All Clinical Trials

This protocol describes a multicenter, prospective randomized superiority trial of medial epicondyle fracture treatments comparing functional outcomes between children treated with operative reduction and fixation or non-operative immobilization. Read Less

Sleep disturbance has a range of negative effects on psychosocial and biological processes important for academic and social success as well as mental and physical health among adolescents and young adults. Limited, inconsistent, and poor quality sleep lead to anxiety, depressive feelings, loneliness, and fatigue over time. These symptoms, in turn, interfere with the ability to get a good night's rest. Sleep disruption can also upregulate inflammatory processes during the years of adolescence and young adulthood in ways that can create risk for the development of chronic health conditions (e.g., diabetes, depression, cardiovascular disease) in later adulthood. Sleep, however, is also a modifiable health behavior, leading many institutions to embark upon efforts to improve the sleep of their students. The challenge is to identify programs and interventions that can simultaneously improve sleep, be delivered at scale, and be easily completed by students. UCLA has developed and validated a group-based mindfulness intervention, Mindful Awareness Practices (MAPs), that has demonstrated beneficial effects on sleep in adults and may offer a promising, scalable approach for reducing sleep disturbance and improving associated psychological and biological outcomes in college students. However, this approach requires validation in this population relative to sleep education programs, which increasingly dominate the college landscape. To address this important public health problem, the investigators propose to conduct a single site, two-arm, parallel group randomized controlled trial to test the efficacy of the validated, group-based, six-week MAPs intervention vs. sleep education, an active time and attention matched control condition, for first year undergraduate students who report poor sleep at this critical transition year. The investigators are aiming to enroll approximately 240 participants. Participants will complete questionnaires, provide blood samples for immune analysis and will be provided with wrist actigraphs to wear for 7 days, in order to collect objective measurements of sleep at pre- and post-intervention visits, and at a 3-month follow-up visit. Additional follow-up assessments will take place at 6-month, and 12-month post-intervention to evaluate persistence of effects. Read Less

To prospectively determine the burden of hypoglycemia (minutes spent below 70 mg/dl per day, measured by continuous glucose monitor (CGM)) among residents of long term care facilities (LTC) with a diagnosis of type 1 or type 2 diabetes including key clinical subgroups (living in skilled nursing facility (SNF) or nursing home (NH), on different hypoglycemic medications). This aim will be achieved by recruiting 300 residents with diabetes in 4 LTC facilities. All participants will undergo masked CGM for 10 days. Read Less

This study aims to provide an evidence-based behavioral intervention to reduce violent behavior for individuals experiencing early psychosis. Read Less

The goal of this clinical trial is to evaluate efficacy of our enhanced version of the CHESS Health eIntervention in a clinical setting for those with moderate risk drug or alcohol use and those at high risk or with Substance Use Disorder (SUD) as measured by the ASSIST and the AUDIT assessment tools. The clinical trial is designed to determine whether SBIRT/eIntervention is significantly more effective than SBIRT/Treatment as usual (TAU) as delivered in a primary care setting. While it is not feasible or practical to individually test all components and features of the planned eIntervention, this design will permit testing of efficacy for reduction of substance use in both risk groups and increased enrollment in treatment for the high risk/SUD group in the SBIRT/eIntervention cohorts compared to the SBIRT/TAU cohorts. Note that the investigators are not including a screening/assessment only or other control condition, as the purpose of this clinical trial is not to test the efficacy of SBIRT itself, but rather to test whether SBIRT/eIntervention improves outcomes and successful referral relative to SBIRT/TAU delivery alone. Read Less

The goal of this clinical trial is to learn about the use of incentives in pediatric patients requiring medical procedures. The main questions it aims to answer are: * Are incentives effective at reducing pediatric anxiety for medical procedures? * What is the best way to use incentives with pediatric populations requiring medical procedures? Participants will be provided support in preparation for their procedure and during the procedure by a child life specialist and might receive an incentive prize after their procedure. Participants distress levels during the procedure will be observed and they will be asked to rate their anxiety on a visual analog scale. Researchers will compare the anxiety of those who did or did not receive an incentive after their procedure to see if incentives reduced procedural anxiety. Read Less

The Epilepsy Learning Health System (ELHS) is a quality improvement and research network to improve outcomes for people with epilepsy. The ELHS is designed as a model of value-based chronic care for epilepsy as envisioned by the National Academies of Medicine Committee in their landmark reports "The Learning Health System" and "Epilepsy Across the Spectrum: Promoting Health and Understanding". The ELHS network is a collaboration among clinicians, patients and researchers that promotes the use of data for multiple purposes including one-on-one clinical care, population management, quality improvement and research. The ELHS Registry includes data on children and adults with epilepsy collected during the process of standard epilepsy care. These data are used to create population health reports and to track changes in outcomes over time. ELHS teams use quality improvement methods, such as Plan-Do-Study-Act (PDSA) cycles, to continuously learn how to improve care. Read Less

Ultrasound guidance plays a pivotal role in caudal epidural block in pediatric patients. In comparison to conventional single-plane ultrasound, biplane ultrasound offers the advantage of providing simultaneous transverse and longitudinal imaging. Better visualization under biplane ultrasound is postulated to enhance the efficacy of caudal epidural blocks. This improvement is expected to manifest through higher first puncture success rate, shorter procedure time, and longer time to first postoperative analgesics use. Read Less

The proposed research is relevant to public health because stroke is a leading cause of long-term disability among older adults and communication impairments resulting from stroke have a significant negative impact on quality of life. By seeking to better understand post-stroke aphasia, this project lays the groundwork for development of new interventions, and aligns with NIDCD's priority areas 1 (understanding normal function), 2 (understanding diseases), and 3 (improving diagnosis, treatment, and prevention). Read Less

Adolescents with ASD often have co-occurring mental health symptoms like stress, anxiety, and depression. The investigators are conducting this research study to develop interventions for adolescents with ASD that will improve co-occurring mental health symptoms. Read Less

GMK Revision Knee System is part of the Medacta GMK® (Global Medacta Knee) Total Knee System and is indicated when a higher level of varus/valgus constraint is needed. The external shape of the GMK® Revision femoral component is identical to that of GMK® Primary. The GMK® Revision differs from GMK® Primary by three important design features: i. The addition of a box which allows a stem to be inserted into the femoral canal; ii. The addition of screw lugs so that augments can be placed on the distal and posterior resections, and; iii. The box which also allows various levels of constraint to be added to the polyethylene insert. The tibial component offers the ability to place augments. Indications for Use: The GMK® Total Knee System is designed for cemented use in total knee arthroplasty if there is evidence of sufficient sound bone to seat and support the components. This knee replacement system is indicated in the following cases: * Severely painful and/or disabled joint as a result of arthritis, traumatic arthritis, rheumatoid arthritis or polyarthritis * Avascular necrosis of femoral condyle * Post traumatic loss of joint configuration * Primary implantation failure * Ligamentous Instability Tibial augments are to be attached to the tibial baseplate with both the fixing cylinders and bone cement. In case a semi-constrained liner is used, an extension stem must be implanted both on the tibial and on the femoral component. GMK® Revision femoral components are manufactured of Cobalt Chromium Molybdenum (CoCrMo) according to ISO 5832-4:1996, Implants for Surgery- Metallic materials - Part 4: Cobalt-Chromium-Molybdenum Casting Alloy, the same as the GMK® Primary femoral components. They have an asymmetric patellar groove (left and right) with different radii of curvature in coronal plane as well as non-parallel anterior and posterior cuts (wedge shape). The GMK® Revision posterior stabilized femoral components are designed for use without cruciate ligaments when additional stability is required to prevent subluxation of the femur to the tibia in flexion, same as the GMK® Primary femoral components. In case of severe bone loss, the tibial cones and femoral cones may be used to respectively reinforce the proximal tibia cavity and the distal femoral cavity, providing structural support and load redistribution on the remaining bone. Being an integral part of revision TKA for patients with such bone loss, the clinical outcomes for revision TKAs using the cone components are important for the knowledge regarding performance and survivorship of the Revision TKA as a whole. Read Less

A study to assess the effect of multiple doses of venetoclax on the pharmacokinetics of ethinyl estradiol and levonorgestrel in female participants with different hematological malignancies. Upon completion of this study, participants receiving clinical benefit in the opinion of the investigator and without any clinically significant evidence of disease progression with no access to venetoclax (not approved for the treated indication) may continue receiving venetoclax at the discretion of the investigator in a separate extension study. Read Less