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8 results on '"Major clinical study"'

1. Understanding the relationship between cognitive performance and function in daily life after traumatic brain injury

Author

Wilson, Lindsay, Horton, Lindsay, Kunzmann, Kevin, Sahakian, Barbara J., Newcombe, Virginia, Stamatakis, E, Steinbuechel, Nicole, Cunitz, Kathrin, Covic, Amra, Maas, Andrew, van Praag, Dominigue, Menon, David, Andelic, Nada, Andreassen, Lasse, Anke, Audny, Frisvold, Shirin, Helseth, Eirik, Røe, Cecilie, Røise, Olav, Skandsen, Toril, Vik, Anne, Åkerlund, Cecilia, Amrein, Krisztina, Antoni, Anna, Audibert, Gerard, Azouvi, Philippe, Azzolini, Maria Luisa, Bartels, Ronald, Barzo, Pal, Beauvais, Romuald, Beer, Ronny, Bellander, Bo-Michael, Belli, Antonio, Benali, Habib, Berardino, Maurizio, Beretta, Luigi, Blaabjerg, Morten, Bragge, Peter, Brazinova, Alexandra, Brinck, Vibeke, Brooker, Joanne, Brorsson, Camilla, Buki, Andras, Bullinger, Monika, Cabeleira, Manuel, Caccioppola, Alessio, Calappi, Emiliana, Calvi, Maria Rosa, Cameron, Peter, Lozano, Guillermo Carbayo, Centre of Excellence in Complex Disease Genetics, Aarno Palotie / Principal Investigator, Institute for Molecular Medicine Finland, Genomics of Neurological and Neuropsychiatric Disorders, HUS Neurocenter, Neurokirurgian yksikkö, Statistical and population genetics, Biostatistics Helsinki, Samuli Olli Ripatti / Principal Investigator, Complex Disease Genetics, Helsinki University Hospital Area, Ragauskas, Arminas, Rocka, Saulius, Tamosuitis, Tomas, Vilcinis, Rimantas, BMJ Publishing Group, Ročka, Saulius, Tamošuitis, Tomas, Wilson, L, Horton, L, Kunzmann, K, Sahakian, B, Newcombe, V, Stamatakis, E, Von Steinbuechel, N, Cunitz, K, Covic, A, Maas, A, Van Praag, D, Menon, D, Citerio, G, Neurology, Public Health, Neurosurgery, Intensive Care, Pediatric Surgery, Wilson, Lindsay [0000-0003-4113-2328], Newcombe, Virginia Fj [0000-0001-6044-9035], Apollo - University of Cambridge Repository, CENTER-TBI participants and investigators, Wilson, L., Horton, L., Kunzmann, K., Sahakian, B. J., Newcombe, V. F. J., Stamatakis, E. A., Von Steinbuechel, N., Cunitz, K., Covic, A., Maas, A., Van Praag, D., Menon D., (CENTER-TBI participants and investigators), Beretta, Luigi, and Molecular Neuroscience and Ageing Research (MOLAR)

Subjects
cognition, demography, age distribution, Rey auditory verbal learning test, physical capacity, 3124 Neurology and psychiatry, memory, 0302 clinical medicine, Medicine, processing speed, 030212 general & internal medicine, Cognitive impairment, learning, adult, traumatic brain injury, Cambridge Neuropsychological Test Automated Battery, Cognition, prospective observational study, Cognitive test, Psychiatry and Mental health, Short Form 12, female, injury severity, mental health, Clinical psychology, Traumatic brain injury, sex difference, Article, functional outcome, 03 medical and health sciences, SDG 3 - Good Health and Well-being, male, controlled study, Effects of sleep deprivation on cognitive performance, human, outcome assessment, CENTER-TBI participants and investigators, trail making test, business.industry, cognition assessment, medicine.disease, daily life activity, Mental health, Glasgow outcome scale, major clinical study, Surgery, Observational study, Neurology (clinical), Human medicine, functional assessment, business, 030217 neurology & neurosurgery
Abstract

ObjectiveCognitive impairment is a key cause of disability after traumatic brain injury (TBI) but relationships with overall functioning in daily life are often modest. The aim is to examine cognition at different levels of function and identify domains associated with disability.Methods1554 patients with mild-to-severe TBI were assessed at 6 months post injury on the Glasgow Outcome Scale—Extended (GOSE), the Short Form-12v2 and a battery of cognitive tests. Outcomes across GOSE categories were compared using analysis of covariance adjusting for age, sex and education.ResultsOverall effect sizes were small to medium, and greatest for tests involving processing speed (ηp2 0.057–0.067) and learning and memory (ηp2 0.048–0.052). Deficits in cognitive performance were particularly evident in patients who were dependent (GOSE 3 or 4) or who were unable to participate in one or more major life activities (GOSE 5). At higher levels of function (GOSE 6–8), cognitive performance was surprisingly similar across categories. There were decreases in performance even in patients reporting complete recovery without significant symptoms. Medium to large effect sizes were present for summary measures of cognition (ηp2 0.111), mental health (ηp2 0.131) and physical health (ηp2 0.252).ConclusionsThis large-scale study provides novel insights into cognitive performance at different levels of disability and highlights the importance of processing speed in function in daily life. At upper levels of outcome, any influence of cognition on overall function is markedly attenuated and differences in mental health are salient.

Published
2021

2. Favourable effects of fenofibrate on lipids and cardiovascular disease in women with type 2 diabetes: results from the Fenofibrate Intervention and Event Lowering in Diabetes (FIELD) study.

Author

d'Emden, Michael, Jenkins, Alicia, Li, Liping, Zannino, Diana, Mann, Kristy, Best, James, Stuckey, Bronwyn, Park, Kris, Saltevo, Juha, and Keech, Anthony

Abstract

Aims/hypothesis: In the double-blind placebo-controlled Fenofibrate Intervention and Event Lowering in Diabetes trial ( n = 9,795), fenofibrate reduced major cardiovascular events in type 2 diabetes. Sex-related differences in fenofibrate response could be clinically relevant and were pre-specified analyses. Methods: Women ( n = 3,657) and men ( n = 6,138) with type 2 diabetes not using statins were assigned fenofibrate (200 mg/day) or placebo for 5 years. Effects on lipoproteins and total cardiovascular events were evaluated by sex. Results: Baseline total, LDL-, HDL- and non-HDL cholesterol and apolipoproteins A-I and B differed between sexes, and these and triacylglycerol levels improved with fenofibrate in both sexes (all p < 0.001). Fenofibrate reduced total, LDL- and non-HDL cholesterol and apolipoprotein B more in women (all p < 0.001), independent of menopausal status and statin uptake. Adjusted for covariates, fenofibrate reduced total cardiovascular outcomes (cardiovascular death, fatal and non-fatal stroke and carotid and coronary revascularisation) by 30% in women (95% CI 8%, 46%; p = 0.008) and 13% in men (95% CI −1%, 24%; p = 0.07) with no treatment-by-sex interaction ( p > 0.1). In patients with high triacylglycerol levels and low HDL-cholesterol, fenofibrate reduced total cardiovascular outcomes by 30% (95% CI −7%, 54%) in women and 24% (95% CI 2%, 42%) in men, with no treatment-by-sex interaction ( p > 0.1). Conclusions/interpretation: Fenofibrate improved the lipoprotein profile more in women than men. Cardiovascular event reductions with fenofibrate were consistently similar in women and men, both overall and among those with low HDL-cholesterol and high triacylglycerol levels. These data provide reassurance about fenofibrate efficacy in women and men. Both sexes with type 2 diabetes should be considered for fenofibrate therapy for cardioprotection. [ABSTRACT FROM AUTHOR]

Published
2014
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3. Long-term complications to reflux disease in community practice. A 17-year cohort study of 4706 patients.

Author

Hvid-Jensen, Frederik, Pedersen, Lars, Munk, Estrid Muff, Drewes, Asbjørn Mohr, and Funch-Jensen, Peter

Subjects
*GASTROESOPHAGEAL reflux, *COHORT analysis, *PROTON pump inhibitors, *CONFIDENCE intervals, *ESOPHAGEAL stenosis, *POPULATION research, *RELATIVE medical risk
Abstract

Objective. To examine the risk of developing strictures in patients with erosive and non-erosive gastroesophageal reflux disease in a community-based setting, since controlled trials indicate that the use of proton pump inhibitors renders the risk of strictures insignificant. Material and methods. A 17-year cohort study of 4706 patients referred to endoscopy due to upper GI symptoms, with a population comparison cohort of 47,060 individuals. All patients were followed and treated according to prevailing guidelines by their usual care provider. Main outcomes were relative risks (RR) and 95% confidence intervals (CI) for incident strictures and dilatations. Results. 776 (16.5%) patients were diagnosed with erosive esophagitis, particularly men (61.2%). Over a period of 1-17 years (mean 10.5), 20 patients (2.6%) in the esophagitis group developed a peptic stricture, necessitating one or more dilatations in 16 patients (2.1%). Among the non-esophagitis patients, the incidences for both outcomes were 1.2%. Male gender doubled the risk of developing strictures, and alcohol abuse raised the risk four folds. Erosive patients had a risk of developing strictures eight times (95% CI: 5.0-13.0) higher than controls, whereas non-erosive patients' risk was 4.0 (95% CI: 2.8-5.7). The majority of strictures developed within the first 10 years after a diagnosis of esophagitis. Conclusion. Patients with esophagitis had eight times higher risk of strictures than population controls and two times higher than dyspeptic patients without esophagitis. This indicates that long-term outcomes in general practice are poorer than in controlled trials, most likely due to a lack of compliance with medication. [ABSTRACT FROM AUTHOR]

Published
2011
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5. Effect van een FTO-programma over astma op kwaliteit van leven bij patiënten. Verbetering blijft nog uit

Subjects
quality of life, general practitioner, pharmacist, article, controlled study, human, asthma, major clinical study, patient education
Abstract

In a randomised trial the effect of a peer review programme for groups of GPs and pharmacists was determined on the quality of life of their patients. Included were 96 asthma patients from 7 groups that had received the intervention, and 104 patients from 8 control groups. It is concluded that the programme, that had been effective in changing the participants' knowledge and prescribing behaviour, did not lead to immediate changes in the quality of life of the patients. One explanation for this lack of effect lies in the high number of chronic asthma patients that did not have a face-to-face contact with their doctor during one year.

Published
2003

6. Limited cross-border infections in patients newly diagnosed with HIV in Europe

Author

Moutschen, M., Frentz, D., Wensing, A. M. J., Albert, Jan, Paraskevis, Dimitrios N., Abecasis, A. B., Hamouda, O., Jørgensen, L. B., Kücherer, C., Struck, D., Schmit, J. -C, Åsjö, Birgitta, Balotta, Claudia, Beshkov, Danail, Camacho, Ricardo J., Clotet, B., Coughlan, S., De Wit, S., Griskevicius, A., Grossman, Z., Horban, A., Kolupajeva, T., Korn, K., Kostrikis, Leontios G., Liitsola, K., Linka, M., Nielsen, C., Otelea, D., Paredes, R., Poljak, M., Puchhammer-Stöckl, E., Sönnerborg, A., Stanekova, D., Stanojevic, M., Vandamme, A. -M, Boucher, C. A. B., Van de Vijver, D. A. M. C., Balluch, G., Vercauteren, J., Derdelinckx, I., Sasse, A., Bogaert, M., Ceunen, H., De Roo, A., Echahidi, F., Fransen, K., Goffard, J. -C, Goubau, P., Goudeseune, E., Yombi, J. -C, Lacor, P., Liesnard, C., Pierard, D., Rens, R., Schrooten, Y., Vaira, D., Vandekerckhove, L. P. R., Van den Heuvel, A., Van Der Gucht, B., Van Ranst, M., Van Wijngaerden, E., Vandercam, B., Vekemans, M., Verhofstede, C., Clumeck, N., Van Laethem, K., Demetriades, Ioannis, Kousiappa, Ioanna, Demetriou, Victoria L., Hezka, Johana, Bruckova, M., Machala, L., Gerstoft, J., Mathiesen, L., Pedersen, C., Nielsen, H., Laursen, A., Kvinesdal, B., Salminen, M., Ristola, M., Suni, J., Sutinen, J., Berg, T., Braun, P., Poggensee, G., Däumer, M., Eberle, J., Heiken, H., Kaiser, R., Knechten, H., Müller, H., Neifer, S., Schmidt, B., Walter, H., Gunsenheimer-Bartmeyer, B., Harrer, T., Hatzakis, Angelos E., Magiorkinis, Emmanouil N., Hatzitheodorou, Eleni, Haida, Catherine, Zavitsanou, Assimina, Magiorkinis, Gkikas, Lazanas, Marios C., Chini, Maria C., Magafas, N., Tsogas, Nickolaos, Paparizos, Vassilios A., Kourkounti, Sofia, Antoniadou, Anastasia C., Papadopoulos, Antonios I., Panagopoulos, Periklis, Poulakou, Garyphallia G., Sakka, V., Chryssos, Georgios, Drimis, Stylianos, Gargalianos, Panagiotis, Lelekis, Moyssis I., Chilomenos, G., Psichogiou, Mina A., Daikos, George L., Panos, George, Haratsis, G., Kordossis, Theodore, Kontos, Athanasios N., Koratzanis, Georgios, Theodoridou, Maria C., Mostrou, Glykeria J., Spoulou, Vana I., De Gascun, C., Byrne, C., Duffy, M., Bergin, C., Reidy, D., Farrell, G., Lambert, J., O'Connor, E., Rochford, A., Low, J., Coakely, P., O'Dea, S., Hall, W., Levi, I., Chemtob, D., Franzetti, M., Lai, A., Binda, F., Tramuto, F., Ciccozzi, M., Mussini, C., Angarano, G., Rezza, G., Schmit, J. C., Hemmer, R., Arendt, V., Staub, T., Schneider, F., Roman, F., van Kessel, A., van Bentum, P. H. M., Brinkman, K., de Coul, E. L., van der Ende, M. E., Hoepelman, I. M., van Kasteren, M., Juttmann, J., Kuipers, M., Langebeek, N., Richter, C., Santegoets, R. M. W. J., Schrijnders-Gudde, L., Schuurman, R., van de Ven, B. J. M., Ormaasen, V., Aavitsland, P., Stanczak, J. J., Stanczak, G. P., Firlag-Burkacka, E., Wiercinska-Drapalo, A., Jablonowska, E., Malolepsza, E., Leszczyszyn-Pynka, M., Szata, W., Palma, C., Borges, F., Paixão, T., Duque, V., Araújo, F., Jevtovic, D., Salemovic, D., Habekova, M., Mokráš, Miloš, Truska, P., Lunar, M., Babic, Dunja Z., Tomazic, J., Vidmar, L., Vovko, T., Karner, P., Domingo, P., Galindo, M. J., Miralles, C., del Pozo, M. A., Ribera, E., Iribarren, J. A., Ruiz, L., de la Torre, J., Vidal, F., Garcia, F., Heidarian, A., Aperia-Peipke, K., Axelsson, M., Mild, M., Karlsson, A., Thalme, A., Navér, L., Bratt, G., Blaxhult, A., Gisslén, M., Svennerholm, B., Bergbrant, I., Björkman, Per, Säll, C., Mellgren, Å., Lindholm, A., Kuylenstierna, N., Montelius, R., Azimi, F., Johansson, B., Carlsson, M., Johansson, E., Ljungberg, B., Ekvall, H., Strand, A., Mäkitalo, S., öberg, S., Holmblad, P., Höfer, M., Holmberg, H., Josefson, P., Ryding, U., Van Kessel, A., Instituto de Higiene e Medicina Tropical (IHMT), Centro de Malária e outras Doenças Tropicais (CMDT), Clinicum, Department of Medicine, Infektiosairauksien yksikkö, Frentz, D, Wensing, AMJ, Albert, J, Paraskevis, D, Abecasis, AB, Hamouda, O, Jørgensen, LB, Kücherer, C, Struck, D, Schmit, JC, Åsjö, B, Balotta, C, Beshkov, D, Camacho, RJ, Clotet, B, Coughlan, S, De Wit, S, Griskevicius, A, Grossman, Z, Horban, A, Kolupajeva, T, Korn, K, Kostrikis, LG, Liitsola, K, Linka, M, Nielsen, C, Otelea, D, Paredes, R, Poljak, M, Puchhammer-Stöckl, E, Sönnerborg, A, Stanekova, D, Stanojevic, M, Vandamme, AM, Boucher, CAB, Van de Vijver, DAMC, Tramuto, F, Van Wijngaerden, Eric, Van Ranst, Marc, Van Laethem, Kristel, Derdelinckx, Inge, Kostrikis, Leontios G. [0000-0002-5340-7109], Paraskevis, Dimitrios [0000-0001-6167-7152], Virology, and Graduate School

Subjects
Male, Epidemiology, Human immunodeficiency virus (HIV), Human immunodeficiency virus 1, HIV Infections, medicine.disease_cause, Virologie générale, phylogeny, Settore MED/42 - Igiene Generale E Applicata, Men who have sex with men, EMERGENCE, 0302 clinical medicine, Medicine and Health Sciences, Medicine, Infection control, Cluster Analysis, 030212 general & internal medicine, Israel, Pathologie maladies infectieuses, travel, Phylogeny, 0303 health sciences, Molecular Epidemiology, Travel, Transmission (medicine), article, virus transmission, IMMUNODEFICIENCY-VIRUS TYPE-1, 3. Good health, Europe, female, Infectious Diseases, SUBTYPE B, DRUG-RESISTANT HIV-1, RNA, Viral, male homosexual, Adult, structural gene, Molecular Sequence Data, Newly diagnosed, Clusters, 03 medical and health sciences, male, SDG 3 - Good Health and Well-being, MOLECULAR EPIDEMIOLOGY, SWITZERLAND, Virology, geographic distribution, Humans, Transmission, In patient, human, 030304 developmental biology, nonhuman, Molecular epidemiology, business.industry, Research, high risk population, Virologie médicale, nucleotide sequence, Sequence Analysis, DNA, Human immunodeficiency virus 1 infection, major clinical study, unindexed sequence, 3121 General medicine, internal medicine and other clinical medicine, HIV-1, business, Europe, HIV-1, Transmission, Clusters, Demography, cluster analysis
Abstract

Background: International travel plays a role in the spread of HIV-1 across Europe. It is, however, not known whether international travel is more important for spread of the epidemic as compared to endogenous infections within single countries. In this study, phylogenetic associations among HIV of newly diagnosed patients were determined across Europe.Results: Data came from the SPREAD programme which collects samples of newly diagnosed patients that are representative for national HIV epidemics. 4260 pol sequences from 25 European countries and Israel collected in 2002-2007 were included.We identified 457 clusters including 1330 persons (31.2% of all patients). The cluster size ranged between 2 and 28. A number of 987 patients (74.2%) were part of a cluster that consisted only of patients originating from the same country. In addition, 135 patients (10.2%) were in a cluster including only individuals from neighboring countries. Finally, 208 patients (15.6%) clustered with individuals from countries without a common border. Clustering with patients from the same country was less prevalent in patients being infected with B subtype (P-value, SCOPUS: ar.j, info:eu-repo/semantics/published

Published
2013

7. The prognostic value of histological grading of posterior fossa ependymomas in children: a Children's Oncology Group study and a review of prognostic factors

Author

Peter C. Burger, Elisabeth J. Rushing, Emi Holmes, Tianni Zhou, Tarik Tihan, Sema Özuysal, Uludağ Üniversitesi/Tıp Fakültesi/Patoloji Anabilim Dalı., and Özuysal, Sema

Subjects
Oncology, Ependymoma, Male, Pathology, Posterior fossa, Infratentorial Neoplasms, Supratentorial ependymomas, Central Pathology Review, Re-Irradiation, Neuroepithelial Neoplasms, Cancer risk, Cancer surgery, Medicine, Pediatric ependymoma, Overall survival, Disease free survival, Child, Priority journal, Intracranial ependymomas, Correlation analysis, Prognosis, Survival Rate, Cancer radiotherapy, Child, Preschool, Posterior cranial fossa tumor, Female, Human, Childhood brain tumor, Prognostic variable, medicine.medical_specialty, Consensus, Adolescent, Histopathology, Major clinical study, Relevance, World health organization, Article, Disease-Free Survival, Pathology and Forensic Medicine, Cancer grading, Age, Predictive Value of Tests, Internal medicine, Chemotherapy, Humans, Preschool, Grading (tumors), Tumors, Neoplasm Staging, Retrospective Studies, business.industry, Intermethod comparison, Infant, medicine.disease, Childhood, Cancer survival, United States, Clinical trial, Outcome assessment, Review pediatric glioma, Radiation-therapy, Relative risk, Irradiation, business, Controlled study
Abstract

We performed a retrospective analysis of 96 pediatric posterior fossa ependymomas in order to determine the prognostic value of histological grade based on the current WHO grading scheme. The patients were selected among Children's Oncology Group (previously Pediatric Oncology Group-POG) patients enrolled in clinical trials, and on the basis of central pathology review, location, and age. We excluded entities such as sub-ependymoma, myxopapillary, or clear-cell ependymoma, after a consensus diagnosis by three neuropathologists. A total of 66 males and 30 females with a median age of 48 months were identified. The group was analyzed to determine the effects of histological grade, age, gender, and extent of resection on event-free and overall survival. Our results showed that extent of resection, age, and histological grade were independent prognostic variables for event-free survival. The relative risk for extent of resection and histological grade was calculated as 3.59 (P

Published
2007

8. Effect van een FTO-programma over astma op kwaliteit van leven bij patiënten. Verbetering blijft nog uit

Author

Petra Denig, Onnes, B., Haaijer-Ruskamp, F. M., and Methods in Medicines evaluation & Outcomes research

Subjects
quality of life, general practitioner, pharmacist, education, article, controlled study, human, asthma, major clinical study, patient education
Abstract

In a randomised trial the effect of a peer review programme for groups of GPs and pharmacists was determined on the quality of life of their patients. Included were 96 asthma patients from 7 groups that had received the intervention, and 104 patients from 8 control groups. It is concluded that the programme, that had been effective in changing the participants' knowledge and prescribing behaviour, did not lead to immediate changes in the quality of life of the patients. One explanation for this lack of effect lies in the high number of chronic asthma patients that did not have a face-to-face contact with their doctor during one year.

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