Research Associates Program (CTSI-RAP)

Women’s Alzheimer’s-related inflammation and immunoregulatory deficiency [IRB 18-000434]

PI: Molly Fox, PhD

Study Liaison: Pending

Description: STUDY AIMS: This study investigates how various aspects of a woman's experiences across her lifespan shape how her immune system functions during the geriatric phase of her life, and specifically how this affects the inflammatory aspects of Alzheimer's Disease risk. We will focus our assessments on women's reproductive life-history, infectious disease history, medical history of autoimmunity, and dental health history -- and explore how these together affect inflammatory processes in geriatric life. Immunological dysfunction is an early feature of Alzheimer's Disease progression, so understanding how lifespan predictors affect immune function can help us discern the biomechanism by which certain lifespan risk factors affect the development of Alzheimer's Disease. 

METHODOLOGY: Target cohort: This is a cross-sectional case/control study of 40 geriatric women (30 with/ 10 without AD), assessing reproductive history, AD status and age-at-onset, olfactory function and immunoregulatory cell concentration in peripheral blood. Participants are recruited from the Pacific Brain Health Center in Santa Monica and Olive-View UCLA Medical Center. 

Session activities: Interviews with proband and informant, odor identification test, phlebotomy.

RAP Responsibilities: Student will abstract relevant information from medical* and dental records of research participants, and input this into our database. This activity will be performed in Dr. Fox’s lab on desktop computers provided. Interested student may also participate in the processing of biological specimens (swabs, blood, saliva) collected from research participants and dropped off at PI’s lab, or conducting phone/zoom consent and interviews with participants and informants.

Pediatric Neonatology - Nutrition and Infant Development (Study 1): Metabolic mechanisms induced by enteral DHA and ARA supplementation in preterm infants [IRB 22-001345] (Study 2): Closing the gaps in neonatal nutrition through data science [IRB 21-000379]. 

PI: Kara Calkins, MD

Study Liaison: Nicolette Zargari

Description: (Study 1) This study involves the use of a nutritional supplement called DHA & ARA. DHA and ARA are fatty acids. The researchers hope to learn if providing this supplement to premature infants will be beneficial to them, and what dose and regimen works best. The study will enroll infants born prematurely between 25 and 30 weeks of gestation. Participants will be randomized to one of four groups. Group 1 will receive the nutritional supplement throughout the duration of the study. Group 2 will receive no nutritional supplements. Group 3 will receive supplements from enrollment through 31 6/7 post-menstrual age (PMA), then no supplement from 32 to 36 weeks PMA. Group 4 will not receive supplements from enrollment through 31 6/7 PMA, but will receive them from 32 to 36 weeks PMA. Participation involves 8 visits with the research staff. During these visits, participants will have body measurements performed, and samples collected (milk, blood, urine, stool, and saliva samples). Information from the medical record will be collected throughout the study. The intervention will last through 36 weeks PMA or at discharge from the hospital.

(Study 2) Studies examining the impact of nutrition on short and long-term outcomes in infants in the neonatal intensive care unit (NICU) are often limited to single centers and by small numbers. As a result, we cannot evaluate practices in nutritional delivery for specific groups of infants. To address these gaps, we aim to establish a NICU Nutrition Collaborative (NNC) where longitudinal data across multiple centers can accrue data large enough to answer questions across a range of birth weights and gestational ages. We will then approach these questions using evolving data analytical approaches such as advanced population statistics and machine learning.

RAP Responsibilities: 

• Collecting detailed nutritional and demographic data along with data about the subject's hospital course from the EMR
• Entering, organizing, and verifying data into a secure database (REDCap) used across our collaborators: UT Health and Cornell
• Attend lab meetings for UCLA and collaborators
• Prepare specimen collection kits and labels for subjects' specimen collections
• Assist with data analysis 
• Assist with specimen collections and measurements
• Opportunities are available to formulate and answer research questions with appropriate mentorship; data can be presented in abstracts and manuscripts

G34 Mutant Pilot Study - neoantigen-targeted dendritic cell vaccination in diffuse hemispheric glioma, H3 G34-mutant (brain cancer) [IRB 23-001700]

PI: Anthony Wang, MD

Study Liaison: Collin Le

Description: The aim of this research study is to evaluate the safety, tolerability, and early immunogenicity (ability to provoke an immune response) of a novel mode of cancer treatment- Peptide-pulsed dendritic cell (ppDC) for patients with diffuse hemispheric glioma, H3 G34-mutant (DHG). We hypothesize that anti-tumor immunity can be safely stimulated in the target patients population by ppDC vaccination. ppDC vaccine is vaccine that produces immune cells called tumor-specific tumor-infiltrating T lymphocytes (TILs). TILs can specifically break down tumor cells. 

The study is unanticipated to enroll 3-6 participants. Each participant will be on the study for about 24 months. After screening and being confirmed as eligible, the patients undergo Leukapheresis visit to collect their white cells which will be sent to the GMP lab to make the ppDC. Patients will receive 3 doses of vaccine 2 weeks apart, and then receive another 3 doses of vaccine every 6 months. Each visit involves physical/neurological exam, vital sign, medication review, performance assessment, symptom monitoring. Clinical labs will be done at screening. Brain MRI will be done at screening, at 3rd through 6th vaccination. Research blood will be collected at screening, and at 3rd through 6th vaccination. Research stool will be collected after 3rdvaccine visit and prior to 4th vaccine visit.

The primary endpoint is safety analysis. This will be conducted by analyzing the AE/SAE collected from screening through 30 days (for AE)/120 days (for SAE) after the last vaccination. The secondary endpoints are to evaluate the anti-tumor immunity induced by the ppDC vaccination. This will be performed by research lab testing on the research blood samples collected throughout the study. As exploratory endpoints, the study will estimate the progression free survival (PFS and PFS6) and overall survival (OS and OS2), perform correlative imaging analysis, immune profiling and gastrointestinal microbiota profiling.

RAP Responsibilities: Meet participant, guide to treatment area for first treatment, data collection from medical records, verify specimen collection, specimen delivery to lab, phone call follow-up and scheduling follow-up.

Assessing a Virtual Genetic Counseling Assistant for Returning Genetic Results – vGCA [IRB 22-001123; 23-001196]

PI: Nanibaa Garrison, PhD

Study Liaison: Madeline Mai

Description: Digital tools have the ability to advance health equity among underrepresented minority communities who experience low rates of genetic testing and referrals to Genetic Counselors (GCs). This study will elicit feedback from underrepresented minority adults to assess features of a new virtual genetic counseling assistant (vGCA) that has been developed at UCLA to aid in the return of genetic results process for the UCLA ATLAS Community Health Initiative. The goal of this study is to understand how to implement tools that can make genetic counseling services more accessible. The vGCA is an interactive educational toolkit for patients who have opted in to UCLA ATLAS and indicated wanting to receive any actionable genetic findings. We hypothesize that the vGCA can be a significant resource for increasing support for underrepresented minority adults receiving genetic counseling services.

This study takes a mixed methods approach: 1) a literature search to evaluate the range of tools available in the genetic counseling setting, 2) qualitative methods to elicit perspectives on the vGCA, and 3) quantitative survey instruments to understand the larger impacts. To conduct qualitative assessment about the vGCA, we will conduct focus groups with eligible underrepresented minority adults in LA county, stratified by age (18-55 and 56+) to encourage robust discussion by which elders are not influencing the younger generation. A survey will be conducted at the end of the focus groups to collect demographic data as well as additional feedback pertaining to the focus group discussions. Our goal is to expand recruitment to other communities that are served by UCLA Health and providers who would interface with the vGCA.

RAP Responsibilities: 

• Attend weekly project meetings, assist with IRB updates.
• Participation in the recruitment and consenting process.
• Data collection (assisting and/or conducting focus groups, cleaning up transcript data, organize data for analysis).
• Data analysis (developing a codebook, analyzing transcripts in Dedoose).
• Involvement in presentations, write-up of abstracts, posters, or manuscripts (which may include literature searches etc.)

Alpha-1 Antitrypsin Response in the Acute Phase of Systemic Inflammation [IRB PRE#23-006664]

PI: Igor Barjaktarevic, MD, PhD

Study Liaison: Ashley Michel

Description: Alpha-1 antitrypsin (A1AT) is an abundant protein in the serum of healthy individuals, with levels increasing significantly in response to systemic inflammation. We propose a prospective observational study to enroll individuals with the PiMM genotype admitted to the inpatient medical ward with an acute respiratory infection and evidence of systemic inflammation to compare A1AT levels and functional activity in this state and upon resolution of the acute inflammatory response. We propose a targeted, prospective assessment of A1AT response in the setting of a highly inflammatory acute state as defined by the presence of the systemic inflammatory response syndrome (SIRS) secondary to acute lower respiratory infection with respiratory insufficiency. This will be compared to the steady-state level upon the resolution of inflammation. Our study aims to comprehensively compare the acute phase reaction and steady state of A1AT antigenic levels and functional activity in serum, sputum, nasal epithelium and bronchoalveolar lavage specimen

RAP Responsibilities: Based on EPIC report (already created), daily screening for patients who fit the criteria, communicating with the rest of study team about potential candidates, contacting patients and initiating contact/offering the study information, assisting the study coordinator in their activities, charting data into the redcap and participating in data analysis with possibility of participation in abstract/manuscript preparation.

Characterizing the Microbiome-Gut-Brain Axis in Individuals with Alcohol Use Disorder [IRB 21-001339]

PI: Erica Grodin, PhD

Study Liaison: Grace Sawyer

Description: The objective of this proposal is to characterize the microbiome-gut-brain axis in individuals with an alcohol use disorder (AUD). Specifically, this proposal seeks to evaluate the relationship between gut dysbiosis, clinical phenomenology of AUD, and a brain-based biomarker in individuals with AUD and matched controls. AUD is a chronic relapsing disease with a major public health impact. While substantial research has been done to understand the neural circuitry underlying AUD, the role of the periphery and the connections between the periphery and the central nervous system have been understudied. One promising avenue of study is the gut microbiome and the microbiota-gut-brain axis, which have only recently been recognized as contributing to the pathogenesis of AUD. Despite the promise of the microbiota-gut-brain axis as an important contributor to AUD, there have been no comprehensive investigations of the microbiota-gut-brain axis in a single sample of individuals with AUD. Therefore, this proposal seeks to evaluate the relationship between gut dysbiosis, clinical phenomenology of AUD, and a brain-based biomarker in individuals with AUD and matched controls. Specifically, 64 individuals with AUD and 64 matched healthy

controls will provide a fecal sample to localize the effects of chronic alcohol use on the gut microbiome. Participants will also provide a blood sample to evaluate gut permeability through serum biomarkers. Participants will also complete an in- depth neuroscience-informed clinical assessment battery, which will allow for phenotyping individuals into the three domains of the Addiction Neuroclinical Assessment (ANA): incentive salience, negative emotionality, and executive dysfunction. Finally, participants with AUD will complete an alcohol cue-reactivity neuroimaging task to obtain a brain-based biomarker of AUD. The specific aims of the proposed project are: (1) to identify the gut microbiota discriminating individuals with AUD from controls; (2) to evaluate the relationship between the gut microbiome and AUD phenomenology; and (3) to test the relationship between gut microbiota and a brain- based biomarker for AUD.  

RAP Responsibilities: 

• Phone screening potential participants
• Scheduling participant visits 
• Running behavioral screening visits
• Collecting clinical research data from participants
• Participating in MRI data collection (acting as safety second)
• Assisting with literature searches
• Potential for writing abstracts and posters

mHealth for Heart Failure: Predictive Models of Readmission Risk and Self-care Using Consumer Activity Trackers- R01 [IRB 19-000399]

PI: Corey Arnold, PhD

Study Liaison: Mirna Issa

Description: Gay, bisexual, transgender, and homeless youth are at high risk of HIV infection and other sexually-transmitted infections, as well as other public health concerns like mental health, homelessness, and substance use - especially so if they are Black and/or Latino due to racial/ethnic disparities. In this study, youth in Los Angles and New Orleans, were followed over 24 months and interviewed about sexual health, mental health, economic security amongst other things as they were undergoing 4 different interventions methods. Using these interviews, the study hopes to find primary and secondary outcomes to inform understanding of risk relationships, policy proposals, and improvements to strength-based, youths-centered coaching model.

RAP Responsibilities: CTSI-RAP students, each week, go through the transcribed interviews and conduct a qualitative analysis on the topic of interest, such as strengths with mental health, in the qualitative research software, Dedoose. They read the file, highlight excerpts, and code them to the respective parent, child, and grandchild code that they see fit.

QUIT MOBILE: mHealth to Enhance & Sustain Drug Use Reductions of the QUIT BI in Primary Care [IRB 20-000088]

PI: Lillian Gelberg, MD and Dallas Swendeman PhD, MPH

Study Liaison: Ishika Seth

Description: QUIT-Mobile is a NIDA-funded R01 randomized controlled trial (RCT) of screening, brief intervention, and referral to treatment (SBIRT) for moderate risk substance use to prevent addiction among primary care patients in Los Angeles Federally Qualified Health Centers (FWHC) community clinics over 12-month follow-up. The study compares usual care to the QUIT intervention (PCP brief advice at primary care visit, brief 30-minute telehealth coaching sessions at 2-weeks and 6-weeks post primary care visit, demonstrated efficacious at 3-month follow-up in prior RCTs), and the novel QUIT-Mobile intervention that incorporates weekly self-monitoring by mobile-web app or text messaging plus automated feedback text-messaging to enhance and sustain the effects of the PCP brief advice and coaching intervention. Piloting is concluding and full RCT is launching in February 2021. All procedures have been re-designed for the telehealth environment with remote mobile-web based screening, enrollment, and assessment, in addition to in-person clinic waiting room procedures as covid precautions allow.  The project will be recruiting for 2.5 years. The Multiple Principal Investigators are Dr. Lillian Gelberg, M.D., M.P.H., in the Department of Family Medicine and Dr. Dallas Swendeman, Ph.D., M.P.H., in the Department of Psychiatry and Biobehavioral Sciences.

RAP Responsibilities: 

Administrative support and follow-up in patient screening and assessment, such as:

• Entering patient data from EHRs into the study mobile-web system
• Mailing urine drug screen kits to patients
• Mailing study letters to patients
•  Texting and emailing patients and PCPs to follow-up on completion of screening and study assessments. 
• Similar support will be needed in clinics when covid precautions allow. When the team is recruiting in person, students can help research assistants set up our study outreach table.

As study data is collected, support could be provided in:

• Study data management and cleaning
• Qualitative data coding and analysis of implementation science focused stakeholder discussions of the study and its activities from meeting notes with clinic stakeholders and new potential clinic partner meetings. 

Students might also participate in training and eventually delivery of the telehealth coaching intervention focused on substance use and co-occurring quality of life factors using elements of motivational interviewing and cognitive behavior therapy

Rheumatology - Hydroxychloroquine for Systemic Lupus Erythematosus [IRB 20-002231]

PI: Maureen McMahon, MD

Study Liaison: Sara Piao

Description: 1. Determine the cross-sectional frequency of anti-retinal antibodies in a cohort of 285 patients with SLE and 100 healthy age-matched controls, and determine the relationship with a) the length of HCQ exposure and b) the relationship with abnormalities on retinal screening tests, and 2. Prospectively examine the impact of HCQ on anti-retinal antibody formation and conditions leading to antibody formation by testing: a. whether exposure to HCQ induces anti-retinal antibodies by testing a cohort of 45 SLE patients prior to any HCQ exposure, 3 months, 6 months, and 9 months after exposure, and b. Determine possible retinopathy mechanisms in SLE patients taking HCQ by examining PBMCs from patients before and after HCQ treatment vs. patients with retinopathy for IL10/IFNgamma secretion. These studies should give us a more thorough insight into the potential role of anti-retinal AAbs as predictors of HCQ toxicity in SLE and might provide a simple test to identify SLE patients at greater risk for retinopathy. Studies may also implicate an autoimmune mechanism rather than true HCQ toxicity in some patients.

RAP Responsibilities: CTSI-RAP students function as clincal coordinator assistants within the research study. Students conduct patient screening to determine study eligiblity for prospective participants, audit and maintain patient files, optimize and conduct study participant recruitment strategies, and observe consenting process and guidance of subjects through experimental procedures. Students also assist with blood sample handling and processing. Students will escort patients to study appointments within the UCLA-Westwood campus and conduct phone calls to study participants to ensure their return for follow-up testing. CTSI-RAP students will become familiar with UCLA electronic medical record system by accessing patient charts for data collection and analysis.

Rheumatology - Belimumab for Early Lupus [IRB 19-002181]

PI: Maureen McMahon, MD

Study Liaison: Sara Piao

Description: Belimumab (also known as BENLYSTA™), given into a vein by intravenous (IV) infusion, has been approved in the United States, Canada, Europe and Japan for the treatment of adults with active SLE who are receiving other lupus medicines. However, the effects of belimumab when it is given to patients with early lupus (within 2 years of diagnosis) who have not received lupus medications other than hydroxychloroquine(Plaquenil) are not known. Belimumab has additionally been approved in the United States to be given as a subcutaneous injection which is an injection under the skin. In this study, belimumab will be given as a subcutaneous injection (under the skin).This is randomized double-blind placebo controlled trial of belimumab in 30 subjects with early lupus with mild to moderate clinical symptoms and evidence of autoreactivity. Subjects will be randomized in a double-blind, placebo-controlled fashion in a 2:1 ratio to receive treatment with subcutaneous belimumab 200 mg weekly and stratification of study arms after one year of treatment. Study objectives are as follows: Primary objective: To evaluate the immunologic effects of belimumab in early SLE Secondary objectives: 1)To evaluate the clinical effects of belimumab in early SLE (2) To evaluate safety and tolerability of belimumab in early SLE (3) To evaluate the immunologic effects of belimumab withdrawal in early SLE (4) To evaluate effects of belimumab on cardiovascular risk in early SLE.

RAP Responsibilities: CTSI-RAP students function as clinical coordinator assistants within the research study. Students conduct patient screening to determine study eligibility for prospective participants, audit and maintain patient files, optimize and conduct study participant recruitment strategies, and observe consenting process and guidance of subjects through experimental procedures. Students also assist with blood sample handling and processing. Students will escort patients to study appointments within the UCLA-Westwood campus and conduct phone calls to study participants to ensure their return for follow-up testing. CTSI-RAP students will become familiar with UCLA electronic medical record system by accessing patient charts for data collection and analysis.

Pediatric Immunology and Allergies [IRB 19-001413, 20-000897]

PI: Maria Garcia-Loret, MD

Study Liaison: Sohan Talluri

Description: EPOPEX: This is an open-label, follow-up study for subjects who completed the EPITOPE study. The objectives of this follow-up study are to assess the clinical benefit of Viaskin Peanut after up to 3 years of epicutaneous immunotherapy (EPIT) to induce/maintain desensitization to peanut in peanut-allergic children and to evaluate the safety of long-term treatment with Viaskin Peanut. Repeated daily application of Viaskin Peanut dosed at 250 ìg peanut protein per patch is planned for 2 years or 3 years. Food challenges will be conducted after 1, 2 and 3 years of EPIT treatment with Viaskin Peanut.

COMBINE: This is a prospective Phase 2, multi-allergen oral immunotherapy (OIT) study in participants with proven allergies to 2 or 3 different foods in which one must be peanut. Our intent is to treat a population of 110 participants, ages 5 to 55 years, with combinations of placebo, omalizumab, and dupilumab. All cohorts will receive multi-food allergen oral immunotherapy. At week 32, participants will discontinue treatment and will undergo food challenges. Participants who tolerate food challenges will stop active OIT dosing and undergo food challenges at week 44. Participants who tolerate food challenges at week 44 will be considered as achieving sustained unresponsiveness.

VITESSE: This is a 12-month, Phase 3, double-blind, placebo-controlled, randomized study to assess the efficacy and safety of daily DBV712 250 ìg in peanut-allergic children aged 4-7 years. The study duration is approximately 58 weeks: 4-week Screening Period, 12-month Treatment Period and 2-week Follow-up Period. 600 subjects will be enrolled in a 2:1 ratio (400 subjects in the DBV712 250 ìg group and 200 subjects in the placebo group). Subjects will apply either DBV712 250 ìg or placebo daily for a period of 12 months. At Month 12, a post-treatment food challenge will be performed.

ADORED: This is a Phase 1b/2, randomized, double-blind, multi-center study to evaluate the safety, tolerability, and preliminary clinical efficacy of STMC-103H in neonates and infants at risk for developing allergic disease (Type 1 hypersensitivity). Participants in the safety-run portion of the study will receive 28 days of treatment with STMC-103H or placebo, followed by 28 days of follow-up. Afterwards, we will enroll 224 patients for 336 days of treatment with STMC-103H or placebo, followed by 336 days of follow-up. The primary efficacy endpoint is incidence of physician-diagnosed atopic dermatitis at day 336.

Long Term OIT Follow-up Study: Efficacy and compliance of oral immunotherapy (OIT) for food allergy has not been examined beyond two years of treatment. The objective of the Long Term OIT Follow-up study is to conduct a telephone survey of patients previously enrolled in our OIT programs (both clinical and research). We will assess patient satisfaction, compliance with prolonged treatment, adverse events, and effects on their quality of life.

RAP Responsibilities: - Patient recruitment

- Coordinating patient visits

- Participation in the consenting process

- Patient interaction during telephone and physical visits

- Collection of clinical research data

- Data entry and data analysis

- Observation of procedures (food challenges, OIT updosing, etc.)

- Involvement in case conferences and journal clubs

- Write-up of study applications, papers, abstracts, and posters

Imaging of intraocular inflammation [IRB 19-001732]

PI: Edmund Tsui, MD

Study Liaison: Nicolette Zargari

Description: Uveitis (inflammation inside the eye) is one of the leading causes of blindness and is associated with significant complications such as vision loss, band keratopathy, and uveitic glaucoma. Therefore, the evaluation and detection of inflammation is critical in management of uveitis. Utilizing state of the art ophthalmic imaging technology will provide objective, reproducible measures of intraocular inflammation that can be quantified and monitored longitudinally. The proposed study will enroll all consecutive patients with either non-infectious or infectious uveitis in the Uveitis Service at the Stein Eye Institute. Each participant will undergo their routine clinical examination at the Stein Eye Institute, which will include a full clinical examination and photos to be taken of the eye using cameras, such as anterior segment optical coherence tomography, laser flare photometry and other ancillary testing which would be performed routinely as part of their clinical care.

RAP Responsibilities: 

• Collection of clinical research information
• Observation of procedures
• Transfer of imaging data
• Assisting with creation of REDCap database

Study of ocular disease using hyper parallel OCT [IRB 20-000286]

PI: Edmund Tsui, MD

Study Liaison: Nicolette Zargari

Description: A novel imaging technology termed Hyper Parallel OCT (HP-OCT) will be used to evaluate patients with cataracts, corneal disease, macular disease, optic nerve disease, iris changes that may occur from associated ocular diseases and procedures and uveitic diseases. Imaging obtained with theHP-OCT will be compared to routine standard of care imaging.

RAP Responsibilities: 

• Collection of clinical research information
• Observation of procedures
• Transfer of imaging data
• Assisting with creation of REDCap database

Alzheimer's Disease Neuroimaging Initiative [IRB 16-002070]

PI: Maryam Belgi, MD

Study Liaison: Brittney Luong, Ashley Ko

Description: The goal of the ADN13 is to continue to improve clinical trial measures and biomarkers used in Alzheimer’s disease research, and to study novel interventions for treatment/prevention of AD. This is a longitudinal observation study enrolling cognitive unimpaired, MCI, or mild AD dementia patients. The durations is for 2 to 5 years. Rates of cognitive and functional decline, likelihood of progression to MC/AD, brain scans, and biomarkers will be collected and analyzed. Also, patients will be consented for brain autopsy donation in order to study the value of brain autopsies in diagnosing AD. ADN13 will rollover to the ADN14 protocol between 2022 and 2023, with similar goals. Additional goals will be to increase recruitment and retention of participants from underserved populations (e.g. Black/African American, LatinX, Asian American and Pacific Islander). 

RAP Responsibilities: 

• Assist research coordinator with study visits per protocol. 
• Assist with Initiating and maintaining partnerships in the community with underrepresented communities In research to raise awareness and improve access to clinical research studies at e UCLA Easton Center. Assist with recruitment, enrollment of eligible community members, manage and coordinate research participant activities, perform evaluations including cognitive testing, and implement retention strategies.
• Must comp y with Federal Regulations, Good Clinical Practice (GCP), and University and Clinical Partner policies as it relates to assigned research protocols.
• Assist with communicating with UCLA IRB, sponsoring agencies, principal investigator(s), other service providers, participants, families, and research team members.
• Assist with timely and accurate data entry and regulatory (IRB) publication (does not include the actual IRB submission); engage with providers and investigators to ensure adequate source documentation is available; assist with maintenance of participant research charts.
• Assist with other supportive activities (e.g., administrative assistance with moving documents for record retention, optimizing workspace for current studies.)

Universal Consent and AtLAs: UCLA Quality Initiative-Universal Consent for Biological Samples use for Research [IRB 15-001395]

PI: Arash Naeim, PhD

Study Liaison: Jyotsna Hirandani

Description: The Universal Consent was developed by the UCLA CTSI’s Embedded Clinical Research and Innovation Unit (ECRI) to ensure that all UCLA Health patients have an opportunity to tell us whether they want blood from leftover lab tests used for research.  It is important for patients to let us know how they want their de-identified (no identifying information) biological samples (blood, saliva, skin, leftover specimens) and clinical data used for a variety of research purposes. UCLA is also using the Universal Consent as the primary recruitment engine for the UCLA ATLAS Community Health Initiative. Before signing the consent, our participants view a short video outlining the goal of the initiative and document their choice.

RAP Responsibilities: 

• Study of clinic workflow
• Participant recruitment
• Recruitment and enrollment metrics

Cardiology: Study of metabolomics and gene expression correlated with myocardial infarction in patients [IRB 22-001562 or 22-001058]

PI: Jessica Wang, MD

Study Liaison: Jyotsna Hirandani

Description: The Universal Consent was developed by the UCLA CTSI’s Embedded Clinical Research and Innovation Unit (ECRI) to ensure that all UCLA Health patients have an opportunity to tell us whether they want blood from leftover lab tests used for research.  It is important for patients to let us know how they want their de-identified (no identifying information) biological samples (blood, saliva, skin, leftover specimens) and clinical data used for a variety of research purposes. UCLA is also using the Universal Consent as the primary recruitment engine for the UCLA ATLAS Community Health Initiative. Before signing the consent, our participants view a short video outlining the goal of the initiative and document their choice.

RAP Responsibilities: 

• Study of clinic workflow
• Participant recruitment
• Recruitment and enrollment metrics

Pediatrics Rare Diseases - Clinical Trial of Leniolisib in APDS for Children [IRB 23-5092 and 22-5030]

PI: Manish Butte, MD, PhD

Study Liaison: Isabella Machado

Description: Safety and efficacy of using Leniolisib in a pediatric population. This is a rare disease where patients will be seen for a duration of 1.5 years. This is two separate studies with nearly identical protocols.

RAP Responsibilities: 

• Attend CTRC visits 
• Data Entry
• Regulatory documents

Targeted Upstream Prevention (T-UP) Diabetes Prevention [IRB Pending]

PI: Lauren Wisk, PhD

Study Liaison: Ashley Michel, Ashley Ko

Description: One-in-four youth are currently living with prediabetes but are less likely than older age groups to know that they are at risk for type 2 diabetes and disparities are pervasive. The Diabetes Prevention Program (DPP) is an intensive lifestyle intervention proven to significantly reduce the risk of developing type 2 diabetes, but startlingly few adolescents/young adults (AYA) participate in this program. Improving the delivery of this program for AYA, especially those who are most at risk for later disparities in diabetes incidence and outcomes, has enormous potential to generate meaningful improvements in their health and well-being and to mitigate the burden of diabetes for already vulnerable populations. This project seeks to empirically test age-and culturally-tailored enhancements to University of California (UC) DPP for their efficacy (Aim 1) and acceptability (Aim 2) for program recruitment, retention, and impact (on weight change) in a pre/post pilot trial among vulnerable AYA. Qualitative methodologies will then be used to identify barriers and facilitators of program completion in order to identify further opportunities to improve implementation of the intervention for students (Aim 3). This work will utilize the considerable existing resources of the UC DPP Initiative as the basis for recruitment and service delivery. Findings from this study can inform diabetes prevention efforts across the UC system and beyond in that novel enhancements can be used to reach AYA at greatest risk for diabetes disparities who are also the least likely to engage in diabetes prevention.

RAP Responsibilities: Participation in the collection of clinical research information (both qualitative and quantitative), observation of procedures, some basic data analysis, write up of abstracts, posters or paper, including literature searches, assisting with outreach materials

UCLA Bipolar Disorder – 2 [IRB 23-5190]

PI: Jennifer Kruse, MD

Study Liaison: Grace Sawyer, Libby Stafford

Description: The purpose of the Integrated Network (BD2 Study) is to improve the health and well-being of people living with bipolar disorder by engaging a network of collaborating investigators and clinicians to implement and inform data-driven improvements in care, build an unprecedented data ecosystem for bipolar disorder comprised of longitudinal clinical and biological data, generate novel insights for interventional approaches. Following phone screening to determine potential eligibility, participants will undergo two in-person sessions. Following informed consent, the first session will consist of a blood draw, questionnaires, cognitive testing and a 60-minute MRI scan. At the end of the first session, participants will be asked to complete remote interim assessments consisting of diaries, questionnaires, and use of a wearable data collection device. The second session will occur approximately 12 months later, and will once again consist of a blood draw, questionnaires, cognitive testing and a 60-minute MRI scan.

RAP Responsibilities: 

1) Conducting phone screening of potential subjects

2) Preparing recruitment materials, such as recruitment outreach letters

3) Scheduling participants for in-person clinical visits

4) Administration of structured interview and assessment materials

5) Preparation and download of wearable data collection devices

6) Assisting as a Second Safety for MRI scans

7) Assisting project coordinator with remote and in-person patient evaluations (ie: cognitive assessments)

8) Data entry and cleaning

9) Accompanying participants from one campus location to another

10) Transporting blood specimens from one campus location to another

Cardiac Neuromodulation Therapy Database [IRB 23-000056]

PI: Olujimi Ajijola, MD, PhD

Study Liaison: Nicolette Simoni

Description:

RAP Responsibilities: 

Experimental Models of Depression and Aging: anxiety, inflammation, and reward mechanisms [IRB 21-001246]

PI: Chloe Boyle, PhD

Study Liaison: Daniel Hong

Description: The purpose of this study is to use an experimental inflammatory challenge to examine whether older adults with symptoms of anxiety experience loss of pleasure or loss of motivation when they are exposed to inflammation. Loss of pleasure or loss of motivation will be evaluated using self-report questionnaires, computer tasks, and during a brain scan. Participants will undergo phone screening, two in-person visits, and telephone follow-up. The first visit will last 4 hours and the second visit will last 10.5 hours.  Phone Screening and Visit #1: following phone screening to determine potential eligibility, participants will have an in-person evaluation. Following informed consent in the first session, participants will undergo semi-structured clinical interviews and complete questionnaires to assess medical- and medication histories; current- and past history of psychiatric disorders, and evaluation of behavioral symptoms of anxiety and depression. They will also complete behavioral reward tasks. Visit #2 and telephone follow-up the second session begins at 7:30AM and involves placement of two intravenous catheters, evaluation of heart rate and blood pressure, administration of endotoxin vs. placebo, repeated blood sampling, computer tasks, and self-report questionnaires for 10.5 hours. Two hours post-injection participants will complete a 1-hour brain scan. Study staff will escort the participant to a nearby facility to complete the brain scan. 24 hrs and 2-weeks following this session, staff will call the subject and ask about physical and mood symptoms.

RAP Responsibilities: 

• Assist with patient screening (via standardized phone script) and recruitment (sending out letters) at the Cousins Center Call Center
• Administer behavioral tests and questionnaires during experimental appointments and complete mood assessments via phone.
• Assist in fMRI scans as a “safety second” - this will be under the direct supervision of the study PI. This will require the student to be available from 11:40AM-12:50PM on weekdays to attend the scan (the specific day will depend on the scheduling availability at the CTRC). The student will have the opportunity to learn how to conduct fMRI safety screening, set up a participant for a scan, and collect data. The student may also assist in patient transport from the CTRC to CCN for the fMRI scan (and vice versa).
• Participate in bi-weekly journal club/lab meetings; focus will be on study review, preparing abstracts/posters/papers (depending on the level of interest in the student); conducting literature searches (related to anxiety, inflammation, aging, and reward).
• Data analysis and preparation

Adolescents HIV Trials Network and ATN-CARES [IRB 16-001819]

PI: Dallas Swendeman PhD, MPH

Study Liaison: Curtis Wong

Description: Gay, bisexual, transgender, and homeless youth are at high risk of HIV infection and other sexually-transmitted infections, as well as other public health concerns like mental health, homelessness, and substance use - especially so if they are Black and/or Latino due to racial/ethnic disparities. In this study, youth in Los Angles and New Orleans, were followed over 24 months and interviewed about sexual health, mental health, economic security amongst other things as they were undergoing 4 different interventions methods. Using these interviews, the study hopes to find primary and secondary outcomes to inform understanding of risk relationships, policy proposals, and improvements to strength-based, youths-centered coaching model.

RAP Responsibilities: CTSI-RAP students, each week, go through the transcribed interviews and conduct a qualitative analysis on the topic of interest, such as strengths with mental health, in the qualitative research software, Deduce. They read the file, highlight excerpts, and code them to the respective parent, child, and grandchild code that they see fit.

Pediatric ASXL and Biobank Studies [IRB 18-001553, 22-000182]

PI: Bianca Russell, MD

Study Liaison: Amanda Piring

Description: Clinical Registry for ASXL-Related Disorders and Disorders of Chromatin Remodeling study aims to learn better ways of caring for individuals with chromatin remodeling disorders through gathering information about progression, treatments, and outcomes. The Characterization of the Neurological Features of Bohring-Opitz Syndrome study aims to better understand brain activity of children with Bohring-Opitz Syndrome through by analyzing EEG data. Our goal is to better understand learning and brain wave patterns in order to comprehend how BOS impacts the brain.

RAP Responsibilities: 

• Participation in the consenting process
• Collection of clinical research information 
• Parent interview 
• Enter data into database
• Data Analysis
• Helping coordinate study visits

Neurocognition, Depression, and Alzheimer's; Long-haul COVID [IRB 15-000184; 17-001218;17-001876; 18-001442]

PI: Helen Lavretsky, MD, MS

Study Liaison: Jonathan Malau

Description: There are several studies under Dr. Lavretsky. We perform clinical trials with antidepressants for treatment resistant depression, compare brain activation and functional connectivity of the amygdala during exposure to visual art/nature stimuli vs. neutral stimuli, and use MRI to study the blood-brain barrier for participants with and without COVID-19.

RAP Responsibilities: RAP student responsibilities include the following: telephone screenings, participating in consent process, collection of clinical research information, data entry, transport of biological samples, observations of procedures, MRI second safety, and write-ups of abstracts and posters.

Impact of COVID-19 Pandemic on the Lives and Livelihoods of Sex Workers and their Families in West Bengal, India [IRB 21-001402]

PI: Dallas Swendeman PhD, MPH

Study Liaison: Katarina Scala

Description: The COVID-19 pandemic had a devastating impact in India, with over 45 million confirmed cases and 500,000 deaths to date. In response to the pandemic, the government of India implemented one of the strictest lockdowns in the world with only essential travel outside the home permitted at certain hours. Although sex work is legal in India, sex workers face persistent stigma alongside elevated HIV risk. Global literature has shown that the COVID-19 pandemic disproportionately impacted communities with pre-existing vulnerabilities, including sex workers, whose work often requires close physical proximity. The present project is a mixed-methods, cross-sectional study of male, female, and transgender completed with a local community-based organization. The project includes a quantitative survey of over 200 sex workers and qualitative individual in-depth interviews with 40 sex workers. The study seeks to understand the impact of the COVID-19 pandemic and lockdowns on the lives and livelihoods of sex workers and their families in West Bengal, India. Female, male, and transgender sex workers were recruited from five areas in Kolkata, West Bengal, through our research partner Durbar Mahila Samanwaya Committee (Durbar). Durbar’s empowerment-based approach has been recognized by the WHO as a model HIV/STI prevention program, and Durbar has a long-standing research partnership with centers at UCLA. Qualitative and quantitative data analysis and manuscript preparation are in progress. 

RAP Responsibilities: 

• Literature reviews
• Draft manuscript sections for qualitative and quantitative papers
• Draft abstracts using qualitative and quantitative data
• Draft posters for qualitative and quantitative analyses
• Qualitative data analysis (coding using Dedoose software) 
• Quantitative data analysis support 

Brown Adipose Tissue Activity in Response to Semaglutide Administered to Obese Subjects [IRB 22-000718]

PI: Preethi Srikanthan, MD

Study Liaison: Nicolette Simoni

Description:

RAP Responsibilities: 

Pediatric Neurology: Developmental Synaptopathies Associated with TSC, PTEN, and SHANK3 Mutations [IRB 15-000205]

PI: Rajsekar Rajaraman, MD, MS

Study Liaison: Amanda Piring

Description: An observational, prospective, longitudinal, multi‐center study looking at Tuberous Sclerosis Complex (TSC) patients to characterize developmental phenotype of Autism Spectrum Disorder (ADS) and Intellectual Disabilities (ID). There will be 20 participants enrolled locally and 195 across all sites.

RAP Responsibilities: 

• Participation in the consenting process
• Collection of clinical research information
• Parent interview
• Coordinating visits
• Maintaining subject binders
• Observation of procedures (blood draw/EEG)
• Enter data into database

A Phase 3, Randomized, Double-Blind, Placebo-Controlled, Fixed-Dose, Multicenter Study to Examine the Efficacy and Safety of ZX008 in Subjects with CDKL5 Deficiency Disorder Followed by an Open-Label Extension [IRB 22-001758]

PI: Rajsekar Rajaraman, MD, MS

Study Liaison: Kaitlyn Smolens

Description: CDKL5 deficiency disorder is a rare developmental epileptic encephalopathy caused by mutations in the CDKL5 gene, and this can manifest in a broad range of clinical symptoms and severity. Core symptoms are epilepsy and severe developmental delays. Study is composed of two parts the double-blind portion followed by open-label extension. There will be 80 subjects enrolled and up to 2 subjects at UCLA. Part 1 has screening, titration, maintenance and transition period. In total, there are 8 visits (6 in-person and 2 phone call follow-ups). Subjects will be evaluated for overall health, adverse events, have laboratory tests, answer questionnaires and when required an ECHO. In person visits can take between 1-3 hours. Phone calls will take up to 30 minutes. Part 2 has a total of 10 visits. All visits will be in-person. Subjects will be evaluated for overall health, adverse events, have laboratory

tests, answer questionnaires and when required an ECHO. In person visits can take between 1-3 hours.

An observational, prospective, longitudinal, multi‐center study looking at Tuberous Sclerosis

Complex (TSC) patients to characterize developmental phenotype of Autism Spectrum

Disorder (ADS) and Intellectual Disabilities (ID). There will be 20 participants enrolled locally

and 195 across all sites.

RAP Responsibilities: 

• Participation in the consenting process
• Collection of clinical research information
• Parent interview
• Coordinating visits
• Maintaining subject binders
• Observation of procedures (blood draw/EEG)
• Enter data into database

OVID: TAK-935 (OV935) as Adjunctive Therapy in Patients with Developmental Epileptic Encephalopathies Including Dravet Syndrome, Lennox Gastaut Syndrome, CDKL5 Deficiency Disorder, and Chromosome 15 Duplication Syndrome (ENDYMION) [IRB 19-001569]

PI: Rajsekar Rajaraman, MD, MS

Study Liaison: Kaitlyn Smolens

Description: CDKL5 deficiency disorder is a rare developmental epileptic encephalopathy caused by mutations in the CDKL5 gene, and this can manifest in a broad range of clinical symptoms and severity. Core symptoms are epilepsy and severe developmental delays. Study is composed of two parts the double-blind portion followed by open-label extension. There will be 80 subjects enrolled and up to 2 subjects at UCLA. Part 1 has screening, titration, maintenance and transition period. In total, there are 8 visits (6 in-person and 2 phone call follow-ups). Subjects will be evaluated for overall health, adverse events, have laboratory tests, answer questionnaires and when required an ECHO. In person visits can take between 1-3 hours. Phone calls will take up to 30 minutes. Part 2 has a total of 10 visits. All visits will be in-person. Subjects will be evaluated for overall health, adverse events, have laboratory

tests, answer questionnaires and when required an ECHO. In person visits can take between 1-3 hours.

An observational, prospective, longitudinal, multi‐center study looking at Tuberous Sclerosis

Complex (TSC) patients to characterize developmental phenotype of Autism Spectrum

Disorder (ADS) and Intellectual Disabilities (ID). There will be 20 participants enrolled locally

and 195 across all sites.

RAP Responsibilities: 

• Participation in the consenting process
• Collection of clinical research information
• Parent interview
• Coordinating visits
• Maintaining subject binders
• Observation of procedures (blood draw/EEG)
• Enter data into database

RHEUM CMCR Cannabidiol (CBD) in RA [IRB 19-001551]

PI: Veena Ranganath, MD, MS

Study Liaison: Sam Duong-Brett

Description: This study seeks to assess the efficacy and safety of cannabidiol use in patients with moderate to severe rheumatoid arthritis.

RAP Responsibilities: Associates assist with compilation of patient data, data entry and organization, recruiting eligible study participants, blood transport, and logistical preparation as needed.

Serum Collection in Healthy AB Donors [IRB:18-000099]

• PI: Antoni Ribas, MD, PhD
• Study Liaisons: Serena Burgos, Michelle Tenggara
• The purpose of this protocol is to collect serum from healthy donors with AB blood type to aid in the expansion of Tumor Infiltrating Lymphocytes (TILs) in vitro in the Ribas laboratory at UCLA. The ability to expand TILs in vitro from resected material has been demonstrated to require a high-quality source of human AB serum, of which commercially available products have been demonstrated to be ineffective.

An Exploratory Study of Nivolumab with or without Ipilimumab in Advanced Metastatic Cancer [IRB:18-001539]

• PI: Alexandra Drakaki, MD, PhD
• Study Liaisons: Serena Burgos, Michelle Tenggara
• This is an open-label, exploratory study to evaluate nivolumab with or without ipilimumab based on the percentage of CD8 cells in a patient's tumor. This study is open to any type of solid tumor. The primary objective is to assess the proportion of participants whose tumor change from CD8 low to CD8 high, based on the percentage of CD8 cells in the tumor.

Monocyte E-cigarette Study[IRB:18-001147]

• PI: Holly Middlekauff, MD
• Study Liaison: Joyce Ma
• The study is a randomized, controlled study. The goal of the study is to understand the health effects of electronic e- cigarettes compared to tobacco cigarettes or not smoking at all. Specifically, the study attempts to determine whether using an e-cigarette (for chronic e-cigarette users and non-users) for approximately 30 minutes or smoking a tobacco cigarette for chronic tobacco cigarette smokers will change the blood level of inflammatory markers in the subject's blood.

Sleep Health Aging Research for Depression [IRB:16-000583]

• PI: Michael Irwin, MD
• Study Liaison: Michelle Tenggara, Angela Wang, and Jordan Lo
• Late-life depression is a significant public health concern, and effective interventions for prevention and treatment are needed. Insomnia and inflammation are modifiable targets for depression prevention, and this study is significant in using an experimental approach (i.e., inflammatory challenge) to probe acute inflammatory and depression responses as a function of insomnia, which will inform identification of molecular targets for pharmacologic interventions, and improvement of insomnia treatments to prevent depression in older adults.

ICVD Diagnosis by PhekB [IRB: 18-001167]

• PI: Jessica Wang MD, PhD
• Study Liaison: Hyejin Hong
• Familial Hypercholerolemia (FH) is a commonly inherited cardiovascular disease that is clinically underdiagnosed. This study aims to develop an algorithm to identify individuals who are at high risk for FH. This is done by filtering through various key factors such as LDL levels, family history, and statin use. We hope to refine the algorithm in order to increase its scope of diagnosis.

Polycystic Ovary Syndrome [IRB: 12-001780]

• PI: Daniel Dumesic, MD
• Study Liaison: Sohini Halder, Aditya Mamtora
• Polycystic Ovary Syndrome (PCOS) is an endocrine system disorder caused by hormone imbalance. Women with PCOS have enlarged ovaries filled with small collections of fluid. Symptoms include irregular menstrual cycles, pelvic pain, and infertility, and associated long-term complications are Type II diabetes, heart disease, and endometrial cancer. The purpose of this research study is to identify changes that take place in the body that result in PCOS by collecting specimen samples and medical information from women with or without PCOS. As part of this study, all patients will undergo a physical exam, blood tests, diagnostic procedures and surveys. Women with PCOS will be placed in randomized groups to receive the drug flutamide or a placebo in 6 - 28 day cycles until all post treatment assessments are completed.

The Dilated Cardiomyopathy (DCM) Consortium

• PI: Martin Caderias, M.D; Jessica Wang, MD, PhD
• Study Liaison: Mario Martinez, Terry Nguyen, Eman Burney 
• The DCM Consortium is a national registry aiming to identify a genetic cause of dilated cardiomyopathy (DCM) by gathering DNA samples and survey information from 2000 families affected by idiopathic DCM in the US.

The Myocardial Infarction Biomarkers Project [IRB: 16-002018]

• PI: Linda Cai MD, PhD; Rushi Parikh, MD
• Study Liaison: Diana Trujilo
• The MI Biomarker Project is being performed in order to better understand myocardial infarction (MI also known as a heart attack) by better characterizing a biological marker of interest, netrin-1-DCC, or netrin-1. Netrin-1 has been identified as a biomarker that improves cardiac function in mice. By collecting blood samples from patients that have recently had a heart attack, we are trying to better characterize the relationship between pathways of netrin-1 signaling and various characteristics of heart attacks in patients, including clinical information about cardiovascular risk factors and outcomes. There is also a genetic component to the study, with the genetic information being collected through blood samples and studied in order to see any connections to heart attacks.

Pediatric Immunodeficiency Study [IRB:11-002303]

• PI: Donald Kohn, MD
• Study Liaisons: Xena Martinez, Bryanna Reinhardt 
• The major focus of the research is the development and implementation of gene therapy using hematopoietic stem cells (HSC). New approaches to gene therapy for ADA-deficient SCID are emphasized, such as the use of lentiviral and foamy viral vectors for ex vivo gene transfer to HSC, direct in vivo ADA gene delivery and ADA gene correction using site-specific endonucleases to augment homologous recombination. Investigators are determining whether using a lentiviral vector (based on HIV-1) will be more effective and safer at gene transfer to HSC compared to previous gene transfer vectors based on murine (mouse) retroviruses for ADA-deficient SCID. The study entails the treatment of infants and children diagnosed with ADA-deficient SCID, in which the EFS-ADA lentiviral vector with the human ADA cDNA is used to transduce autologous CD34+ cells from the bone marrow of the subjects. Following the re-infusion of the gene-modified cells, investigators look to determine whether the cells can engraft and produce mature cells that contain and express the corrected ADA gene in the absence of PEG-ADA enzyme replacement therapy (ERT). Efficacy studies are then conducted to evaluate the level of immune reconstitution in the first year and beyond.

The Inherited Cardiovascular Disease Registry (ICDR) [IRB:13-001772]

• PI: Jessica Wang, MD, PhD
• Study Liaisons: Mario Martinez, Terry Nguyen 
• The ICDR aims to understand genetic factors influencing heart- related disease progression within affected families. After whole exome sequencing or genetic tests, resulting data is statistically analyzed to characterize how genomic factors influence disease manifestation. Collected samples may also be used to advance the understanding of disease mechanisms within families or disease conditions to uncover treatment options in the future. 

Desmoid Tumors/Fibromatosis  [IRB: 18-001815]

• PI: Noah Federman, MD
• Study Liaisons: Aditya Mamtora, Jessica Osanyinpeju

Peanut Oral Immunotherapy [IRB:18-000124; 18-0001392]

• PI: Maria Garcia-Lloret, MD
• Study Liaisons: Jolene Chan, Brandon Ton

Pre-Operative Telemedicine Consultation  [IRB:19-000554]

• PI: Nirav Kamdar, MD
• Study Liaison: Muskaan Mehra, Anne Nguyen

Microbiome and Diet in Irritable Bowel Syndrome (IBS) [IRB:13-000080; 15-000691]

• PI: Lin Chang, MD; Swapna Joshi, PhD
• Study Liaison: Jolene Chan

Cannabis Questionnaire in Rheumatology Patients [IRB:19-001123]

• PI: Veena Raganath, MD, MS
• Study Liaison: Rebecca Phelan

Prospective Assessment of Premature Ventricular Contractions (PVCs) Supression in Cardiomyopathy (PAPS): A Pilot Study [IRB:18-001006]

• PI: Marmar Vaseghi, MD, PhD
• Study Liaisons: Gabrielle Le, Mayilone Sathialingam
• This study intended to assess how premature ventricular contractions (PVCs) affect heart function and which treatment strategy, radio frequency ablation or antiarrhythmic drugs, was more effective at eliminating PVCs and possibly improving heart function. Part I of this study compared the two standard of care therapies, and part II estimated the prevalence of cardiomyopathy and frequent PVCs in the overall population by evaluating ECG holter monitors.

The Caregiver Sleep (CARES) Study [IRB:16-001256]

• PI: Michael Irwin, MD
• Study Liaison: Michelle Tenggara, Dean Renna
• This study examined the ability of Mindfulness Meditation versus Cognitive Behavioral Therapy for Insomnia to reduce caregiver distress, improve sleep, and promote changes in overall health in caregivers age 50 and above. RAP students performed baseline patient assessments and eligibility interviews.

The Role of Vitamin C in Pediatric Critical Care [IRB:17-00128]

• PI: Michelle Korn, MD
• Study Liaison: Victoria Ford, Ryan McLaughlin, Ankita Nair
• As pediatric patients present a unique case due to their undergoing physical and neurological growth and development, this study aimed to better understand the role of Vitamin C in critically ill pediatric patients through measurement of Vitamin C levels throughout the child’s hospital stay. RAP students conducted informed consent process for patients, transported blood samples, and performed data collection and analysis.

The Teen Resilience Project (TRP) [IRB:16-001848]

• PI: Katie Kuhlman, PhD
• Study Liaison: Afrida Sara
• The Teen Resilience Project aimed to characterize the impact that acute stress has on immunological mechanisms in teenagers aged 12-15.  A biological response to the stress test can indicate disregulation of the immune system, which may correlate to a reduced response to stress throughout life.

Systemic Lupus Erythematosus (SLE) Atherosclerosis [IRB: 13-001285, 15-000786]

• PI: Maureen McMahon, MD
• Study Liaison: Harrison Lam
• Since the underlying mechanism for the accelerated atherosclerotic risk for SLE patients is not well understood, this study aimed to identify lipid and protein biomarkers to predict the risk of ATH in SLE patients by tracking the changes in arterial wall thickness and plaque buildup. 

BrainMapD - Threat and Reward Neurocircuitry  

• PI: Michelle Craske, PhD
• Study Liaison: Sienna Ringgenberg
• This study examined the relationship between threat- and reward-related neural circuitry and symptom dimensions of anxiety and depression during the transition from adolescence to adulthood. The study aimed to identify new strategies for psychiatric classification based on observable dimensions and their corresponding neural circuitry.

Undiagnosed Disease Network 

• PI: Katrin Dipple, MD, PhD; Stanley Nelson MD; Christina Palmer PhD; Eric Viliain MD, PhD
• Study Liaisons: Ryan McLaughlin, Elizabeth Tran 
• The Undiagnosed Diseases Network (UDN) worked to diagnose patients that previously could not be diagnosed by other physicians and medical centers. The UDN primarily conducted genetic testing in order to find mutations or genetic abnormalities in order to explain the patients' conditions. 

ADAPTABLE Trial 

• PI: Douglas Bell, MD, PhD
• Study Liaisons: Jack Buckanavage, Shirley Wong
• ADAPTABLE (Aspirin Dosing: A Patient-centric Trial Assessing Benefits and Long-Term Effectiveness) was a three-year pragmatic clinical trial compared the effectiveness of two different daily doses of aspirin which were widely used to prevent heart attacks and strokes in individuals living with heart disease.

POMA Phase 1 Interaction Study 

• PI: Keith Heinzerling MD
• Study Liaisons: Jack Buckanavage, Sienna Ringgenberg
• The study design was a randomized, double-blind, placebo-controlled multiple ascending-dose study with aims to determine the safety and tolerability of POMA, whether co-administration of POMA and methamphetamine (MA) alters the pharmacokinetics of MA and/or POMA, and whether treatment with POMA alters MA self-administration in a model of MA relapse.

UCLA Steve Tisch BrainSPORT

• PI: Christopher Giza, MD
• Study Liaison: Adrian Jones
• The UCLA Steve Tisch BrainSPORT program utilized clinical care, education, and research to characterize the true nature of clinical and physiological recovery after sport-related concussions (SRC). CTSI research associates are trained to assist the BrainSPORT multidisciplinary team with obtaining baseline concussion information from collegiate athletes and children. 

Neural, Inflammatory, and Genomic Mechanisms Underlying Risk for Depression in Adolescence

• PI: George M. Slavich, PhD
• Study Liaison: Mimi Lu
• This was the first integrative, multi-level fMRI study of both high (maternal history of depression) and low (no maternal history of depression) risk female adolescents and their responses to social stressors at the psychological, neural, physiological, molecular, and genomic level. RAP students participate in subject recruitment, observation of the consenting process, and guidance of subjects through experimental procedures. 

Cord Umbilical Blood Study (CUB)

• PI: Kara Calkins, MD
• Study Liaison: Stevyndennis Onggo
• The CUB research study assessed biomarkers in cord blood that may be indicators for hepatic issues such as Nonalcoholic Fatty Liver Disease (NAFLD). By analyzing the micro-RNA in the cord blood and studying the metabolomics of the individual, this study aimed to find associations to higher susceptibility to liver disease. CTSI-RAP students contribute by screening pregnant mothers for gestational age, among other factors, and consented qualifying patients before the baby was born.

PREDICTS - QRISK3 and Lupus and Depression [IRB:13-001285; 15-000786]

• PI: Maureen McMahon, MD
• Study Liaisons: Manpreet Singh, Sonia Lele 

Asthma Phenotypes Assessment [IRB:18-002015]

• PI: Mindy Ross, MD, MAS, MBA
• Study Liaison: Hyejin Hong 

Visual Aid - PrEP in HIV High Risk Youth 

• PI: Joan Christodoulou, PhD, MPhil
• Study Liaison: Disha Nangia 

USIDNET Registry for Immune Disorders [IRB:17-001393; 16-001950]

• PI: Manish Butte, MD, PhD

RUSH Project

• PI: Elizabeth Turner MD; Igor Barjaktarevic MD
• This study assessed whether systematic inclusion of a bedside ultrasound protocol early in the assessment of patients in shock (RUSH-Rapid Ultrasound in Shock) impacts clinically relevant outcomes. The RUSH evaluation included a focused and rapid assessment of cardiac function, intravascular volume status, large vessel pathology (aortic dissection, deep vein clots), and significant lung pathologies (effusion and pneumothorax).

Copper Touch

• PI: Daniel Uslan, MD
• The Copper Touch project aimed to assess the health benefits and costs of coating high touch surfaces within selected ICU rooms with copper-infused materials. Over a period of three years, the project compared the incidence of Healthcare-associated infections (HAIs) using data collected by the Infections Prevention teams. 

Actigraphy

• PI: Biren Kamdar, MD
• Actigraphy built upon a previous Intensive Care Unit (ICU) sleep quality improvement (QI) project by performing a multi-ICU intervention effort aimed at promoting nighttime rest and daytime activity in non-surgical critically ill adult patients. This observational pilot study assessed the feasibility of using the Philips Respironics Actiwatch 2 (AW-2) to measure patient rest and motion for ≥24 hours in non-surgical critically ill adult patients.

Orthostasis

• PI: Jeremy Moore MD, MPH; Benjamin Hendrickson, MD
• This project measured the orthostatic responses of asymptomatic children over a broad age range using common, easily obtainable methods that are available in the ambulatory setting. The data was used to create an age-based reference for normal ranges of orthostatic vitals and to identify characteristics that may influence those responses, enabling better care for pediatric patients with abnormal orthostatic responses or symptoms of orthostatic intolerance. 

Carotid-corrected Flow Time

• PI: Igor Barjaktarevic, MD
• Ultrasound assessment of systolic corrected flow-time in carotid arteries (ccFT) has been suggested as, potentially, an easy, non-invasive method to assess fluid resuscitation. This study assessed the value of ultrasonographic evaluation of the carotid artery in patients with shock as a tool to predict fluid responsiveness and to evaluate whether or not change in ccFT as a test can predict IV fluid responsiveness in shock states.

2024 Abstracts – Featured at the virtual 2023 Undergraduate Research Day at UCLA:

• Safety and Tolerability in Pediatric Patients Under Age 12
• 2024 RAP General Poster
• Baseline Inflammation is Positively Associated with Recent Drinking in Individuals with an Alcohol Use Disorder
• Characterization of Adaptive Behavior in Individuals with Tuberous Sclerosis and Cyclin-Dependent Kinase-Like 5 Deficiency Disorder Using the Vineland Adaptive Behavior Scale - Version 3
• Structural MRI correlates of Cognitive and Neuropsychiatric symptoms in Long-COVID
• Evaluating Epicutaneous Immunotherapy for Peanut Desensitization in Pediatric Allergy Patients

2023 Abstracts – Featured at the virtual 2023 Undergraduate Research Day at UCLA:

• UCLA CTSI Research Associates Program: A Clinical Research and Healthcare Sciences Initiative
• Development and Improvement on Thermal Imaging Methods and Technology as a Non-Invasive Measurement of Brown Adipose Tissue Activity in Humans
• A Mobile Health (mHealth) Home Monitoring Regimen to Improve Self-Care Adherence and Health Outcomes Among Heart Failure Patients
• Review of tuberous sclerosis-associated neuropsychiatric disorders (TAND): an analysis of completed TAND-L questionnaires in a UCLA Cohort
• Assessing the Relationship Between Body Image and Sexual Health Risk Factors Among Youth At-Risk or Living with HIV
• “There's a reason we call Whole Foods, WHOLE PAYCHECK": Barriers to Healthy Diet and Exercise Among Youth At-Risk for and Living with HIV

2021 Abstracts - Featured at the virtual 2021 Undergraduate Research Day at UCLA:

• Assessing the Reproductive Life History of Women Through Alzheimers Related Inflammation
• Effect of Tai Chi on Quality of Life in Older Adults with Major Depression
• Identifying Variation in Community-Level COVID-19 Case Counts and Health Determinants to Promote Safer Behaviors Amidst the Los Angeles Unified School District (LAUSD) Reopening
• Impacts of COVID-19 On Chronic Disease Management - A Mixed Methods Study
• Operational Changes in the UCLA-Westwood Clinical Translational Research Center during the COVID-19 Pandemic.pdf
• Reported Impact of COVID-19 on Chronic Mental Health Condition Management
• The Use of Standard Operating Procedures (SOPs) in Clinical and Translational Research Centers (CTRCs)

2020 Abstracts - Virtual presentations featured at the 2020 Virtual Undergraduate Research Day at UCLA (due to the COVID-19 pandemic, abstracts are shared in lieu of poster presentations):

• When Are 3 ECG-Leads Better Than 12? Streamlining and Optimizing ECG Assessment in Sudden Death Prediction
• A Randomized, Double-Blind, Placebo-Controlled, Phase 3 Trial (NCT03785964) of Nirogacestat Versus Placebo In Adult Patients With Progressing Desmoid Tumors/Aggressive Fibromatosis (DT/AF)
• Long-term Outcomes after Gene Therapy for Adenosine Deaminase-deficient Severe Combined Immune Deficiency (ADA-SCID)
• Differences in Inflammatory Response to Endotoxin in Older Adults by Sex
• Assessing the Effect of Cumulative Hydroxychloroquine Dose on Lifetime Disease Damage vs Risk of Retinal Toxicity in Systemic Lupus Erythematosus Patients
• UCLA CTSI Research Associates Program: Promoting Clinical Research and Cultivating the Next Generation of Medical Scientists

2019 Posters - Featured at the 2019 Undergraduate Research Day at UCLA:

• CTSI RAP - program poster
• Investigation of the Differential Effects of Inflammation and Depression Between Males and Females
• Assessing the Validity of QRISK3 at Predicting Cardiovascular Events in Systemic Lupus Erythematosus (SLE) Patients
• The Role of Vitamin C in Pediatric Critical Care

2018 Posters - Featured at the 2018 Undergraduate Research Day at UCLA:

• CTSI RAP - program poster
• Whole Exome Sequencing Identifies a Novel Candidate Gene in an Ashkenazi Jewish Family with Tetralogy of Fallot
• Lupus Low Disease Activity State: Predicting Organ Damage Accrual and Cardiovascular Risk in Patients with Systemic Lupus Erythematosus

2017 Posters - Featured at the 2017 Undergraduate Research Day at UCLA:

• CTSI RAP Poster: Building Future Leaders in Clinical Research
• The Copper Touch Project: Implementing Antimicrobial Surfaces to Reduce Hospital-Acquired Infections

2016 Posters - Featured at the 2016 Undergraduate Research Day at UCLA:

• CTSI RAP Poster (includes summaries on multiple projects)