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Filter by:The main objective of this type 2 hybrid implementation effectiveness trial is to implement a contextually appropriate preventive intervention for 12 weeks face to face group foot and ankle exercises for people with diabetic foot in the primary care of the city of Limeira/SP, through the training of Primary Care workers. The study will monitor the implementation itself and the clinical outcomes: clinical and functional status and quality of life.
Angina is a common clinical symptom of ischemic heart disease, affecting up to 11 million people in the United States alone, and 112 million people globally. Despite this, 4 in 10 patients undergoing elective coronary angiography for angina and ischemia do not have evidence of obstructive coronary artery disease (CAD). This condition of ischemia with no obstructive CAD (INOCA) is associated with high clinical and economic morbidity, as these patients have a higher rate of repeat procedures and hospitalizations, worse quality of life, future adverse cardiovascular events and frequent time missed from work. The overall objective of this study is to develop and validate a non-invasive algorithm for diagnosis and management of patients with INOCA and suspected microvascular dysfunction centered around cardiac PET MPI. A secondary goal of the study is to assess for improvement in patient symptoms, function and quality of life from PET-guided management of CMD in patients with INOCA. This study will take place at Mount Sinai Morningside in the PET and CTunit on the 3rd floor. The sub-study will occur at Mount Sinai Morningside Cath Lab on the 3rd floor. The study will enroll an estimated total of 70 subjects, 12 of which will also participate in the sub-study. The study is estimated to last 2 years.
Primary Objectives: 1. The primary efficacy objective is to assess the efficacy of 52 weeks of open-label treatment with HZN-825 in participants with diffuse cutaneous systemic sclerosis, as measured by change from both baselines in forced vital capacity percent (FVC %) predicted. 2. The primary safety objective is to examine the safety and tolerability of 52 weeks of open-label treatment with HZN-825, inclusive of, but not limited to, adverse events (AEs), serious AEs (SAEs) and the adverse event of special interest (AESI), from Day 1 to 4 weeks after last dose.
This observational study aims to assess recovery of the immune system and immunity to vaccine-preventable diseases in children and adolescents who recently completed treatment for acute lymphoblastic leukemia (ALL). Several children's hospitals in the United States are participating in the study, which will enroll approximately 75 pediatric participants. The study is intended to determine the rate of infection after leukemia treatment and to inform future studies and recommendations about whether children and adolescents who have leukemia should receive additional vaccine doses or boosters after treatment.
Pulmonary arterial hypertension (PAH) and chronic thromboembolic pulmonary hypertension (CTEPH) are severe clinical conditions that, despite advances in therapeutics over the past 20 years, lead to serious morbidity and mortality. Guidelines on the diagnosis and treatment of pulmonary hypertension (PH) recommend the use of a multiparametric risk stratification tool to determine severity of disease, which should guide initial therapy and therapy modulation. This multiparametric risk stratification schema includes objective assessment of exercise capacity, right ventricular function and hemodynamic parameters in order to classify patients into severity categories. Cardiac index (CI) and right atrial pressure (RAP), measured via right heart catheterization (RHC), are the hemodynamic parameters used in risk assessment of PH. Arguably, stroke volume index (SVI) is the most important hemodynamic parameter for assessment of PH severity and there is currently no validated method for noninvasive measurement of cardiac output (CO), CI or SVI. Currently, a major obstacle in the field is that hemodynamic measurements are not obtained on a regular basis in the risk assessment and therapy modulation of patients with PAH and CTEPH. If a noninvasive method of hemodynamic measurement could be correlated with other objective measurements of risk assessment, it could become an invaluable tool in therapy initiation and modulation in the ambulatory setting. This is a single center study to evaluate the use of non-invasive measurement of CO and stroke volume to assess risk and response to treatment in patients with PAH and non- operable CTEPH. We anticipate to enroll a total of 100 subjects at Ronald Reagan UCLA Medical Center. A maximum of 10 hour in total for the study including the consent process, pre-procedure care, RHC procedure, and follow up visit. The initial visit will be approximately 4 hours with the RHC procedure itself will only be 20 minutes. Each follow up visit will be 1.5 hour. Patients with known or suspected PAH or CTEPH will undergo a RHC as part of his or her standard of care. Three techniques of CO measurement will be performed sequentially at the time of the RHC. The device that will be used is the Edwards ClearSight system and EV1000 clinical platform, a device that measures NIBP. Patients will be followed over the period of 1 year every 3 months to obtain serial measurements for six-minute walk distance (6MWD), World Health Organization (WHO)/New York Heart Association Functional Class (FC), B-type natriuretic peptide (BNP) or N-terminal-pro hormone BNP (NT-proBNP), and non-invasive hemodynamic measurements. Additional visits will be scheduled to obtain the serial measurements one month prior and one month following if a patient is initiating or changing PH-specific therapy. As this is a study looking at the feasibility of non-invasive measurement of cardiac output and stroke volume for risk assessment and response to therapy in pulmonary arterial hypertension (PAH) or chronic thromboembolic pulmonary hypertension (CTEPH), study personnel performing the study procedures will not be blinded to the clinical diagnosis and the management of the subject.
To investigate the safety and feasibility of a personalized Ho-166-PLLA-MS TARE approach by using MRI guidance in inoperable patients with HCC.
The goal of this clinical trial is to test reducing procedure time of percutaneous coronary intervention (PCI) in ST elevation myocardial infarction by single catheter PCI (SC-PCI) method. The main question it aims to answer is: • [question 1] SC-PCI method is skipping catheter exchange with use of a right and left dual purpose universal guiding catheter Ikari Left curve. Does SC-PCI method reduce PCI procedure time? Participants will be randomly assigned to SC-PCI method or conventional method and emergency PCI is performed. Researchers will compare time from sheath insertion to first device activation between the SC-PCI method and the conventional method.
This study will collect and characterize ventilator use during patient care with a ZOLL 731 Series ventilator in a pre-hospital setting.
More children will survive to adulthood today than at any other point in human history, as evidenced by the proportion of live births and absolute numbers. The present generation of young people who have lived to the age of five will reach adulthood around 2030 and will be the generation of the Sustainable Development Goals (SDGs). These children's health and nutrition as they grow from 5 to 19 years will have permanent ramifications on the development of the coming generation. The Comprehensive National Nutrition Survey was conducted between 2016 and 2018, indicating unacceptably high levels of malnutrition among Indian children and adolescents. It was discovered that one out of every five children aged 5 to 9 was stunted, indicating they were malnourished for their age. Undernourished girls are more likely to become short-statured mothers, giving birth to low-birth-weight and stunted newborns who are more prone to disease and linear growth failure. Evidence suggests that maternal short stature (less than 150 cm) predicts childhood growth failure and increases the risk of having a stunted baby by two years. The common genetic background and environmental influences that affect the mother during her early childhood and adolescence play a substantial role in the relationship between maternal stature and the linear growth of the child. This causes a cycle of undernutrition and poor growth that continues through generations and impacts the offspring's growth. Adolescence is a key period of physical and social development when the physiological, mental, and behavioural underpinnings of long-term health are established. The development of critical bone mass is crucial during this time because it lays the foundation for preserving bone mineral integrity later in life. During adolescence, over 40% of peak bone mass is achieved. Changes in body composition are also seen during early adolescence. These physiological processes are both nutritionally sensitive and predictive of their future health. Adolescent behaviour is also linked to 33 percent of sickness and 60 percent of premature deaths in adulthood. Because adolescence is also a critical period for the development of the ability to make independent decisions, follow them through, and achieve goals- enabling healthy social networks, is critical. This includes Social and Behavioural Change Communications, which can assist early adolescents create lifetime behaviour patterns, such as good nutrition and physical exercise choices. Investing in adolescent health and well-being pays off in three ways: during their adolescence, in their adulthood, and for their future offspring generations. Thus, young adolescence provides a "window of opportunity" for children to improve their nutritional health and outcomes. Therefore, this cohort aims to explore the trajectories of growth (including anthropometric measures, bone mass, and muscle mass and function) among rural young adolescents and its association with intergenerational nutritional status through a longitudinal study. A greater understanding of growth trajectories set in a longitudinal study would aid in the discovery of particular variables that influence the timing of young adolescents' growth and the factors associated with intergenerational nutritional status.
To determine the accuracy of continuous glucose monitoring (CGM) with point of care (POC) fingerstick glucose monitoring and venous blood glucose in patients with eating disorders, specifically anorexia nervosa, restricting subtype (AN-R); avoidant/restrictive food intake disorder (ARFID); and anorexia nervosa, binge/purge subtype (AN-BP).