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Filter by:The purpose of this study is to assess long-term side effects from subjects who receive an Adicet Bio γδ CAR T cell product. Subjects will join this study once they complete the parent interventional study. No additional study drug will be given, but subjects can receive other therapies for their cancer while they are being followed for long term safety in this study. For a period of 15 years from the first administration of Adicet Bio allogeneic γδ CAR T cell product, subjects will be assessed for long-term safety and survival through collection of data that include safety, efficacy, pharmacokinetics and immunogenicity.
Data and specimens will be collected longitudinally from patients seen in the UVA Interstitial Lung Disease (ILD) clinic in order to describe the phenotypic expression of various interstitial lung diseases. Samples will also be collected from a control group for comparison purposes. All data will be entered into a repository for future research purposes or screening for new studies that become available. This data will help identify trends and hopefully lead to a better understanding of the disease progression, treatment options, and outcomes.
The purpose of this study is to evaluate the use of virtual reality (VR) technology as adjunct to routine anesthesia care for patients undergoing electrophysiology (EP) procedures.
This is a Prospective, observational research study for patients with NMOSD under the care of a licensed neurologist. Approximately 800 patients and 35 clinical sites in North America will be recruited to participate with no defined upper limit for either target.
A randomized controlled trial, nested within an existing prospective cohort (Dutch Pancreatic Cancer Project; PACAP) according to the 'trials within cohorts' (TwiCs) design in which the effect of a standardized surveillance, with serial tumor marker testing and routine imaging, compared to current non-standardized practice, on overall survival and quality of life in patients with primary resected PDAC is investigated. The most important secondary endpoint is quality of life. Other secondary endpoints are clinical and radiological patterns of PDAC recurrence, the compliance of patients to our standardized follow-up strategy, the impact of a standardized surveillance on (eligibility for) additional treatment, and the tolerance of additional treatment. The need for this clinical trial is emphasized by the the emergence of more potent local and more effective systemic treatments for PDAC recurrence, leading to a rising interest in early diagnosis by a standardized approach to follow-up with routine imaging and serial serum tumor marker testing.
Pulmonary embolism impacts over 1 in 1000 adults annually and is the third leading cause of cardiovascular death after heart attack and stroke. The consequence of each PE is widely variable. Physiologically, the morbidity and mortality of PE is ultimately caused by failure of the right ventricle. The acute rise in pulmonary vascular resistance caused by a PE can overwhelm the right ventricle, resulting in a drop in cardiac output and death from failure of the heart to provide vital perfusion. Despite the importance of stroke volume and cardiac output in the current understanding of PE mortality, they are notably absent from risk stratification scores because they historically could only be measured invasively. Novel non-invasive methods of estimating stroke volume and associated cardiac output have the potential to revolutionize PE risk stratification and care. Non-invasive blood pressure (NIBP) monitors can even measure stroke volume beat to beat, allowing for continuous evaluation of cardiac function. NIBP systems are typically composed of a finger cuff with an inflatable bladder, pressure sensors, and light sensors. An arterial pulse contour is formed using the volume clamp method of blood pressure measurement combined with calibration and brachial pressure reconstruction algorithms. The stroke volume with each heart beat can be estimated as the area under the systolic portion of the blood pressure curve divided by the afterload. NIBP monitors may improve clinical care of PE because they allow for assessment of dynamic cardiac changes in real time. Detection of worsening stroke volume in acute PE could inform providers of impending cardiac collapse, and improvement of stroke volume may function as a positive prognostic factor or marker of therapeutic success. Use of NIBP monitors during acute PE to identify clinically significant changes in cardiac function may advance both PE prognostication and management. Our clinical study proposes to monitor hemodynamic parameters including stroke volume in patients with acute pulmonary embolism using non-invasive blood pressure monitors. The relationship between hemodynamic parameters and PE outcomes will be assessed, as well as the changes in hemodynamic parameters with PE intervention. To our knowledge, interval monitoring of stroke volume during acute PE with NIBP monitors has never been reported before.
BACKGROUND COVID-19 response is heavily impacting the availability of essential health services, especially services for pregnant women and newborns that cannot be delayed or rapidly reorganized in other settings. In the current pandemic, due to multiple factors access to high quality and timely maternal and newborn (MN) health care is threatened. Major concerns have also been raised with respect to maternal rights and on disruption of essential practices and increased medicalization of care, despite existing WHO guidance. Based on preliminary reports heterogeneities in practices is expected within the WHO European Region, with major inequities (eg women experiencing disruption of essential MC health services only in selected countries or areas within the countries, while having access to adequate care in others). With IMAgiNE EURO we aim at conducting a survey to explore the health service preparedness, quality and resilience, with a specific focus on health services around the time of childbirth, in the WHO European Region during COVID-19 pandemic, and to make available data, which, in collaboration with WHO and other partners, can contribute in improving the quality of MN health care. HYPHOTESIS AND SIGNIFICANCE - This project has been developed in coordination with WHO Regional Office for Europe (EURO) and other partners, and ultimately aims at making available and disseminate data that can help improving the quality of MN health services in the Region. Collecting data on the quality of essential MN health services across different countries within the WHO European Region will help addressing specific gaps and planning coordinate response to improve quality of MN care and improve MN health outcomes. - The project will also offer the opportunity to develop tools and methods to monitor the quality of MN health care across different countries and settings. - The project will establish and consolidate a research network Primary objective: 1. Record, analyse, and describe data on MN health service preparedness, quality and resilience - with a specific focus around the time of childbirth as measured both from health workers and women perspectives- across different countries within the WHO European Region, during COVID-19 pandemic. Secondary objectives: 2.Develop tools and methods to measure, through rapid online surveys, the quality of MN health care across different countries and settings 3.Establish and consolidate a research network
The study is to evaluate the efficacy and safety of SHR6390 combined with endocrine therapy for the adjuvant treatment of hormone receptor positive,Human Epidermal Receptor 2 negative. To observe the PK characteristics of SHR6390 combined with endocrine therapy for the adjuvant treatment of hormone receptor positive,Human Epidermal Receptor 2 negative.
Variable outcomes after weight loss surgery are likely attributable to complex, poorly understood mechanisms. Due to the significant impact that morbid obesity has on a patient's health, successful management of obesity and its related comorbid medical conditions is important and thus necessitates continued improved therapies for treating obesity. Although the mechanisms of weight loss after surgical intervention are poorly understood, improved understanding of molecular and metabolic changes that occur after weight loss surgery may offer the ability to provide targeted precision therapy for patients with morbid obesity undergoing surgical therapy. In this proposal, the investigators will combine a clinical trial whereby modifications to the gold-standard for weight loss surgery, the gastric bypass, are evaluated while simultaneously measuring molecular and metabolic changes that occur in response to these weight loss procedures. Through creating variable lengths of bypass intestine after gastric bypass, the investigators will be able to determine the effect of malabsorption on clinical outcomes and mechanisms involved in weight loss after gastric bypass. The investigators will also use two control groups. One will be a surgical weight loss control group and consist of patients undergoing a laparoscopic sleeve gastrectomy, a non-intestinal bypass procedure. The other group will consist of patients having non-surgical weight loss therapy. To asses metabolic changes that occur in response to surgical weight therapy and specifically intestinal bypass and malabsorption, the investigators will examine changes in the gut microbiome and plasma gut enteroendocrine hormones. To evaluate molecular pathways that are impacted as a result of gastric bypass and malabsorption, the investigators will measure circulating microRNAs (miRNAs) in the blood. Measurement of miRNAs will provide data on an easily measurable molecular marker for each treatment group. This is a first step in translational exploration of mechanisms of weight loss after surgery by evaluating both clinical and molecular/metabolic outcomes and begin an explorative process towards creating an individualized approach to improving outcomes after weight loss surgery.
This is an open-label, single arm, multi-center study, assessing efficacy and safety of BI-754091 in combination with afatinib as treatment in patients with advanced or metastatic ESCC refractory to at least 1 line of systemic treatment (including chemotherapy or radiation therapy).