birth between 30 to 34 weeks' gestation, where birth is planned or definitely expected within 24 hours, with a singleton or twin pregnancy and no contraindications to the use of magnesium sulphate.Trial entry & randomisation: Eligible women will be randomly allocated to receive either magnesium sulphate or placebo.Treatment groups: Women in the magnesium sulphate group will be administered 50 ml of a 100 ml infusion bag containing 8 g magnesium sulphate heptahydrate [16 mmol magnesium ions]. Women in the placebo group will be administered 50 ml of a 100 ml infusion bag containing isotonic sodium chloride solution (0.9%). Both treatments will be administered through a dedicated IV infusion line over 30 minutes. Death or cerebral palsy measured in children at two years' corrected age.


SAMPLE SIZE
1676 children are required to detect a decrease in the combined outcome of death or cerebral palsy, from 9.6% with placebo to 5.4% with magnesium sulphate (two-sided alpha 0.05, 80% power, 5% loss to follow up, design effect 1.2).



Given the magnitude of the protective effect in the systematic review, the ongoing uncertainty about benefits at later gestational ages, the serious health and cost consequences of cerebral palsy for the child, family and society, a trial of magnesium sulphate for women at risk of preterm birth between 30 to 34 weeks' gestation is both important and relevant for clinical practice globally.
Increased airway responsiveness to acetaldehyde in asthmatic subjects with alcohol-induced bronchoconstriction.

Bronchial responsiveness to acetaldehyde, a main factor in alcohol-induced bronchoconstriction, and methacholine were compared between 10 subjects with alcohol-induced bronchoconstriction and 16 asthmatic subjects without alcohol sensitivity. In the alcohol-sensitive group, the geometric mean (geometric SEM (GSEM)) of the provocative concentration of methacholine (PC20,meth) and acetaldehyde (PC20,acet) causing a 20% fall in forced expiratory volume in one second were 0.947 mg x mL(-1) (GSEM 0.139) and 21.0 mg x mL(-1) (GSEM 0.112), respectively, which were not significantly different from those in the nonalcohol-sensitive group, which were 0.634 mg x mL(-1) (GSEM 0.115) and 31.7 mg x mL(-1) (GSEM 0.077), respectively. The ratio of airway responsiveness to acetaldehyde relative to methacholine (log PC20,acet/PC20,meth) was 1.345+/-0.093 (mean+/-SEM) in the alcohol-sensitive group, which was significantly different from the value of 1.699+/-0.059 in the nonalcohol-sensitive group (p=0.0025). A significant correlation was observed between PC20,meth and PC20,acet in both the alcohol-sensitive group (r=-0.742, p=0.0115) and nonsensitive group (r=0.882, p<0.0001). In conclusion, the airways of asthmatic subjects with alcohol-induced bronchoconstriction have a selective hyperresponsiveness to acetaldehyde.
A phase I study of oral panobinostat (LBH589) in Japanese patients with advanced solid tumors

The objective was to determine the maximum tolerated dose and the dose-limiting toxicity of panobinostat (LBH589) when administered as a single agent to adult patients with advanced solid tumors or cutaneous T-cell lymphoma whose disease had progressed despite standard therapy or for whom no standard therapy existed.  Panobinostat was administered orally once daily on Monday, Wednesday, and Friday of each week. A total of 13 patients were treated with one of three initial doses: 10 mg (n = 3), 15 mg (n = 4), or 20 mg (n = 6).  No dose-limiting toxicity was observed in 12 evaluable patients. The most frequently reported adverse events, regardless of whether they were related to the study drug, were diarrhea and nausea in 10 patients (76.9%). Thrombocytopenia was reported in 12 of 13 patients (92.3%). Five of 11 patients (45.4%) had stable disease.  Panobinostat administered orally once daily on Monday, Wednesday, and Friday of each week was well tolerated at doses up to 20 mg in Japanese patients. Dose escalation did not proceed after exploration of the 20 mg dose due to emerging global clinical data at that time.
Late cardiomyopathy in childhood acute myeloid leukemia survivors: a study from the L.E.A. program.

HAL is a multi-disciplinary open access archive for the deposit and dissemination of scientific research documents, whether they are published or not. The documents may come from teaching and research institutions in France or abroad, or from public or private research centers. L’archive ouverte pluridisciplinaire HAL, est destinée au dépôt et à la diffusion de documents scientifiques de niveau recherche, publiés ou non, émanant des établissements d’enseignement et de recherche français ou étrangers, des laboratoires publics ou privés. Late cardiomyopathy in childhood acute myeloid leukemia survivors: a study from the LEA program Vincent Barlogis, Pascal Auquier, Yves Bertrand, Pascal Chastagner, Dominique Plantaz, Maryline Poiree, Justyna Kanold, Julie Berbis, Claire Oudin, Camille Vercasson, et al.
The contribution of intimate live music performances to the quality of life for persons with dementia.

The aim of this study was to assess the effect of intimate live music performances delivered by professional singers on the quality of life of persons with mild and severe dementia in nursing homes.



A sample of 54 persons with varying degrees of dementia participated in the study. Complete data sets are available for 45 persons. Using a quasi-experimental design, quality of life was assessed on the dimensions of participation (human contact, care relationship and communication) and mental well-being (positive emotions, negative emotions and communication). Observational rating scales were completed by caregivers and family after the performance.



Intimate live music performances have a positive effect on human contact, care relationships, positive emotions and negative emotions, especially for the mild dementia group. They lead to improved human contact, better communication, more positive and less negative emotions, and an improved relationship between caregiver and receiver.



Intimate live music performances are an inexpensive, non-invasive, feasible way to improve a deteriorating quality of life for persons suffering from dementia. This form of supplementary care may also alleviate the task of caregivers.



Nursing homes should make more use of intimate live music performances as forms of complementary care.
A multicenter retrospective cohort study of practice patterns and clinical outcome on radiotherapy for hepatocellular carcinoma in Korea.

To determine the national practice processes of care and outcomes of radiotherapy for hepatocellular carcinoma (HCC) in Korea.



A national survey of 53 institutions nationwide was conducted by requesting data on their experience of radiotherapy for HCC. Among them, 10 institutions were selected for performing more detailed analysis, based on the radiotherapy experience of at least five HCC patients between 2004 and 2005.



This study covered the treatment of 398 HCC patients for 2 years. Most patients (78%) were in stage III or IV. Radiotherapy was chosen after the failure of other treatments, most frequently transarterial chemoembolization. Radiotherapy was performed predominantly using the three-dimensional conformal technique (3D-CRT, 81.9%) mostly with a total dose of >/=45 Gy. In 9.3% of the patients, radiotherapy was performed using radiosurgery. In a biologically effective dose (BED) with 10 Gy of alpha/beta, 4.2-124.3 Gy(10) was delivered. The median survival time was 12 months, and the 2-year overall survival rate was 27.9%. A tumour size <5 cm, a negative lymph node and BED >53.1 Gy(10) were shown by multivariate analysis to be significant factors for a better prognosis. In a subset analysis for the 326 patients treated with 3D-CRT, better liver function with Child-Pugh class A was shown to be an additional factor for a better prognosis.



Radiotherapy has been used to treat advanced HCC in various modes, but mostly as a salvage treatment. Although this study was retrospective, it indicates that radiotherapy is a quite effective modality for HCC patients.
Quantification of left ventricular function and mass in heart transplant recipients using dual-source CT and MRI: initial clinical experience

The purpose of this study was to compare LV function and mass quantification derived from cardiac dual-source CT (DSCT) exams with those obtained by MRI in heart transplant recipients. Twelve heart transplant recipients who underwent cardiac DSCT and MRI examination were included. Double-oblique short-axis 8-mm slice thickness images were evaluated. Left ventricular ejection fraction, end-diastolic volume, end-systolic volume, stroke volume, cardiac output and myocardial mass were manually assessed for each patient by two blinded readers. A systematic overestimation of all left ventricular volumes by DSCT when compared with MRI was observed. Mean difference was 16.58 ± 18.61 ml for EDV, 4.9 4 ±  6.84 ml for ESV, 11.64 ± 13.58 ml for SV and 5.73 ± 1.14 l/min for CO. Slightly lower values for left ventricular ejection fraction with DSCT compared with MRI were observed (mean difference 0.34 ± 3.18%, p = 0.754). Correlation between DSCT and MRI for left ventricular mass was excellent (rho  = 0.972). Bland and Altman plots and CCC indicated good agreement between DSCT and MRI left ventricular function and mass measurements. The interobserver correlation was good. In conclusion, DSCT accurately estimates left ventricular ejection fraction, volumes and mass in heart transplant recipients.
Ondansetron for reduction of drinking among biologically predisposed alcoholic patients: A randomized controlled trial.

Early-onset alcoholism differs from late-onset alcoholism by its association with greater serotonergic abnormality and antisocial behaviors. Thus, individuals with early-onset alcoholism may be responsive to treatment with a selective serotonergic agent.



To test the hypothesis that drinking outcomes associated with early vs late-onset alcoholism are differentially improved by the selective 5-HT(3) (serotonin) antagonist ondansetron.



Double-blind, randomized, placebo-controlled clinical trial.



University of Texas Health Science Center in Houston (April 1995-June 1998) and University of Texas Health Science Center in San Antonio (July 1998-December 1999).



A total of 321 patients with diagnosed alcoholism (mean age, 40.6 years; 70.5% male; 78.6% white) were enrolled, 271 of whom proceeded to randomization.



After 1 lead-in week of single-blind placebo, patients were randomly assigned to receive 11 weeks of treatment with ondansetron, 1 microg/kg (n = 67), 4 microg/kg (n = 77), or 16 microg/kg (n = 71) twice per day; or identical placebo (n = 56). All patients also participated in weekly standardized group cognitive behavioral therapy.



Self-reported alcohol consumption (drinks per day, drinks per drinking day, percentage of days abstinent, and total days abstinent per study week); and plasma carbohydrate deficient transferrin (CDT) level, an objective and sensitive marker of transient alcohol consumption.



Patients with early-onset alcoholism who received ondansetron (1, 4, and 16 microg/kg twice per day) compared with those who were administered placebo, had fewer drinks per day (1.89, 1.56, and 1.87 vs 3.30; P =.03, P =.01, and P =.02, respectively) and drinks per drinking day (4.75, 4.28, and 5.18 vs 6.90; P =.03, P =.004, and P =.03, respectively). Ondansetron, 4 microg/kg twice per day, was superior to placebo in increasing percentage of days abstinent (70.10 vs 50.20; P =.02) and total days abstinent per study week (6.74 vs 5.92; P =.03). Among patients with early-onset alcoholism, there was a significant difference in the mean log CDT ratio between those who received ondansetron (1 and 4 microg/kg twice per day) compared with those who received the placebo (-0.17 and -0.19 vs 0.12; P =.03 and P =.01, respectively).



Our results suggest that ondansetron (particularly the 4 microg/kg twice per day dosage) is an effective treatment for patients with early-onset alcoholism, presumably by ameliorating an underlying serotonergic abnormality. JAMA. 2000;284:963-971
Psychobiological correlates of improved mental health in patients with musculoskeletal pain after a mindfulness-based pain management program.

Mindfulness-based pain management programs (MBPMs) aim to improve mental and physical health in individuals with chronic pain. In this study, we investigated whether improvement in mental health might require (1) reduction in the sensory pain experience and brain correlates of that experience, and/or (2) improved perceptions of the controllability of pain and corresponding brain activity related to cognitive control and emotional regulation.



Twenty-eight patients with chronic pain were assessed and randomized into an intervention group (who attended an 8-wk MBPM) or a control group (treatment-as-usual), before being reassessed after 8 weeks. Outcome measures included clinical pain, perceived control over pain, mental and physical health, and mindfulness. Neural activity was measured during the anticipation and experience of acute experimental pain, using electroencephalography with source reconstruction.



Improvements were found in the MBPM group relative to the control group in mental health, which related to greater perceived control of pain, but not to reductions in clinical or experimental pain ratings. Anticipatory and pain-evoked event-related potentials to acute experimental pain were decreased, but sources of these event-related potentials were estimated to be in regions that modulate emotional responses rather than pain intensity. Mental health and perceived control outcomes correlated with reduced anticipatory deactivations of dorsolateral prefrontal and somatosensory cortices.



Increased activity in cognitive control regions of the brain during pain anticipation related to improved mental health and perceived control over pain, but not to decreased pain experience. Greater perceived control may therefore result from improved regulation of the emotional response to pain.
Nine-year trends in the morbidity of mental disorders and psychotropic drug utilization in Croatia: over-diagnosis and over-utilization?

Overall drug overuse, including psychotropic, is the Croatian reality. Therefore, in between 2000 and 2012, the interventions to control drug overspending were undertaken. The main aims of the study are: to determine the morbidity trends of mental disorders registered in family medicine (FM), the trends in psychotropic drug utilization and to identify whether the trends of utilization have any relation to the interventions. The results indicate that mental disorders represent a high disease burden in Croatia. It was also present a higher burden of psychotropic drug utilization; second ranked in the total drug utilization during the nine-year follow up period. The utilization of psycholeptic's, was even higher; from 2004 to 2008; those drugs were ranked first in terms of utilization. Between 20-25% of Croatia's total health care budget is usually spent on drugs. The interventions that are currently being implemented to control drug utilization have not brought about any changes.