Search results for "Nausea"
showing 8 items of 138 documents
Multizentrische Phase II — Studie der Arbeitsgruppe Lebermetastasen zur wöchentlichen intraarteriellen 24 h Hochdosistherapie mit 5-FU und Folinsäure…
1998
This prospective multicenter trial was performed to determine the response rate, toxicity and applicability of continuous 24 h hepatic arterial infusion of high-dose 5-FU and folinic acid. An improved response rate (60.5% in non-pretreated patients) was however associated with many systemic side-effects (340/509), mainly nausea and diarrhea. Therefore this treatment should be applied only in selected patients in specialized centers.
Phase IA/II Study of Oral LBH589, a Novel Deacetylase Inhibitor (DACi), Administered on 2 Schedules, in Patients with Advanced Hematologic Malignanci…
2007
Abstract LBH589 is a novel cinnamic acid hydroxamate DACi which induces apoptosis in multiple hematologic tumor cell lines in vitro at nanomolar levels. LBH589 has been administered orally, once-a-day, on Monday/Wednesday/Friday, every week (Arm 1) or every other week (Arm 2), in cycles of 28 days, to adult pts with advanced hematologic malignancies. A 3-parameter Bayesian logistic regression model guided dose escalation. To date, 61 pts, median age 67 yrs (range 16–87), 40 male, 21 female, have been enrolled: 33 pts in Arm 1 at dose levels (mg/dose) of 20 (9 pts), 30 (12 pts), 40 (10 pts), and 60 (2 pts); 28 pts in Arm 2 at dose levels (mg/dose) of 30 (7 pts), 45 (12 pts), and 60 (9 pts). …
FS-HAI for Relapsed AML
2003
Treatment results in patients with refractory and relapsed acute myeloid leukemia (AML) need to be improved. The current study aimed at enhancing the anti-leukemic efficacy of the sequential high-dose AraC and idarubicin (S-HAI) regimen by the addition of fludarabine as a chemo-modulator. High-dose AraC was applied q 12 hours on days on days 1, 2, 8, and 9 and idarubicin on days 3, 4, 10, and 11. Patients were randomized to receive fludarabine q 12 hours on days 1, 2, 8, and 9 in addition to S-HAI or S-HAI alone. Of 179 patients having entered the study 120 are fully evaluable at the present time (median age 55 years, range 20–77). Thirty-eight percent of the patients had refractory disease…
Ambulante und tageschirurgische Eingriffe
2003
Ambulatory surgical care is intended to save healthcare expenditure from the economical viewpoint. From the patients point of view significant advantages as well as specific disadvantages of ambulatory surgery are known. The increase in the volume and complexity of procedures provided in an ambulatory setting are driven by improvements in anesthesia and surgical technique as well as by changes in financing and reimbursement. Therefore careful quality control and scientific evidence for the safety of increasingly used complex surgical procedures for higher risk patients is essential. Reducing the surgical trauma by minimally invasive surgical techniques and very good controllability by moder…
5PSQ-100 Comparative analysis of the safety and tolerability profile of pirfenidone and nintedanib in the treatment of idiopathic pulmonary fibrosis
2020
Background and importance The main treatments for idiopathic pulmonary fibrosis are pirfenidone and nintedanib. Although their efficacy is known, further studies are needed to evaluate the safety and tolerability profiles (STPs) based on real world data. Aim and objectives The aim of this study was to evaluate the STP of nintedanib and pirfenidone according to our hospital data. Material and methods We analysed 148 patients treated with pirfenidone (72% men; 28% women) and 120 treated with nintedanib (77% men; 23% women) from September 2016 to September 2019. The average age of the patients treated with pirfenidone and nintedanib was 72.7 and 74.4 years, respectively. Drug tolerability was …
Modulation of AraC by Fludarabine: Results of Salvage Therapy by AMLCG
2001
Fludarabine was shown to increase the intracellular formation of AraCTP during treatment with AraC both in vitro and in vivo and had significant activity in patients with advanced acute myeloid leukemia (AML) when used in combination with AraC in phase II studies. However, the efficacy of fludarabin as chemo-modulatior of the AraC metabolism has not yet been assessed in phase III studies. Based on the S-HAI salvage regimen comprizing high-dose AraC q 12 hours on days 1,2,8, and 9 and idarubicin on days 3,4,10, and 11, the German AML Cooperative Group initiated a prospective randomized comparison between fludarabine q 12 hours on days 1, 2, 8, and 9 in addition to S-HAI as compared with S-HA…
NEO1 and NEO-EXT studies: Long-term safety of repeat avalglucosidase alfa dosing for 4.5 years in late-onset Pompe disease patients
2019
Safety, tolerability, pharmacokinetics, pharmacodynamics, and exploratory efficacy of repeat avalglucosidase alfa dosing (5, 10, or 20 mg/kg qow) for 6 months were evaluated in NEO1 (NCT01898364) in late-onset Pompe disease patients either treatment-naive (Naive) or having received alglucosidase alfa for ≥9 months (Switch). In NEO-EXT (NCT02032524), an ongoing NEO1 extension, long-term safety and pharmacokinetics of repeat avalglucosidase alfa dosing will be monitored over 6 years. Interim safety results after 4.5 years of NEO-EXT are reported here. Mean ages at NEO1 enrollment were: Naive: 44.8 (SD:20.3, range:20-78) years and Switch: 46.7 (SD:14.1, range:21-68) years. Of the 24 NEO1 parti…
Methylprednisolone-induced hepatotoxicity in a 16-year-old girl with multiple sclerosis.
2018
Multiple sclerosis (MS) is a chronic inflammatory disease with demyelination of the central nervous system. High-dosage corticosteroids are the first-line therapy in the acute relapsing of MS. We report a case of severe high-dose methylprednisolone-induced acute hepatitis in a patient with a new diagnosis of MS. A 16-year-old girl was admitted for urticaria, angioedema, nausea and vomiting a month later she had been diagnosed with MS and treated with high-dosage methylprednisolone. Laboratory investigations showed hepatic insufficiency with grossly elevated liver enzymes. A liver biopsy showed focal centrilobular hepatocyte necrosis with interface hepatitis. Methylprednisolone-induced hepat…