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Group-randomized trials --- Randomized Controlled Trials as Topic. --- Clinical Trials. --- Group-randomized trials.

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OBJECTIVES: The primary objective of this master thesis in clinical research is to evaluate the proportion of patients who are eligible for the sympathetic renal denervation, the power of the criteria for eligibility and the causes of exclusion in the pilot phase of the academic randomized trial INSPiRED. BACKGROUND: The efficacy and the security of the renal denervation by catheterization in the treatment of resistant hypertension are controversial. The randomized Belgian prospective study of phase 2 INSPiRED has been launched in 2014 in order to respond to the criticisms made of previous trials. New criteria of eligibility and exclusion were submitted in order to better target the population of patients with hypertension that could benefit from this approach. According to the results of the pilot phase, on the way to completion, the scope of the study could be extended to the European web ENCORED.METHODS: In the pilot phase of the trial INSPiRED, the resistant hypertension patients were randomly assigned in a 1:1 ratio in the denervation group or contra! (Maximized medical treatment). Twenty-three patients were equally referred to the center of the Cliniques Universitaires Saint-Luc and the Grand Hospital de Charleroi. We will compare our results to the other randomized studies - some double-blinded - carried out between 2010 and 2015.RESULTS Out of the 23 analyzed patients, 18 patients (78%) were eligible and 5 were immediately excluded. However, 7 out of the 18 eligible patients were lost to follow-up (38%), despite our energetic efforts to get back in touch with them. Only 11 patients were randomized (48%), 6 in the denervation group and 5 in the contra! group. Ultimately, 12 patients (52%) were excluded. The exclusions were due to patients lost to follow-up (64%), normalized blood pressure at the screening (27%), the discovery of fibromuscular dysplasia during the renal angiography (15%), and the withdrawal consent (9%).CONCLUSION In our pilot phase, the proportion of eligible patients is higher than in the other studies. The refractory phenotype of the resistant hypertension and the use of severest criteria for the eligibility and the exclusion may partially explain our results.The legitimacy of those criteria will be shown after the analysis of the results of the study, in terms of efficacy and security. After the exclusion of vascular patients and/or very old patients, white coat hypertensions and/or secondary hypertensions, we are still left with a group of patients who are less reliable, difficult to follow and probably less compliant to treatment. Renal denervation might be efficacy, even radical but costly for some patients. Otherwise, evaluate the psychological statement of those patients to describe the care, including psychological aspects which are supposed to perform the response and the compliance to treatment. OBJECTIFS : Ce mémoire a pour objectif principal d'évaluer la proportion de patients éligibles pour la dénervation sympathique rénale, la pertinence des critères d'éligibilité et les causes d'exclusion dans la phase pilote de l'essai randomisé académique INSPiRED.CONTEXTE L'efficacité et la sécurité de la dénervation rénale par voie endovasculaire dans le traitement de l'hypertension artérielle résistante restent controversés. L'étude belge prospective randomisée de phase 2 INSPiRED a été initiée en 2014 pour répondre aux critiques soulevées par les essais précédents. De nouveaux critères d'éligibilité et d'exclusion ont été proposés afin de mieux cibler la population d'hypertendus susceptibles de bénéficier de cette approche. En fonction des résultats de la phase pilote, en voie d'achèvement, l'étude pourrait être élargie à l'ensemble du réseau européen ENCORED.METHODE Dans la phase pilote de l'étude INSPiRED, les patients hypertendus résistants ont été randomisés (1: 1) dans le groupe dénervé versus contrôle (traitement médicamenteux optimal). Vingt-trois patients ont été référés, également sur le site des Cliniques Universitaires Saint-Luc et du Grand Hôpital de Charleroi. Nous comparons nos résultats à ceux des études randomisées, certaines en double aveugle, menées de 2010 à 2015.RESULTATS Parmi les 23 patients analysés, 18 patients (78%) se sont avérés éligibles et 5 ont été exclus d'emblée. Néanmoins, 7 des 18 patients éligibles ont été perdus de vue (38%), malgré des efforts énergiques pour les recontacter. Dès lors, seuls 11 patients ont été randomisés (48%), 6 dans le groupe dénervation rénale et 5 dans le groupe contrôle. In fine, 12 patients ont été exclus. Les exclusions sont imputables aux perdus de vue (64%), à la normalisation de la pression artérielle lors du screening (27%), à la découverte d'une dysplasie fibromusculaire à l'angiographie des artères rénales (15%) et au retrait du consentement (9%)CONCLUSION Dans notre phase pilote, la proportion de patients éligibles pour la dénervation rénale est supérieure aux autres études. Ces résultats s'expliquent en partie par le phénotype réfractaire des hypertensions artérielles résistantes et l'utilisation de critères d'éligibilité et d'exclusion plus stricts. La légitimité de ces critères ne sera démontrée qu'après analyse des résultats de l'étude, en termes d'efficacité et de sécurité. Après avoir exclu les patients vasculaires et/ou très âgés, les hypertensions artérielles résistantes « blouse blanche » et/ou les hypertensions artérielles secondaires, nous nous retrouvons avec un groupe de patients peu fiables, difficiles à suivre et probablement médiocrement adhérents au traitement. La dénervation rénale pourrait s'avérer une solution efficace, voire radicale mais coûteuses pour certains d'entre eux. Une autre voie consiste à étudier le profil psychologique de ces patients, afin de définir une prise en charge intégrant les aspects psychologiques susceptibles d'améliorer la réponse et l'adhésion au traitement.

Sympathectomy --- Randomized Controlled Trials as Topic --- Kidney

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Group-randomized trials --- Randomized Controlled Trials as Topic. --- Group-randomized trials. --- Research --- Trials, Randomized Clinical --- Clinical Trials, Randomized --- Controlled Clinical Trials, Randomized --- Non-Randomized Controlled Trials as Topic --- Human medicine --- Health Sciences --- Cardiology --- Clinical Medicine --- Diabetes and Hypertension --- General and Others --- Pharmacy and Pharmacology --- clinical trials --- medical trials --- trial methodology --- trial protocols --- randomised controlled trials --- Blood physiology. Circulatory physiology --- Pathology of the circulatory system

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Objectives: The aim of this following study was to assess dimensional changes after two different socket sealing techniques. Material and methods: Twelve patients, 5 males and 7 females, aged from 37 to 75, requiring a tooth and a delayed implant placement were randomly selected to receive two different alveolar ridge preservation techniques. In the control group the extraction socket was filled with demineralized bovine bone mineral (DBBM) and sealed with a gingival soft tissue punch and in the test group the extraction socket was also filled with DBBM but sealed with a hemostatic gelatin sponge. Impressions were assessed before and six months after tooth extraction, the casts were digitalized and compared on horizontal (Level 1, 3, 5) and vertical dimensions. A visual pain scale was used to compare pain between groups. Results: The mean vertical loss for the control group was 1, 25 ± 0, 44 mm. The test group showed vertical loss of 0, 86 ± 0, and 71 mm. The horizontal dimensional changes of the alveolar socket were 5, 15 ± 1, 69/ 3, 15 ± 0, 90 at levels 3 and 5 mm for the control group, no statistically significant dimensional changes could be assessed at level 1 mm du to important vertical loss. The test group showed dimensional changes of 6, 51 ± 3,54/3,54 ± 1.27/1,79 ± 0.70 mm at the three different levels. When these horizontal and vertical dimensions were tested with an unpaired t-test no statistical significance could be found between the groups (P-value > 0, 05). Regarding the post-operative pain, patients reported more severe pain in the control group (5.5/10) compared to the test groups (3.5/10) but the difference was not statistically significant .Conclusion: the finding of this present study confirm that a complete preservation of the alveolar crest with an alveolar preservation technique is unlikely. No significant difference was found between the control and test group regarding the horizontal dimensional changes and post-operative pain was reported to be higher in the control group. Concerning these results, the socket sealing technique with a homeostatic sponge provides a ready-to-use, inexpensive protocol with less post-operative pain and avoids the disadvantages of a palatal donor site.

Alveolar Ridge Augmentation --- Tooth Socket --- Randomized Controlled Trials as Topic

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This study conducted an experimental intervention in unelectrified areas of northern Bangladesh to investigate the effectiveness of solar products in improving children's educational achievement. It found that treated households substituted solar lanterns for kerosene-based lighting products, helping to decrease total household expenditure. Solar lanterns increased the children's home-study hours, particularly at night and before exams. The solar lanterns initially led to an increase in school attendance, but this effect diminished over time. However, the increased study hours and initial improvement in school attendance did not translate into improved academic performance. Varying the number of solar products within the treated households did not alter these results. Analyses that exploited the school grade treatment intensity also provided no evidence suggesting that spillover effects explained the "no academic performance effects." These findings suggest that improving the home-study environment solely through the provision of solar products may have a limited impact on children's educational achievement.

Clean And Renewable Energy --- Randomized Control Trials --- Solar Light