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Filter by:This is an open label, two-stratum, phase 2 clinical trial evaluating the efficacy of 9-ING-41 in combination with gemcitabine/docetaxel in patients ≥10 years of age with advanced sarcoma. 9-ING-41 in combination with gemcitabine and docetaxel will lead to sustained disease control and/or increase the rates of objective response in patients with unresectable or metastatic soft tissue and bone sarcomas.
This is a single-center randomized controlled trial of a new medical device (Bocaliner™) that has been designed to improve the treatment of chemotherapy-induced oral mucositis in patients undergoing cancer treatment. The goal of this study is to determine tolerance and response to the use of Bocaliner™ as reported by patients with chemotherapy and/or radiation therapy-induced oral mucositis.
This clinical trial studies the effect and underlying mechanisms of sleep and circadian rhythm factors on oral mucositis pain in head and neck cancer patients treated by chemoradiotherapy. Poor sleep may have a correlation to increased pain. A behavioral intervention, Brief Behavioral Therapy for Cancer related Insomnia, may improve patients' sleep and may also reduce oral mucositis pain.
This is a multicenter, open-label study to evaluate the safety and tolerability and explore the efficacy of FCR001 cell therapy in adults with rapidly progressive Diffuse Cutaneous Systemic Sclerosis (dcSSc) at risk for organ failure.
Sleep has a number of health benefits, including memory and learning, vitality and energy as well as high quality of life levels. Lack of sleep impairs judgment, impacts longevity and safety, and increases the risk of a number of diseases including obesity, hypertension, heart disease, diabetes, mood disorders, and impaired immune function. In addition lack of sleep or disturbance of normal sleep cycle could have a major impact on people's lives and working performance such as driving. Daily sleepiness is a problem concerning professions with a non-fixed schedule. Specifically, professional long-haul drivers confront sleepiness problems and in combination with fatigue, they are prone to driving accidents and other incidents. Sleep quality and quantity are closed related to fatigue which is one of the most common reasons for driving and working accidents. In recent years, car accidents involving professional drives have increased significantly. The main reasons for those accidents were fatigue and sleepiness due to long hours of driving or difficult working conditions according to the recent European report (Driver Fatigue in European Road Transport - etf-europe.org). Lifestyle Medicine addresses health risk factors in primary, secondary, and tertiary prevention of developing disease rather than on acute care and reacting to illness, injury, and disease. Lifestyle Medicine strategies targeting modifiable risk factors, such as diet, sleep, stress, and physical activity. By applying those regimes the investigators could improve physical and mental health levels that can affect the quality of sleep, reducing daily sleepiness and fatigue, in professional drivers operating coaches and trucks. Any intervention that could improve alertness and reduce fatigue and sleepiness in those people, will automatically improve safety, reduce driving accidents and save lives and resources.
Randomized controlled trial to determine the effectiveness of a five-day course of pre-operative oral steroids on decreasing intra-operative blood loss during endoscopic sinus surgery.
This is a prospective, observational, single center pilot trial to find out if a new computerized technology for analysis of the electrical activity recorded during atrial fibrillation can identify the electrical source of this arrhythmia. If we are able to reliably identify the source, then in the future we may be able to use this technology to determine the optimal sites for catheter ablation of atrial fibrillation in the heart. The present study will compare the standard electrical recordings to the new computerized algorithm analysis of recordings gathered at the same time. The study will enroll 30 participants with persistent or longstanding persistent atrial fibrillation (AF) that are scheduled for elective catheter ablation of AF. The catheters that are being placed in the heart are standard Food and Drug Administration (FDA)-approved mapping catheters. The investigational computerized software that will be employed in the trial will be used after the case has done and will not directly impact any of the activities during the ablation procedure. Information learned from this trial will improve understanding of the mechanisms of atrial fibrillation and will potentially improve success rates of AF ablation for patients in the future and will be used to design a prospective trial.
This study investigates the health literacy, cervical cancer knowledge, and radiation knowledge of patients with cervical cancer. The goal of this study is to develop a video that can improve patients 'understanding of cervical cancer and its treatment.
This phase I trial studies the effect of SGT-53, carboplatin, and pembrolizumab in treating patients with triple negative inflammatory breast that has spread to other parts of the body (metastatic). SGT-53 is a gene therapy that changes the deoxyribonucleic acid (DNA) of patients' tumor cells to make it easier for the immune system to recognize them. SGT-53 targets the TP53 gene, which is frequently mutated in IBC cells. Chemotherapy drugs, such as carboplatin, work in different ways to stop the growth of tumor cells, either by killing the cells, by stopping them from dividing, or by stopping them from spreading. Immunotherapy with monoclonal antibodies, such as pembrolizumab, may help the body's immune system attack the cancer, and may interfere with the ability of tumor cells to grow and spread. Giving SGT-53, pembrolizumab, and carboplatin may help the control the disease in patients with triple negative inflammatory breast cancer.
The objective of this study is to establish reasonable assurance of safety and effectiveness to support an FDA premarket approval (PMA) application for the SeQuent® Please ReX™ Drug Coated PTCA Balloon Catheter as indicated.