Minneapolis, MN Paid Clinical Trials

While the maternal-newborn exchange of airway microbiota is well-documented, no studies have examined within-subject relationships among the mouth, sinuses, nasopharynx and lungs and the relative abundance of bacterial taxa at those sites. Recent evidence suggests the oral cavity may serve as a reservoir for pathogens that translocate to non-oral locations; oral-associated microbes infect most other body sites as evidence by 16S sequencing. By using a combination of oral and throat swabs, together with nasal suction of mucus samples, the investigators will use metagenomic sequencing to characterize the composition of bacterial communities at each anatomical site. Beginning at birth, a time-series of swabs will be collected from each subject, and monitor changes in the development of microbiota over time. By doing so, our studies will illuminate airway trafficking of both beneficial and pathogenic microbes and may represent an essential pathophysiological step towards shifting the balance between airway health and disease. Read Less

This is a phase IV, prospective, open label, randomized-controlled study that will compare radial access with state-of-the-art femoral access in patients without ST-segment elevation acute myocardial infarction undergoing cardiac catheterization. Subjects will be randomized 1:1 into 2 treatment groups: radial access and state-of-the-art femoral access. Randomization will be performed in blocks of 50 per site. Similarly, a second sub-randomization will be performed in the femoral access group into use of 18 vs 21 gauge needles, also in a 1:1 fashion. Read Less

This study will help us better understand how the brain works in people with Parkinson's disease (PD). PD is a brain disease that gets worse over time, and affects over 10 million people world-wide. A common treatment for PD is Deep Brain Stimulation (DBS). To improve DBS therapy for PD, we need a deeper understanding of how the different parts of the brain work together in PD, and how this relates to movement and thinking problems that people with PD experience. We may be able to use the results of this study to improve DBS treatments in the future. Read Less

This trial studies how well proton beam radiation therapy compared with intensity modulated photon radiotherapy works in treating patients with stage I-IVA esophageal cancer. Proton beam radiation therapy uses a beam of protons (rather than x-rays) to send radiation inside the body to the tumor without damaging much of the healthy tissue around it. Intensity modulated photon radiotherapy uses high-energy x-rays to deliver radiation directly to the tumor without damaging much of the healthy tissue around it. It is not yet known whether proton beam therapy or intensity modulated photon radiotherapy will work better in treating patients with esophageal cancer. Read Less

The study will recruit 50 adults with stimulant use disorder currently in treatment and abstinent for at least 2 weeks. The study will also recruit up to 10 healthy controls (adults without StUD) for initial study configuration. The study will consist of five steps that are expected to be completed over two lab visits. Step 1: The 3T MRI scan will provide accurate prefrontal cortex anatomy for using neuronavigation for TMS. In addition, the study will use an analysis of resting fMRI connectivity to determine the location in the left DLPFC that has the maximum connectivity with the incentive-salience network. Step 2: The study will use the data collected at the MRI to select the individual TMS location. EEG will be used to collect TEPs in response to single pulse TMS at the left DLPFC. Participants will then be randomized to one of three conditions: A) TMS unsynchronized with EEG, B) TMS synchronized with EEG theta frequency trough, and C) TMS synchronized with EEG theta frequency peak. The stimulation will be applied with an intensity of up to 120% of the resting motor threshold (which is a safe and common practice; Rossi et al., 2021). The intensity can be decreased for individual participants. Step 3: Following randomization, the study will administer a pre-iTBS assessment. Step 4: The study will compare brain and behavioral responses before and after the iTBS session with TMS and EEG synchronization as assigned by their randomized group. Step 5: The study will administer a post-iTBS assessment. Read Less

The purpose of this study is to evaluate the efficacy and safety of selinexor as a maintenance treatment in patients with p53 wt endometrial carcinoma (EC), who have achieved a partial response (PR) or complete response (CR) (per Response Evaluation Criteria in Solid Tumors version 1.1 \[RECIST v 1.1\]) after completing at least 12 weeks of platinum-based therapy. A total of 220 participants will be enrolled in the study and randomized in a 1:1 ratio to maintenance therapy with either selinexor or placebo. Read Less

Vedolizumab is a medicine that helps to reduce inflammation and pain in the digestive system. In this study, children and teenagers with moderate to severe Crohn's disease will be treated with vedolizumab. The main aim of the study is to check if participants achieve remission after treatment with the vedolizumab. Remission means symptoms improve or disappear and an endoscopy shows no signs of inflammation. Participants will receive 3 infusions of vedolizumab over 6 weeks. Then, those who have a clinical response will receive either a high dose or low dose of vedolizumab once every 8 weeks. They will receive the same dose every time. Read Less

This is a prospective multicenter biomarker study evaluating the prognostic impact of ctDNA detection at diagnosis in patients with Ewing sarcoma or osteosarcoma. Read Less

The purpose of this research is to evaluate the effect of a wearable insulin pump on blood sugar levels during sleep. The study device works with continuous glucose monitors (CGM) to calculate and deliver rapid-acting insulin doses during sleep. The study device does not replace long-acting, correction, or mealtime insulin. The study will involve applying the study device before bed for a period of 13 weeks. The overall study length is approximately 17 weeks. The study aims to evaluate whether the study device is safe and if it lowers blood sugar levels in people who have consistently high blood sugar during sleep and at wake. Read Less

Objective/Hypotheses and Specific Aims: The first aim of this proposal is to determine the effects of commercial prosthetic feet of varying stiffness on stability and falls-related outcomes in Veterans with TTA. The second aim is to determine whether a PFE can be used to predict stability and balance-confidence outcomes with corresponding commercial prosthetic feet. The third and final aim is to determine whether a brief trial of commercial prosthetic feet can predict longer-term stability and balance-confidence outcomes in Veterans with TTA. Study Design: The investigators will use a participant blinded cross-over study with repeated measurements in Veterans and Service members with TTA. Up to 50 participants will be enrolled at each of the two study sites VA Puget Sound and VA Minneapolis. Participants will complete up to 6 visits. After an initial assessment visit, participants will be assigned to the 'high' or 'low' mobility group, and then during visit 2 they will be randomized to use the PFE in three foot modes or the three corresponding actual (commercially available) feet during walking tests on difference surfaces in the laboratory (cross-slopes, inclines, even, and uneven ground). During visit 3 participants will repeat the procedures in the other condition (e.g., PFE if visit 2 included actual feet testing). At the end of visit 3 participants will be fit with one of the actual feet and wear it at home and in the community for approximately one week. At visit 4 participants will be fit with the next actual foot and repeat the 1 week use window. The same process will be followed for the final foot at visit 5, and the study foot will be returned at visit 6. Read Less

The acute and chronic effects of VNS stimulation on various on the autonomic nervous, cardiovascular, immune, and metabolic systems will be compared from noninvasive and minimally invasive physiological recordings and blood draws at various time points throughout the study. These interventions and assessments will be performed in individuals 18 years of age and older who are implanted with a VNS device, which consists of patients who have been diagnosed with drug resistant epilepsy or major depressive disorder. The REVEAL study is not a treatment study; its primary objective is to scientifically investigate the contributing roles of efferent versus afferent vagus nerve modulation of multiple peripheral organs and their dependence on stimulation parameters, in which participants are those who have been implanted with a VNS device be receive standard of care treatment for their epilepsy or depressive disorder. Read Less

When a patient gets DBS surgery, the neurosurgeon makes a hole in the skull through which they can put the DBS lead down in deep parts of the brain that help control movement. For this study, research participants will also have an ECoG strip put through the same hole (no extra holes are being made for research purposes). The ECoG strip is a little less than half an inch wide, and a little more than 2.5 inches long. It is very, very thin; it is a thin plastic film with flat metal sensors that can record the electrical activity in the brain. The ECoG strips are FDA approved. The neurosurgeon will slide the ECoG strip under the skull but on top of the brain, over another area of the brain that helps control hand/arm movement (motor cortex), so that the study team can record the activity there. The study team will record brain activity from the DBS lead and the ECoG strip simultaneously to try to understand how the brain communicates and sends information. The study team will check that the ECoG strip is in the right place by delivering a very small electrical pulse to the wrist. If the ECoG strip is in the correct location, this electrical pulse will show up on the brain activity being recorded by the sensors in the ECoG strip. Fluoroscopy (i.e. X-ray images that can be taken quickly) will also be done at the end of the surgery to help confirm the location of the ECoG strip. During fluoroscopy, an X-ray beam is used to track a contrast agent ("X-ray dye") through the body, so that the body can be seen in detail. This involves some radiation exposure for the participant, so this is described in the consent form. Patients who want to sign up for the study will not be allowed to do so if they have had other radiation exposures within the past year that would go over a safe limit when added to the amount of radiation expected from the fluoroscopy for this study. Read Less