Minneapolis, MN Paid Clinical Trials

This study is conducted to confirm whether etavopivat works well at reducing the number of Vaso-occlusive crisis VOCs (sickle cell pain crises) caused by obstructions in blood vessels in adults and adolescents living with sickle cell disease. The study will also evaluate how well etavopivat can reduce the damage to different organs, improve your exercise tolerance and reduce fatigue in people with sickle cell disease.The participants will either get etavopivat or placebo. Which treatment the participants will get is decided by chance. Etavopivat is a new medicine and is currently being tested in other studies in addition to this one. The study will last for about 2 years. Read Less

Hematopoietic stem cell transplant (HSCT) is an effective but toxic therapy, and lung injury affects as many as 25% of children receiving HSCT. Improved transplant techniques and major improvements in survival mean that HSCT is being more widely used, and more mismatched grafts are being used. Bronchiolitis obliterans (BO) is a major limitation of pediatric HSCT success as BO is commonly diagnosed late in children, when lung injury is irreversible, leading to long term morbidity or even death. Currently, there are major gaps in our knowledge regarding incidence, etiology and optimal treatment of BO following HSCT, and important diagnostic limitations specific to children. Diagnosis of BO is usually based on performance of pulmonary function tests, which is usually impossible in ill children under 10. Even older children who feel unwell or un-cooperative may be unable to produce interpretable data. These deficiencies in diagnosis mean that BO is commonly diagnosed late, meaning fibrosis has occurred and lesions are irreversible. The hypothesis for this interventional trial is that early treatment with standard Flovent/montelukast and steroids plus ruxolitinib will reverse lung injury and reduce the frequency of chronic pulmonary impairment or florid BO. Read Less

Hematopoietic stem cell transplant (HSCT) is an effective but toxic therapy and pulmonary morbidity affects as many as 25% of children receiving transplant. Early pulmonary injury includes diffuse alveolar hemorrhage (DAH), thrombotic microangiopathy (TMA) interstitial pneumonitis (IPS) and infection, while later, bronchiolitis obliterans is a complication of chronic GVHD associated with severe morbidity and mortality. Improved diagnosis and treatment of pulmonary complications are urgently needed as survival after HSCT improves, and as HSCT is increasingly used for non-malignant disorders such as sickle cell disease. Currently, there are large and important gaps in the investigator's knowledge regarding incidence, etiology and optimal treatment of pulmonary complications. Moreover, young children unable to perform spirometry are often diagnosed late, and strategies for monitoring therapeutic response are limited. This is a prospective multi-institutional cohort study in pediatric patients undergoing allogeneic hematopoietic stem cell transplantation (alloHSCT). Assembly of a large prospective uniformly screened cohort of children receiving HSCT, together with collection of biological samples, will be an effective strategy to identify mechanisms of lung injury, test novel diagnostic strategies for earlier diagnosis, and novel treatments to reduce morbidity and mortality from lung injury after transplant. Read Less

The overarching goal of this study is to determine if baricitinib, as compared to placebo, will improve neurocognitive function, along with measures of physical function, quality of life, post-exertional malaise, effect of breathlessness on daily activities, post-COVID-19 symptom burden, and biomarkers of inflammation and viral measures, in participants with Long COVID. Read Less

The purpose of this study is to evaluate the efficacy, safety and tolerability of pelacarsen (TQJ230) administered subcutaneously once monthly compared to placebo in slowing the progression of calcific aortic valve stenosis. Read Less

This study will evaluate the long-term safety and tolerability of the Port Delivery System with ranibizumab (PDS) (100 mg/mL) in participants with neovascular age-related macular degeneration (nAMD) who have either completed Phase II Study GX28228 (Ladder), Phase III Study GR40548 (Archway), Phase IIIb Study WR42221 (Velodrome), or completed Week 24 visit in Study WR42221 but were not eligible to be randomized in WR42221. Read Less

The aim of this clinical trial is to test the efficacy of a culturally aligned digital smoking cessation resource for American Indian persons who smoke, via a remotely conducted randomized controlled trial. Read Less

Tourette Syndrome and Persistent Motor/Vocal Tic Disorder affect 1-3% of youth and can be associated with impaired functioning, emotional and behavioral problems, physical pain, diminished quality of life, and peer victimization. Chronic tics are the primary symptom. Comprehensive Behavioral Intervention for Tics (CBIT) is a manualized treatment focused on tic management skills. During the core CBIT procedure, competing response training, patients learn to inhibit tics by engaging in a competing motor action. The overall objective of this study is to identify bio-behavioral predictors and correlates of response and the most potent aspects of CBIT. Participants with chronic tics will complete a manualized course of 8-session CBIT. Neural, behavioral, psychosocial, and global functioning will be assessed longitudinally to examine predictors and correlates of response. CBIT sessions will be video recorded. CBIT process will be measured with a video-based behavioral coding scheme that will be refined and validated during years 1-2 using archival CBIT videos Read Less

The goal of this clinical trial is to examine 3 interventions designed to increase physical activity in older adults with HIV. We will examine 3 potential components of an intervention package: physical activity coaching, cognitive behavioral therapy targeted toward common barriers to physical activity such as low motivation or chronic pain, and a Fitbit-based social support intervention. Our primary outcome will be physical activity, defined as steps per day. Results will guide choice of intervention components to be used in an optimized behavioral intervention. Read Less

This study is researching a drug called dupilumab. The study is focused on patients who have uncontrolled asthma. Asthma is a condition where the airways narrow and swell, making it difficult to breathe. Uncontrolled asthma means that patients are still having frequent symptoms while taking their current asthma medication. The aim of the study is to see which regimen is more effective: taking dupilumab with an inhaled asthma medication or only taking a higher dose of the inhaled asthma medication. The type of asthma medication that will be used is a combination inhaled corticosteroid and long-acting beta-agonist (referred to as an ICS/LABA). Some patients may also receive an additional asthma medication called a long-acting muscarinic antagonist (referred to as a LAMA) if they are already receiving a LAMA. The study is also looking at: • What side effects may happen from taking dupilumab Read Less

The proposed research aims to reduce obesity-related health disparities by promoting healthy lifestyle behaviors among African Americans (AAs), given the high disease burdens associated with low physical activity, insufficient sleep, and obesity. There will be two phases to the proposed research. Phase 1 (Aim 1) will encompass formative research and community engagement activities, and Phase 2 (Aim 2a and 2b) will be a randomized clinical trial. The primary goal of Aim 1 is to conduct in-depth qualitative interviews in order to: (1) better understand sleep-related social contextual factors, knowledge, behaviors, and beliefs, and (2) discuss and receive feedback on an existing sleep intervention design and materials. The primary goal of Aim 2 is to explore the feasibility, satisfaction, and preliminary efficacy of a sleep intervention to increase sleep and physical activity (PA) among sedentary and short sleeping (≤6 hrs/night) African American adults with overweight/obesity, compared to a contact control group. (Aim 2a) An additional exploratory (Aim 2b) examines changes in cancer-relevant biomarkers between those who received the intervention vs the control condition (n = 20). Data will be collected from a sample of 20 participants (10 per condition) who volunteer to have their blood drawn pre- and post-intervention. There are two phases of the study, and information gained during Phase 1 (Aim 1) will be used to inform Phase 2 (Aim 2). Thus, additional modifications to the protocol will be submitted prior to engagement in Phase 2. Read Less

The purpose of the study is to identify novel blood-based biomarkers for prediction and diagnosis of infected pancreatic necrosis (IPN) in patients with necrotizing pancreatitis (NP). Acute pancreatitis (AP) is the leading cause of gastrointestinal hospital admissions, accounting for over 300,000 emergency department visits annually and imposing a significant socio-economic burden. It is an acute inflammatory condition of the pancreas characterized by damage to the acinar cells, which triggers an inflammatory response and causes widespread systemic damage. In about 20% of cases, the disease progresses to necrotizing pancreatitis (NP), a severe form characterized by tissue necrosis. NP poses serious health risks, especially when the necrotic tissue becomes infected, leading to infected (peri-)pancreatic necrosis (IPN), which is associated with secondary organ failure (OF), sepsis, and mortality rates as high as 40%. While patients with sterile (peri-)pancreatic necrosis (SPN) can often be managed conservatively, those with IPN typically require antibiotics and therapeutic interventions such as endoscopic drainage or surgery. Timely recognition and treatment of IPN are crucial for improving patient outcomes, yet current diagnostic methods based on clinical symptoms and routine lab markers lack the specificity to reliably distinguish SPN from IPN in the early stages. Furthermore, while multifactorial scoring systems like Ranson, Imrie, and APACHE II predict necrosis and overall severity in AP, they are not accurate for identifying IPN or predicting mortality in NP. The diagnostic gap delays appropriate treatment, allowing the infection to advance and limiting available therapeutic options. The growing incidence and significant impact of AP and NP in the general population underscore the urgent need to better understand IPN pathophysiology and to develop specific diagnostic biomarkers that can improve prognosis, guide therapeutic decisions, and enhance patient outcomes. Read Less