Iowa Paid Clinical Trials

The goal of this study is to determine the effects of stimulant medication on disruptive behavior, function, preference and choice; however, it is primarily methodological and will add to current research by establishing an effective evaluation of the impact of stimulant medication on these behaviors. Three behavior assessments for children and adolescents diagnosed with AD/HD who exhibit disruptive behavior will be conducted: 1. Preference assessments will be conducted to determine whether preference for social and nonsocial items and activities differs under medication and non-medication conditions. 2. Functional analyses will be conducted to determine whether stimulant medication has an effect on the frequency and function or purpose of disruptive behavior. 3. Choice assessments will be conducted to evaluate the impact of stimulant medication on impulse control/delay discounting. This study will be conducted in three phases. For each of the 5 to 10 participants there will be 8 total visits. The first 4 visits will entail a preference assessment, followed by a functional analysis. On visits 1 and 3, the participant will be asked to take his/her stimulant medication as is typically done; however, on visits 2 and 4, the participant will be asked to refrain from taking the medication. For visits 5-8, participants will continue to participate in preference assessments, but will also be presented with a choice arrangement with work and play. In the choice arrangement, participants will be given four work cards and four play cards that they can organize in any order. Work cards will be associated with a brief academic task and play cards will be associated with a brief play period using high-preferred toys/activities. On visits 5 and 7 the participant will be asked to take his or her stimulant medication as usual, while on visits 6 and 8 the participant will be asked to refrain from taking his or her medication. Read Less

The purpose of this study is to evaluate the efficacy and safety of repotrectinib and crizotinib in participants with locally advanced or metastatic TKI-naïve ROS1-positive non-small cell lung cancer (NSCLC). Read Less

The purpose of eVOLVE-Lung02 is to test the effectiveness (efficacy) and measure the safety of volrustomig in combination with chemotherapy compared with pembrolizumab in combination with chemotherapy as 1L treatment in participants with mNSCLC in PD-L1 \< 50%. Read Less

The objective of DIAGNODE-3 is to evaluate the efficacy and safety of three intranodal injections of 4 μg of Diamyd compared to placebo, along with oral Vitamin D supplementation, to preserve endogenous beta cell function and influence glycemic parameters in adolescent and adults recently diagnosed with T1D carrying the HLA DR3-DQ2 haplotype. Read Less

The purpose of this study is to test the long-term safety of rimegepant in the acute treatment of migraine in children and adolescents (≥ 6 to \< 18 years of age). Read Less

The purpose of this study is to test the safety and efficacy of BHV-3000 versus placebo in the acute treatment of moderate or severe migraine in children and adolescents. Read Less

The study investigators are interested in learning more about how drugs, that are given to children by their health care provider, act in the bodies of children and young adults in hopes to find the most safe and effective dose for children. The primary objective of this study is to evaluate the PK of understudied drugs currently being administered to children per SOC as prescribed by their treating provider. Read Less

The objective of this study is to assess whether efficacy of the AcoArt Litos PCB is superior and whether safety of AcoArt Litos PCB is noninferior to the control device (FDA cleared PTA Balloon Catheter) regarding treatment of obstructions in the infrapopliteal arteries (located distal to the P3 segment of the popliteal artery and extending to the tibiotalar joint) in patients presenting with chronic limb-threatening ischemia (CLTI)(Rutherford 4-5) Read Less

The purpose of this randomized, double-blind, placebo-controlled, parallel group study is to determine the efficacy of frexalimab in delaying the disability progression and the safety up to 36 months double-blind administration of study intervention compared to placebo in male and female participants with nrSPMS (aged 18 to 60 years at the time of enrollment). People diagnosed with nrSPMS are eligible for enrollment as long as they meet all the inclusion criteria and none of the exclusion criteria. Study details include: * This event-driven study will end when the target number of 6-month cCDP events is achieved, and the study is expected to last 43 months from randomization of the first participant to the common study end. * The number of scheduled visits will be up to 25 (including 3 follow-up visits) with a visit frequency of every month for the first 6 months and then every 3 months. Read Less

This clinical trial is studying lymphoma. Lymphoma is a cancer that starts in the blood cells that fight infections. There are several types of lymphoma. This study will enroll people who have lymphoma, such as classical Hodgkin lymphoma, peripheral T-cell lymphoma including systemic anaplastic large cell lymphoma, diffuse large B-cell lymphoma, or types of primary cutaneous lymphoma. This clinical trial uses a drug called SGN-35T. The study drug is in testing and has not been approved for sale. This is the first time SGN-35T will be used in people. The study drug will be given as an infusion through a vein. This study will test the safety of SGN-35T in participants with lymphoma. It will also study the side effects of this drug. A side effect is anything a drug does to the body besides treating the disease. This study will have three parts. Parts A and B of the study will find out the best dose and dosing schedule for SGN-35T. Part C will use the dose found in parts A and B to find out how safe SGN-35T is and if it works to treat select lymphomas. Read Less

To compare the efficacy and safety in subjects with advanced or metastatic LMS previously treated with an anthracycline. Read Less

Diabetic peripheral neuropathy (DPN) is the most common chronic complication of diabetes, affecting about 50% of patients with diabetes and leading to severe morbidity, poor quality of life, high mortality, and high health care costs. Due to the complex structure and anatomy of the peripheral nervous system, DPN presents with a very broad spectrum of clinical symptoms and deficits, including severe pain, sensory deficits, foot ulcers and amputations. Presently there is no treatment for DPN and even with good blood glucose control DPN develops especially in patients with type 2 diabetes. There is a need to identify effective interventions for DPN. Preclinical studies have provided evidence that the combination of fish oil and salsalate is an effective treatment of DPN. The human subject study to be performed will examine the effect of fish oil with and without salsalate on the blood lipid profile and circulating metabolites of omega-3 polyunsaturated fatty acids (PUFA). Fish oil is an excellent source for the nutrition dependent omega-3 PUFA, primarily eicosapentaenoic acid (EPA; 20:5) and docosahexaenoic acid (DHA; 22:6). These fatty acids are the source of anti-inflammatory metabolites known as resolvin, neuroprotectin and maresin. Preclinical studies have also demonstrated that the metabolites of EPA and DHA are neuroprotective. Furthermore, when fish oil is combined with salsalate the production of these metabolites is increased in vivo. Thus, the investigators hypothesize that fish oil and salsalate will be an effective therapy of DPN. However, prior to doing a formal study of the effect of fish oil + salsalate on DPN there is a need to learn more about what concentration combination will provide the most efficacious effect on the omega-3 index (defined as the sum of EPA and DHA, as a percentage of total fatty acids in red blood cells) and that will safely increase the production of the anti-inflammatory metabolites. These studies will be performed at two sites the University of Iowa (Dr. Yorek) and University of Michigan (Dr. Pop-Busui) by treating human subjects with type 2 diabetes and DPN with either 2g or 4g of fish oil per day (capsules) for 4 months and then adding salsalate 1.5 g or 3g per day (tablets) to the fish oil treatments for an additional 2 months. At baseline and after treatment with fish oil alone and after treatment with the combination of fish oil and salsalate the omega-3 index and levels of circulating omega-3 PUFA metabolites will be determined as primary endpoints. Secondary endpoints will include determination of circulatory inflammatory markers and non-invasive measurements for DPN. The risks to subjects are minimal and are very reasonable in relation to the importance of the knowledge to be gained. Read Less