Search results for "nausea"
showing 10 items of 138 documents
Iron Fortification of Milk and Dairy Products
2013
Blood haemoglobin level is used to define anaemia. Thresholds are given by category of age, of sex, and also of physiological status such as pregnancy. For example, the threshold is 120 g L–1 of haemoglobin in blood for a nonpregnant adult woman, 110 for a pregnant woman, 130 for a man older than 15 years, 110 for a child under 5 years… Iron deficiency constitutes the most important worldwide problem of human nutrition. In 2005, 1.62 billions of people were concerned by iron deficiency. Iron deficiency is encountered mostly in poor countries and particularly in Western Pacific, except Australia and New Zealand, in India and Pakistan, in the great majority of countries in Africa, in South Am…
A pharmacokinetically (PK) and pharmacodynamically (PD) driven phase I trial of the pan-AKT inhibitor AZD5363 with expansion cohorts in PIK3CA mutant…
2015
Background: AZD5363 is a novel potent pan-AKT inhibitor (IC50of AKT1, AKT2 and AKT3 of 3, 7 and 7nM respectively) with preclinical activity across a range of models. Methods: The trial had an adaptive design that allowed changes in schedule based on toxicity, PK, and PD findings. AZD5363 was administered orally (PO) twice a day (BID). Three schedules were explored: continuous dosing (7/7), four days a week, (4/7) and two days a week (2/7). PD biomarkers including pAKT, pGSK3?, and pPRAS40 were measured by IHC in pre- and post-treatment tumor biopsies. Once a RP2D was established, two expansion cohorts of PIK3CA-mutant ER+ve breast (B) and gynecological (G) cancers were explored. Results: 47…
Effectiveness and tolerability of amidotrizoate for the treatment of constipation resistant to laxatives in advanced cancer patients.
2011
Abstract Context Constipation is a common problem for advanced cancer patients, and is generally inadequately treated. Objectives The aim of this study was to prospectively evaluate the effectiveness and tolerability of amidotrizoate (AM) in patients unresponsive to current laxatives. Methods A consecutive sample of advanced cancer patients was surveyed. Inclusion criteria were no bowel movements for three days despite receiving regular doses of senna or lactulose. AM 50mL was administered orally; the dose could be repeated the day after, based on clinical judgment and/or patients' preference. Age, sex, primary tumor, previous abdominal surgery, chemotherapy and radiotherapy performed in th…
Analysis of Safety and Tolerability Data Obtained from Over 1,500 Patients Receiving Topiramate for Migraine Prevention in Controlled Trials
2008
Objective. Topiramate is an effective and generally well-tolerated migraine preventive therapy, as shown in three large, randomized, double-blind, placebo-controlled registration trials. Based upon efficacy/tolerability, topiramate 100 mg/day (50 mg BID) is the recommended target dose for most patients with migraine. To further assess the safety and tolerability of topiramate for migraine prevention, we analyzed safety data from 1,580 patients who participated in the three pivotal registration trials or an earlier pilot, randomized, double-blind, placebo-controlled trial. Methods. The safety population consisted of all patients who took ≥1 dose of study medication during the double-blind …
Salvage Re-irradiation Options in Adult Medulloblastoma: A Case Report and Review of the Literature
2020
Background/aim Medulloblastoma is a rare tumor of adult age, while it occurs more frequently in children. Given the rarity, there is a lack of evidence for the treatment of recurrent disease. Few data are available about salvage re-irradiation collecting very heterogeneous series. Case report A 51-year-old male presented with headache, nausea, double vision, and gait disorders. A contrast-enhanced brain-MRI showed the presence of multifocal medulloblastoma. After surgery, adjuvant craniospinal radiotherapy was performed, chemotherapy was stopped due to toxicity. After 27 months, a new MRI and a Methionine-PET revealed a late pontocerebellar relapse; multidisciplinary board decided for a SBR…
Accumulated safety data of micafungin in therapy and prophylaxis in fungal diseases
2011
To define better the safety profile of micafungin, an analysis of micafungin clinical trial safety data was undertaken.Adverse event data were pooled worldwide from 17 clinical efficacy and safety studies. Adverse events were coded using the Medical Dictionary for Regulatory Activities version 5.0.In the pooled clinical trial data set, 3028 patients received at least one dose of micafungin. The mean age of patients was 41.4 years; with 296 (9.8%) children (16 years) and 387 (12.8%) elderly patients (≥ 65 years). Common underlying conditions were hematopoietic stem cell and other transplantations (26.1%), malignancies (20.8%) and HIV (32.9%). Mean exposure was 18 days for adults and 29 days …
Patients' and physicians' preferences for type 2 diabetes mellitus treatments in Spain and Portugal: a discrete choice experiment.
2015
Objective: To assess Spanish and Portuguese patients' and physicians' preferences regarding type 2 diabetes mellitus (T2DM) treatments and the monthly willingness to pay (WTP) to gain benefits or avoid side effects. Methods: An observational, multicenter, exploratory study focused on routine clinical practice in Spain and Portugal. Physicians were recruited from multiple hospitals and outpatient clinics, while patients were recruited from eleven centers operating in the public health care system in different autonomous communities in Spain and Portugal. Preferences were measured via a discrete choice experiment by rating multiple T2DM medication attributes. Data were analyzed using the cond…
Chemotherapy in advanced pancreatic cancer
1997
Patients with advanced adenocarcinomas of the pancreas have an exceptionally poor prognosis. Modest activity has been demonstrated with single agents (response rates of 25% at best with 5-fluorouracil [5-FU] and mitomycin). Better results have not been obtained by combination chemotherapy. Improvements in the palliation have been achieved by treatment with 5-FU, folinic acid (FA), and interferon-alpha-2A (IFN-alpha) weekly in the context of a phase II trial. Of 57 evaluable patients, eight (14%) had a partial response (PR), eight (14%) a minor response (MR), and 28 (49%) had no change of disease (NC). The median survival time was 10 mo for patients with progressive disease. Twenty-two out o…
The course of symptom frequency and intensity in advanced cancer patients followed at home
2000
Four hundred consecutive patients who were referred to a home palliative care program were prospectively surveyed to estimate the prevalence and severity of common symptoms according to the changes in the performance status. Patients were admitted for the presence of different symptoms and psychosocial support. Common symptoms included in a standard form were rated for severity (absent 0, mild 1, moderate 2, severe 3) for each visit. Pain intensity was rated on a numerical scale (0-10). For each level of Karnofsky performance score (K), the frequency and the worse symptom intensity were recorded until patient's death. Data from 370 patients were analyzed. Pain was effectively controlled. In…
Oxaliplatin and Capecitabine-Based Chemoradiotherapy for Gastric Cancer—An Extended Phase I MARGIT and AIO Trial
2008
Purpose Adjuvant 5-fluorouracil–based chemoradiotherapy has been shown to improve the prognosis of gastric cancer. To optimize these results, in the present study oxaliplatin and capecitabine were used instead of 5-fluorouracil. We sought to determine the maximum tolerated dose and the dose-limiting toxicities (DLT) of these drugs in combination with intensity-modulated radiotherapy. Methods and Materials Patients with resected adenocarcinoma of the stomach or the gastroesophageal junction were included. They received two cycles of induction chemotherapy (oxaliplatin and capecitabine [XelOx] regimen). Using standard Phase I methodology, patients received 45 Gy in 1.8-Gy fractions either in …