Klima K.,Fakultni Nemocnice V Motole
Anesteziologie a Intenzivni Medicina | Year: 2010
In 1970, the new University Children's Hospital was opened in Prague-Motol. The 12-bed Department of Maxillofacial and Dental Surgery for children was the first one to be opened in the former Czechoslovakia. Prof. Jaroslav Komínek, the head of the department, organised an internship programme with the Department of Anaesthesiology for his physician. The head of the anaesthetic department Miloslav Drapka was the founder of paediatric anaesthesiology in Czechoslovakia. The initial attempts at anaesthesia for dental surgery were not very successful. Operations in the buccal cavity without tracheal intubation were very hazardous. The author describes the transition of the intubation technique from orotracheal to nasotracheal with packing of the oropharynx. The author also describes a breathing circuit with a low resistance water valve, premedication, parenteral analgesic sedation for inpatients and oral analgesic sedation for outpatients. Ketamine anaesthesia without intubation enabled the dental surgeons to treat large numbers of children. Information abou the mandatory pre-anaesthetic visit and examination, pre-operative preparation and special anaesthetic procedures is presented.
Agency: Cordis | Branch: FP7 | Program: CP-FP | Phase: HEALTH.2013.2.4.1-3 | Award Amount: 7.81M | Year: 2013
Survival rates after childhood cancer now reach nearly 80% in developed European countries as a result of more effective therapies and better supportive care, leading to a steady increase in the number of survivors in the population. However, the treatments that have improved survival are harsh and cause serious side-effects that can greatly impact survivors quality of life in the long term. The goal of PanCareLIFE is that survivors of cancer diagnosed before age 25 should enjoy the same quality of life and opportunities as their peers who have not had cancer. Using observational studies and molecular genetic investigations PanCareLIFE will investigate late effects that impact fertility and hearing impairment (ototoxicity), and will assess health-related quality of life. Information from PanCareLIFEs studies will be incorporated into new guidelines for fertility preservation. As the number of survivors with late effects in any one country is small, large cohorts are required for accurate estimation of risk. PanCareLIFE has assembled a team of prominent investigators from 8 European countries who will contribute in total over 12,000 well-characterised research subjects to identify risk factors, both genetic and non-genetic, linked to decrements in fertility and ototoxicity. Quality-of-life studies will evaluate the impact of fertility and ototoxicity. PanCareLIFE will advance the state-of-the-art in survivorship studies by evaluation of large cohorts with observational and genetic tools that will provide better knowledge of individual risk factors. Survivors can then be stratified into groups benefitting from personalized, evidence-based, care; future patients may expect effective therapies to have less severe side effects, and plans for a seamless transition to long-term follow-up care can be made. These approaches will result in better quality of life for survivors of cancer diagnosed at a young age.
Aflibercept versus placebo in combination with fluorouracil, leucovorin and irinotecan in the treatment of previously treated metastatic colorectal cancer: Prespecified subgroup analyses from the VELOUR trial
Tabernero J.,Autonomous University of Barcelona |
Van Cutsem E.,Catholic University of Leuven |
Lakomy R.,Masaryk Memorial Cancer Institute |
Prausova J.,Fakultni Nemocnice V Motole |
And 8 more authors.
European Journal of Cancer | Year: 2014
Purpose The antiangiogenic agent aflibercept (ziv-aflibercept in the United States) in combination with 5-fluorouracil, leucovorin and irinotecan (FOLFIRI) significantly improved survival in a phase III study of patients with metastatic colorectal cancer (mCRC) previously treated with an oxaliplatin-based regimen. In the present analysis, outcomes were evaluated in prespecified subgroups to assess the consistency of the treatment effect. Methods Patients were randomised to receive FOLFIRI plus aflibercept or placebo every 2 weeks until disease progression or unacceptable toxicity occurred. Efficacy and safety outcomes were analysed with respect to demographic and baseline characteristics, and stratification factors (prior bevacizumab treatment and Eastern Cooperative Oncology Group performance status). Results Median overall survival (OS, months [95.34% confidence interval (CI)]) for aflibercept versus placebo was 12.5 (10.8-15.5) versus 11.7 (9.8-13.8) in patients with prior bevacizumab treatment and 13.9 (12.7-15.6) versus 12.4 (11.2-13.5) in patients with no prior bevacizumab treatment. The p value for interaction was 0.5668, indicating there was no heterogeneity in these subgroups. For OS and progression-free survival (PFS), there was a significantly greater benefit (at the 2-sided 10% level) of treatment for patients with liver only metastases versus patients with no liver metastases/liver metastases with other organ involvement (p value for interaction: 0.0899 [OS]; 0.0076 [PFS]). There was no evidence of heterogeneity in treatment effect in any of the other subgroups examined. Conclusions The benefits of aflibercept in combination with FOLFIRI in patients with mCRC previously treated with oxaliplatin were maintained across the specified patient subgroups, including in patients with or without prior bevacizumab treatment. © 2013 Elsevier Ltd. All rights reserved.
Agency: Cordis | Branch: H2020 | Program: RIA | Phase: PHC-15-2015 | Award Amount: 6.70M | Year: 2016
Spinal cord injury is a severe and devastating neurological disorder that leaves patients with permanent paralysis of the body. No treatment is available today to regenerate interrupted nerve fibers and repair the damaged spinal cord. The incidence of spinal cord injury is about newly injured 10000 people per year in the EU, and due to an almost normal life expectancy more than 200000 patients are living with a spinal cord injury in the EU. The impact on the individual quality of life is high, and social costs are enormous. Recent preclinical research in animal models succeeded to greatly enhance axonal sprouting, fiber regeneration and neuroplasticity following injuries of brain and spinal cord. These results warrant translation now to patients suffering from acute spinal cord injury. A previous phase I clinical study using intrathecal application of a nerve fiber growth promoting antibody against the growth inhibitory protein Nogo-A has shown in patients with complete spinal cord injury that this treatment is safe and well tolerated. The present study will enroll patients with various degrees of complete to incomplete acute spinal cord injury for a double-blind, placebo-controlled trial to test the efficacy of this antibody therapy to improve motor outcome and quality of life of tetraplegic patients. The enrollment of patients with different degrees of spinal cord injury is considered essential to reveal drug activity and eventual proof of concept in a broad patient population. Advancements in clinical trial design, improved prediction algorithms of clinical outcomes and development of surrogate markers (in cerebro-spinal fluid/serum and by neuroimaging) will allow for scrutinizing the effectiveness of this novel treatment in an unprecedented way. A positive outcome of this trial will represent a breakthrough for the future therapy of spinal cord injuries and beyond (traumatic brain injury, stroke, multiple sclerosis).
Agency: Cordis | Branch: FP7 | Program: CP-FP | Phase: HEALTH.2011.2.4.1-1 | Award Amount: 7.74M | Year: 2011
Though survival of children with acute lymphoblastic leukaemia (ALL) has improved, relapse remains a leading cause of mortality in childhood cancer. Given the rarity of the disease, only a large international cooperative group can recruit sufficient patients for prospective studies with specific questions in biologic subgroups. Under the umbrella of the I-BFM SG all relevant mainly European study groups are creating the worldwide largest Study for Children with Relapsed ALL (IntReALL 2010). The aim is to develop optimized standard treatment as platform for systematic randomized phase II and III studies on the most promising new and targeted agents. An adequate trial structure, an optimized web based database, and standardized diagnostic methods need to be established. Patients are stratified into a standard (SR) and a high risk (HR) group according to established factors. For SR patients, the best available treatment protocols ALL-REZ BFM 2002 and ALL R3 are randomly compared, and the additional effect on survival of the humanized monoclonal CD22 directed antibody epratuzumab is investigated. HR patients who have unsatisfying remission rates will receive an intensified induction with the new nucleoside analogue clofarabine compared to standard induction therapy. IntReALL 2010 allows for comprehensive tumour banking and systematic biologic research in subgroups with correlation to clinical outcome. SMEs will be involved into project management, data base development, and pharmaceutical and biotechnological research to ensure innovation in the respective areas. IntReALL 2010 is embedded in a network of European academic structures relevant for childhood cancer. It will be a cornerstone of drug development in childhood leukaemia and the only trial with the potential for well powered phase III studies in this indication. IntReALL 2010 will harmonize ALL-relapse therapy, establish highest diagnostic and therapeutic standard and improve survival of children with ALL.