30 Clinical Trials for Various Conditions
Technology has been created to help older adults age well in their homes, but adoption and acceptance have been slow. The researchers are developing a low-cost web-based technology, called Elder Tree, for older adults and caregivers to address key challenges older adults face, such as loneliness and isolation, falls, loss of driving privileges, relapsing from proven falls prevention strategies, and unreliable home services. Elder Tree is being developed and tested with older adults and caregivers to identify, 1) usability issues such as font size, navigation and interface (audio, video,text) and 2) content and tailoring issues such as identifying local resources and events. This study will employ a randomized longitudinal design comparing a control group to an intervention group over a 12-month period. Investigators hypothesize that older adults using Elder Tree will experience greater independence and quality of life when compared to the control group. Investigators will use quantitative measures to determine how much our intervention improves: quality of life and health system use. These measures will help us to determine the cost effectiveness of Elder Tree. Investigators will recruit and test Elder Tree in 3 Regional Aging and Disability Resource Centers; one urban, one suburban and one rural setting, so to account for environmental and community differences. The older adult and their caregiver will be randomized to the same treatment group. Investigators will measure the effect over the 12 month intervention period and a 6 month follow-up period at 18 months.
The researchers are doing this study to find out if an allogeneic hematopoietic stem cell transplant (HSCT) or maintenance therapy with azacitidine and venetoclax is more effective at keeping AML from coming back (relapsing).
The purpose of this study is to learn about how well the Prevnar 20 vaccine (PCV20) stops invasive pneumococcal disease (a group of severe infections caused by a bacteria called Streptococcus pneumoniae), pneumococcal pneumonia (a bacterial lung disease caused by the germ Streptococcus pneumoniae), all-cause pneumonia (pneumonia caused by any germ including bacteria, a virus, or a fungus), and lower respiratory tract infection (infection of the lower airways in the lung) in people 65 years and older. This study will use a database of people who have Medicare insurance with names and other identifying information removed. This study will include people who: * are 65 years and older, * live in one of the 50 United States or Washington DC, and * are enrolled in Medicare Fee-for-Service Parts A and B for at least 1 year. The study uses data that is already being collected and no treatment or vaccine will be given in the study. People that fit the description above will be followed in the Medicare database for about two years. Their information will be reviewed to see if they had vaccines for pneumonia or had certain health events, such as pneumonia or lower respiratory tract infection. The experiences of people that received Prevnar 20 will be compared to the experiences of people that did not receive the vaccine. This will help to show how well Prevnar 20 works at stopping invasive pneumococcal disease, pneumococcal pneumonia, all-cause pneumonia, and lower respiratory tract infection.
The purpose of this study is to show that high-dose quadrivalent seasonal influenza vaccine (HD QIV) given together with 9-valent extraintestinal pathogenic Escherichia coli vaccine (ExPEC9V) does not induce lower antibody response against each of the 4 influenza vaccine strains, as compared to HD QIV given alone and further show that ExPEC9V given together with HD QIV does not induce lower antibody response against each of the vaccine O-serotype antigens, as compared to ExPEC9V given alone.
The purpose of this study is to evaluate the immunogenicity and safety of Ad26.RSV.preF-based vaccine and quadrivalent high-dose seasonal influenza vaccine when administered either concomitantly or separately.
The purpose of this study is to demonstrate the efficacy of active study vaccine in the prevention of reverse transcriptase polymerase chain reaction (RT-PCR) confirmed respiratory syncytial virus (RSV)-mediated lower respiratory tract disease (LRTD), when compared to placebo.
The aim of the study is to assess the safety and immunogenicity of two formulations of the high-dose quadrivalent influenza vaccine compared to the licensed high-dose trivalent influenza vaccine control in healthy elderly subjects aged 65 years of age and above. Primary objectives: * To describe the safety profile of all subjects in each study group. * To demonstrate that the high-dose quadrivalent influenza vaccine induces an immune response (as assessed by HAI geometric mean titers (GMTs) that is non-inferior to responses induced by the licensed high-dose trivalent influenza vaccine for the 3 common virus strains at 28 days post-vaccination. Secondary objectives: * To describe post-vaccination immunogenicity for the 4 virus strains (as assessed by seroconversion and seroprotection) for subjects who receive the high-dose quadrivalent influenza vaccine and the licensed high-dose trivalent influenza vaccine. * To describe post-vaccination immunogenicity for the 4 virus strains (as assessed by GMTs, seroconversion, and seroprotection) for subjects who receive the high-dose quadrivalent influenza vaccine and the investigational high-dose trivalent influenza vaccine.
Evaluate the safety and immunogenicity of three dosage levels of swine influenza vaccine in children ages 3 to \<9 years, adolescents 9 to \<18 years, adults 18 to \<65 years and elderly 65 years and older.
An Open-label Extension Study in Patients 65 Years or Older with Chronic Lymphocytic Leukemia (CLL) or Small Lymphocytic Lymphoma (SLL) Who Participated in Study PCYC-1115-CA (Ibrutinib versus Chlorambucil)
A Randomized, Multicenter, Open-label, Phase 3 Study of the Bruton's Tyrosine Kinase Inhibitor PCI-32765 versus Chlorambucil in Patients 65 Years or Older with Treatment-naive Chronic Lymphocytic Leukemia or Small Lymphocytic Lymphoma.
In this study the investigators are comparing this standard regimen to the newly established regimen of melphalan and bortezomib.
The aim of this study is to determine the efficacy of Fluzone High Dose vaccine and that of Fluzone® vaccine in the elderly. Primary objective: To measure the efficacy of the vaccine, defined as the prevention of laboratory-confirmed influenza caused by viral types/subtypes that are antigenically similar to those contained in the respective annual vaccine formulations. Secondary objectives: * To compare the clinical efficacy of Fluzone High Dose vaccine with that of Fluzone® vaccine in elderly adults, with respect to laboratory-confirmed influenza illness caused by any type or subtype of influenza virus. * To compare the clinical efficacy of Fluzone High Dose vaccine with that of Fluzone® vaccine in elderly adults, in preventing culture-confirmed influenza illness caused by viral types/subtypes antigenically similar to those contained in the respective annual vaccine formulations.
This clinical trial aims to study the immunogenicity of GSK Biologicals' influenza vaccine GSK2186877A in people aged 65 years or older.
This study investigates the safety and efficacy of a new dosage form of Vardenafil, an orodispersible tablet (ODT), and compares it to the safety and efficacy of a placebo (inactive) tablet in the treatment of erectile dysfunction. After a 4-week unmedicated phase, patients will receive Vardenafil ODT or matching placebo for 12 weeks. Safety will be determined by laboratory and other evaluations. Efficacy will be determined by the results of different questionnaires and the patient diary that will be used.
Sleep problems, like insomnia, are common in older African Americans. About 25% of older adults in the US have at least 2 symptoms of insomnia, such as having trouble falling asleep, staying asleep, or getting good sleep for a month or more. Cognitive Behavioral Therapy for Insomnia (CBT-I) is a recommended non-pharmacological treatment for insomnia. Unlike medicines that might only help for a short time or have many side effects, CBT-I deals with the root causes of insomnia. It helps people change how they think and act about sleep, leading to better habits and attitudes. This can make sleep better for a long time, even after the treatment is over. While CBT-I is commonly used among adults with insomnia, its benefits among older adults and specifically older African American adults are not well understood. Thus, the current pilot study will investigate the feasibility of CBT-I in older African American adults and establish preliminary evidence for the potential benefit of CBT-I on sleep as well as cognition in this population. For this study, participants will be asked to complete pencil-and-paper questionnaires, psychological tests of cognition, 7-day actigraphy, 2 nights of at home sleep monitoring, which collects specific sleep measures such as brain waves and sleep stage timing, and computer-based neuropsychological tests before and after intervention. Study interventions will consist of 8 weekly sleep training sessions via Zoom or a single session of education on strategies to improve sleep quality. Sleep training sessions will include education about strategies to improve sleep quality, changing thought process that contribute to insomnia, training the brain on the optimal sleep environment, and reducing sleep initially to establish a consistent sleep schedule before increasing sleep time. Three months after the post-intervention visit, participants will be asked to come back in for a follow-up evaluation which consists of complete pencil-and-paper questionnaires, psychological tests of cognition, 7-day actigraphy, 2 nights of at home sleep monitoring, and computer-based neuropsychological tests.
Hispanic Americans are the fastest growing older adult group in the United States, disproportionally increasing the risk of an Alzheimer's disease and related dementias diagnosis. Efforts to reduce this risk and mitigate the related cognitive/physical declines are critical. The aim of this study is to assess the feasibility of enrolling older adults into an aging trajectory cohort, while generating preliminary data on associations of physical and cognitive aging trajectories. Our secondary objective is to generate preliminary data on the association of standard measures of physical activity and physical function with cognitive status. This study fits within our longitudinal research goal to reduce dementia incidence by understanding the mechanisms that drive the cognitive-physical aging trajectory.
Per-capita consumption of medication is higher in older adults than any other sector of the population. In fact, it has been estimated that although older adults comprise 13% of the population they take 34% of all prescriptions and 30% of the over-the-counter (OTCs) consumed in the US (National Council on Patient Information and Education, 2010). Given current trends in aging, the savings, freedom and flexibility that self-medicating provides, as well as the trends to switch prescription products to an OTC status, it is likely that older adults will increasingly turn to OTCs as part of their medical regimens for years to come (Hanlon, J et al, 2001). In addition to the advantages that self-medicating offers, there are risks. These risks are more pronounced in older consumers, who are likely experiencing physiological changes (e.g. pharmacokinetics, pharmacodynamics, perceptual, cognitive and motor); this combines with a propensity for poly-pharmacy that escalates the likelihood of adverse drug reactions. It has also been suggested that low health literacy rates in older consumers detrimentally impact health and health outcomes in this population (Kutner et al., 2005 and Federman et al., 2009). Despite the risks associated with improper OTC use, the critical importance of OTC labeling information (there is no learned intermediary), and the fact that older consumers are significantly more likely to experience an adverse drug reaction than younger adults, surprisingly little information exists about the decision making process older adults employ when selecting and using an OTC product. We propose to recruit people 65 and older for an eye tracking study of mock OTC brands. The study has the following objectives: 1. To begin to garner insights regarding the proportion of subjects who closely examine (e.g. turn to the Drug Facts Label) the labeling of an OTC when deciding whether (or not) a drug is appropriate for them (based on their health history and current medications). 2. To quantify and compare the attentive behaviors to specific information (Specifically: name, active ingredient, symptom relief). 3. To quantify and compare the attentive behaviors to different formats of information (prominently featured information vs less prominently featured information). 4. To begin to benchmark whether or not older consumers make appropriate choices based on their current conditions and medication history.
This randomized controlled pragmatic pilot study examines the feasibility and acceptability of a population health-based deprescribing intervention that leverages a polypharmacy risk prediction model. It includes four arms (2 intervention and 2 control arms) and uses a parallel arm study design.
The purpose of this study is to look at mental health services for adults with depressed mood who were diagnosed with cancer at the age of 65 or older. This study will compare the usual approach for connecting older adults with depressed mood to mental health services with the Open Door for Cancer (OD-C) approach. We will find out if the OD-C approach is practical and useful for cancer patients who participate in the intervention and for providers who see or treat cancer patients.
The main purpose of this Phase II study was to assess the safety and immunogenicity of a dose of Fluzone High-Dose (HD) Quadrivalent vaccine and a third dose or booster dose of Moderna coronavirus disease 19 (COVID-19) vaccine administered concomitantly or singly in adults 65 years of age and older having received their second dose of the 2-dose schedule of Moderna COVID-19 vaccine at least 5 months before enrollment in the study.
Study to evaluate the safety and immunogenicity of H7N9 antigen in combination with full or half doses of AS03 adjuvant system in healthy adults.
This randomized, partially-blinded, active comparator-controlled was conducted at multiple sites globally. The composition of QVLP used in this study includes a mix of recombinant H1, H3, and two B hemagglutinin proteins expressed as VLPs and is based on the 2020-2021 influenza virus strains. In this study, 3 dose levels (15 μg/strain, 30 μg/strain, and 45 μg/strain) of QVLP were planned to be tested in combination with 2 dose levels of AS03 adjuvant (full and half dose) in a single-dose regimen to select a dose level of QVLP and adjuvant dose level-combination that is safe and effective for further development. Participants participated in this study for up to approximately 13 months, during which the first visit was scheduled for screening (up to 7 days in advance of vaccine administration) and the second visit on Day 0 was scheduled for vaccine administration. Telephone contacts were made on Day 1, Day 8, and monthly (starting after Day 28) until the end of the study for safety assessments, including concomitant medication use review. Blood draws at the clinic site for key safety assessments were made on Day 3, and Day 28 and for key immunogenicity assessments on Day 0, Day 28, Day 182 (6-month follow-up), and Day 365 (12-month follow-up).
This Phase 3 will describe the safety and immunogenicity of a 20-valent pneumococcal conjugate vaccine formulation in adults 65 years of age or older with prior pneumococcal vaccination
The overall objectives of this study are to improve outcomes of surgical patients 65 years of age or older through risk stratification based on preoperative screening of cognition / mental function. Aim 1 is to determine the prevalence of cognitive impairment among patients 65 years of age or older presenting for elective joint replacement surgery by structured cognitive screening versus standard practice. Aim 2 is to ascertain whether preoperative cognitive impairment in patients 65 years of age or older undergoing elective joint replacement surgery is an independent predictor of adverse postoperative events and/or mortality. Aim 3 is to implement routine structured preoperative cognitive screening of patients 65 years of age or older undergoing elective surgical procedures in a busy preoperative clinic.
The purpose of this placebo controlled study is to evaluate the safety and immunogenicity of different formulations of GSK Biologicals H7N1 influenza vaccine in subjects 65 years of age and older. The study will evaluate safety related events and antibody immune responses to different formulations of study vaccine.
The purpose of this study is to: Determine the likelihood that lenalidomide will adequately control the disease for at least one year. Lenalidomide is a drug that alters the immune system and it may also interfere with the development of tiny blood vessels that help support tumor growth. Therefore, in theory, it may reduce or prevent the growth of cancer cells. Lenalidomide is approved by the Food and Drug Administration (FDA) for the treatment of specific types of myelodysplastic syndrome (MDS) and in combination with dexamethasone for patients with multiple myeloma (MM) who have received at least 1 prior therapy. MDS and MM are cancers of the blood. It is currently being tested in a variety of cancer conditions. In this case it is considered experimental. The lenalidomide being administered in this study is not a commercially marketed product. Although it is expected to be very similar in safety and activity to the commercially marketed drug, it is possible that some differences may exist. Because this is not a commercially marketed drug, lenalidomide can only be administered to patients enrolled in this clinical trial and may only be administered under the direction of physicians who are investigators in this clinical trial.
The purpose of this study is to assess the diagnostic efficacy of the Tinetti Assessment, Timed up and Go test (TUG) and Gait Speed on predicting fall risk in adults 65 years of age or greater who are community ambulators.
The purpose of this study is to evaluate the efficacy of GlaxoSmithKline Biologicals' influenza vaccine GSK2186877A in adults 65 year of age and older. The study design is divided in two surveillance phases: one passive phase along the study during the influenza season and one active surveillance phase during the influenza peak season.
Infections due to influenza and pneumococcus can be very serious and cause death. Anyone can get these infections. However, some people are at greater risk from the disease, including people 65 and older, the very young, and people with special health problems such as people with certain types of cancer, heart, lung, or kidney disease, or diabetes. Influenza can cause a very serious lung infection (pneumonia) and increase the risk of stroke and heart attacks. Pneumococcal disease can lead to serious infections in the lungs (pneumonia), the blood (bacteremia), and the covering of the brain (meningitis). People with the special health problems mentioned above are even more likely to die from the disease. Although there are drugs to treat these infections, they are not always effective. This makes prevention of the disease through vaccination even more important. This study will look at the body's response to influenza and pneumococcal vaccination. We want to see how well they it will protect. Immunization is the same as vaccination. Our goal is to protect as much as we can. We are doing the study because more information is needed to see how well older patients with cancer respond to these vaccines and how well they protect against disease caused by influenza and pneumococcus.
It is well recognized that older adults can contract pertussis, suffer its complications, and unwittingly transmit it to close contacts, which may well include infants too young to have received their primary series of DTaP vaccinations. ADACEL® vaccine is currently licensed in the US for persons 11 - 64 years of age, but no pertussis vaccine is yet approved for administration to older adults. The most widely used Td vaccine in the US, DECAVAC®, has no upper limit on its age indication. The purpose of this trial is to describe the safety and immunogenicity of ADACEL® vaccine among individuals ≥ 65 years of age.