Los Angeles, CA Paid Clinical Trials

Patients with inflammatory bowel disease (IBD) often have narrowed microbial diversity and altered composition and function of the gut microbiome. We anticipate the anti-inflammatory diet, when compared with the usual diet, to produce favorable changes in these multi-omics profiles. These findings will provide insight into the interactions between diet and host biology, while providing clues on the mechanisms of diet therapy's effect and CD pathogenesis. Read Less

Our intent is to establish the International Registry to Improve Outcomes in Men with Advanced Prostate Cancer (IRONMAN) as a prospective, international cohort of minimum 5,000 men with advanced cancer, including men with mHSPC and M0/M1 CRPC. The goal is to establish a population-based registry and recruit patients across academic and community practices from Australia, Barbados, Brazil, Canada, Ireland, Jamaica, Kenya, Nigeria, Norway, Spain, South Africa, Sweden, Switzerland, the United Kingdom (UK), and the United States (US). Target accrual number and number of participating sites are subject to change based on accrual, funding, and interest in participation by other international sites. This cohort study will facilitate a better understanding of the variation in care and treatment of advanced prostate cancer across countries and across academia and community based practices. Detailed data will be collected from patients at study enrollment and then during follow-up, for a minimum of five years. Patients will be followed prospectively for overall survival, clinically significant adverse events, comorbidities, changes in cancer treatments, and PROMs. PROMs questionnaires will be collected at enrollment and every three months thereafter. Physician Questionnaires will be collected from all participating sites at patient enrollment, time of first change in treatment and/or one year follow-up, at each subsequent change of treatment, and discontinuation of treatment. As such, this registry will help identify the treatment sequences or combinations that optimize overall survival and PROMs for men with mHSPC and M0/M1 CRPC. By collecting blood at enrollment, time of first change in treatment and/or one year follow-up (plasma, cell free DNA, buffy coat / RNA), this registry will further identify and validate molecular phenotypes of disease that predict response and resistance to specific therapeutics. Additionally, every effort will be made to collect blood specimen at each subsequent change in treatment due to progression of disease. When feasible, existing tumor tissue may be collected for correlation with described blood based studies. All samples will be used for future research. This cohort study will provide the research community with a unique biorepository to identify biomarkers of treatment response and resistance. Read Less

Intracranial aneurysm rupture is a leading cause of hemorrhagic strokes which carry high mortality and disability rates as well as high healthcare costs. Unruptured intracranial aneurysms (UIA) are common in the general population, occurring in 1-2% of individuals. Previous studies have shown that UIA growth and rupture are strongly associated with each other, with growing aneurysms 9-12 times more likely to rupture, and nearly all aneurysms growing prior to rupture. Thanks to advanced medical imaging, UIA are now more and more often detected incidentally. However not all aneurysms qualify for preventive surgical or interventional procedures according to current International Study of Unruptured Intracranial Aneurysms (ISUIA) guidelines, and some must therefore be monitored for growth. Current guidelines are based heavily on size, an inconsistent predictor of future growth. To improve management strategies for individual patients and more comprehensively assess aneurysm risk, the investigators propose to identify risk factors related to growth. Aneurysm etiology is multifactorial, with both genetic and environmental contributions to aneurysm formation, growth, and rupture. Exploring new risk factors based on aneurysm natural history and understanding the mechanisms underlying aneurysm rupture have been extensive research areas. As previous studies have shown that quantitative imaging biomarkers (QIB) can provide a more accurate assessment of the characteristics of aneurysms, the investigators propose a combined study which identifies QIB associated with aneurysm growth to identify factors related to growth. Read Less

The purpose of this study is to assess the safety of metformin for treatment of progressive multiple sclerosis Read Less

Management of ACLF is mainly supportive. The poor outcomes lead physicians to consider liver transplantation as an option, even if controversial. In sicker recipients, LT results in immediate survival, but poor medium-term survival rates in some studies. The scarcity of deceased donors obliges to maximize LT success. Alternative strategies, as living-donor LT, should be explored. LDLT has impressive results in Eastern centers, but it is restrained in Western countries, due to potential life-threatening complications in the donor. Read Less

Because of its simplicity, TLE may represent a more feasible approach for adolescents than other caloric restriction regimens based on macronutrient composition and kilocalories. Our preliminary data support TLE feasibility, acceptability, and safety in adolescents with obesity, with and without T2D. However, no trial to date has studied the effects of TLE on glycemic control and body composition in adolescents with T2D. Our long-term goal is to determine whether TLE is a beneficial as part of the medical regimen early in diagnosis in adolescents living with T2D, and if so, to identify: 1) participant characteristics associated with positive response, 2) mechanisms by which TLE operates, and 2) the best methods to administer TLE to maximally harness its effects. Therefore, the aim of this study will be to compare cardiometabolic effects of TLE (8-hr eating period/16-hr of daily fasting) versus a prolonged eating period (12+hour eating period) in a randomized pilot study with careful control of timely compliance, dietary composition, calorie intake, and physical activity to accurately capture the dosage of the intervention received. We hypothesize that TLE will minimize glycemic excursions, delay β-cell deterioration, and reduce body fat mass in adolescents with T2D when compared to prolonged eating periods. One-hundred adolescents with T2D will be recruited. All participants will be randomized to one of two meal-timing schedules to be followed for 12 weeks: (1) Control: >12-hour eating period or (2) TLE. Read Less

This study evaluates KRT-232, a novel oral small molecule inhibitor of MDM2, for the treatment of patients with myelofibrosis (MF) who no longer benefit from treatment with a JAK inhibitor. Inhibition of MDM2 is a novel mechanism of action in MF. This study will be conducted in 2 phases. Phase 2 will determine the KRT-232 recommended dose and dosing schedule; Phase 3 will test KRT-232 vs Best Available Therapy (BAT). Patients in the Phase 3 part of the study will be randomized 2:1 to receive either KRT-232 (Arm 1) or BAT (Arm 2). The BAT administered will be determined by the treating physician, with the option to "cross-over" to KRT-232 treatment after 6 months of BAT or if the disease worsens at any time. Read Less

The purpose of this study is to examine the mechanisms of brain injury contributing to postoperative neurocognitive disorders (PNCD) in an at-risk population (obstructive sleep apnea (OSA)) undergoing surgery. The investigators will enroll 50 OSA patients scheduled for surgery. All patients will have a brain scan (fMRI) within five days before surgery and two days and six months after surgery. During this visit cognitive function will be assessed using the Wide Range Assessment of Memory and Learning (WRAML2) and Montreal Cognitive Assessment (MoCA) tests. Patients will also be asked to participate in a blood draw during the first 2 visits for fMRI (within five days of surgery and two days after surgery). The Confusion Assessment Method (CAM-S) test, will be used to examine postoperative delirium. Read Less

Students in marginalized communities who 'strive' to rise above adversity to achieve academic success are considered 'resilient'. However, youths' resilience in one domain (i.e. academic) can come at a cost in other domains including physical and mental health morbidities that are under-identified and under-treated. Previous research suggests that Black, Indigenous and People of Color (BIPOC) who exhibit a "striving persistent behavioral style" in the face of adversity evince later health morbidities. Ironically, the same self-regulatory skills that promote academic achievement amid chronic stress can also result in physiological dysregulation that harms health and mental health. Self-regulatory processes that involve emotion suppression, experiential avoidance, and unmodulated perseverance can culminate in allostatic load which fuels health disparities and internalizing symptoms of depression and anxiety. The proposed mechanistic trial will utilize mindfulness training to permit examination of questions about the causal role of emotion regulation strategies linked to the striving persistent behavioral style in driving mental health and health morbidities among BIPOC. The proposed Project STRIVE (STudents RIsing aboVE) will identify BIPOC students who are academically resilient in the face of disadvantage and will offer a tailored mindfulness intervention targeting self-regulation processes as a putative mechanism to interrupt the links between the striving persistent behavioral style and negative health outcomes. Investigators propose a multisite randomized trial randomizing 504 high achieving, socioeconomically disadvantaged Black, Latinx and Asian American students in 18 schools to receive a mindfulness intervention or an attention control condition focused on study skills. The study will: (1) test the effects of the STRIVE intervention on putative self-regulation mechanisms (emotion suppression, experiential avoidance, and unmodulated perseverance) among identified BIPOC students, (2) test the effects of the STRIVE intervention on health and mental health outcomes at 12-month post-treatment, including biomarkers of allostatic load (cortisol, blood pressure, body-mass-index, waist/hip/neck circumference), health complaints, and internalizing symptoms, and (3) examine the mechanistic model linking striving persistent behavioral style and health outcomes within the STRIVE trial. Read Less

This study will adapt Safe Alternatives For Teens and Youth - Acute (SAFETY-A) for implementation in low-resourced school districts to reduce racial/ethnic disparities in mental health service use (MHS) following identification of suicide risk in youth. SAFETY-A will be adapted to fit the organizational context of school districts and to reduce mistrust of MHS, internalized stigma, and concealment of youth emotional distress that arise in school suicide risk assessments with Asian American and Latinx students. Following a prototyping case series, a feasibility trial will assign four districts to the timing of SAFETY-A implementation to generate preliminary data on feasibility and impacts on proposed mechanisms and youth MHS utilization and clinical outcomes across racial/ethnic groups. Read Less

The proposed study in patients with previously untreated locally advanced head and neck squamous cell carcinoma (HNSCC) is designed to evaluate the efficacy and safety of three different doses of MIT-001 compared to the placebo in prevention of oral mucositis (OM) in patients with HNSCC who are undergoing concurrent chemoradiotherapy (CCRT). Read Less

The overall objective of this research is to test the effectiveness of a parenting program on Filipino parents living in California. The sample will include 180 Filipino immigrant families, half of which will receive the Online Incredible Years® School Age Basic & Advanced Parent Training Program (intervention) and the other half will receive the American Academy of Pediatrics' Bright Futures handouts (control) and be placed on a 3-month waitlist for the IY parenting program. Read Less