2,321 Clinical Trials for Various Conditions
This is a phase 3, multicenter, 78-week randomized, double-blind, placebo-controlled, parallel arm study that will evaluate the weight loss efficacy as well as safety, tolerability, pharmacodynamic effects, and pharmacokinetics of VK2735 in adults who are obese (BMI ≥30 kg/m2) or overweight (BMI ≥27 kg/m2) with one or more weight related comorbid condition without Type 2 Diabetes.
This is a phase 3, multicenter, 78-week randomized, double-blind, placebo-controlled, parallel arm study that will evaluate the weight loss efficacy as well as safety, tolerability, pharmacodynamic effects, and pharmacokinetics of VK2735 in adults with Type 2 Diabetes who are obese or overweight
This research project entails delivery of a personalized antisense oligonucleotide (ASO) drug designed for a single participant with dentatorubral-pallidoluysian atrophy (DRPLA) due to a heterozygous pathogenic CAG trinucleotide expansion in ATN1
This study aims to help Native Hawaiian adults quit smoking by testing two common methods: nicotine gum and group-based counseling. Participants will be assigned to one of three groups: (1) nicotine gum only, (2) group counseling only, or (3) a combination of both. The study will take place at public housing sites on O'ahu. Researchers will check if these approaches-alone or in combination-can support people in successfully quitting smoking. The goal is to find out which method works best and is most acceptable in this community.
Hepatocellular carcinoma (HCC) is a major cause of cancer-related deaths globally, with Native Hawaiian and Pacific Islander (NHPI) populations experiencing significantly higher mortality rates compared to other groups in Hawaii. This disparity is influenced by factors such as higher prevalence of chronic hepatitis B, non-alcoholic fatty liver disease, limited access to early detection, and delayed diagnoses. NHPI patients are also underrepresented in clinical trials, limiting the relevance of treatment advances for this population. The standard treatment for HCC is surgical resection; however, many NHPI patients present with unresectable disease. Recent advances with immune checkpoint inhibitors (ICIs), such as nivolumab and ipilimumab, have shown promise in treating advanced HCC and improving survival in previously untreatable cases. Additionally, stereotactic body radiotherapy (SBRT) has been shown to enhance survival and local control when combined with systemic therapies like ICIs. However, without surgery, outcomes remain suboptimal, with response rates for ICIs alone at 20-30%, and combination ICI-SBRT treatment showing slightly better results but still a high risk of progression. Despite improvements in HCC treatment, significant gaps remain in managing borderline resectable disease, especially in NHPI patients. This study aims to evaluate the safety and efficacy of combining ICIs and SBRT with curative surgery for patients with borderline resectable HCC, focusing on NHPI populations. The study will also explore the use of biomarkers such as cell-free DNA (cfDNA), CD8+ T-cell infiltration, and serum cytokine markers to guide personalized treatment strategies. Preliminary findings suggest that this multimodal approach may improve outcomes and enable surgical resection for patients previously considered inoperable. This study seeks to address the unmet need for effective treatment strategies in borderline resectable HCC and to improve survival outcomes for underserved NHPI populations.
This is a Phase III, 2-arm, randomized, open label, multicenter, global study assessing the efficacy and safety of puxitatug samrotecan compared to physician's choice of chemotherapy (doxorubicin or paclitaxel) in participants with B7-H4 selected advanced/metastatic EC that progressed following platinum based chemotherapy and anti-PD-1/anti-PD-L1 therapy.
The goal of this study is to examine if e-cigarette education messages delivered using a source and presentation tailored to one's vaping status influences young adults' vaping behaviors. The main questions it aims to answer are: 1. Does receiving e-cigarette education messages presented using a source (expert or peer) and sidedness (one or two-sided) optimized for the current vaper group influence vaping cessation among young adults who vape daily? 2. Does receiving e-cigarette education messages presented using a source (expert or peer) and sidedness (one or two-sided) optimized for the non-vaper group influence vaping initiation among young adults who are susceptible to vaping? Participants will be randomly assigned to either the treatment (receiving messages tailored to one's vaping status) or the control (receiving non-tobacco messages) condition and receive SMS three times per week over the course of 6 months. They will complete self-report assessment and show salivary cotinine results for nicotine testing at 4 timepoints.
DESTINY-Endometrial01 will investigate the efficacy of first-line T-DXd + rilvegostomig (Arm A) and/or T-DXd+ pembrolizumab (Arm B) when compared to chemotherapy (carboplatin + paclitaxel) + pembrolizumab (Arm C), by assessment of progression free survival (PFS), as assessed by BICR, in participants with HER2-expressing (IHC 3+/2+), pMMR, primary advanced (Stage III/IV) or recurrent EC.
The goal of this clinical trial is to learn if a substance use prevention intervention decreases substance use, increases resistance skill use, and decreases substance use risk in intermediate school students. The main questions it aims to answer: Does the intervention decrease 30-day substance use? Does the intervention increase 30-day resistance skill use? Participants will be asked to participate in the intervention and provide their self-reported answers to behavioral questions before and after the intervention.
The Ku Ola Project: The goal of this study is to determine if community-based discussion groups and small educational sessions enhance health awareness and behaviors among Native Hawaiian men. The study will examine if these interventions improve participants' health knowledge, attitudes, and self-efficacy while fostering local networks to support ongoing health promotion. Participants will engage in group discussions and educational sessions designed to build capacity and encourage healthy lifestyle choices.
GZL2 is an independent study conducted under the GZPL master protocol. GZL2 study will evaluate the efficacy and safety of orforglipron for treatment of hypertension in participants with obesity or overweight.
The goal of this interventional study is to provide more access to STI testing for patients who seek abortion care through telemedicine, particularly for those whose access to STI testing is otherwise limited. The main questions it aims to answer are: What is the acceptability, feasibility, and utilization of self-collected STI screening at the time of telemedicine medication abortion provision? How does the uptake of such a service among patients receiving telemedicine abortion care compare to the population of patients who seek in-person medication abortion care? What are the positivity rates for STIs in among patients receiving telemedicine medication abortion care compared to the positivity rates for a contemporaneous, in-clinic population? What is the average time to between testing and treatment for patients who test positive for an STI using the self-collection service? Researchers will compare the intervention group to a contemporaneous, in-clinic population on uptake of STI screening, as well as on positivity rates for the STIs tested. Participants will be asked to perform self-swab collection for STI testing for gonorrhea, chlamydia, and trichomonas. They will be instructed to send their specimens to a lab using prepaid postage. Upon completion of sample collection and shipping, they will be asked to complete a survey assessing basic demographic information, as well as acceptability and feasibility of the intervention. Patients who test positive for an STI will be promptly provided/referred to treatment.
GZL1 is an independent study conducted under the GZPL master protocol. GZL1 will evaluate the efficacy and safety of orforglipron for treatment of hypertension in participants with obesity or overweight.
The GZPL master protocol will support 2 independent studies, J2A-MC-GZL1 (GZL1) and J2A-MC-GZL2 (GZL2). The purpose of this study is to create a framework to evaluate the safety and efficacy of orforglipron for the treatment of hypertension in participants with obesity or overweight.
The goal of this study is to improve pain care in the MHS by identifying effective, whole-person, non-pharmacologic interventions for persons with chronic musculoskeletal pain. The investigators will evaluate two promising, evidence-based holistic health interventions and compare them to usual care.
The goal of this controlled randomized clinical study is to learn if a Tao Calligraphy Mindfulness and Energized water Practice works to improve Unipolar Depression. The main questions it aims to answer are: * Does Tao Calligraphy Mindfulness practice and drinking Energized water improve the subjective symptoms of Unipolar Depression in adults? * Does Tao Calligraphy Mindfulness practice and drinking Energized water improve the clinical symptoms and signs of Unipolar Depression in adults? * Will any improvement in the John Ware's SF-36 Quality of Life questionnaire, in the Patient Health Questionnaire (PHQ) -9 and in the Beckman Anxiety Inventory (BAI) -21 in adults be statistically significant? Investigators will compare the values of these three scales at the beginning of the mindfulness and energized water practices to their values at six weeks of practice and control groups. Participants will: * be randomized into practice and control groups * complete the set of three questionnaires upon entry into the study - (the baseline or zero time point; at the 6-weeks time point, and at the 12-weeks time point * practice the mindfulness techniques with Tao Calligraphy for a minimum of thirty minutes daily and energized water practice for a minimum of five minutes daily.
The purpose of this study is to assess if Pain Ease vapocoolant spray decreases pain associated with lidocaine injection during Nexplanon insertion procedures.
This clinical trial is to implement contingency management (CM) as an intervention tool to address methamphetamine use and will be initiated during inpatient acute hospitalization in trauma injured patients. The goals are: * Gather effectiveness data on a CM program for participants in Hawaii who use methamphetamine during hospitalization and following discharge due to trauma injury * To assess participant perspectives on engaging with a CM program based at a Level 1 Trauma Center. Researches will assess both patient-reported and biologically-confirmed medium-term program effectiveness and conduct qualitative interviews with participants post-program. * To assess the rate of leaving against medical advice (AMA) and treatment completion in acute hospital setting in participants. * To assess the optimal timing of CM initiation for traumatically injured hospitalized patients by comparing patient outcomes (i.e. duration of CM participation and rates of CM program completion and providing negative urine samples) to NCT06532370 where CM was initiated after discharge from the hospital. For total of 12 weeks, participants will: * Be visited on Mondays, Wednesdays and Fridays by the research team to complete urine analysis during the hospitalization * Visit a follow up clinic up to 3 times per week on Mondays, Wednesdays and Fridays to complete urinalysis following discharge from the hospital * Complete Treatment Effectiveness Assessments at 6 and 12 weeks * Engage in qualitative interview at the end of the CM program
The purpose of this research proposal is to develop and evaluate a culturally grounded, ENDS prevention intervention for rural Hawaiian youth. This will be accomplished through two specific aims. AIM 1 (Years 1-3) are focused on pre-intervention and intervention development. In Year 1, youth focus groups will be conducted to assess the environmental demands related to ENDS use in rural Hawai'i. In Year 2, specific ENDS-related problem situations (i.e., situations that increase risk for ENDS use) will be extracted from the Year 1 focus groups and prioritized through survey methods with 200-250 predominately Native Hawaiian youth across 16 different middle/intermediate schools on Hawai'i Island. In Year 3, five situations found to be the most frequently experienced and/or difficult to manage by youth surveyed in Year 2 will serve as the foundation for the development of narrative scripts. Three of these scripts will be cast and filmed on location on Hawai'i Island by a professional film director, and will be edited into three short films, 6-8 video clips, and 6-8 professional photos or production stills. Similar to the investigators' prior drug prevention research in rural Hawai'i, classroom-based lessons will be created to support the short films. Additional lessons and videos from an evidence-based, culturally grounded substance abuse prevention curriculum for Hawaiian youth (Ho'ouna Pono) will be used to create a modular classroom curriculum. The video clips and professional photography/production stills will be embedded with prevention messaging, and will be used for a social and print media campaign to reinforce the classroom curriculum. AIM 2 (Years 4-5) is to evaluate the ENDS prevention intervention (classroom curriculum plus social/print media campaign) across all middle/intermediate public or public-charter schools (N = 16) and up to 11 different cultural immersion charter schools on Hawai'i Island using a dynamic wait-listed control group design.
The main purpose of this study is to find out how well and how safely tirzepatide works in adults who have type 1 diabetes and obesity or overweight. Participation in the study will last about 49 weeks.
The main purpose of this study is to see how well and how safely bimagrumab, tirzepatide, and the combination, work in lowering body weight in participants with obesity or overweight and type 2 diabetes. Participation in the study will last about 13 months.
A Phase 3, Randomized, Double-Masked, Active-Controlled Trial in Adults with Macular Neovascularization Secondary to Age-Related Macular Degeneration
This is a study of retatrutide in participants with obesity. The main purpose is to learn more about how retatrutide maintains body weight loss. The study will have two treatment phases: an 80 week lead-in phase in which all participants will take retatrutide dose 1 and a 36 week randomized, double-blinded phase in which participants will either take retatrutide dose 1, retatrutide dose 2, or switch to placebo. Participation in the study will last around 125 weeks.
The primary objective of this study is to demonstrate that maridebart cafraglutide is superior to placebo for percent change in body weight.
The purpose of this Phase 3 study is to demonstrate the efficacy of DNTH103 as compared to placebo in participants with chronic inflammatory demyelinating polyneuropathy (CIDP).
This is a multi-center, randomized, double-masked, active-comparator-controlled, Phase 3 study in a broad participant population (treatment-naïve and treatment-experienced) with neovascular (wet) age-related macular degeneration (nAMD). The study will evaluate a single intravitreal (IVT) injection of Ixo-vec compared to an active comparator. The primary endpoint of this study is the mean change in best corrected visual acuity (BCVA) of Ixo-vec compared to an active comparator measured at an average of Weeks 52 and 56. Safety, tolerability, and efficacy will be evaluated throughout the study.
Purpose: Investigators propose a three-arm RCT across two military treatment facilities:1) in-person STAR-C, 2) telehealth STAR-C, and 3) no treatment control. Outcomes will be assessed immediately and at one- and three-months post treatment. Hypothesis/Objectives: STAR-C, delivered in-person and via telehealth, will be effective in decreasing everyday cognitive complaints among patients with a history of mTBI. Effectiveness will be moderated by patient characteristics. Stakeholder feedback will yield a process map for broad implementation of STAR-C in varied clinical environments.
This study aims to evaluate the ocular and systemic safety, tolerability and efficacy of RO7446603 in participants with diabetic macular edema (DME). The study consists of 2 segments: Phase I (Parts 1-4) and Phase II (Part 5). Phase I investigated the safety of RO7446603 following a single and multiple intravitreal (IVT) doses as monotherapy or co-administered with IVT aflibercept or IVT faricimab (in separate injections). Phase II will investigate the safety, tolerability, pharmacokinetics (PK) and efficacy of two dose levels of RO7446603 in combination with faricimab, with the two drugs co-mixed and administered as a single IVT injection, compared to faricimab alone. The first participant was enrolled in the Phase I segment on June 22, 2022. Phase I has been completed.
This study will assess the serum uric acid lowering effect and safety of AR882 in gout patients at two doses compared to placebo over 12 months
Native Hawaiians (NH) are 9.5 times more likely to be on dialysis or need a kidney transplant compared to Whites. They have the highest end-stage kidney disease (ESKD) incidence rates in the nation, begin dialysis at younger ages (30-50 years), and one of the most under-studied racial/ethnic groups in chronic kidney disease (CKD) research. This project's outcome is to improve kidney disease follow-up among early stage NHs at high risk by aligning health equity with a culturally appropriate care coordination systems model.