Search results for "Chills"
showing 10 items of 11 documents
Phase I study of OM-174, a lipid A analogue, with assessment of immunological response, in patients with refractory solid tumors.
2013
International audience; BACKGROUND: Lipids A, the lipophilic partial structure of lipopolysaccharides, induce regression of several tumor types in animal models. Rather than exerting direct cytotoxic effect, these compounds trigger the immune system which in turn stimulates secretion of cytokines, and activates the inducible nitric oxide synthase, as well as immune cell infiltration of tumors. OM-174 is an analogue of lipid A with dual action on toll-like receptors 2 and 4. In an experimental model of peritoneal carcinomatosis induced in BDIX rats by intraperitoneal injection of syngeneic PROb colon cancer cells, it induced a complete regression of tumors. The present phase I trial was cond…
Fourth case of louse-borne relapsing fever in Young Migrant, Sicily, Italy, December 2015. Mini Review Article
2016
Abstract Objectives Currently louse-borne relapsing fever (LBRF) is primarily found in limited endemic foci in Ethiopia, Somalia and Sudan; no case of imported LBRF has been reported in Europe in the 9 years prior to 2015. The aim of our paper is to describe a new case of imported LBRF detected in Sicily, Italy, and to review all cases reported in migrants arrived in Europe in the last 10 years. Study design Mini review of all published cases of louse-borne relapsing fever in Europe in the last 10 years. Methods A computerized search without language restriction was conducted using PubMed combining the terms ‘(louse-borne relapsing fever or LBRF or recurrentis) and (refugee or Europe or mig…
Safety and Pharmacokinetics/Pharmacodynamics of the First-in-Class Dual Action HER3/EGFR Antibody MEHD7945A in Locally Advanced or Metastatic Epithel…
2015
Abstract Purpose: The novel dual-action humanized IgG1 antibody MEHD7945A targeting HER3 and EGFR inhibits ligand-dependent HER dimer signaling. This phase I study evaluated the safety, pharmacokinetics, pharmacodynamics, and antitumor activity of MEHD7945A. Experimental Design: Patients with locally advanced or metastatic epithelial tumors received escalating doses of MEHD7945A (1–30 mg/kg) every 2 weeks (q2w) until disease progression or intolerable toxicity. An expansion cohort was enrolled at the recommended phase II dose (14 mg/kg, q2w). Plasma samples, tumor biopsies, FDG-PET were obtained for assessment of pharmacokinetics, and pharmacodynamic modulation downstream of EGFR and HER3. …
Clinical Cases on Colorectal Cancer Emergency
2019
You have to manage in the emergency room a 75-year-old man with a medical history of pulmonary embolism 4 months ago and currently treated with warfarin. He has no history of abdominal surgery. He consults for diffuse abdominal pain, cessation of flatus and stools for 4 days, and fever of 38.7 °C and chills for 24 h. He vomited once 24 h ago. He also experienced asthenia and recent weight loss of 7 kg over the past 6 months not attributable to diet or exercise. He complains of progressively aggravating alternation of diarrhea and constipation for 3 months. He finally remembers that he noticed several times in the last months the presence of red blood in the stools, about which he did not wo…
Safety of micafungin in prospective and retrospective clinical trials
2012
Summary Managing fungal diseases remains a major challenge for clinicians despite the improved armamentarium of antifungal agents. This review identified 19 publications reporting safety data on micafungin. Two of these publications were spin off publications, the remaining 17 (15 prospective, two retrospective) were included in the main assessment. Major adverse events reported which occurred in more than 2% in the study populations were infusion-related, gastro-intestinal and hepatic (LFT parameters elevations). Micafungin demonstrated significantly less renal events compared with liposomal amphotericin B and less hepatic events compared with voriconazole. Compared with fluconazole no sig…
Abstract CT-08: A Phase 1 study of MEHD7945A (MEHD), a first-in-class EGFR/HER3 dual action antibody, in patients (pts) with locally advanced or meta…
2012
Abstract Background Dysregulated human epidermal growth factor receptor tyrosine kinase (HER RTK) signaling is an important driver of tumor growth, metastasis, and survival. Extensive HER RTK co-expression and heterodimerization suggest that simultaneous blockade of multiple RTKs may be more effective than targeting individual RTKs, and may help prevent or delay development of resistance mechanisms. MEHD is a novel dual-action human IgG1 antibody. Each antigen-binding fragment blocks ligand binding to both EGFR and HER3, which is meant to inhibit the activity of the major ligand-dependent HER dimers in cancer. MEHD also elicits antibody-dependent cell-mediated cytotoxicity, and has single-a…
Safety and immunogenicity of the PRAME cancer immunotherapeutic in metastatic melanoma: results of a phase I dose escalation study
2016
Purpose The PRAME tumour antigen is expressed in several tumour types but in few normal adult tissues. A dose-escalation phase I/II study (NCT01149343) assessed the safety, immunogenicity and clinical activity of the PRAME immunotherapeutic (recombinant PRAME protein (recPRAME) with the AS15 immunostimulant) in patients with advanced melanoma. Here, we report the phase I dose-escalation study segment. Patients and methods Patients with stage IV PRAME-positive melanoma were enrolled to 3 consecutive cohorts to receive up to 24 intramuscular injections of the PRAME immunotherapeutic. The RecPRAME dose was 20, 100 or 500 µg in cohorts 1, 2 and 3, respectively, with a fixed dose of AS15. Advers…
Cortical Patterns of Pleasurable Musical Chills Revealed by High-Density EEG
2020
Music has the capacity to elicit strong positive feelings in humans by activating the brain’s reward system. Because group emotional dynamics is a central concern of social neurosciences, the study of emotion in natural/ecological conditions is gaining interest. This study aimed to show that high-density EEG (HD-EEG) is able to reveal patterns of cerebral activities previously identified by fMRI or PET scans when the subject experiences pleasurable musical chills. We used HD-EEG to record participants (11 female, 7 male) while listening to their favorite pleasurable chill-inducing musical excerpts; they reported their subjective emotional state from low pleasure up to chills. HD-EEG results…
Louseborne relapsing fever in young migrants, sicily, Italy, july-september 2015
2016
To the Editor: During the early 20th century, at the end of World War I, and during World War II, louseborne relapsing fever (LBRF) caused by Borrelia recurrentis was a major public health problem, especially in eastern Europe and northern Africa (1,2). Currently, poor living conditions, famine, war, and refugee camps are major risk factors for epidemics of LBRF in resource-poor countries, such as those in the Horn of Africa (3,4). Increased migration from resource-poor countries and war/violence create new routes for spread of vectorborne diseases. Recently, several cases of LBRF have been reported among asylum seekers from Eritrea in the Netherlands, Switzerland, and Germany (5–8). All of…
Phase I trial of recombinant human tumour necrosis factor alpha in patients with advanced malignancy.
1991
A phase I clinical trial was conducted with recombinant human tumour necrosis factor alpha (rhTNF-alpha) in 62 patients with advanced malignancy refractory to previous standard therapy. rhTNF-alpha was given as a 30 min infusion twice a day at 6 h intervals. A total of 10 different dose levels was escalated in cohorts of 6 patients ranging from 2.5 to 200 micrograms/m2 twice a day for 5 days every second week for a total of 8 weeks followed by a 4-week observation period. Major side-effects of TNF-alpha therapy, seen in almost all patients studied, were fever and chills. As dose-limiting side-effects hypotension and liver toxicity were recorded in 4 of 5 patients treated with 200 micrograms…