Honolulu, HI Paid Clinical Trials

Children living in food-insecure homes, defined as at some time during the last year their household not having enough food, money, or resources to feed the family experience low intake of fresh fruits and vegetables (FV), and a trajectory for increased risk of obesity and chronic diseases in adulthood. In Hawai'i, a higher proportion of Native Hawaiian (NH) and other Pacific Islander (OPI) children live in food-insecure households when compared with the state average (30% and 50%, respectively vs. 18%) and NHOPI adults suffer disproportionately from chronic disease. Produce prescription programs, provide vouchers to individuals to purchase fresh FV, are promising strategies to improve diet quality and reduce chronic disease risk among food insecure populations. The long-term objective of this research is to reduce nutrition-related health disparities via clinical-community based programming. The Keiki (child) Produce Prescription (KPRx) program was developed and implemented by enlisting University and community researchers and health care providers at the Waianae Coast Comprehensive Health Center (WCCHC). The current study builds on the community-academic partnership to achieve the following specific aim, to measure effectiveness of the KPRx on FV intake, gut microbiome composition, and health related biomarkers in 100 parent-child dyads in the context of household food insecurity from a predominantly NHOPI community in Hawai'i. A community based participatory research approach to carry out a randomized controlled trial that measures the effect of the KPRx on child diet and microbiome, and parent/caregiver diet and health-related biomarkers on 100 parent-child dyads in the context of household food insecurity will be conducted. The community-informed research study will provide data to inform local and state healthcare and nutrition assistance programming policies aimed at reducing food insecurity and health disparities among NHOPI and minority populations. Read Less

The purpose of this study is to assess if using the Impella® CP (or Impella® 2.5) device during high-risk PCI in patients with reduced left-sided heart function will result in an improvement in symptoms, heart function and health after a heart procedure compared to the current standard of care. Read Less

The objective of this study is to assess the long-term safety, tolerability, and efficacy of adjunctive therapy of LP352 in subjects with developmental and epileptic encephalopathies who completed participation in Study LP352-201. Read Less

A 52-Week, Multi-center, Open-label, Active Treatment Extension Study to Evaluate Safety and Tolerability of Once Daily, Oral Administration of Resmetirom (MGL-3196) Read Less

This study is designed to help patients with type 2 diabetes and their clinicians: (a) identify which glucose lowering medications have the most favorable effects on heart health and other patient-important outcomes, (b) inform the timing of medication initiation, and (c) identify whether medication benefits apply equally to all adults with type 2 diabetes, or may be different based on age, sex, race/ethnicity, baseline heart health status, baseline renal function, or other factors. Read Less

This phase III trial compares the effect of active symptom monitoring and patient education to patient education alone in helping young women with stage I-III breast cancer stay on their hormone therapy medicines. The patient education tool contains interactive weblinks which provide patients with education material about breast cancer and side effects of therapy. Symptom monitoring is a weblink via email or text message with questions asking about symptoms. Hormone therapy for breast cancer can cause side effects, and may cause some women to stop treatment early. Asking about symptoms more often may help women keep taking hormone therapy medicines. Read Less

NatPro is a two-arm, parallel-group, multi-center, randomized trial in which women undergoing frozen embryo transfer (FET) will be randomized to receive either a modified natural cycle (corpus luteum present) or a programmed cycle (corpus luteum absent). Read Less

This is a combined retrospective and prospective, longitudinal, observational meta-cohort of individuals who will enter the cohort with and without SARS-CoV-2 infection and at varying stages before and after infection. Individuals with and without SARS-CoV-2 infection and with or without Post-Acute Sequelae of COVID-19 (PASC) symptoms will be followed to identify risk factors and occurrence of PASC. This study will be conducted in the United States and subjects will be recruited through inpatient, outpatient, and community-based settings. Study data including age, demographics, social determinants of health, medical history, vaccination history, details of acute SARS-CoV-2 infection, overall health and physical function, and PASC symptom screen will be reported by subjects or collected from the electronic health record using a case report form at specified intervals. Biologic specimens will be collected at specified intervals, with some tests performed in local clinical laboratories and others performed by centralized research centers or banked in the Biospecimen Repository. Advanced clinical examinations and radiologic examinations will be performed at local study sites with cross-site standardization. Read Less

TSR-022 (cobolimab, TIM-3 binding antibody) and TSR-042 (dostarlimab, PD-1 binding antibody) may stop the growth of tumor cells by allowing the immune system to attack the cancer. This phase II trial is studying how well TSR-022 (cobolimab, TIM-3 binding antibody) and TSR-042 (dostarlimab, PD-1 binding antibody) work in combination in treating patients with locally advanced or metastatic liver cancer. Read Less

The investigators are doing this study to determine if there are body composition changes after a 12-week exercise program in breast cancer patients and determine what factors contribute to sustained physical activity after the 12-week exercise program intervention. Read Less

This study will evaluate neurofeedback (NFB) training as a low risk, non-invasive, effective treatment for Veterans diagnosed with mild traumatic brain injury (mTBI) and experiencing chronic post-concussive symptoms (PCSs). It is being funded by the Department of Veterans Affairs. Doing this study will help to determine if NFB will reduce chronic headaches and enhance sleep, attention and quality of life in Veterans with mTBI. NFB is like other biofeedback processes in which information about a person's specific body functioning is made known to the person through a special computer program, which can help that person make the specific body function work better through training. This type of training is usually fun and easy with the help of a coach and a computer. Nothing is ever put into a person's body with biofeedback and it is natural and safe. When a person becomes focused, calm and alert while training on an NFB system, the computer will recognize this and let the trainee know by automatically displaying on the computer screen the positive progression of the game they are playing, such as the plane moving forward or a flower opening. The brain really likes to be in this pattern and when it is happening, people feel good. As a result, any discomforts, like headaches or insomnia, experienced may decrease. After learning about the study, Veterans who agree to participate will be randomly placed into one of two groups, either an intervention group (who will receive NFB) or a control group (who will receive only usual care plus once a week 15-minute calls on health topics). Veterans will have an equal chance of being in either group. Those placed in the control, will also receive NFB after completion of the control group activities. Veterans who are placed in the intervention or delayed intervention group will receive NFB up to 5 times a week, but usually 3 times a week for a total of 20 sessions. Each session is an hour long. Both the intervention and control group will participate in four assessment sessions (lasting up to 2 1/2 hours each) that involve completing 12 questionnaires and a 20-minute attention evaluation. The assessment sessions will occur at the beginning of the study, at 4-6 weeks, at 8-10 weeks, and 2-months later. The participant will receive financial compensation for taking the baseline assessment, 4-6 week, 8-10-week assessments, and for the 2-month follow-up assessment. A participant will receive financial compensation for gas, time and valet parking for each intervention and assessment session. Participation in this research will last about 4 months for those in the intervention and 8 months for those in the delayed intervention group. All participants will receive the NFB treatment by the end of the study. A person who participates in this study may experience a reduction in his or her chronic headaches, and an enhancement of sleep, attention and quality of life. There may be a worsening of symptoms until the individualized training plan for a person can be identified. During an NFB session, brief moments, lasting only seconds or minutes, of dizziness while sitting, muscle tension, or tingling may be experienced. Most people feel relaxed and calm during and after NFB training. This project will be an important step towards a broader implementation of an evidence-based treatment solution for Veterans experiencing chronic headaches, insomnia and attention disorders. The experience of these chronic symptoms can lead to debilitation in all areas of Veterans' lives. This project will provide evidence for the use of NFB with Veterans to alleviate their chronic symptoms and enhance their quality of life. If supported, NFB will offer the investigators' Veterans an effective and non-invasive treatment option. NFB is a patient focused intervention that enables Veterans the opportunity for self-health management. Read Less

The aim of this 12-month randomized multi-regional double-blind parallel group allopurinol and placebo-controlled phase 3 study is to assess the efficacy and safety of three different doses of Tigulixostat in gout patients with hyperuricemia. Read Less