The long-term safety and efficacy of bilateral transplantation of human fetal striatal tissue in patients with mild to moderate Huntington's disease.

Huntington's disease (HD) is a fatal autosomal dominant neurodegenerative disease involving progressive motor, cognitive and behavioural decline, leading to death approximately 20 years after motor onset. The disease is characterised pathologically by an early and progressive striatal neuronal cell loss and atrophy, which has provided the rationale for first clinical trials of neural repair using fetal striatal cell transplantation. Between 2000 and 2003, the 'NEST-UK' consortium carried out bilateral striatal transplants of human fetal striatal tissue in five HD patients. This paper describes the long-term follow up over a 3-10-year postoperative period of the patients, grafted and non-grafted, recruited to this cohort using the 'Core assessment program for intracerebral transplantations-HD' assessment protocol. No significant differences were found over time between the patients, grafted and non-grafted, on any subscore of the Unified Huntington's Disease Rating Scale, nor on the Mini Mental State Examination. There was a trend towards a slowing of progression on some timed motor tasks in four of the five patients with transplants, but overall, the trial showed no significant benefit of striatal allografts in comparison with a reference cohort of patients without grafts. Importantly, no significant adverse or placebo effects were seen. Notably, the raclopride positron emission tomography (PET) signal in individuals with transplants, indicated that there was no obvious surviving striatal graft tissue. This study concludes that fetal striatal allografting in HD is safe. While no sustained functional benefit was seen, we conclude that this may relate to the small amount of tissue that was grafted in this safety study compared with other reports of more successful transplants in patients with HD.

The role of temperament and family environment in the development of anxiety disorder: two-year follow-up

Objective Behavioural inhibition (BI) in early childhood is associated with increased risk for anxiety. The present research examines BI alongside family environment factors, specifically maternal negativity and overinvolvement, maternal anxiety and mother-child attachment, with a view to providing a broader understanding of the development of child anxiety. Method Participants were 202 children classified at age 4 as either behaviourally inhibited (N=102) or uninhibited (N=100). Family environment, BI and child anxiety were assessed at baseline and child anxiety and BI were assessed again two-years later when participants were aged 6 years. Results After controlling for baseline anxiety, inhibited participants were significantly more likely to meet criteria for a diagnosis of social phobia and generalized anxiety disorder at follow-up. Path analysis suggested that maternal anxiety significantly affected child anxiety over time, even after controlling for the effects of BI and baseline anxiety. No significant paths from parenting or attachment to child anxiety were found. Maternal overinvolvement was significantly associated with BI at follow-up. Conclusions At age 4, BI, maternal anxiety and child anxiety represent risk factors for anxiety at age 6. Furthermore, overinvolved parenting increases risk for BI at age 6, which may then lead to the development of anxiety in later childhood.

A Prospective Follow-up Study of 44 Mandibular Immediately Loaded Implants Using Resonance Frequency Analysis: Preliminary 1-Year Results

Purpose: This clinical study aimed to evaluate initial, 4-months, and 1-year stability of immediately loaded dental implants inserted according to a protocol of lower rehabilitation with prefabricated bars. Materials and Methods: The sample was composed of 11 edentulous patients. In each patient, 4 interforaminal implants were inserted. Immediately after implant installation, resonance frequency analysis (RFA) for each fixation was registered as well as after 4 months and 1 year with the prosthetic bar removed as it is a screwed system. Results: The clinical implant survival rate was 100%. The RFA showed an increase in stability after 4 months from 64.09 +/- 648 to 64.31 +/- 4.96 and I year, 67.11 +/- 4.37. The analysis of variance showed a statistically significant result (P = 0.015) among implant stability quotient values for the different periods evaluated. Tukey test results showed statistically significant differences between 1-year results and the initial periods but there was no statistically significant difference between initial and 4-month results (P > 0.05). Conclusion: These preliminary 1-year results indicate that immediate loading of mandibular dental implants using the studied prefabricated bars protocol is a reliable treatment as it is in accordance with the results described in the literature for other similar techniques. (Implant Dent 2009; 18:530-538)

Subclinical thyroid dysfunctions are independent risk factors for mortality in a 7.5-year follow-up: the Japanese-Brazilian thyroid study

Objective: The currently available data concerning the influence of subclinical thyroid disease (STD) on morbidity and mortality are conflicting. Our objective was to investigate the relationships between STD and cardiometabolic profile and cardiovascular disease at baseline, as well as with all-cause and cardiovascular mortality in a 7.5-year follow-up. Design: Prospective, observational study. Methods: An overall of 1110 Japanese-Brazilians aged above 30 years, free of thyroid disease, and not taking thyroid medication at baseline were studied. In a cross-sectional analysis, we investigated the prevalence of STD and its relationship with cardiometabolic profile and cardiovascular disease. All-cause and cardiovascular mortality rates were assessed for participants followed for up to 7.5 years. Association between STD and mortality was drawn using multivariate analysis, adjusting for potential confounders. Results: A total of 913 (82.3%) participants had euthyroidism, 99 (8.7%) had subclinical hypothyroidism, and 69 (6.2%) had subclinical hyperthyroidism. At baseline, no association was found between STD and cardiometabolic profile or cardiovascular disease. Multivariate-adjusted hazard ratios (HRs (95% confidence interval)) for all-cause mortality were significantly higher for individuals with both subclinical hyperthyroidism (HR, 3.0 (1.5-5.9); n=14) and subclinical hypothyroidism (HR, 2.3 (1.2-4.4); n=13) than for euthyroid subjects. Cardiovascular mortality was significantly associated with subclinical hyperthyroidism (HR, 3.3 (1.4-7.5); n=8), but not with subclinical hypothyroidism (HR, 1.6 (0.6-4.2); n=5). Conclusion: In the Japanese-Brazilian population, subclinical hyperthyroidism is an independent risk factor for all-cause and cardiovascular mortality, while subclinical hypothyroidism is associated with all-cause mortality.

A 2-year follow-up study of work ability among college educators

The aim of this study was to evaluate work ability among college educators before and after an intervention at the workplace. An administrative restructuring in the workplace started to be implemented in 2005. The work ability index (WAI) was administered to 154 educators before the restructure in 2004 and to 60 educators following the restructure in 2006. A mest comparing the WAI score of the 60 educators who took part in both phases showed a trend of improving work ability (p = 0.06; mean WAI in 2004 was 41.7 and 43.3 in 2006). The results suggest that the intervention led to an improvement in psychosocial factors, which in turn positively influenced work ability. (c) 2008 Elsevier Ltd. All rights reserved.

Contribution to the ground-based follow-up of the Gaia space mission

The Gaia Space Mission [Mignard, F., 2005. The three-dimensional universe with Gaia. ESA/SP-576; Perryman, M., 2005. The three-dimensional universe with Gaia. ESA/SP-576] will observe several transient events as supernovae, microlensing, gamma ray bursts and new Solar System objects. The satellite, due to its scanning law, will detect these events but will not be able to monitor them. So, to take these events into consideration and to perform further studies it is necessary to follow them with Earth-based observations. These observations could be efficiently done by a ground-based network of well-equipped telescopes scattered in both hemispheres. Here we focus our attention at the new Solar System objects to be discovered and observed by the Gaia satellite [Mignard, F., 2002. Observations of Solar System objects by Gaia I. Detection of NEOS. Astron. Astrophys. 393, 727] mainly asteroids, NEOs and comets. A dedicated ground-based network of telescopes as proposed by Thuillot [2005. The three-dimensional universe with Gaia. ESA/SP-576] will allow to monitor those events, to avoid losing them and to perform a quick characterization of some physical properties which will be important for the identification of these objects in further measurements by Gaia. We present in this paper, the beginning of the organization of a Latin-American ground-based network of telescopes and observers joining several institutions in Argentina, Bolivia, Brazil and other Latin-American countries aiming to contribute to the follow-up of Gaia science alerts for Solar System objects. (C) 2008 Elsevier Ltd. All rights reserved.

A Bayesian model for estimating the malaria transition probabilities considering individuals lost to follow-up

It is known that patients may cease participating in a longitudinal study and become lost to follow-up. The objective of this article is to present a Bayesian model to estimate the malaria transition probabilities considering individuals lost to follow-up. We consider a homogeneous population, and it is assumed that the considered period of time is small enough to avoid two or more transitions from one state of health to another. The proposed model is based on a Gibbs sampling algorithm that uses information of lost to follow-up at the end of the longitudinal study. To simulate the unknown number of individuals with positive and negative states of malaria at the end of the study and lost to follow-up, two latent variables were introduced in the model. We used a real data set and a simulated data to illustrate the application of the methodology. The proposed model showed a good fit to these data sets, and the algorithm did not show problems of convergence or lack of identifiability. We conclude that the proposed model is a good alternative to estimate probabilities of transitions from one state of health to the other in studies with low adherence to follow-up.

A web application for follow-up of results from a mobile device test battery for parkinson’s disease patients

Background: A test battery consisting of self-assessments and motor tests (tapping and spiral drawing) was developed for a hand computer with touch screen in a telemedicine setting. Objectives: To develop and evaluate a web-based system that delivers decision support information to the treating clinical staff for assessing PD symptoms in their patients based on the test battery data. Methods: The test battery is currently being used in a clinical trial (DAPHNE, EudraCT No. 2005-002654-21) by sixty five patients with advanced Parkinson’s disease (PD) on 9991 test occasions (four tests per day during in all 362 week-long test periods) at nine clinics around Sweden. Test results are sent continuously from the hand unit over a mobile net to a central computer and processed with statistical methods. They are summarized into scores for different dimensions of the symptom state and an ‘overall test score’ reflecting the overall condition of the patient during a test period. The information in the web application is organized and presented graphically in a way that the general overview of the patient performance per test period is emphasized. Focus is on the overall test score, symptom dimensions and daily summaries. In a recent preliminary user evaluation, the web application was demonstrated to the fifteen study nurses who had used the test battery in the clinical trial. At least one patient per clinic was shown. Results: In general, the responses from nurses were positive. They claimed that the test results shown in the system were consistent with their own clinical observations. They could follow complications, changes and trends within their patients. Discussion: In conclusion, the system is able to summarise the various time series of motor test results and self-assessments during test periods and present them in a useful manner. Its main contribution is a novel and reliable way to capture and easily access symptom information from patients’ home environment. The convenient access to current symptom profile as well as symptom history provides a basis for individualized evaluation and adjustment of treatments.

Simplified follow-up after medical abortion using a low-sensitivity urinary pregnancy test and a pictorial instruction sheet in Rajasthan, India : study protocol and intervention adaptation of a randomised control trial

The World Health Organisation suggests that simplification of the medical abortion regime will contribute to an increased acceptability of medical abortion, among women as well as providers. It is expected that a home-based follow-up after a medical abortion will increase the willingness to opt for medical abortion as well as decrease the workload and service costs in the clinic. Trial design The study is a randomised, controlled, non-superiority trial . Methods Women screened to participate in the study are those with unwanted pregnancies and gestational ages equal to or less than nine weeks. Eligible women randomised to the home-based assessment group will use a low-sensitivity pregnancy test and a pictorial instruction sheet at home, while the women in the clinic follow-up group will return to the clinic for routine follow-up carried out by a doctor. The primary objective of the study is to evaluate the effectiveness of home-based assessment using a low-sensitivity pregnancy test and a pictorial instruction sheet 10-14 days after an early medical abortion. Providers or research assistants will not be blinded during outcome assessment. To ensure feasibility of the self-assessment intervention an adaption phase took place at the selected study sites before study initiation. This was to optimise and tailor-make the intervention and the study procedures and resulted in the development of the pictorial instruction sheet for how to use the low-sensitivity pregnancy test and the danger signs after a medical abortion. Discussion In this paper, we will describe the study protocol for a randomised control trial investigating the efficacy of simplified follow-up in terms of home-based assessment, 10-14 days after a medical abortion. Moreover, a description of the adaptation phase is included for a better understanding of the implementation of the intervention in a setting where literacy is low and the road-connections are poor. Trial registration: Clinicaltrials.gov NCT01827995. Registered 04 May 2013

Self-assessment of the outcome of early medical abortion versus clinic follow-up in India : a randomised, controlled, non-inferiority trial

Background: The need for multiple clinical visits remains a barrier to women accessing safe legal medical abortion services. Alternatives to routine clinic follow-up visits have not been assessed in rural low-resource settings. We compared the effectiveness of standard clinic follow-up versus home assessment of outcome of medical abortion in a low-resource setting. Methods: This randomised, controlled, non-inferiority trial was done in six health centres (three rural, three urban) in Rajasthan, India. Women seeking early medical abortion up to 9 weeks of gestation were randomly assigned (1:1) to either routine clinic follow-up or self-assessment at home. Randomisation was done with a computer-generated randomisation sequence, with a block size of six. The study was not blinded. Women in the home-assessment group were advised to use a pictorial instruction sheet and take a low-sensitivity urine pregnancy test at home, 10-14 days after intake of mifepristone, and were contacted by a home visit or telephone call to record the outcome of the abortion. The primary (non-inferiority) outcome was complete abortion without continuing pregnancy or need for surgical evacuation or additional mifepristone and misoprostol. The non-inferiority margin for the risk difference was 5%. All participants with a reported primary outcome and who followed the clinical protocol were included in the analysis. This study is registered with ClinicalTrials.gov, number NCT01827995. Findings: Between April 23, 2013, and May 15, 2014, 731 women were recruited and assigned to clinic follow-up (n=366) or home assessment (n=365), of whom 700 were analysed for the main outcomes (n=336 and n=364, respectively). Complete abortion without continuing pregnancy, surgical intervention, or additional mifepristone and misoprostol was reported in 313 (93%) of 336 women in the clinic follow-up group and 347 (95%) of 364 women in the home-assessment group (difference -2.2%, 95% CI -5.9 to 1.6). One case of haemorrhage occurred in each group (rate of adverse events 0.3% in each group); no other adverse events were noted. Interpretation Home assessment of medical abortion outcome with a low-sensitivity urine pregnancy test is non-inferior to clinic follow-up, and could be introduced instead of a clinic follow-up visit in a low-resource setting.

Follow-up study of morphology and cardiac function in rats undergoing induction of supravalvular aortic stenosis

Conselho Nacional de Desenvolvimento Científico e Tecnológico (CNPq)