Bibliografie tematiche / Multicenter clinical trial

Letteratura scientifica selezionata sul tema "Multicenter clinical trial"

Autore: Grafiati

Pubblicato: 7 luglio 2024

Ultima modifica: 7 luglio 2024

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Articoli di riviste sul tema "Multicenter clinical trial":

Justice, Jamie N., George A. Kuchel, Nir Barzilai e Stephen Kritchevsky. "BIOMARKER STRATEGIES FOR GEROSCIENCE-GUIDED CLINICAL TRIALS". Innovation in Aging 3, Supplement_1 (novembre 2019): S745—S746. http://dx.doi.org/10.1093/geroni/igz038.2731.

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Abstract Significant progress in the biology of aging and animal models supports the geroscience hypothesis: by targeting biological aging the onset of age-related diseases can be delayed. Geroscience investigators will test this hypothesis in a multicenter clinical trial, to determine if interventions on biological aging processes can prevent accumulation of multiple age-related diseases and aging phenotypes in older adults. Prodigious activity is underway to develop markers of biological aging, but currently there is no aging biomarker consensus to support geroscience-guided clinical trial outcomes. We convened an expert committee to establish a framework for selection of blood-based biomarkers, emphasizing: feasibility/reliability; aging relevance; ability to predict clinical trial outcomes; and responsiveness to intervention. We applied this framework and identified a short-list of blood-based biomarkers with potential use in multicenter trials on aging. We review progress on efforts to test these candidate biomarkers of aging and development of biomarkers strategy for geroscience-guided clinical trials.

Chung, Kevin C., e Jae W. Song. "A Guide to Organizing a Multicenter Clinical Trial". Plastic and Reconstructive Surgery 126, n. 2 (agosto 2010): 515–23. http://dx.doi.org/10.1097/prs.0b013e3181df64fa.

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Chung, Kevin C., Sunitha Malay e Melissa J. Shauver. "The Complexity of Conducting a Multicenter Clinical Trial". Plastic and Reconstructive Surgery 144, n. 6 (dicembre 2019): 1095e—1103e. http://dx.doi.org/10.1097/prs.0000000000006271.

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Abbas, E. E., P. Dham e D. Shaker. "A multicenter clinical trial in the Arab world". Transplantation Proceedings 36, n. 6 (luglio 2004): 1801–4. http://dx.doi.org/10.1016/j.transproceed.2004.07.037.

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Craig, M. T., N. S. Abramson, P. Safar e H. Herzog. "Deferred consent in a multicenter prehospital clinical trial". Annals of Emergency Medicine 23, n. 3 (marzo 1994): 619–20. http://dx.doi.org/10.1016/s0196-0644(94)80337-4.

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Kim, Paul, Paul E. Beaulé, Yves LaFlamme e Michael Dunbar. "Prospective Multicenter Clinical Trial of Hip Resurfacing Arthroplasty". Journal of Arthroplasty 23, n. 2 (febbraio 2008): 318. http://dx.doi.org/10.1016/j.arth.2008.01.235.

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Cauch, Karen. "Early patient accrual for a multicenter clinical trial". Controlled Clinical Trials 12, n. 5 (ottobre 1991): 717. http://dx.doi.org/10.1016/0197-2456(91)90330-o.

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HODISH, ISRAEL, RICHARD M. BERGENSTAL, MARY L. JOHNSON, REBECCA A. PASSI, ANUJ BHARGAVA, NATALIE YOUNG, DAVIDA F. KRUGER, ANGELA HAILEY, EMILY UNGER e ERAN BASHAN. "Digitally Enhanced Insulin Therapy—A Multicenter Clinical Trial". Diabetes 67, Supplement 1 (maggio 2018): 353—OR. http://dx.doi.org/10.2337/db18-353-or.

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Howard, Virginia J. "Recruitment of clinicaal centers in an investigator-initiated multicenter clinical trial". Controlled Clinical Trials 13, n. 5 (ottobre 1992): 394. http://dx.doi.org/10.1016/0197-2456(92)90084-d.

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KITABATAKE, AKIRA. "Ideal way of multicenter clinical trial - science and ethics. Clinical trial in circulatory diseases." Nihon Naika Gakkai Zasshi 86, n. 9 (1997): 1680–83. http://dx.doi.org/10.2169/naika.86.1680.

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Più fonti

Tesi sul tema "Multicenter clinical trial":

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.

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Objective: To evaluate the safety and effectiveness of round window (RW), oval window (OW), CliP and Bell couplers for use with an active middle ear implant. Methods: This is a multicenter, long-term, prospective trial with consecutive enrollment, involving 6 university hospitals in Germany. Bone conduction, air conduction, implant-aided warbletone thresholds and Freiburger monosyllable word recognition scores were compared with unaided preimplantation results in 28 moderate-to-profound hearing-impaired patients after 12 months of follow-up. All patients had previously undergone failed reconstruction surgeries (up to 5 or more). In a subset of patients, additional speech tests at 12 months postoperatively were used to compare the aided with the unaided condition after implantation with the processor switched off. An established quality-of-life questionnaire for hearing aids was used to determine patient satisfaction. Results: Postoperative bone conduction remained stable. Mean functional gain for all couplers was 37 dB HL (RW = 42 dB, OW = 35 dB, Bell = 38 dB, CliP = 27 dB). The mean postoperative Freiburger monosyllable score was 71% at 65 dB SPL. The postimplantation mean SRT 50 (speech reception in quiet for 50% understanding of words in sentences) improved on average by 23 dB over unaided testing and signal-to-noise ratios also improved in all patients. The International Outcome Inventory for Hearing Aids (IOI-HA) quality-of-life questionnaire was scored very positively by all patients. Conclusion: A significant improvement was seen with all couplers, and patients were satisfied with the device at 12 months postoperatively. These results demonstrate that an active implant is an advantage in achieving good hearing benefit in patients with prior failed reconstruction surgery.

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.

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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.

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A técnica da remoção seletiva de tecido cariado (RSTC) para lesões de cárie profundas em dentina de dentes decíduos e permanentes, já é consenso na literatura e é sustentada por pesquisas que demonstram excelentes resultados clínicos, radiográficos e microbiológicos. No entanto, a longevidade de restaurações adesivas realizadas após a RSTC, principalmente na dentição decídua, vem gerando algumas dúvidas e preocupações quanto ao seu desempenho, merecendo esclarecimentos. O objetivo deste estudo randomizado, controlado e multicêntrico foi comparar a taxa de sucesso de restaurações adesivas realizadas em dentes decíduos posteriores após a remoção total (RTTC) ou seletiva (RSTC) de tecido cariado ao longo de 30 meses. Métodos: Crianças de 4 a 8 anos de idade portadoras de pelo menos duas lesões cavitadas ativas em metade interna de dentina (metade interna da dentina na avaliação do RX interproximal e com pelo menos 1mm de dentina separando a lesão cariosa da polpa) e que se enquadrassem nos critérios de inclusão e exclusão participaram do estudo. Para cada criança os dentes (no mínimo dois, mas podendo ser mais) foram aleatoriamente divididos de acordo com os seguintes tratamentos: RTTC (grupo controle) ou RSTC (grupo teste). Nos casos em que ocorreu exposição pulpar, o dente foi devidamente tratado e excluído da amostra, os dados em relação ao tipo de remoção de tecido cariado que levou à exposição foram coletados. Quatro instituições participaram do estudo (Universidade Federal do Rio Grande do Sul; Universidade de São Paulo; Universidade Peruana Cayetano Heredia; Universidade Internacional do Equador), resultando em quatro odontopediatras que realizaram os procedimentos de remoção de tecido cariado e posterior restauração em resina composta, avaliadas clinicamente no baseline, 6, 12, 18, 24 e 30 meses. Todos os procedimentos foram realizados sob anestesia local e isolamento absoluto. Características sociodemográficas foram coletadas no baseline e características clínicas como índice ceod/CPOD, índice de placa visível (IPV) e índice de sangramento gengival (ISG) foram coletados em todos os períodos de acompanhamento. Em todos os momentos experimentais foram avaliados os aspectos clínicos das restaurações por um examinador cego e calibrado através do índice FDI adaptado. Para determinar as taxas de sucesso das restaurações de resina composta foram geradas curvas de sobrevida com o estimador Kaplan-Meyer para cada grupo avaliado, assim como as taxas de falha anual das restaurações. O modelo de regressão de Cox com falhas compartilhadas foi realizado para avaliar diferenças nas taxas de sobrevida das restaurações de acordo com o tratamento, instituição e características clínicas e demográficas da amostra. Resultados: Cento e seis crianças (51 meninos e 55 meninas) colaboraram com 278 dentes submetidos a restaurações adesivas, 137 após RTTC e 141 após RSTC. Oito exposições pulpares ocorreram no grupo da RTTC e quatro no grupo da RSTC. A taxa global de sucesso das restaurações foi 87,1% (85,4% para RTTC e 88,7% para RSTC) e o tempo médio de sobrevida foi de 30 meses. A taxa anual de falha foi de 7% após 24 meses de acompanhamento. Não houve diferença no risco de falha (TR) de acordo com o grupo de tratamento (TR 0,75; IC 95%: 0,38-1,46) e instituição (USP TR 0,44; IC 95%: 0,94-2,09; PERU TR 0,92; IC 95%: 0,26-3,19 EQUADOR TR 1,39; IC 95%: 0,45-4,28). Foram encontradas observações análogas em relação a todas as variáveis clínicas e demográficas. Conclusões: As restaurações adesivas realizadas em dentes decíduos com lesões cavitadas profundas em dentina apresentam sobrevida satisfatória após 33 meses de acompanhamento, independentemente da técnica realizada para remoção de tecido cariado.
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 e 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.

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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.

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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/.

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Meta-analysis is now commonly used in medical research. However there are statistical issues relating to the subject that require investigation and some are considered here, from both a methodological and a practical perspective. Each of the fixed effect and the random effects models for meta-analysis are based on certain assumptions and the validity of these is investigated. A formal test of the homogeneity assumption made in the fixed effect model may be performed. Since the test has low power, simulation was used to investigate the power under various conditions. The random effects model incorporates a between-study component of variance into the model. A likelihood based method was used to obtain a confidence interval for this variance and also to provide an interval for the overall treatment effect which takes into account the fact that the between-study variance is estimated, rather than assuming it to be known. In order to obtain confidence intervals for the treatment effect for both the fixed effect and the random effects models, distributional assumptions of normality are usually made. Such assumptions may be checked using q-q plots of the residuals obtained for each trial in the meta-analysis. In both meta-analysis models it is assumed that the weight allocated to each study is known, when in fact it must be estimated from the data. The effect of estimating the weights on the overall treatment effect estimate, its confidence intervals, the between-study variance estimate and the test statistic for homogeneity, is investigated by both analytic and simulation methods. It is shown how meta-analysis methods may be used to analyse multicentre trials of a paired cluster randomised design. Meta-analysis techniques are found to be preferable to previously published methods specifically developed for the analysis of such designs, which produce biased and potentially misleading results when a large treatment effect is present.

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.

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The usefulness of time-to-event (survival) analysis has made it gain a wide applicability in statistically modelling research. The methodological developments of time-to-event analysis that have been widely adopted are: (i) The Kaplan-Meier method, for estimating the survival function; (ii) The log-rank test, for comparing the equality of two or more survival distributions; (m) The Cox proportional hazards model, for examining the covariate effects on the hazard function; and (iv) The accelerated failure time model, for examining the covariate effects on the survival function. Nonetheless, in time-to-event endpoints assessment, if subjects can fail from multiple mutually-exclusive causes, data are said to have competing risks. For competing risks data, the Fine and Gray proportional hazards model for sub-distributions has gained popularity due to its convenience in directly assessing the effect of covariates on the cumulative incidence function. Furthermore, sometimes competing risks data cannot be considered as independent because of a clustered design; for instance, in registry cohorts or multi-centre clinical trials. The Fine and Gray model has been extended to the analysis of clustered time-to-event data, by including random-centre effects or frailties in the sub-distribution hazard. This research focuses on the analysis of clustered competing risks with an application to the investigation of the management of pericarditis clinical trial (IMPI) dataset. IMPI is a multi- centre clinical trial that was carried out from 19 centres in 8 African countries with the principal objective of assessing the effectiveness and safety of adjunctive prednisolone and Mycobacterium indicus pranii immunotherapy, in reducing the composite outcome of death, constriction or cardiac tamponade, requiring pericardial drainage in patients with probable or definite tuberculous pericarditis. The clinical objective in this thesis is therefore to analyse time to these outcomes. In addition, the risk factors associated with these outcomes were determined, and the effect of the prednisolone and M. indcus pranii was examined, while adjusting for these risk factors and considering centres as a random effect. Using Cox proportional hazards model, it was found that age, weight, New York Heart Association (NYHA) class, hypotension, creatinine, and peripheral oedema show a statistically significant association with the composite outcome. Furthermore, weight, NYHA class, hypotension, creatinine and peripherial oedema show a statistically significant association with death. In addition, NYHA class and hypotension show a statistically significant association with cardiac tamponade. Lastly, prednisolone, gender, NYHA class, tachycardia, haemoglobin level, peripheral oedema, pulmonary infiltrate and HIV status show a statistically significant association with constriction. A value of 0.1 significance level was used to identify variables as significant in the univariate model using forward stepwise regression method. The random effect was found to be significant in the incidence of composite outcomes of death, cardiac tamponade and constriction, and in the individual outcome of constriction, but this only slightly changed the estimated effect of the covariates as compared to when the random effect was not considered. Accounting for death as a competing event to the outcomes of cardiac tamponade or constriction, does not affect the effect of the covariates on these outcomes. In addition, in the multivariate models that adjust for other risk factors, there was no significant difference in the primary outcome between patients who received prednisolone, and those who received placebo, or between those who received M. indicus pranii immunotherapy, and those who received placebo.

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.

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La qualité des données est une préoccupation fondamentale de la recherche clinique. Pour garantir cette qualité, il faut pratiquer un monitorage continu des données. Les organismes internationaux de régulation des médicaments recommandent que ce monitorage soit ciblé, basé sur une analyse des risques. De cette recommandation a germé le concept de « monitoring statistique centralisé » (MSC) qui consiste à détecter des distributions de variables atypiques dans un centre par rapport aux autres centres. Cette thèse recense les méthodes de MSC existants, en propose de nouvelles, et compare les performances des unes et des autres. Dans la première partie, nous rappelons l’intérêt du sujet, dans un contexte marqué par l’accroissement du nombre d’essais cliniques, la nécessité de travailler de plus en plus à distance et le besoin de nouveaux paradigmes de monitorage. Dans la seconde partie, nous recensons les méthodes de MSC existantes, analysons leurs performances rapportées dans la littérature et en tirons deux observations majeurs : (i) le nombre de méthodes est limité; (ii) leurs évaluations par des travaux de simulations et des applications sur données réelles rapportées dans la littérature sont également limitées. Dans la troisième partie nous proposons deux nouvelles méthodes de MSC pour détecter les distributions de variables atypiques dans les essais multicentriques, l’une pour données quantitatives qui utilise une mesure de distance standardisée (méthode de la Distance) et l’autre pour données catégorielles, qui utilise un modèle Bayésien hiérarchique bêta-binomial (HBBB). Nous évaluons les performances de ces méthodes en utilisant des simulations d'essais cliniques, puis les comparons à d’autres méthodes de MSC identifiées dans la littérature. Pour les données quantitatives, la méthode de la Distance a des performances similaires à la méthode proposée par Desmet et al., et supérieures à celles des deux autres méthodes existantes. Pour les données catégorielles, la méthode HBBB a des performances similaires à la seule autre méthode existante, également proposée par Desmet et al. Pour les deux méthodes, Distance et HBBB, la sensibilité est globalement médiocre, mais la spécificité excellente, y compris dans de nombreux scénarios impliquant de petits effectifs. La sensibilité faible suggère que le MSC est un outil supplémentaire pouvant être utilisé en complément des autres procédures de monitoring conventionnelles, mais ne les remplace pas. La spécificité forte et le caractère convivial suggère que ces méthodes peuvent être appliquées en routine dans tous les essais cliniques, car leur utilisation ne prendra pas beaucoup de temps au niveau central et n'engendrera pas de charge de travail inutile dans les centres investigateurs
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.

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Proportional hazards models are among the most popular regression models in survival analysis. Multi-state models generalise them in the sense of jointly considering different types of events along with their interrelations, whereas frailty models introduce random effects to account for unobserved risk factors, possibly shared by groups of subjects. The integration of frailty and multi-state methodology is interesting to control for unobserved heterogeneity in presence of complex event history structures, particularly appealing in multicenter clinical trials applications. In the present thesis we propose the incorporation of nested frailties in the transition-specific hazard function; then, we develop and evaluate both parametric and semi-parametric inference. Simulation studies, performed thanks to an innovative method for generating dependent multi-state survival data, show that parametric inference is correct but extremely imprecise, whilst semiparametric methods are very competitive to evaluate the effect of covariates. Two case studies are presented, relative to cancer multicenter clinical trials. The multi-state nature of the models allows to study the treatment effect taking into account intermediate events, while the presence of frailties reduces the attenuation effect due to clustering. Finally, we present two new software tools, one to fit parametric frailty models with up to twenty possible combinations of baseline and frailty distributions, and one implementing semiparametric inference for multilevel frailty models, essential to fit the new nested frailty multi-state models.
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.

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The general aims of the thesis were to study GH responsiveness by estimation of pharmacokinetics and bioavailability of injected recombinant human GH (rhGH), of growth response as gain in heightSDS during childhood and puberty, and IGF-I response as change in circulating IGF-ISDS and IGFBP3SDS. Methods Short children were recruited during 1988–1999 into two national randomized multicentre clinical trials on growth until adult height. A group of 117 GHD patients who had been treated from prepuberty with a single GH dose of 33μg/kg/day for at least 1 year were randomized at onset of puberty either to remain on this dose regimen or to an increased dose, GH67μg/kg/day, administered once daily or divided into two doses, GH33x2μg/kg/day. Data on IGF-ISDS and IGF binding protein 3 (IGFBP3)SDS were available from 111 patients and analysed as stated below. The 151 short prepubertal non-GHD patients were randomized into three groups: untreated controls, GH33 or GH67μg/kg/day. A subpopulation from both trials, 128 patients examined annually in Gothenburg, formed the study sample on GH uptake. They received sc GH injections to obtain 16–24 hour GH curves and the GH pharmacokinetics and bioavailability was calculated. Results: A dose-dependent effect on Cmax was found with great intra- and inter-individual variability. Of the Cmax variability, 43% was explained by the rhGH dose and proxies for injection depth. Median bioavailability of the injected dose was 71%, with great variation, mainly dependent on injection depth. In the IGHD group a dose-dependent difference in pubertal gain in heightSDS was found, with mean of 0.8 for the GH67 group and 0.4 for GH33, p<0.01. The mean total gain in heightSDS during treatment was 1.9 for GH67 and 1.4 for GH33, p<0.01. A dose-dependent pubertal ΔIGF-ISDS was 0.5 vs −0.1, p=0.007, correlating to pubertal gain in heightSDS, p=0.003; and was the most important variable to explain the variation in pubertal gain in heightSDS. In the non-GHD group the ΔIGF-ISDS from baseline to mean study level was dose-dependent 2.07 vs 1.20, p=0.001; and correlated negatively with baseline values of IGF-ISDS, rho= -0.56 for GH67, p=0.001, vs rho= -0.82 for GH33, p=0.0001, and correlated positively with gain in heightSDS in both GH-treated groups, rho= 0.42, p<0.001. In multivariable regression analyses, ΔIGF-ISDS was always an important explanatory variable for long-term growth response from the prepubertal period until adult height, while the IGF-ISDS study level per se was not. Conclusion: Growth response to GH treatment was dose dependent with great variability between patients. More pubertal growth was attained by an increased rhGH dose, mimicking the physiology of healthy children, in whom GH secretion rate increases during puberty. This resulted in a gain in IGF-ISDS closely correlating to pubertal gain in heightSDS in both IGHD and non-GHD patients. A broad range in GH responsiveness was found for both growth and IGF response in both diagnostic groups, but lower in the non-GHD group. Higher uptake of a given GH dose was observed after a deep injection and a higher GH concentration. These results are clinically applicable for individuals who remain short close to onset of puberty; by identifying and deeply injecting a rhGH dose that accounts for individual responsiveness, we can stimulate an increment in IGF-ISDS that correlates to gain in heightSDS during puberty.

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Libri sul tema "Multicenter clinical trial":

Margie, Patlak, Nass Sharyl J, Micheel Christine, National Cancer Policy Forum (U.S.). e Institute of Medicine (U.S.), a cura di. Multi-center phase III clinical trials and NCI cooperative groups: Workshop summary. Washington, D.C: National Academies Press, 2009.

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Demitrack, Mark A., e Sarah H. Lisanby. Methodological issues in clinical trial design for TMS. A cura di Charles M. Epstein, Eric M. Wassermann e Ulf Ziemann. Oxford University Press, 2012. http://dx.doi.org/10.1093/oxfordhb/9780198568926.013.0039.

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This article explores the emergence of transcranial magnetic stimulation (TMS) as a new therapeutic approach and the implications of this technology for the study and treatment of neuropsychiatric disorders, with a focus on major depression. Relapse, chronicity, and varying degrees of treatment resistance characterize major depression. A substantial number of patients are not effectively treated with pharmacology or medications alone. It is proposed that TMS, along with other device-based therapies emerging in psychiatry, may define a potential new treatment platform, with existing therapeutics for major depression. Through the example of a study, this article describes the methodological considerations in the development of TMS for the treatment of major depression. Device-based approaches to therapeutic neuromodulation hold the promise of significant clinical advantages compared to existing treatments for major depression, but evidence in well designed and properly blinded multicenter trials is still lacking, hence, research in this area is ongoing.

Mecca, Adam P., e Rajesh R. Tampi. Effectiveness of Atypical Antipsychotic Drugs in Patients with Alzheimer’s Disease. A cura di Ish P. Bhalla, Rajesh R. Tampi, Vinod H. Srihari e Michael E. Hochman. Oxford University Press, 2018. http://dx.doi.org/10.1093/med/9780190625085.003.0015.

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This chapter provides a summary of the Clinical Antipsychotic Trials of Intervention Effectiveness—Alzheimer’s disease (CATIE-AD), a multicenter trial that investigated whether atypical antipsychotics are an effective treatment for psychosis, aggression, or agitation in outpatients with Alzheimer’s disease. The chapter briefly reviews the study design, as well as implications and limitations. A relevant clinical case concludes the chapter. In summary, atypical antipsychotic use for up to 36 weeks did not lead to clinical improvement based on time to discontinuation, or symptom reduction. Risk of discontinuation due to adverse events and side-effects with worse with antipsychotic treatment compared to placebo. In patients with psychosis, agitation, or aggression due to Alzheimer’s disease, the efficacy of atypical antipsychotics is questionable and their use comes with considerable risks of side effects and adverse events.

Jones, Byron. The Design and Analysis of Multicentre Clinical Trials. John Wiley and Sons Ltd, 2008.

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Webb, Jason A., e Arif H. Kamal. Palliative Oxygen Versus Room Air for Refractory Dyspnea (DRAFT). A cura di Nathan A. Gray e Thomas W. LeBlanc. Oxford University Press, 2018. http://dx.doi.org/10.1093/med/9780190658618.003.0017.

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Palliative oxygen therapy is used for treating dyspnea in patients with cancer and advanced cardiopulmonary diseases, however, small trials have suggested that circulating air may be just as effective. This international, multicenter, randomized controlled trial compared oxygen versus room air delivered by a nasal cannula for relief of dyspnea for patients with any life-limiting illness. Patients were adults >18 years of age, with PaO2 > 7.3kPa, on optimized therapies for their illness, and an expected survival of >1 month. The study demonstrated no clinically significant symptomatic benefit of palliative oxygen versus room air delivered via nasal cannula for seven days in patients with life-limiting illnesses and refractory dyspnea.

Patlak, Margie, Institute of Medicine, National Cancer Policy Forum, Christine Micheel e Sharyl Nass. Multi-Center Phase III Clinical Trials and NCI Cooperative Groups: Workshop Summary. National Academies Press, 2009.

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Capitoli di libri sul tema "Multicenter clinical trial":

Svantesson, Eleonor, Eric Hamrin Senorski, Alicia Oostdyk, Yuichi Hoshino, Kristian Samuelsson e Volker Musahl. "Multicenter Study: How to Pull It Off? The PIVOT Trial". In Basic Methods Handbook for Clinical Orthopaedic Research, 403–13. Berlin, Heidelberg: Springer Berlin Heidelberg, 2019. http://dx.doi.org/10.1007/978-3-662-58254-1_43.

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Hébert, P. C. "Transfusion Requirements in Critical Care: A Multicenter Controlled Clinical Trial". In Yearbook of Intensive Care and Emergency Medicine, 202–17. Berlin, Heidelberg: Springer Berlin Heidelberg, 1998. http://dx.doi.org/10.1007/978-3-642-72038-3_18.

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Rutsch, Wolfgang, Patrick W. Serruys, Guy R. Heyndrickx, Nicolas Danchin, E. Gijs Mast, William Wijns, Jeroen Vos e J. Stibbe. "CARPORT — Coronary artery restenosis prevention on repeated thromboxane antagonism. A multicenter randomized clinical trial". In Developments in Cardiovascular Medicine, 351–64. Dordrecht: Springer Netherlands, 1993. http://dx.doi.org/10.1007/978-94-011-1854-5_20.

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Kichikawa, Kimihiko, Shoji Sakaguchi, Wataru Higashiura e Hideo Uchida. "Multicenter Clinical trial of Zenith AAA Endovascular Graft for Abdominal Aortic Aneurysm in Japan". In Advances in Understanding Aortic Diseases, 135. Tokyo: Springer Japan, 2009. http://dx.doi.org/10.1007/978-4-431-99237-0_22.

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Koh, Jason L., Shital Parikh e Beth Shubin Stein. "Conducting a Multicenter Trial: Learning from the JUPITER (Justifying Patellar Instability Treatment by Early Results) Experience". In Basic Methods Handbook for Clinical Orthopaedic Research, 415–25. Berlin, Heidelberg: Springer Berlin Heidelberg, 2019. http://dx.doi.org/10.1007/978-3-662-58254-1_44.

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Kasuya, H. "Clinical Trial of Nicardipine Prolonged-Release Implants for Preventing Cerebral Vasospasm: Multicenter Cooperative Study in Tokyo". In Early Brain Injury or Cerebral Vasospasm, 165–67. Vienna: Springer Vienna, 2011. http://dx.doi.org/10.1007/978-3-7091-0356-2_30.

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Ginsberg, Myron D. "High-Dose Albumin for Neuroprotection in Acute Ischemic Stroke: From Basic Investigations to Multicenter Clinical Trial". In Translational Stroke Research, 691–719. New York, NY: Springer New York, 2012. http://dx.doi.org/10.1007/978-1-4419-9530-8_34.

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Friedman, Lawrence M., Curt D. Furberg e David L. DeMets. "Multicenter Trials". In Fundamentals of Clinical Trials, 427–40. New York, NY: Springer New York, 2010. http://dx.doi.org/10.1007/978-1-4419-1586-3_20.

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Friedman, Lawrence M., Curt D. Furberg e David L. DeMets. "Multicenter Trials". In Fundamentals of Clinical Trials, 345–56. New York, NY: Springer New York, 1998. http://dx.doi.org/10.1007/978-1-4757-2915-3_19.

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Friedman, Lawrence M., Curt D. Furberg, David L. DeMets, David M. Reboussin e Christopher B. Granger. "Multicenter Trials". In Fundamentals of Clinical Trials, 501–18. Cham: Springer International Publishing, 2015. http://dx.doi.org/10.1007/978-3-319-18539-2_21.

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Atti di convegni sul tema "Multicenter clinical trial":

Ingeholm, Mary-Lou, Betty A. Levine, Florian Eichler, Huacheng Tu, Gerardo Jimenez-Sanchez e Hugo Moser. "Multicenter clinical trial using next-generation Internet technology". In Medical Imaging 2001, a cura di Eliot L. Siegel e H. K. Huang. SPIE, 2001. http://dx.doi.org/10.1117/12.435470.

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Borges, Guilherme Ferreira, Hélio Rubens de Carvalho Nunes, Gustavo José Luvizutto, Taís Regina da Silva e Rodrigo Bazan. "Lessons of a multicenter noninvasive brain stimulation trial in patients with unilateral spatial neglect after stroke: barriers to trial participation from a developing country". In XIII Congresso Paulista de Neurologia. Zeppelini Editorial e Comunicação, 2021. http://dx.doi.org/10.5327/1516-3180.482.

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Background: There is a high demand for stroke rehabilitation in the Brazilian public health system, however most studies that addressed rehabilitation for unilateral spatial neglect (USN) after stroke have been performed in highincome countries. Objectives: Analyze the USN patient recruitment in a multicenter non-invasive brain stimulation clinical trial performed in Brazil. Design and setting: Observation study of reasons for exclusion of patients in a multicenter, randomized, double-blinded clinical trial performed at Botucatu Medical School. Methods: We evaluated reasons for exclusion of patients in a multicenter, randomized, double-blinded clinical trial of rehabilitation of USN patients after stroke. Results: 173 of 1956 potential neglect patients (8.8%) passed initial screening. After screening evaluation, 87/173 patients (50.3%) were excluded for clinical reasons. Cognitive impairment led to exclusion of 21/87 patients (24.1%). Low socioeconomic status led to exclusion of 37/173 patients (21.4%). Difficulty in transportation to access treatment was the most common reason (16/37 patients, 43.3%). Conclusions: The analyzed Brazilian institutions have potential for conducting studies in USN. Recruitment of stroke survivors with USN was restricted by the study design and limited financial support. Cognitive impairment, presence of stent or craniectomy and lack of transportation was the most common barriers to participate in a multicenter non-invasive brain stimulation trial in patients with unilateral spatial neglect after stroke.

Zaccaria, Gian Maria, Samanta Rosati, Cristina Castagneri, Simone Ferrero, Marco Ladetto, Mario Boccadoro e Gabriella Balestra. "Data quality improvement of a multicenter clinical trial dataset". In 2017 39th Annual International Conference of the IEEE Engineering in Medicine and Biology Society (EMBC). IEEE, 2017. http://dx.doi.org/10.1109/embc.2017.8037043.

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Tavanapong, Wallapak, JungHwan Oh, Gavin Kijkul, Jacob Pratt, Johnny Wong e Piet deGroen. "Real-Time Feedback for Colonoscopy in a Multicenter Clinical Trial". In 2020 IEEE 33rd International Symposium on Computer-Based Medical Systems (CBMS). IEEE, 2020. http://dx.doi.org/10.1109/cbms49503.2020.00010.

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Winslow, C. J., D. P. Edelson, M. M. Churpek, M. Taneja, M. Kharasch, A. Datta, P. McNulty e M. Halasyamani. "The Impact of an Early Warning Score on Hospital Mortality: A Multicenter Clinical Intervention Trial". In American Thoracic Society 2019 International Conference, May 17-22, 2019 - Dallas, TX. American Thoracic Society, 2019. http://dx.doi.org/10.1164/ajrccm-conference.2019.199.1_meetingabstracts.a2462.

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Santos, Gabriel Cerqueira, Caio de Almeida Lellis, Bruno Coelho Duarte Oliveira, Letícia Romeira Belchior, Caíque Seabra Garcia de Menezes Figueiredo e Ledismar José da Silva. "Botulinum toxin type A in the treatment of Myofascial Pain Syndrome: A Systematic Review". In XIII Congresso Paulista de Neurologia. Zeppelini Editorial e Comunicação, 2021. http://dx.doi.org/10.5327/1516-3180.263.

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Introduction: Myofascial pain syndrome (MPS) is a regional painful condition characterized by the presence of trigger points in the affected muscles, and botulinum toxin type A (BoNT-A) is a possible therapeutic option. Objectives: To evaluate the safety and efficacy of botulinum toxin in the management of MSD. Design and setting: A systematic review conducted at the Pontifical Catholic University of Goiás. Methodology: A systematic review was conducted in the PubMed, IBECS and VHL databases: “(Myofascial Pain Syndromes OR Myofascial Trigger Point Pain) AND Botulinum toxin”. Randomized studies, clinical trials and case reports published in the last 10 years were selected. Results: Two randomized trials concluded that application of BoNT-A, regard less of the application site, did not show significant improvement in pain intensity compared to the control group. Also, another multicenter, random ized trial reported that application of ToNB-A to the masseter muscles did not result in improvement of SDM within three months of application. Finally, a clinical trial reported improvement in visual numeric scores of myofascial pain in the scapular girdle in subjects who received a second dose (P = 0.019). Conclusion: BoNT-A was not effective in improving SDM at any site of ap plication and in any dosage studied, except in a single study, therefore insuf ficient to state whether subsequent doses have better results.

Galperin-Aizenberg, Maya, Hyun J. G. Kim, Peiyun Lu, Daniel Chong, Laura Guzman, Heidi Coy, Matthew S. Brown e Jonathan G. Goldin. "Reproducibility Of Lung Volume Measurements Using Computed Tomography From Repeated Scans In A Multicenter Clinical Trial". In American Thoracic Society 2011 International Conference, May 13-18, 2011 • Denver Colorado. American Thoracic Society, 2011. http://dx.doi.org/10.1164/ajrccm-conference.2011.183.1_meetingabstracts.a4607.

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Karimzadeh, A., SA Raeissadat, S. Erfani fam e L. Sedighipour. "SAT0604 Autologous blood and corticosteroid local injection in treatment of plantar fasciitis (randomized, controlled multicenter clinical trial)". In Annual European Congress of Rheumatology, 14–17 June, 2017. BMJ Publishing Group Ltd and European League Against Rheumatism, 2017. http://dx.doi.org/10.1136/annrheumdis-2017-eular.1771.

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Meyer, JS, S. Seefeldt, J. Lange, M. Heiss, D. Seidel e R. Lefering. "BIOLAP: Biological versus synthetic mesh in laparoscopic hernia repair-a randomized multicenter, prospective, self-controlled clinical trial". In Viszeralmedizin 2017. Georg Thieme Verlag KG, 2017. http://dx.doi.org/10.1055/s-0037-1605325.

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Maas, M., H. Neumann, H. Shirin, L. Katz, A. Benson, A. Kahloon, E. Soons et al. "A novel computer-aided polyp detection system in daily clinical care: an international multicenter, randomized, tandem trial". In ESGE Days 2023. Georg Thieme Verlag KG, 2023. http://dx.doi.org/10.1055/s-0043-1765015.

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Rapporti di organizzazioni sul tema "Multicenter clinical trial":

Robles, Marcelo, Claudio Dachevsky e Héctor Llovera. Prospective study: evaluation of the efficacy and longevity of cross-linked hyaluronic acid in nasolabial folds filling. Editorial Lugones, dicembre 2023. http://dx.doi.org/10.47196/0574.

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Introduction: the choice of minimally invasive methods positions hyaluronic acid fillers as a leading facial rejuvenation technique. Injectable hyaluronic acid fillers have been widely used in the clinical treatment of facial wrinkles. However, additional information and clinical evidence on the longevity of hyaluronic acid filler after injection is limited. Objectives: to demonstrate the efficacy, safety and longevity of cross-linked HA (AHR) 30 mg/ml (Estrianon Hyaluronic Implant 30® Allanmar International Company S.R.L., Argentina) for filling nasolabial folds (NLF). Design: multicenter, prospective and controlled clinical trial of 12 months duration. Materials and methods: 160 patients were included (132 women and 28 men) divided into 100, 30 and 30 of each cohort) and an injectable gel of cross-linked HA 30 mg/ml was applied in the correction of NLF to evaluate the safety, efficacy and longevity of the product. Results: a correction of the depression in the relevant sulci was observed, which was maintained until the end of the study. The mean level of improvement was clinically significant in 94% of cases. The severity of NLF was reduced by approximately 2 points to the range of mild or barely visible. Conclusions: Estrianon Hyaluronic Implant 30® proved to be a safe, effective filler with considerable longevity. At 12 months, significant correction was still observed and the treatment was well tolerated by patients.

Viskochil, David, Brigitte Widemann, Jan Friedman, Rosalie Ferner e Arie Perry. Malignant Peripheral Nerve Sheath Tumors in Neurofibromatosis Type 1: A Multicenter Project With 3 Clinical Trials. Fort Belvoir, VA: Defense Technical Information Center, giugno 2006. http://dx.doi.org/10.21236/ada460467.

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