Washington Paid Clinical Trials

Our intent is to establish the International Registry to Improve Outcomes in Men with Advanced Prostate Cancer (IRONMAN) as a prospective, international cohort of minimum 5,000 men with advanced cancer, including men with mHSPC and M0/M1 CRPC. The goal is to establish a population-based registry and recruit patients across academic and community practices from Australia, Barbados, Brazil, Canada, Ireland, Jamaica, Kenya, Nigeria, Norway, Spain, South Africa, Sweden, Switzerland, the United Kingdom (UK), and the United States (US). Target accrual number and number of participating sites are subject to change based on accrual, funding, and interest in participation by other international sites. This cohort study will facilitate a better understanding of the variation in care and treatment of advanced prostate cancer across countries and across academia and community based practices. Detailed data will be collected from patients at study enrollment and then during follow-up, for a minimum of five years. Patients will be followed prospectively for overall survival, clinically significant adverse events, comorbidities, changes in cancer treatments, and PROMs. PROMs questionnaires will be collected at enrollment and every three months thereafter. Physician Questionnaires will be collected from all participating sites at patient enrollment, time of first change in treatment and/or one year follow-up, at each subsequent change of treatment, and discontinuation of treatment. As such, this registry will help identify the treatment sequences or combinations that optimize overall survival and PROMs for men with mHSPC and M0/M1 CRPC. By collecting blood at enrollment, time of first change in treatment and/or one year follow-up (plasma, cell free DNA, buffy coat / RNA), this registry will further identify and validate molecular phenotypes of disease that predict response and resistance to specific therapeutics. Additionally, every effort will be made to collect blood specimen at each subsequent change in treatment due to progression of disease. When feasible, existing tumor tissue may be collected for correlation with described blood based studies. All samples will be used for future research. This cohort study will provide the research community with a unique biorepository to identify biomarkers of treatment response and resistance. Read Less

This is a Phase 1b, open-label, multicenter, safety, tolerability and efficacy study of HC-7366 in combination with belzutifan (WELIREG™). This is a multipart study that consists of a HC-7366 monotherapy cohort, a combination dose escalation, and a combination dose expansion. Approximately 80 patients will be enrolled in this study (up to 20 patients will be enrolled into the HC-7366 monotherapy cohort, up to 30 patients into the combination dose escalation, and up to 30 patients into the combination dose expansion). The primary purpose of this study is to determine the maximum tolerated dose of HC-7366 in combination with belzutifan in patients with locally advanced (inoperable) or metastatic RCC with predominantly clear cell histology, irrespective of VHL gene mutation status. Read Less

Efficacy Study: This randomized, double-blinded, placebo-controlled Phase 3 study is designed to assess the safety, immunogenicity, and efficacy of a single dose of RSVpreF in the prevention of LRTI-RSV in adults: * At a dose of 120µg. * In adults 60 years of age and older. * The duration of the study for each participant will be up to approximately 24 months. * The study will be conducted in the United States, Canada, Netherlands, Finland, Argentina, Japan and South Africa. Substudy A: This study is an extension of the efficacy study and was designed to evaluate the safety and immunogenicity of a second dose of RSVpreF when administered after a dosing interval of approximately 2 years: * At a dose of 120µg (as studied in the Phase 3 Efficacy Study) * Blood samples will be collected for antibody testing. * The duration of the study for each participant will be up to approximately 18 months. * The study will be conducted in the United States and Argentina. Substudy B: This study was designed to evaluate the safety and immunogenicity of a second dose of RSVpreF when administered after a dosing interval of approximately 1 year: * At a dose of 120µg (as studied in the Phase 3 Efficacy Study) * Blood samples will be collected for antibody testing. * The duration of the study for each participant will be up to approximately 18 months. * The study will be conducted in Argentina. Substudy C: This study was designed to evaluate the safety and immunogenicity of a second dose of RSVpreF when administered after a dosing interval of either 3 or 4 years: * At a dose of 120µg (as studied in the Phase 3 Efficacy Study) * Participants will receive either placebo or a second dose of RSVpreF approximately 3 or 4 years after receiving the initial dose of RSVpreF in the main efficacy study. * Blood samples will be collected for antibody testing. * The duration of the study for each participant will be up to approximately 18 months. * The study will be conducted in the United States and Canada. Read Less

The ICGG Gaucher Registry is an ongoing, international multi-center, strictly observational program that tracks the routine clinical outcomes for patients with Gaucher disease, irrespective of treatment status. No experimental intervention is involved; patients in the Registry undergo clinical assessments and receive care as determined by the patient's treating physician. The objectives of the Registry are: * To enhance understanding of the variability, progression, identification, and natural history of Gaucher disease, with the ultimate goal of better guiding and assessing therapeutic intervention. * To assist the Gaucher medical community with the development of recommendations for monitoring patients, and to provide reports on patient outcomes, to optimize patient care. * To characterize the Gaucher disease population. * To evaluate the long-term effectiveness of imiglucerase and of eliglustat. Gaucher Pregnancy Sub-registry: The primary objective of this Sub-registry is to track pregnancy outcomes, including complications and infant growth, in all women with Gaucher disease during pregnancy, regardless of whether they receive disease-specific therapy. No experimental intervention is given; thus a patient will undergo clinical assessments and receive standard of care treatment as determined by the patient's physician.If a patient consents to this Sub-registry, information about the patient's medical and obstetric history, pregnancy, and birth will be collected, and, if a patient consents to data collection for her infant, data on infant growth through month 36 postpartum will be collected. Read Less

The Mucopolysaccharidosis I (MPS I) Registry is an ongoing, observational database that tracks the outcomes of patients with MPS I. The data collected by the MPS I Registry will provide information to better characterize the natural history and progression of MPS I as well as the clinical responses of patients receiving enzyme replacement therapy, such as Aldurazyme (Recombinant Human Alpha-L-Iduronidase), or other treatment modalities. The objectives of the Registry are: * To evaluate the long-term effectiveness and safety of Aldurazyme® (laronidase) * To characterize and describe the MPS I population as a whole, including the variability, progression, and natural history of MPS I * To help the MPS I medical community with the development of recommendations for monitoring patients and reports on patient outcomes to optimize patient care Read Less

The type and number of chemicals in exhaled breath are different in people with infection as compared to those without infection. In this study, the breath of people with and without COVID infection will be measured. Changes in the amount and type of chemicals in breath will be used to determine if an individual does or does not have COVID infection. If the measurements of breath are a reliable measure of COVID infection, this device may be used to rapidly screen people who are attending large public events (for example, music concert or baseball game) to minimize the spread of COVID at the event. Read Less

The purpose of this observational study is to learn about the effects of etrasimod as a treatment for adult patients with moderate to severe ulcerative colitis. Patients will be treated according to standard of care and will only be included in the study if etrasimod is the best treatment of choice according to the physician and they have not previously taken etrasimod. All patients will be prescribed etrasimod according to standard of care. Tests and doctor visits will be conducted according to standard of care with the exception of health questionnaires about ulcerative colitis symptoms. These questionnaires will be completed by patients at various timepoints during the study using their mobile phone, tablet, or computer. The study is 52 weeks with 28 days of safety follow up. The effects of etrasimod will be analyzed for each patient comparing their disease activity prior to the start of etrasimod. Read Less

Esophageal cancer, which has a low 5-year overall survival rate (\<20%) is increasing in incidence. Previous studies have shown that Hedgehog, AKT, and angiogenic signaling pathways are activated in a significant number of esophageal cancers. Itraconazole, a widely used anti-fungal medication, effectively inhibits these pathways. In this multi-site phase II trial, the investigators will evaluate the effect of itraconazole as a neoadjuvant therapy added to standard of care chemoradiation and surgery in the the treatment of locoregional esophageal and gastroesophageal junction cancers. Read Less

This study will seek to enroll immunocompromised patients with Lower Tract parainfluenza infection. It also contains a sub-study to enroll patients with severe COVID-19. Read Less

A 10 week trial to assess the ability of Tempol to prevent and/or reduce toxicities associated with cisplatin and radiation treatment in head and neck cancer patients. Over the course of the 10 week trial, mucositis, nephrotoxicity, and ototoxicity will be monitored and assessed. Read Less

The goal of this clinical trial is to determine how two different doses of cannabidiol (CBD), given as a hemp product, change the blood concentrations of the drug clopidogrel in the body. Results will be used to help design future studies and to assist healthcare providers in informing their patients about the safe use of CBD. Read Less

One in 10 Veterans have an alcohol use disorder. However, few Veterans receive evidenced-based psychosocial interventions or medications to treat alcohol use disorder. Barriers to receiving these treatments include long wait times, stigma, and long distances from treatment facilities. Even fewer Veterans receive psychosocial and medication interventions together, despite clinical practice guidelines recommending both and evidence of better outcomes. Expanding access to these treatments in primary care is a VA priority but delivering psychosocial interventions is difficult in this setting, and medication is often the only option. Smartphone apps that deliver alcohol interventions may improve drinking outcomes and ensure Veterans can receive both treatments in primary care. This study will determine whether medications and an app for alcohol use problems offered to Veterans in primary care results in improved drinking outcomes, compared to Veterans receiving medications only. Study data will inform how to spread the app across the VA nationally. Read Less