Randomized, crossover, double-blind, placebo-controlled trial to assess the lipid lowering effect of co-formulated TDF/FTC

Abstract INTRODUCTION: Previous studies have described improvements on lipid parameters when switching from other antiretroviral drugs to tenofovir (TDF) and impairments in lipid profile when discontinuing TDF. [1-3] It is unknown, however, if TDF has an intrinsic lipid-lowering effect or such findings are due to the addition or removal of other offending agents or other reasons. MATERIALS AND METHODS: RESULTS: 46 subjects with a median age of 43 (40-48) years were enrolled in the study: 70% were male, 56% received DRV/r and 44% LPV/r. One subject withdrew the study voluntarily at week 4 and another one interrupted due to diarrhoea at week 24. Treatment with TDF/FTC decreased total, LDL and HDL-cholesterol from 235.9 to 204.9 (p<0.001), 154.7 to 127.6 (p<0.001) and 50.3 to 44.5 mg/dL (p<0.001), respectively. In comparison, total, LDL and HDL-cholesterol levels remained stable during placebo exposure. Week 12 total cholesterol (p<0.001), LDL-cholesterol (p<0.001) and HDL-cholesterol (p=0.011) levels were significantly lower in TDF/FTC versus placebo. Treatment with TDF/FTC reduced the fraction of subjects with abnormal fasting total-cholesterol (≥200 mg/dL) from 86.7% to 56.8% (p=0.001) and LDL-cholesterol (≥130 mg/dL) from 87.8% to 43.9% (p<0.001), which was not observed with placebo. There were no virological failures, and CD4 and triglyceride levels remained stable regardless of exposure. CONCLUSION: Coformulated TDF/FTC has an intrinsic lipid-lowering effect, likely attributable to TDF.

Unsaturated Oxazolopiperidone Lactams: an Unexpected Domino-type Double Conjugate Additioncyclization Process

Reactions of 2-acetylindole enolate with unsaturated oxazolopiperidones 3, 4 and 10 unexpectedly gives pentacyclic dilactams 6, 7 and 11, respectively, resulting from a domino-type process involving two successive conjugate additions and a final cyclization.

A topical microemulsion for the prevention of allergic rhinitis symptoms: results of a randomized, controlled, double-blind, parallel group, multicentre, multinational clinical trial (Nares study)

Background: Since barrier protection measures to avoid contact with allergens are being increasingly developed, we assessed the clinical efficacy and tolerability of a topical nasal microemulsion made of glycerol esters in patients with allergic rhinitis. Methods: Randomized, controlled, double-blind, parallel group, multicentre, multinational clinical trial in which adult patients with allergic rhinitis or rhinoconjunctivitis due to sensitization to birch, grass or olive tree pollens received treatment with topical microemulsion or placebo during the pollen seasons. Efficacy variables included scores in the mini-RQLQ questionnaire, number and severity of nasal, ocular and lung signs and symptoms, need for symptomatic medications and patients" satisfaction with treatment. Adverse events were also recorded. Results: Demographic characteristics were homogeneous between groups and mini-RQLQ scores did not differ significantly at baseline (visit 1). From symptoms recorded in the diary cards, the ME group showed statistically significant better scores for nasal congestion (0.72 vs. 1.01; p = 0.017) and mean total nasal symptoms (0.7 vs. 0.9; p = 0.045). At visit 2 (pollen season), lower values were observed in the mini-RQLQ in the ME group, although there were no statistically significant differences between groups in both full analysis set (FAS) and patients completing treatment (PPS) populations. The results obtained in the nasal symptoms domain of the mini-RQLQ at visit 2 showed the highest difference (−0.43; 95% CI: -0.88 to 0.02) for the ME group in the FAS population. The topical microemulsion was safe and well tolerated and no major discomforts were observed. Satisfaction rating with the treatment was similar between the groups. Conclusions: The topical application of the microemulsion is a feasible and safe therapy in the prevention of allergic symptoms, particularly nasal congestion.

Predictors of psychiatric hospitalization during 6 months of maintenance treatment with olanzapine long-acting injection: post hoc analysis of a randomized, double-blind study.

BACKGROUND: Hospitalization is a costly and distressing event associated with relapse during schizophrenia treatment. No information is available on the predictors of psychiatric hospitalization during maintenance treatment with olanzapine long-acting injection (olanzapine-LAI) or how the risk of hospitalization differs between olanzapine-LAI and oral olanzapine. This study aimed to identify the predictors of psychiatric hospitalization during maintenance treatment with olanzapine-LAI and assessed four parameters: hospitalization prevalence, incidence rate, duration, and the time to first hospitalization. Olanzapine-LAI was also compared with a sub-therapeutic dose of olanzapine-LAI and with oral olanzapine. METHODS: This was a post hoc exploratory analysis of data from a randomized, double-blind study comparing the safety and efficacy of olanzapine-LAI (pooled active depot groups: 405 mg/4 weeks, 300 mg/2 weeks, and 150 mg/2 weeks) with oral olanzapine and sub-therapeutic olanzapine-LAI (45 mg/4 weeks) during 6 months' maintenance treatment of clinically stable schizophrenia outpatients (n=1064). The four psychiatric hospitalization parameters were analyzed for each treatment group. Within the olanzapine-LAI group, patients with and without hospitalization were compared on baseline characteristics. Logistic regression and Cox's proportional hazards models were used to identify the best predictors of hospitalization. Comparisons between the treatment groups employed descriptive statistics, the Kaplan-Meier estimator and Cox's proportional hazards models. RESULTS: Psychiatric hospitalization was best predicted by suicide threats in the 12 months before baseline and by prior hospitalization. Compared with sub-therapeutic olanzapine-LAI, olanzapine-LAI was associated with a significantly lower hospitalization rate (5.2% versus 11.1%, p < 0.01), a lower mean number of hospitalizations (0.1 versus 0.2, p = 0.01), a shorter mean duration of hospitalization (1.5 days versus 2.9 days, p < 0.01), and a similar median time to first hospitalization (35 versus 60 days, p = 0.48). Olanzapine-LAI did not differ significantly from oral olanzapine on the studied hospitalization parameters. CONCLUSIONS: In clinically stable schizophrenia outpatients receiving olanzapine-LAI maintenance treatment, psychiatric hospitalization was best predicted by a history of suicide threats and prior psychiatric hospitalization. Olanzapine-LAI was associated with a significantly lower incidence of psychiatric hospitalization and shorter duration of hospitalization compared with sub-therapeutic olanzapine-LAI. Olanzapine-LAI did not differ significantly from oral olanzapine on hospitalization parameters.

Music-supported training is more efficient than functional motor training for recovery of fine motor skills in stroke patients

MOTOR IMPAIRMENTS ARE COMMON AFTER STROKE but efficacious therapies for these dysfunctions are scarce. Extending an earlier study on the effects of music-supported training (MST), behavioral indices of motor function were obtained before and after a series of training sessions to assess whether this new treatment leads to improved motor functions. Furthermore, music-supported training was contrasted to functional motor training according to the principles of constraint-induced therapy (CIT). In addition to conventional physiotherapy, 32 stroke patients with moderately impaired motor function and no previous musical experience received 15 sessions of MST over a period of three weeks, using a manualized, step-bystep approach. A control group consisting of 15 patients received 15 sessions of CIT in addition to conventional physiotherapy. A third group of 30 patients received exclusively conventional physiotherapy and served as a control group for the other three groups. Fine as well as gross motor skills were trained by using either a MIDI-piano or electronic drum pads programmed to emit piano tones. Motor functions were assessed by an extensive test battery. MST yielded significant improvement in fine as well as gross motor skills with respect to speed, precision, and smoothness of movements. These improvements were greater than after CIT or conventional physiotherapy. In conclusion, with equal treatment intensity, MST leads to more pronounced improvements of motor functions after stroke than CIT.

Tacrolimus vs. Azathioprine in myasthenia gravis treatment: a multicenter, prospective, randomized, double blind, head to head clinical trial

Current evidences show that tacrolimus could be a good therapeutic option in patients non-responsive to first-line treatments and even it could become one of the first-line drugs for treating MG. Our study will try to determine the effectivity and safety of tacrolimus in 190 myasthenia gravis patients with suboptimal response to azathioprine: after 12 months of treatment they will be randomized to continue with azathioprine or they will be switched to tacrolimus. Patients will follow the allocated treatment during 14 months and the response will be assessed as well as adverse effectsPURPOSE: To compare azathioprine vs. tacrolimus effectivity and safety in MG patients with suboptimal response to azathioprine at 12 monthsDESIGN: A 14 months multicenter, prospective, randomized, double blind, head to head clinical trial

Individual Differences in Music Reward Experiences

Music is one of the most pleasant human experiences, even though it has no direct biological advantage. However little is known about individual differences in how people experience reward in music-related activities. The goal of the present study was to describe the main facets of music experience that could explain the variance observed in how people experience reward associated with music. To this end we developed the Barcelona Music Reward Questionnaire (BMRQ), which was administrated to three large samples. Our results showed that the musical reward experience can be decomposed into five reliable factors: Musical Seeking, Emotion Evocation, Mood Regulation, Social Reward, and Sensory-Motor. These factors were correlated with socio-demographic factors and measures of general sensitivity to reward and hedonic experience. We propose that the five-factor structure of musical reward experience might be very relevant in the study of psychological and neural bases of emotion and pleasure associated to music.

Competencias creativas en el aula de música = Creative competences in music classes

En el marco de las competencias profesionales del educador musical, la creatividad ocupa una posición que a menudo ha sido definida como sistémica. La labor del educador y/o formador en el aula de música requiere, de forma genérica, el despliegue de competencias que incorporen la creatividad. En este artículo se presentan los resultados de un trabajo realizado con dos muestras de alumnos, de tercer curso de magisterio y de un curso postgrado. Se ofrecen y se analizan los datos recogidos con la finalidad de desplegar un mapa que integre competencias creativas genéricas, específicas y disciplinares

Yield in double cropping system as affected by N fertilization rate with pig slurry in a Catalonia dryland region

Intensive swine production is an important agricultural and economical activity in Europe. The high availability of pig slurry (PS) lead to attractive fertilization strategy to reduce costs, therefore is mainly applied as fertilizer in agricultural systems. The optimization N fertilization in these areas should be taken in into to avoid nitrates losses by lixiviation and to achieve maximum efficiency in crop nutrition. Many studies have shown that PS applications can achieve satisfactory yields in different crops by partially or completely replacing synthetic fertilizers. In addition, for the last years, in Northeast Spain (Catalonia) has been widely extended the double-cropping forage system.

Bowing the violin : a case study for auditory-motor pattern modelling in the context of music performance

This project addresses methodological and technological challenges in the development of multi-modal data acquisition and analysis methods for the representation of instrumental playing technique in music performance through auditory-motor patterning models. The case study is violin playing: a multi-modal database of violin performances has been constructed by recording different musicians while playing short exercises on different violins. The exercise set and recording protocol have been designed to sample the space defined by dynamics (from piano to forte) and tone (from sul tasto to sul ponticello), for each bow stroke type being played on each of the four strings (three different pitches per string) at two different tempi. The data, containing audio, video, and motion capture streams, has been processed and segmented to facilitate upcoming analyses. From the acquired motion data, the positions of the instrument string ends and the bow hair ribbon ends are tracked and processed to obtain a number of bowing descriptors suited for a detailed description and analysis of the bow motion patterns taking place during performance. Likewise, a number of sound perceptual attributes are computed from the audio streams. Besides the methodology and the implementation of a number of data acquisition tools, this project introduces preliminary results from analyzing bowing technique on a multi-modal violin performance database that is unique in its class. A further contribution of this project is the data itself, which will be made available to the scientific community through the repovizz platform.