Search results for "HERA"

Abemaciclib: safety and effectiveness of a unique cyclin-dependent kinase inhibitor

2020

Introduction: The discovery and the clinical availability of novel cyclin-dependent kinases 4 and 6 inhibitors have profoundly changed the therapeutic scenario of metastatic hormone receptor-positive breast carcinoma. Among these inhibitors, abemaciclib can induce potent and sustained cell cycle arrest and immune system stimulation. Areas covered: This review summarizes the safety profile and clinical efficacy data on abemaciclib alone or in combination with aromatase inhibitors or fulvestrant in metastatic hormone receptor-positive breast carcinoma. The management of patients treated with abemaciclib is the object of this paper. Expert opinion: As shown in phase 2 and 3 clinical trials on …

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…

Polyphenols and Pharmacological Screening of a Monarda fistulosa L. dry Extract Based on a Hydrodistilled Residue By-Product

2021

This study aimed to determine the composition and content of polyphenols in the dry extract obtained from the hydrodistilled residue by-product of the wild bergamot (Monarda fistulosa L., Lamiaceae Martinov family) herb (MFDE) and to evaluate its safety and pharmacological properties. The total phenolic content (TPC) in the MFDE was 120.64 mg GAE/g. The high-performance liquid chromatography (HPLC) analysis showed the presence of a plethora of phenolic compounds, including hydroxycinnamic acids and flavone derivatives in the MFDE, with rosmarinic acid and luteolin-7-O-glucoside being the main components. With an IC50 value of 0.285 mg/mL, it was found to be a strong DPPH radical scavenger. …

Safety and immunogenicity of the therapeutic vaccine TG1050 in chronic hepatitis B patients: a phase 1b placebo-controlled trial

2020

Funding: Transgène; International audience; Treatment of chronic hepatitis B (CHB) typically requires life-long administration of drugs. Cohort and pre-clinical studies have established the link between a functional T-cell-mounted immunity and resolution of infection. TG1050 is an adenovirus 5-based vaccine that expresses HBV polymerase and domains of core and surface antigen and has shown immunogenicity and antiviral effects in mice. We performed a phase 1 clinical trial to assess safety and explore immunogenicity and early efficacy of TG1050 in CHB patients. This randomized, double blind, placebo-controlled study included two sequential phases: one single dose cohort (SD, n = 12) and one …

Tenapanor for the treatment of irritable bowel syndrome with constipation.

2020

Introduction: Irritable bowel syndrome with constipation is associated with higher rates of functional impairment, as compared to other subtypes of the syndrome. Conventional laxative-based pharmacologic therapy of IBS-C, which is mostly symptom-based, is often unsatisfactory. Tenapanor represents a first-in-class orally available inhibitor of NHE3, which is minimally absorbed in the GI tract, what constitutes a significant therapeutic benefit, as it may act on the drug target. Areas covered: Aim of this article is to sum up the evidences about pharmacodynamics and pharmacokinetics of tenapanor, focusing on animal models and in vitro studies, but also discuss clinical trials on tenapanor's …

High training volume is associated with increased prevalence of non-allergic asthma in competitive cross-country skiers.

2022

BackgroundCross-country skiers have a high prevalence of asthma, but its phenotypes and association with success in competitions are not known.ObjectiveTo investigate, by means of a postal survey, the relative proportions of allergic and non-allergic asthma in competitive cross-country skiers compared with the general population, to study how performance level and training volume are related to asthma and its type and to assess the possible risk factors for allergic and non-allergic asthma in competitive skiers.MethodsAll Finnish cross-country skiers enrolled in the largest national competitions in winter 2019 (n=1282), and a random sample (n=1754) of the general population of the same age …

Double blind randomized clinical trial comparing minimally- invasive envelope flap and conventional envelope flap on impacted lower third molar surge…

2022

The latest trend in surgery is to look for minimally invasive procedures, with fewer complications and a shorter recovery time. This study aims to compare the minimally- invasive envelope flap, with smaller incision and fewer dissection and the conventional envelope flap, with a 20mm incision, on impacted mandibular third molar surgery, focusing on the hypothesis that there were no differences in postoperative outcomes. A double-blind randomized clinical trial was designed to compare both incisions, focused on determining the approach with minor postoperative side-effects and minor impact on quality-of-life. A total of 60 patients were enrolled for the study if their presented impacted mand…

Modulation of salivary inflammatory markers and proteomic analysis in HNC and OSCC patients undergoing radiotherapy

2021

Head and neck cancer (HNC) includes malignant tumours that most commonly arise from the oral mucosa or lining of the head and neck regions. They are characterized according to their primary site of origin as malignancies of the nasal cavity and paranasal sinuses, pharynx, larynx, salivary glands and oral cavity. The majority of these neoplasms are epithelial tumours, among them the 90% are squamous cell carcinomas (SCC). HNC including the Oral Squamous cell carcinoma (OSCC), is the sixth most common neoplasia worldwide with an incidence estimated at 650,000 cases and 330,000 deaths per year. Despite all of the diagnostic and therapeutic advances, the 5-year survival rate remains relatively …

The Use of Lenograstim in the prevention of chemotherapy induced neutropenia in patiets with soft tissue sarcoma (STS)

2008

Effects of low laser level therapy in rehabilitation of patients with COVID19 pneumonia

2021

Introduction. An unprecedented public health crisis has been triggered worldwide by SARS-CoV-2’s high contagiosity and it’s mortality rates of 1-5%. Although the majority of COVID-19 cases have a good outcome, there is a small percentage that develop severe pneumonia and citokine storm and may be in the need of mechanical ventilation. Methods. Identifying the exact drivers of the excessive inflammation and the biomarkers that can predict a hyperinflammatory response to SARS-CoV-2 would be extremly helpful in finding efficient anti-inflammatory interventions that may stop the progression to acute respiratory distress syndrome (ARDS). Results. In the search for such interventions we have iden…