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NCT ID: NCT05576090 Active, not recruiting - Inflammation Clinical Trials

UCLA REST Study (REsearch on Sleep Techniques)

REST
Start date: April 3, 2023
Phase: N/A
Study type: Interventional

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.

NCT ID: NCT05575492 Active, not recruiting - Cytomegalovirus Clinical Trials

A Study of mRNA-1647 Cytomegalovirus Vaccine in Healthy Participants 9 to 15 Years of Age and Participants 16 to 25 Years of Age

Start date: November 7, 2022
Phase: Phase 1/Phase 2
Study type: Interventional

The main purpose of study is to evaluate the safety and immunogenicity of different dose levels of mRNA-1647 versus control in healthy cytomegalovirus (CMV)-seronegative and CMV-seropositive female and male participants 9 to 15 years of age. In addition, mRNA-1647 will be evaluated in female participants 16 to 25 years as a comparator cohort.

NCT ID: NCT05574959 Active, not recruiting - Cataracts Clinical Trials

Clinical Investigation of the TECNIS® Next-Generation Intraocular Lens, Model DEN00V

Start date: October 24, 2022
Phase: N/A
Study type: Interventional

Prospective, multicenter, bilateral, masked (sponsor, subject and evaluator), randomized clinical trial to evaluate the safety and effectiveness of the TECNIS IOL, Model DEN00V in comparison to an aspheric monofocal IOL.

NCT ID: NCT05574478 Active, not recruiting - Clinical trials for Metastatic Breast Cancer

Metastatic Breast Cancer-Specific Prognostic Tool

Start date: September 20, 2022
Phase:
Study type: Observational

In this qualitative study, Investigators will conduct semi-structured interviews with clinicians that are involved in the care of patients with breast cancer to evaluate the acceptability, appropriateness, and feasibility/usability of a metastatic breast cancer-specific prognostic tool. These interviews will be conducted by the UNC CHAI Core and will continue until thematic saturation (estimated 20-30 participants). The investigators will code the qualitative data using emerging themes, guided by a well-established implementation science theory, the Consolidated Framework for Implementation Research (CFIR). The information gained from these studies will inform an implementation approach to increase the usability and acceptability of a novel prognostic tool to assist oncologists in the prognosis of patients with metastatic breast cancer.

NCT ID: NCT05574335 Active, not recruiting - Clinical trials for Type 1 Diabetes Mellitus

Siplizumab in T1DM

DESIGNATE
Start date: April 26, 2023
Phase: Phase 1/Phase 2
Study type: Interventional

This is a multicenter, Phase Ib, open-label, siplizumab dose-finding study in individuals aged 8-45 years with a Type 1 diabetes mellitus (T1DM) diagnosis. within 18 months of V0. Participants will be randomized 1:1:1:1 to one of four possible siplizumab dosing arms. All dosing arms will receive weekly siplizumab doses for a total of 12 weeks. After the completion of treatment, participants will undergo follow-up visits at weeks 12, 24, 36 and 52 which include longitudinal MMTTs. If indicated, participants will enter into long-term safety monitoring for up to an additional 48 weeks. Blood samples for mechanistic analyses will be obtained during the treatment phase and thereafter. Adults aged 18- 45 will be enrolled initially at the study sites. The primary objective is to identify a safe, metabolically favorable, dosing regimen for siplizumab in patients with type 1 diabetes that induces changes in T cell phenotypes observed with alefacept therapy in new-onset T1DM. The secondary objectives are to: 1. Assess the safety profile of siplizumab in recently diagnosed T1DM. 2. Assess the effects of siplizumab on residual beta cell function in recently diagnosed T1DM participants.

NCT ID: NCT05573932 Active, not recruiting - Clinical trials for Non-specific Low Back Pain

Gamified Rehab vs Take-home Packet Rehab for Non-specific Low Back Pain

Start date: October 13, 2022
Phase: N/A
Study type: Interventional

Two groups with non-specific low back pain will be completing the same exercise protocol. The leaderboard group will have a gamified experience and the take-home packet group will be using a paper take-home packet. Outcomes will be measured at 3 weeks, 6 weeks, with pain and disability also being measured at 12 and 18 months.

NCT ID: NCT05572658 Active, not recruiting - Clinical trials for Respiratory Syncytial Virus

Moderna Vaccine mRNA-1345 Observational Respiratory Syncytial Virus (RSV) Study

Start date: September 15, 2022
Phase:
Study type: Observational

The main goal of this observational study is to evaluate the real-world effectiveness of the Moderna mRNA-1345 vaccine for protection against RSV lower respiratory tract disease (RSV-LRTD) and to study additional health and economic outcomes.

NCT ID: NCT05572606 Active, not recruiting - Bloating Clinical Trials

Treatment of Symptomatic Bloating Using a Novel Hypnotherapy Protocol

Start date: November 30, 2022
Phase: N/A
Study type: Interventional

The purpose of this research is to evaluate if hypnotherapy delivered electronically will help with bloating symptoms.

NCT ID: NCT05571943 Active, not recruiting - Atopic Dermatitis Clinical Trials

A Open-label Study to Assess the Long-term Safety of Difamilast Ointment 1% in Mild to Moderate Atopic Dermatitis

Start date: September 15, 2022
Phase: Phase 3
Study type: Interventional

This is a Phase 3, open-label study to evaluate the long-term safety of difamilast ointment 1% in subjects ≥2 years of age with mild to moderate AD. The study will also evaluate the long-term efficacy of difamilast ointment 1%, including durability of response.

NCT ID: NCT05571800 Active, not recruiting - Obesity Clinical Trials

Effect of Mango Consumption on Individuals With Pre-diabetes

Start date: May 1, 2022
Phase: N/A
Study type: Interventional

This study is designed to explore the effect of mango consumption on glycemic indices, cardiovascular health, and body composition in overweight and obese individuals with prediabetes.