Los Angeles, CA Paid Clinical Trials

The main goal of this clinical trial is to improve the care for urinary incontinence (UI) provided to adult women by primary care providers. The main questions it aims to answer are: * Can a practice-based intervention involving primary care providers lead to improved quality of incontinence care? * Will this intervention reduce the utilization of specialist care for urinary incontinence? * What effect will this intervention have on patient outcomes, including disease-specific outcomes, symptom severity, quality of life, and patient knowledge? * Does our intervention reduce disparities in care? Provider participants will be randomized at the office level to either an intervention group or a delayed intervention (control) group. The intervention group will receive an intervention consisting of academic detailing, clinical decision support tools, electronic referral, and the ability to refer to an advanced practice provider for co-management. The delayed intervention group will provide usual care until the crossover phase of the study, at which point they will receive the same intervention as the intervention group. Patient participants will bring up urinary incontinence with their primary care provider and complete three electronic surveys. Researchers will compare the intervention group to the delayed intervention (control) group to see if the intervention results in increased adherence to evidence-based quality indicators. Read Less

This phase I trial tests the safety and side effects, and best dose of a vaccine (neoantigen-target ppDC) in treating patients with H3 G34-mutant diffuse hemispheric glioma. Vaccines made from the patient's own white blood cells and peptide-pulsed dendritic cells may help the body build an effective immune response to kill tumor cells. Giving neoantigen-targeted ppDC may be safe, tolerable and/or effective in treating patients with diffuse hemispheric glioma with a H3 G34 mutation. Read Less

The purpose of this investigator-initiated prospective observational cohort study is to establish the new UCLA Perinatal Biospecimen Repository (Perinatal Repository) for collection, storage, and distribution of the human data and biospecimens of the participants with perinatal pathology. The secure and shared high-quality resource of clinical data and biological specimens (Repository Materials), across pregnancy pathology related to research protocols at the Afshar's Lab will be created. Core variables of interest include clinical characteristics and relevant biological samples. Intention to collect perinatal data is aiding the efficiency and effectiveness of de-identified biorepository for pregnancy-at-risk outcome research. The primary aims of the project are: * To design the Case Report Forms (CRFs) for the clinical and biospecimen data. * To create and update the project-specific policies, agreements, and Standard Operating Procedures (SOPs). * To develop the data management system to assure personal health information de-identification, data integrity, participants welfare, and protocol compliance. * To develop and implement a quality management system for the Repository. * To collect and record in the Repository protocol-related clinical information. * To organize a consistent system to bank high-quality biospecimens while protecting participant-donor safety and privacy. * To establish the policies and procedures for Repository Materials dissemination and research collaboration. * To analyze the scientific results of the Repository creation. The secondary aim of the study is to provide a mechanism to store and share for research purposes the de-identified biospecimen and information about participants at risk for adverse pregnancy outcomes. Read Less

There is a growing sector of modern tobacco-free oral nicotine pouches that are federally regulated as non-medicinal nicotine/tobacco products. While nicotine pouches employ marketing approaches that may attract current tobacco users, such as marketing themes connoting minimal harm, information on the long-term health effects of nicotine pouches is lacking. nicotine pouches may appeal to younger adults because they are available in similar product characteristics (e.g., nicotine concentration, protonated nicotine) that many younger people prefer to use in e-cigarettes. In addition, nicotine pouches may be of particular interest to younger adult e-cigarette users because these products can be used discreetly where vaping is not allowed, which may translate into an increased likelihood of becoming dual users of e-cigarettes and nicotine pouches. Indeed, approximately 15% young adults who used e-cigarettes in the past 30 days were past 30-day nicotine pouch users. Manufacturers of modern nicotine pouches use acid additives to lower pH, which changes nicotine from a free-base to a protonated nicotine, resulting in improved appeal and sensory experience and higher abuse liability. Thus, nicotine concentration and pH in modern nicotine pouches should be focal targets for regulatory policies. Evidence is also lacking on mechanisms mediating differences in product appeal and abuse liability of nicotine pouches across products varying in nicotine concentration and pH level. The scientific objective of this research is to assess the effect of variation in nicotine concentration in nicotine pouches and its interaction effect with pH level on the proximal outcomes of relevance to the U.S. Food and Drug Administration regulation: sensory attributes and product appeal among younger adults who use nicotine pouches in the past 30 days (current dual users of nicotine pouches and e-cigarettes and/or combustible cigarettes will be eligible) and are unmotivated to quit nicotine use. This innovative project proposes to conduct a double-blind within-subject randomized study in which participants (N = 72) will administer nicotine pouches varied by nicotine concentration (e.g., 3 vs 6 mg) and pH (e.g., 8.5 or greater vs. less than 8.5) to achieve the project aim: to evaluate the effects of nicotine concentration and pH on subjective product appeal and sensory attributes of nicotine pouches. The findings of this proposed research will provide the U.S. Food and Drug Administration with new evidence necessary to inform regulatory restrictions on product characteristics and constituents of nicotine pouches, which may put young adults at risk of using a novel class of oral nicotine products. Read Less

Misalignment of teeth and jaws (also called malocclusion) is a common life altering problem facing many individuals with Osteogenesis Imperfecta (OI). The presence of Dentinogenesis Imperfecta in teeth of OI individuals makes the use of conventional orthodontics in the form of braces very challenging. Clear aligners are newer form of orthodontic treatment and is less invasive than braces. Therefore, the aim of our study is to evaluate the efficiency and safety of using Invisalign clear aligners for orthodontic treatment in individuals with Osteogenesis Imperfecta. We seek individual with Osteogenesis Imperfecta, with mild to moderate malocclusion and no prior history of orthodontic treatment. This study will be held at three sites - McGill University, University of California Los Angeles and National Institute of Dental and Craniofacial research. This study will for the first time, help define guidelines for safe and efficient orthodontic treatment using clear aligners in individuals with Osteogenesis Imperfecta. If successful, this approach can rapidly be implemented into clinical practice, as the Invisalign system is readily available to orthodontists. Read Less

Osteogenesis imperfecta (OI) is a group of congenital and heritable bone disorders that currently affects at least 50,000 people in the United States. OI varies in severity from perinatally lethal to mild forms. The majority of cases is caused by a dominant mutation in type I collagen genes (COL1α1 and COL1α2), altering the quantity or quality of type I collagen. Although OI is typically characterized as a disease of the bone, it is perhaps more accurately described as a connective tissue disorder. Type I collagen is a major constituent of lung connective tissue. Respiratory insufficiency is the leading cause of death in patients with OI. Thus, it is important and necessary to understand the etiology of the restrictive pulmonary physiology in the OI population. Read Less

This pilot trial compares drug exposure levels using a new method for dosing vincristine in infants and young children compared to the standard dosing method based on body surface area (BSA) in older children. Vincristine is an anticancer drug used to a variety of childhood cancers. The doses anticancer drugs in children must be adjusted based on the size of the child because children vary significantly in size (height, weight, and BSA) and ability to metabolize drugs from infancy to adolescence. The dose of most anticancer drugs is adjusted to BSA, which is calculated from a patient's weight and height. However, infants and young children have more severe side effects if the BSA is used to calculate their dose, so new dosing models have to be made to safely give anticancer drugs to the youngest patients. This new method uses a BSA-banded approach to determine the dose. Collecting blood samples before and after a dose of the drug will help researchers determine whether this new vincristine dosing method results in equivalent drug levels in the blood over time in infants and young children compared to older children. Read Less

Treponema pallidum is a bacterium that causes the disease syphilis. The primary objective of the study is to evaluate the testing performance of two diagnostic molecular techniques \[quantitative polymerase chain reaction (qPCR) and transcription-mediated amplification (TMA)\] for the detection of Treponema pallidum in maternal and neonatal specimens from participants with the diagnosis of syphilis using the Centers for Disease Control's (CDC's) Sexually Transmitted Infections (STI) Treatment Guidelines for adult and congenital syphilis. Read Less

This study is to evaluate how safe and effective ritlecitinib is in participants with non-segmental vitiligo (NSV). Ritlecitinib is studied in patients with non-segmental vitiligo. Vitiligo is a chronic acquired depigmentation disorder characterized by well-defined pale white patches of skin. Non-segmental vitiligo is an autoimmune disorder and is the focus of this study. The study will show: * if the repigmentation (the recovery of pigmentation) achieved in study B7981040 (also called the "parent study") will stay the same or will further increase if you keep receiving the same study medicine (ritlecitinib 50 milligrams or placebo) * Or if more repigmentation can be achieved if you start receiving ritlecitinib 100 milligrams in this study * Or how long the repigmentation achieved during the parent study lasts if you start receiving placebo in this study. This study is seeking for participants who: * have non-segmental vitiligo (either active or stable) and * received ritlecitinib or placebo for 52 weeks in the parent study. A placebo looks exactly like the study capsule but does not contain any medicine in it. All participants in this study will receive the study medicine or placebo. The study medicine (ritlecitinib 50 milligrams or 100 milligrams) or placebo are capsules that are taken by mouth at home every day. At week 4 (or if it cannot be done then, at week 8) study visit, you must take the medication at the study site, and not at home. Participants may receive the study medicine or placebo for up to 52 weeks. The study will look at the experiences of people receiving the study medicine. This will help see if ritlecitinib is better for treating vitiligo. Participants will be involved in this study for a maximum of 60 weeks. During this time, they will have 9 study visits during the study. Ritlecitinib 50 mg is an approved drug for the treatment of severe Alopecia Areata (a disease with similar abnormal changes in the body functions like vitiligo) in the US, EU and Japan. China, Great Britain and other market applications are pending. Read Less

The aim of this study is to find out if using a certain kind of mesh can reduce the chances of hiatal hernias coming back after anti-reflux surgery. Participants undergoing antireflux surgery will be assigned to one of two groups, a group that has surgery with mesh, or a group that has surgery without mesh. Read Less

Systemic lupus erythematosus (SLE) is a chronic inflammatory disease which often has debilitating and potentially life-threatening consequences. The cause of SLE is unknown and current therapies lack specificity and carry significant side-effects. We previously discovered the depletion of glutathione in lymphocytes of patients with SLE and associated this metabolic change with the elevation of the mitochondrial transmembrane potential. This study will titrate to tolerance during an initial 3 month open label period and then subjects will be randomized to one of 2 arms. It was determined by statistical analysis that each group must have 105 subjects. All subjects will be enrolled and evaluated for tolerance of NAC between dosages of 2.4 g/day and 4.8 g/day for 3 months. After A 3-month open-label dose-titration phase, SLE subjects will be randomized into 2 groups of 105 subjects either to continue the tolerated dosage of NAC or switched to equal number of placebo capsules. There will be up to seven study visits per SLE subject, including the screening and wash out visits. Visits 2-6 will be scheduled three months apart. The study will last 13 months with the wash-out visit. Each subject will donate approximately 100 ml of blood for biomarker studies at each visit. Healthy control subjects will donate blood at the same time. They will be matched to the SLE subjects by gender, age within 10 years, and ethnicity. Their blood will be used as reference for biomarker assays. There is a consent form required to participate in the phase II study. Read Less

This a single-center, prospective, exploratory study. Patients with metastatic castration-resistant prostate cancer (mCRPC) scheduled to undergo Lutetium labelled prostate-specific membrane antigen radioligand therapy (LuPSMA RLT) at the West Los Angeles VA (WLA-VA) will be imaged with a baseline F-18 fluorodeoxyglucose positron emission tomography/computed tomography 18F-FDG PET/CT and a 18F-DCFPyL PET/CT (18F-DCFPyL (2-(3-{1-carboxy-5-\[(6-18F-fluoro-pyridine-3-carbonyl)-amino\]-pentyl}-ureido)-pentanedioic acid)positron emission tomography/computed tomography , as per standard of care in our institution. All patients further undergo eventual follow-up prostate-specific membrane antigen positron emission tomography (PSMA PET) after the 2nd, 4th, and 6th LuPSMA RLT cycle. In this prospective study, an18F-Fluciclovine positron emission tomography/computed tomography ( Axumin PET/CT )will be additionally obtained at baseline (pre-LuPSMA RLT), and after the 2nd, 4th, 6th LuPSMA RLT cycles. Axumin PET/CT will be acquired within 7 days from the PSMA PET. This study is open to Veterans only. Read Less