Dissertations / Theses on the topic 'Multicenter clinical trial'
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Zahnert, Thomas, Hubert Löwenheim, Dirk Beutner, Rudolf Hagen, Arneborg Ernst, Hans-Wilhelm Pau, Thorsten Zehlicke, et al. "Multicenter Clinical Trial of Vibroplasty Couplers to Treat Mixed/Conductive Hearing Loss: First Results." Karger, 2016. https://tud.qucosa.de/id/qucosa%3A70599.
Stockddale, Cynthia R. "A Comparison of Community-Based Centers versus University-Based Centers in Clinical Trial Performance." [Tampa, Fla] : University of South Florida, 2008. http://purl.fcla.edu/usf/dc/et/SFE0002472.
Pereira, Joanna Tatith. "Longevidade de restaurações adesivas em dentes decíduos posteriores submetidos à remoção total ou seletiva de tecido cariado : um estudo multicêntrico." reponame:Biblioteca Digital de Teses e Dissertações da UFRGS, 2016. http://hdl.handle.net/10183/152662.
The selective caries removal technique (SCR) for active deep carious lesions in deciduous and permanent teeth is already a consensus in the literature and is supported by studies that demonstrate excellent clinical, radiographic and microbiological results. However, the longevity of restorations performed after the SCR, mainly in primary dentition, has generated some doubts and concerns about its performance, deserving clarification. This multicenter study aimed to compare the success rate of adhesive restorations performed on posterior deciduous teeth after total or selective caries removal over 30 months Methods: Children between 4 - 8 years old with at least two active cavitated lesions in deep dentin (inner half of the dentin in the evaluation of the interproximal RX and with at least 1mm of dentin separating the carious lesion of the pulp) and that met the inclusion and exclusion criteria participated in the study. For each child, teeth were randomized and submitted to one of the treatment groups: total caries removal (TCR - control group) or SCR (test group). Children could have more than 2 teeth included. In cases of pulp exposure, data were analyzed and the tooth was excluded from the sample. Four institutions participated in the study (Federal University of Rio Grande do Sul, Peruvian University Cayetano Heredia and International Universidad of Ecuador), resulting in four pediatric dentists who performed the caries removal procedures and subsequent restorations in composite resin. Clinical evaluation was performed at baseline, 6, 12, 18, 24 and 30 months. All procedures were performed under local anesthesia and rubber dam use. Sociodemographic characteristics were collected at the baseline and clinical characteristics as dmft and visible plaque and gingival bleeding index were collected in all follow-up periods. Radiographs were taken only at baseline and restorations were clinically assessed at baseline, 6, 12, 18, 24 and 33 months by a blinded, trained and calibrated operator in each institution. The characteristics of the restorations were recorded according to an adaptation of the FDI criteria. Survival estimates for restoration longevity were evaluated using the Kaplan-Meier method. We also estimated the annual failure rate of the restorations. Cox regression model with shared frailty was performed to assess differences in survival rates of the restoration according to the intervention treatment, institution and clinical and demographic characteristics of the sample. Results: one hundred and six children (51 boys and 55 girls) collaborated with 278 teeth submitted to adhesive restorations (137 after TCR and 141 after SCR). Pulp exposure occurred in eight teeth (2.8%) allocated to TCR, and in four (1.4%) allocated to SCR group. The overall success rate of restorations was 87.1% (85.4% for TCR and 88.7% for SCR) and mean survival time was 30.3 months. The annual failure rate was 7% after 24 months of follow-up. There were no differences in the risk of failure according to the treatment group (HR 0.75;95%CI:0.38-1.46) and institution (USP HR 0.44;95%CI:0.94-2.09; PERU HR 0.92;95%CI:0.26-3.19; ECUADOR HR 1.39;95%CI:0.45-4.28). Analogous observations were found regarding all the clinical and demographic variables. Conclusions: Composite restorations of active deep carious lesions performed in posterior primary teeth show satisfactory survival of 87.1% after 33 months of follow-up, regardless of the technique performed for carious tissue removal.
Hauke, Christina [Verfasser], Alexander [Akademischer Betreuer] Gerlach, and Susanne [Akademischer Betreuer] Zank. "The role of therapist adherence in a multicenter randomized clinical trial of patients with panic disorder and agoraphobia / Christina Hauke. Gutachter: Alexander Gerlach ; Susanne Zank." Köln : Universitäts- und Stadtbibliothek Köln, 2014. http://d-nb.info/1065801068/34.
Xu, Shilin. "Contributions to the statistical analysis of multicenter clinical trials." Thesis, University of Reading, 1994. http://ethos.bl.uk/OrderDetails.do?uin=uk.bl.ethos.239146.
Hardy, Rebecca Jane. "Meta-analysis techniques in medical research : a statistical perspective." Thesis, London School of Hygiene and Tropical Medicine (University of London), 1995. http://researchonline.lshtm.ac.uk/682268/.
Familusi, Mary Ajibola. "Analysis of clustered competing risks with application to a multicentre clinical trial." Master's thesis, University of Cape Town, 2016. http://hdl.handle.net/11427/23763.
Niangoran, Bessekon. "Apport du monitorage statistique des données dans la gestion des essais cliniques multicentriques en Afrique." Electronic Thesis or Diss., Bordeaux, 2023. http://www.theses.fr/2023BORD0436.
Data quality is a fundamental concern of clinical research. To ensure this quality, continuous data monitoring must be practiced. International drug regulatory bodies recommend that this monitoring be targeted, based on a risk analysis. From this recommendation emerged the concept of “centralized statistical monitoring” (CSM) which consists of detecting atypical distributions of variables in a center compared to other centers. This thesis identifies existing CSM methods, proposes new ones, and compares the performances of each. In the first part, we recall the interest of the subject, in a context marked by the increase in the number of clinical trials, the need to work increasingly remotely and the need for new monitoring paradigms. In the second part, we identify existing CSM methods, analyze their performances reported in the literature and draw two major observations: (i) the number of methods is limited; (ii) their assessments through simulation studies and applications on real data reported in the literature are also limited. In the third part we propose two new CSM methods to detect the distributions of atypical variables in multicenter trials, one for quantitative data which uses a standardized distance measure (Distance method) and the other for categorical data, which uses a hierarchical Bayesian beta-binomial (HBBB) model. We evaluate the performance of these methods using clinical trial simulations and then compare them to other CSM methods identified in the literature. For quantitative data, the Distance method has performances similar to the method proposed by Desmet et al., and superior to those of the two other existing methods. For categorical data, the HBBB method has similar performance to the only other existing method, also proposed by Desmet et al. For both methods, Distance and HBBB, the sensitivity is poor overall, but the specificity is excellent, including in many scenarios involving small sample sizes. The low sensitivity suggests that the CSM is an additional tool that can be used in addition to other conventional monitoring procedures, but does not replace them. The strong specificity and user-friendliness suggest that these methods can be routinely applied in all clinical trials, as their use will not be centrally time consuming and will not create unnecessary workload in investigational centers
Rotolo, Federico. "Frailty multi-state models for the analysis of survival data from multicenter clinical trials." Doctoral thesis, Università degli studi di Padova, 2013. http://hdl.handle.net/11577/3422564.
I modelli a rischi proporzionali sono tra i modelli di regressione più conosciuti ed utilizzati in analisi di sopravvivenza. In modelli multi-stato sono una loro generalizzazione che permette di considerare congiuntamente diversi tipi di eventi e le loro interrelazioni, mentre i modelli di tipo frailty introducono effetti casuali per tenere conto di fattori di rischio non osservati, eventualmente in comune tra soggetti appartenenti allo stesso gruppo. L’integrazione dei modelli multi-stato e dei modelli frailty è interessante al fine di controllare l’eterogeneità non osservata in presenza di strutture complesse di eventi, particolarmente interessante nel caso di studi clinici multicentro. In questa tesi proponiamo di incorporare frailty annidati nella funzione di rischio transizione-specifica, quindi sviluppiamo e valutiamo metodi di inferenza sia parametrica che semiparametrica. Studi di simulazione, effettuati grazie a un metodo innovativo per generare dati di sopravvivenza multi-stato dipendenti, mostrano che l’inferenza parametrica è corretta ma estremamente imprecisa, mentre i metodi semiparametrici sono molto competitivi per valutare l’effetto delle covariate. Due casi-studio relativi a studi clinici multicento in oncologia vengono quindi presentati. La natura multi-stato dei modelli permette di studiare l’effetto del trattamento tenendo conto degli eventi intermedi, mentre la presenza di frailty riduce l’effetto di attenuazione dovuto ai gruppi di pazienti. Infine, presentiamo due nuovi strumenti software, uno per stimare modelli frailty parametrici con fino a venti possibili combinazioni di distribuzioni baseline e frailty, e un altro che implementa metodi di inferenza semiparametrica per modelli frailty multilivello, essenziali per stimare i nuovi modelli multi-stato con frailty annidati.
Lundberg, Elena. "Growth hormone responsiveness in children : results from Swedish multicenter clinical trials of growth hormone treatment." Doctoral thesis, Umeå universitet, Pediatrik, 2017. http://urn.kb.se/resolve?urn=urn:nbn:se:umu:diva-134569.
Braithwaite, Irene E., Alistair W. Stewart, Robert J. Hancox, Rinki Murphy, Clare R. Wall, Richard Beasley, and Edwin A. Mitchell. "Body mass index and vigorous physical activity in children and adolescents: an international cross-sectional study." Blackwell Publishing Ltd, 2017. http://hdl.handle.net/10757/625724.
Revisión por pares
VALENTE, ALESSIA. "Multicentre translational Trial of Remote Ischaemic Conditioning in acute ischaemic Stroke (TRICS)." Doctoral thesis, Università degli Studi di Milano-Bicocca, 2023. https://hdl.handle.net/10281/403045.
In view of fostering transferability of pre-clinical data on the efficacy of remote ischemic conditioning (RIC) in acute ischemic stroke, we designed two multi-centre translational trials in mice and rats of both sexes. We defined to model ischaemic stroke by the transient occlusion of the middle cerebral artery (tMCAo). The improvement of sensorimotor deficits at 48h after tMCAo in RIC-treated animals was defined as the primary outcome. This work presents the harmonization phase relative to the evaluation of sensorimotor deficits by De Simoni neuroscore. Each centre performed different tMCAo durations - 30, 45, 60 min - allowing sufficient variability in the outcome. Animals were monitored post-surgery according to the ARRIVE and IMPROVE guidelines and data was registered into an electronic case report form on RedCap. All animals were video recorded during the neuroscore and the videos (n=11 per species) were distributed and evaluated blindly by raters at all centres. The interrater agreement of neuroscore was described using intraclass correlation coefficient (ICC), ranging between ICC=0 (equivalent to chance) and ICC=1 (perfect agreement), setting a target of ICC≥0.60 as satisfactory. We obtained moderate agreement for mice (ICC=0.50 [0.22-0.77]) and rats (ICC=0.49 [0.21-0.77]). Errors were identified in animal handling and test execution. We thus performed a second training followed by a new blind evaluation replacing the videos with poor experimental execution. The interrater agreement improved for mice (ICC=0.64 [0.37-0.85]) and rats (ICC=0.69 [0.44-0.88]). In conclusion, two dedicated training on the neuroscore allowed us to reach the agreement target for both species and thus next proceed with the interventional phase of the project.
Doyle, Rebecca. "Prohibiting deferred consent can lead to research bias in clinical trials within Paediatric Intensive Care Units." Thesis, Griffith University, 2021. http://hdl.handle.net/10072/406508.
Thesis (Masters)
Master of Medical Research (MMedRes)
School of Pharmacy & Med Sci
Griffith Health
Full Text
Tenório, Marge. "A gestão de redes de pesquisa científica, tecnológica e de inovação em saúde no Brasil." Universidade de São Paulo, 2016. http://www.teses.usp.br/teses/disponiveis/5/5137/tde-07122016-151310/.
This thesis is based on the interfaces between the Brazilian National System for Innovation in Health\'s structure and the Brazilian National Health System - strategic components for the economic and social sectors in the country. The institutional legal framework that gives support to Science and Technology in Health was referred to, considering the policies that sustain technological innovation in the country and the regulatory systems aimed at guaranteeing its sustainability. The goal of this study was to investigate the relationships and the patterns that make it possible to establish ties between actors and that also favor the formation of research networks, seeking to identify which elements require a greater focus from managers in order to strengthen the established ties and to facilitate network monitoring and evaluation. This study is a qualitative one that is elaborated upon critical theory, upon a quantitative approach, and includes an exploratory and analytical case study on the Brazilian National Network of Clinical Research in Teaching Hospitals, comprising a triangulation of methods, based on observation, on content analysis and on bibliographic lines. Upon investigating relationships or patterns, this study relied upon the bases of Actor-Network Theory, which result in ties formed between researchers and institutions. The results gathered from the study added new insight into the management of research networks, whose analysis is currently permeated by literature centered on individual attributes. Upon perceiving multicenter clinical trials as a strategy that fortifies innovation in health, this thesis outlined management alternatives that may expand the relational connections believed to foment, increase and strengthen the Brazilian National Science, Technology and Innovation System and its associations with Brazilian Public Health System needs
Glasbrenner, Michaela Carla [Verfasser]. "Center weighting factors and treatment effects in multicenter clinical trials : application of the analysis of variance in medicine / Michaela Carla Glasbrenner." Ulm : Universität Ulm. Medizinische Fakultät, 2003. http://d-nb.info/1015354513/34.
Touat, Mahdi. "Mécanismes et implications thérapeutiques de l'hypermutation dans les gliomes Mechanisms and Therapeutic Implications of Hypermutation in Gliomas Mismatch Repair Deficiency in High-Grade Meningioma: A Rare but Recurrent Event Associated With Dramatic Immune Activation and Clinical Response to PD-1 Blockade Buparlisib in Patients With Recurrent Glioblastoma Harboring Phosphatidylinositol 3-Kinase Pathway Activation: An Open-Label, Multicenter, Multi-Arm, Phase II Trial Hyman DM. BRAF Inhibition in BRAFV600-Mutant Gliomas: Results From the VE-BASKET Study Glioblastoma Targeted Therapy: Updated Approaches From Recent Biology Successful Targeting of an ATG7-RAF1 Gene Fusion in Anaplastic Pleomorphic Xanthoastrocytoma With Leptomeningeal Dissemination Ivosidenib in IDH1-Mutated Advanced Glioma." Thesis, université Paris-Saclay, 2020. http://www.theses.fr/2020UPASL071.
High tumor mutational burden (hypermutation) is observed in some gliomas; however, the mechanisms by which hypermutation develops and whether it predicts chemotherapy or immunotherapy response are poorly understood. Mechanistically, an association between hypermutation and mutations in the DNA mismatch-repair (MMR) genes has been reported in gliomas, but most MMR mutations observed in this context were not functionally characterized, and their role in causing hypermutation remains unclear. Furthermore, whether hypermutation enhances tumor immunogenicity and renders gliomas responsive to immune checkpoint blockade (e.g. PD-1 blockade) is not known. Here, we comprehensively analyze the clinical and molecular determinants of mutational burden and signatures in 10,294 gliomas, including 558 (5.4%) hypermutated tumors. We delineate two main pathways to hypermutation: a de novo pathway associated with constitutional defects in DNA polymerase and MMR genes, and a more common, post-treatment pathway, associated with acquired resistance driven by MMR defects in chemotherapy-sensitive gliomas recurring after temozolomide. Experimentally, the mutational signature of post-treatment hypermutated gliomas (COSMIC signature 11) was recapitulated by temozolomide-induced damage in MMR-deficient cells. While MMR deficiency was associated with acquired temozolomide resistance in glioma models, clinical and experimental evidence suggest that MMR-deficient cells retain sensitivity to the chloroethylating nitrosourea lomustine. MMR-deficient gliomas exhibited unique features including the lack of prominent T-cell infiltrates, extensive intratumoral heterogeneity, poor survival and low response rate to PD-1 blockade. Moreover, while microsatellite instability in MMR-deficient gliomas was not detected by bulk analyses, single-cell whole-genome sequencing of post-treatment hypermutated glioma cells demonstrated microsatellite mutations. Collectively, these results support a model where differences in the mutation landscape and antigen clonality of MMR-deficient gliomas relative to other MMR-deficient cancers may explain the lack of both immune recognition and response to PD-1 blockade in gliomas. Our data suggest a change in practice whereby tumor re-sequencing at relapse to identify progression and hypermutation could inform prognosis and guide therapeutic management
Hsu, Ya Cing, and 許雅晴. "The quality control of PET imaging in multicenter clinical trial." Thesis, 2012. http://ndltd.ncl.edu.tw/handle/99297049473802043353.
長庚大學
醫學影像暨放射科學系
100
18F-AV-45 and 18F-AV-133 are novel PET tracers for imaging the deposition of amyloid in Alzheimer’s disease and the VMAT2 in dopaminergic neuron degeneration of Parkinson’s disease, respectively. For the purpose of observing the disease progression and the need in clinical diagnosis, we can widely investigate the variation between the control and diseased groups by collecting the data from the multicenter clinical trials. To establish the index of quality control assessment to evaluate the image quality in multicenter clinical trials was the first goal in this thesis. Then, in order to achieve comparability and interchangeability of information from different scanning systems, correcting the variation among images and data conversion from different scanners are the second focus in this thesis. Here, to correct the variation and reduce the variability between images, studies were performed using Hoffman phantom by first evaluating the resolution kernel for each system, and then applying smoothing filters to reduce high-frequency variability. In addition, study using the striatal phantom was used to derive the transformation factor for data conversion in PET images, and using another phantom data to validate the performance of the data conversion. The results demonstrated that all images passed the criteria of quality control assessment. The derived FWHM kernels in high-frequency correction can reduce the variability and increase the comparability between scanners. With the application of the transformation factor, a minor percentage difference between scanners is shown in the retest phantom data. To evaluate its capability, the factor is also applied to the clinical data, and the result shows consistency with those in the phantom study. But for the severely declined area, a specific transformation factor should be used. In conclusion, by applying the FWHM kernels in high frequency correction can reduce the variation between scanners, and make images comparable. Also, the derived transformation factor can be applied for data conversion between scanners.
Chen, Qing-Shui, and 陳清水. "Optimal Number of Centers for Multicenter Clinical Trials." Thesis, 1996. http://ndltd.ncl.edu.tw/handle/38058305974666111893.