Minneapolis, MN Paid Clinical Trials

This study explores the associations between maternal stress, breastmilk composition, and feeding and neurodevelopment for preterm infants in the NICU and at 4 months corrected age. Read Less

The present study seeks to examine the implementation process of culturally tailoring screening and brief intervention for both chronic pain and opioid misuse/opioid use disorder in three American Indian and Alaska Native (AI/AN) serving clinics. The investigators also will assess staff perspectives on this implementation as well as a survey to understand clients at these sites who have chronic pain and opioid misuse/opioid use disorder. Read Less

The gold standard for the diagnosis of allergic contact dermatitis is patch testing, during which allergens are affixed to the skin underneath tape and left for multiple days. A large area of clear skin is thus required for successful testing. While the back is traditionally thought to be the ideal area for testing, the thighs may be more available or advantageous. This study seeks to randomize patients undergoing patch testing to have patches placed on the back or the thighs. The investigators seek to understand the benefits of testing on the legs versus the back in terms of patient experience as well as achieving a successful test. This study will measure patient experience using a survey administered to patients. Quality of testing will be assessed by study coordinators prior the removal of patches. Read Less

The relapsing nature of substance use disorder is a major obstacle to successful treatment. About 70% of those entering treatment will relapse within one year. To improve treatment outcome, new interventions targeting the underlying brain biomarkers of relapse vulnerability hold significant promise in reducing this critical public health problem. This study is testing a new intervention, namely tDCS-Augmented Cognitive Training, to engage these brain biomarkers to improve cognition and improve treatment outcomes. Read Less

A Phase 2/3 study to investigate the efficacy and safety of luveltamab tazevibulin versus IC chemotherapy in women with ovarian cancer (including fallopian tube or primary peritoneal cancers) expressing FOLR1. Read Less

This study is designed to support evidence-based practice and optimal care by evaluating how different configurations of two types of carbon fiber custom dynamic orthoses (CDOs) influences outcomes following traumatic lower extremity injury. Read Less

A prospective open label, multicenter study to evaluate the feasibility and acute toxicity of using molecularly guided therapy in combination with standard therapy followed by a Randomized Controlled Trial of standard immunotherapy with or without DFMO followed by DFMO maintenance for Subjects with Newly Diagnosed High-Risk Neuroblastoma. Read Less

Patients are enrolled to screening (Reg Step 1) prior to or after ASCT but prior to Reg Step 2. Patients are followed until they will begin Maintenance and then registered to Reg Step 2 (first randomization). Patients are randomized between Lenalidomide for 2 years and Lenalidomide + Daratumumab/rHuPH20. After 2 years of Maintenance, MRD is assessed to guide further therapy. MRD-positive patients will continue with the assigned treatment. MRD-negative patients will be further randomized (Reg Step 3) to either continue or discontinue the assigned treatment. Patients are treated for up to 7 years from Step 2 reg and followed for up to 15 years. Read Less

The purpose of the study is to see if Clascoterone can help people with male pattern hair loss to recovery and see if the treatment is effective and safe and how well the drug is tolerated by subjects. Within this study, the Clascoterone solution will be compared to a placebo. The study has 2 parts: Part 1 will see if Clascoterone solution is effective and safe compared to a placebo when applied twice daily for up to 6 months. Part 2 will see the long-term safety and efficacy of the Clascoterone solution compared to placebo for additional 6 months in subjects defined as ''responders'' in Part 1. A responder is defined as someone who have responded to the study drug, based on research data. Part 1 of the study is double-blind, meaning that neither the subject nor the study doctor knows which treatment subject is receiving. Part 2 of the study is single-blind and only the study doctor doing the study knows which treatment subject is receiving. Part 1 of the study will start with baseline visit during which subjects will be randomly assigned (by chance) in ratio 2:1 to apply either Clascoterone or placebo solution to their balding areas of the scalp. Subjects will have 5 clinic visits and 2 follow-up phone calls during 6 months of Part 1 duration. Subjects identified as Part 1 responders at Month 6 visit will be again randomly assigned in ratio 2:1 to receive either study drug or placebo. Part 2 of the study will consist of 2 additional clinic visits and treatment will last for further 6 months. Each subject will have also an end of study visit one month after the study drug treatment has been completed or discontinued (it will be one month after end of Part 1 for not responder subjects). For those subjects who complete the whole study (Part 1 and Part 2), the total duration of the study will be about 14 months, with 12 months of treatment with a total of eight clinic visits and two phone calls. Subjects taking part in this study will have the medical tests or procedures described below. * They will be asked about their previous medical history and current medications. * A brief physical examination will be performed. * Vital signs, weight and height will be measured. * Electrocardiograms will be performed. * Subject's scalp will be checked for any signs of irritation. * Two different types of photos will be taken during this study: "global photos", i.e. general photos of the subject's scalp and "macro photos", i.e. close up photos of a region of the subject's scalp. Global photos will be taken to help the subject and the study doctor to assess whether there has been a change in subject's hair growth. Macro photos will be used to count the number of hairs in a region of the subject's scalp and measure other properties of the hair (hair width and hair darkness). * Blood draws and urine sample collection for safety laboratory tests. * Subject will be asked to complete, on site, the following two questionnaires: * Cosmetic Evaluation - a couple of cosmetic questions on acceptability and how easy the study drug is to use. * Male Androgenetic Alopecia Questionnaire - some questions about subject's hair assessment. Eligible subjects will be given a supply of the study drug and shown how to use and store it. The first study drug dose will be applied at the clinic under the supervision of the study staff. Subjects will be instructed to apply about 1.5 ml of study drug with a dropper to the balding areas of the scalp on the vertex and the temples twice daily, once in the morning and once in the evening. Subjects will be asked to bring back all used containers of study drug and all unused study drug to each study visit. Subjects will also be given a diary, shown what things have to be recorded on it and asked to bring back the completed diary to the study center at each visit. Read Less

Rare tumors are understudied, yet have the potential to shed light on vast areas of cancer research. Ovarian sex cord-stromal tumors, rare tumors of childhood and young adulthood, have recently been found to be associated with a lung cancer of early childhood called pleuropulmonary blastoma (PPB). The cause of these ovarian tumors is unknown. DICER1 mutations are seen in the majority of children with PPB. Research shows DICER1 mutations are also seen in some patients with ovarian tumors. Like PPB, ovarian stromal tumors are highly curable when found in early stage; however, later forms of the disease are aggressive and often fatal. The International Ovarian Stromal Tumor Registry collects clinical and biologic data to understand why these tumors occur and how to treat them. Current work involves the study of the role of DICER1 and miRNA expression in ovarian stromal tumors. Understanding the clinical history, predisposing factors and DICER1 and miRNA expression in these ovarian tumors of childhood will lead to targeted screening and risk stratification for evidence-based treatment and biologically rational therapies. These efforts will improve the lives of children by increasing survival and reducing late effects. The specific goals of the International Ovarian and Testicular Stromal Tumor Registry are: 1. to understand risk factors by studying age, pathologic subtype, histopathologic features, tumor invasiveness, degree of differentiation, presence of metastasis 2. to collect information on personal and family history in order to refine the clinical characteristics of patients and families with and without germline DICER1 mutations and other genetic predisposing factors 3. to determine whether there is a pattern of gene expression or DNA alterations that correlate with predisposition to ovarian tumors, biologic behavior and clinical outcome 4. to determine optimal screening regimens 5. to use clinical data obtained through the Registry to refine treatment algorithms 6. to establish a collection of annotated biology specimens (tumor tissue and germline DNA) for future research Read Less

This project addresses the significant challenge of providing evidence-based non-pharmacologic pain management to rural-dwelling Veterans in the VA healthcare system who have chronic pain. For this preparatory phase (UG3) the investigators will conduct a pilot study of 40 rural VA patients with chronic pain to assess the feasibility of delivering RAMP (experimental intervention for the UH3 trial) in terms of recruitment and engagement, intervention fidelity and adherence, data collection, and other key metrics. Read Less

A prospective, observational, multicenter study where 60 patients needing implants in the maxilla or mandible will be enrolled. The patients will be restored with a final prosthesis no later than 4 months following implant placement surgery. The patients will come back for follow-up evaluations yearly for 2 years. Read Less