Oregon Paid Clinical Trials

This pilot trial will explore the feasibility, acceptability, and effectiveness of the most recently approved formulation of injectable extended-release buprenorphine (XR-BUP) for treatment of opioid use disorder (OUD) in rural settings. We will randomize 144 eligible individuals with moderate to severe OUD in a 2:1 ratio to one of two medication conditions: (1) XR-BUP (128mg target), administered every 4 weeks or (2) SL-BUP (16mg-24 mg/day target).Participants will receive study medication treatment for the 14 week-intervention period, including an initial \~2-week period of induction/stabilization. The study will use a mixed-methods approach (participant assessments, study medication records, qualitative interviews) for assessing feasibility and acceptability, and results will include patient outcome data on the comparative effectiveness of XR-BUP versus SL-BUP for patients with OUD in rural settings. Read Less

The purpose of this study is to assess the long-term safety and to explore the efficacy of astegolimab in participants with chronic obstructive pulmonary disease (COPD) who have completed the 52-week placebo-controlled treatment period in parent studies GB43311 or GB44332. Read Less

The goal of this observational study is to investigate and validate multi-parametric magnetic resonance imaging (MRI) modalities for assessment of breast cancer response to neoadjuvant chemotherapy in a multi-site and multi-MRI scanner platform setting. This study is conducted at Oregon Health \& Science University (OHSU), University of Washington (UW), and University of Iowa (UI) using Siemens, Philips, and General Electric MRI scanners, respectively. MRI is a type of scan that uses a very strong magnet and no radiation to take very detailed pictures of parts of the body. MRI is often used as standard of care to take pictures of breast tumor(s) before and after chemotherapy treatment in order to measure the tumor size changes in response to treatment, and in order to plan for surgery. MRI is used because the images it takes are very clear and the borders of the tumor can be measured very accurately. However the tumor size alone is often not a good early indicator of whether or not the tumor responds to treatment. Tumor size change usually happens late during the period of treatment, and tumor size measured with MRI after treatment can overestimate or underestimate the residual cancer. This makes it difficult to do the right surgical planning. In addition to measuring tumor size, the MRI scans in this research study will also measure changes in tumor blood vessels and the number of cancer cells per unit of tumor volume. The purpose of this study is to see whether MRI measurements of these functional tumor properties provide better early prediction and evaluation of breast cancer response to neoadjuvant chemotherapy than tumor size measurement. This is an observational study because the MRI procedures are not expected to have an effect on health outcomes. Eligible participants on this study are receiving standard of care neoadjuvant treatment for their cancer. Read Less

A multi-center, randomized, 72-month, parallel- group, non-inferiority, phase III study to compare the effectiveness of roflumilast (Daliresp, 500 mcg quaque die (QD) or alternate regimen) therapy versus azithromycin (250 mg QD, 500 mg QD three times per week, or alternate regimen) to prevent hospitalization or death in a patients at high risk for COPD exacerbations. Read Less

The purpose of this Phase I, multicenter study is to evaluate the safety, pharmacokinetics, pharmacodynamics and clinical activity of AG-120 in advanced hematologic malignancies that harbor an IDH1 mutation. The first portion of the study is a dose escalation phase where cohorts of patients will receive ascending oral doses of AG-120 to determine maximum tolerated dose (MTD) and/or the recommended Phase II dose. The second portion of the study is a dose expansion phase where four cohorts of patients will receive AG-120 to further evaluate the safety, tolerability, and clinical activity of the recommended Phase II dose. Additionally, the study includes a substudy evaluating the safety and tolerability, clinical activity, pharmacokinetics, and pharmacodynamics of AG-120 in subjects with relapsed or refractory myelodysplastic syndrome with an IDH1 mutation. Anticipated time on study treatment is until disease progression or unacceptable toxicity occurs. Read Less

Individuals with depression often describe difficulties with memory, attention, concentration, and overall cognitive functioning, which can persist even after mood episodes get better, and can affect treatment and health outcomes. The primary objective of this pilot clinical trial is to evaluate the feasibility and acceptability of a manualized, 8-week, Compensatory Cognitive Training (CCT) intervention for Veterans who received treatment for MDD in the past year and have persistent cognitive functioning deficits. The investigators will compare Motivationally Enhanced Compensatory Cognitive Training for Major Depressive Disorder (ME-CCT-MDD) to a robust comparator, Goal-focused Supportive Contact (GSC), to evaluate differences in outcome measures. The investigators hypothesize that Motivationally Enhanced Compensatory Cognitive Training for Major Depressive Disorder (ME-CCT-MDD) will be feasible and acceptable to participants in a pilot trial of ME-CCT-MDD vs. Goal-focused supportive contact (GSC) for Veterans with recent MDD treatment and persistent cognitive symptoms. This study will also evaluate the preliminary magnitude and direction of symptom change on measures of objective cognitive functioning, psychiatric symptomatology, psychosocial functioning, and quality of life. The investigators hypothesize that CCT will improve objective cognitive functioning, psychiatric outcomes, psychosocial functioning, and quality of life in Veterans with recent MDD-related cognitive functioning deficits. Participants who agree to participate in the study will: 1. Take part in an assessment of their cognition, symptoms, and functioning, which will take approximately 2 hours. The assessment will include an interview about their medical, psychiatric, and cognitive history. It will also include questionnaires about their symptoms and daily functioning as well as neuropsychological tests, which are paper-pencil tests that evaluate aspects of cognition such as memory, attention, and problem-solving skills. 2. Be randomly assigned (like the flip of a coin) to receive Goal-Focused Supportive Contact or Compensatory Cognitive Training. Both treatments will involve weekly groups with a mental health provider for approximately 2 hours per week for 8 weeks. Goal-Focused Treatment includes setting and achieving short-term and long-term goals for improving cognition and functioning. Compensatory Cognitive Training includes training in strategies to improve cognition and manage stress. 3. Complete a follow-up assessment of cognition, symptoms, and functioning 8 weeks after they begin treatment, as well as a brief interview about their experience in the group. These assessment sessions will take approximately 2 hours. Read Less

The purpose of this study is to support the registration plan of sonrotoclax plus zanubrutinib treatment in participants with previously untreated CLL. This study is designed to assess the contribution of sonrotoclax to the efficacy outcome of the combination of zanubrutinib and sonrotoclax. Read Less

The goal of this clinical trial is to evaluate the efficacy, safety and pharmacokinetics of elamipretide in subjects with dry age-related macular degeneration (AMD). The main questions it aims to answer are: what is the rate of change in the macular area of photoreceptor loss in subjects who receive a daily dose of elamipretide compared with those who receive a look-alike substance that contains no active drug, and what is the safety and tolerability of elamipretide daily subcutaneous injections. Participants will receive either once daily subcutaneous doses of 40mg elamipretide or placebo and the two treatment groups will be compared. Read Less

The purpose of this study is to measure the efficacy and safety of baxdrostat/dapagliflozin in participants ≥ 18 years of age with CKD and HTN. This study consists of a screening, a 4-week dapagliflozin run-in period for participants naïve to SGLT2i at baseline; a 24-month double-blind period in which participants will receive either baxdrostat/dapagliflozin or dapagliflozin; and a 6-week open-label period in which all participants will discontinue baxdrostat/placebo and receive dapagliflozin alone. Site visits will take place at 2-, 4-, 8-, and 16- weeks following randomisation. Thereafter visits will occur approximately every 4 months, until the 24-month visit at which time baxdrostat/placebo will be discontinued. Participants will continue open-label dapagliflozin for another 6-weeks (approximately), where reassessment of GFR will occur for the primary efficacy endpoint. In the event of premature discontinuation of blinded study intervention, participants will continue in the study and receive open-label dapagliflozin monotherapy, unless the participant meets dapagliflozin specific discontinuation criteria, in which case all study interventions will be discontinued. Read Less

This study is being done to answer the following questions: Is the chance of rectal cancer responding the same if chemotherapy alone is given before limited surgery compared to chemotherapy and radiation therapy given together before limited surgery? If radiation therapy is not given, is quality of life better? Read Less

This is a first time in human (FTiH) Phase I/IIa, open-label, multi-centre study of AZD3470 in participants with advanced or metastatic solid tumors with MTAP deficiency. The study consists of several study modules, evaluating the safety, tolerability, pharmacokinetic (PK), pharmacodynamics, and preliminary efficacy of AZD3470 as monotherapy or in combination with other anti-cancer agents. Read Less

The purpose of this trial is to test the efficacy of a collaborative care intervention to address opioid- and/or stimulant-involved polysubstance use in adult primary care patients with moderate to severe substance use disorders (SUD). The primary aims are to reduce days of opioid use (illicit or nonmedical opioid use), days of illicit stimulant use (cocaine, methamphetamine), and days of heavy alcohol use. Read Less