Columbus, OH Paid Clinical Trials

ACTEMRA (tocilizumab) is an IL-6 receptor antagonist used for the treatment of adult Rheumatoid Arthritis as well as Polyarticular (PJIA) and Systemic (SJIA) Juvenile Idiopathic Arthritis. In this Phase II, the drug will be used to treat pediatric patients diagnosed with recurrent Adamantinomatous Craniopharyngioma including patients who have undergone surgery and/or radiation therapy. Read Less

The innovative MPBA+F begins with peer-to-peer mentoring followed by structured parental/family support for long-term reinforcement of PA behaviors. Building and reinforcing skills, MPBA+F mitigates resource stressors and strengthens protective factors by providing culturally appropriate knowledge and skills to improve the sustainability of physical activity at home without the use of exercise equipment. By strengthening social support through peer and friendship networks and family-based support, MPBA+F responds to the unique needs of rural Appalachians in a culturally responsive way. This study targets physical activity among children with overweight, obesity, or extreme obesity because rural Appalachian communities identify sedentary activity as a key contributor to the high rates of obesity and diabetes risk among youth. Read Less

Study STX-478-101 is a multipart, open-label, phase 1/2 study evaluating the safety, tolerability, pharmacokinetics (PK), and preliminary antitumor activity of STX-478 (LY4064809) in participants with advanced solid tumors with P13Ka mutations. Part 1 will evaluate STX-478 as monotherapy in participants with advanced solid tumors. Part 2 will evaluate STX-478 therapy as combination therapy with fulvestrant in participants with hormone receptor positive (HR+) breast cancer. Part 3 will evaluate STX-478 as combination therapy with endocrine therapy (aromatase inhibitors, fulvestrant or imlunestrant) and a CDK4/6 Inhibitor (either Ribociclib, Palbociclib or Abemaciclib) in participants with HR+ breast cancer. Each study part will include a 28-day screening period, followed by treatment with STX-478 monotherapy or combination therapy. Read Less

The proposed research is a parallel arm, randomized placebo-controlled clinical trial designed to assess changes in muscle strength, volume, fatigue resistance, and mobility in older adults after daily consumption of 12g of linoleic acid-rich oil. Read Less

The goal of the Shoulder iD™ Primary Reversed Glenoid Outcomes Clinical Study is to collect safety and performance data on the commercially available Shoulder iD™ Primary Reversed Glenoid device. The study will learn about standard device use in adult patients who have a functional deltoid muscle and massive and non-repairable rotator cuff tear. The main questions it aims to answer are: * What is the average improvement in patient-reported shoulder function after 2 years when compared to before the surgery, and * What is the rate of surgical revisions needed over a 10 year period Patients will be asked to will be asked to regularly attend their check-up visits with their surgeon (including having x-rays or CT images taken to check their shoulder and implant), to complete questionnaires to report how their shoulder is doing, and to tell their surgeon when they notice any changes. Read Less

The goal of this clinical trial is to test and improve an online program for caregivers of young childhood cancer survivors called the Preparing for Life and Academics for Young survivors program (PLAY). The PLAY program was created with a group of caregivers of young children with cancer and healthcare providers. Ultimately, investigators hope to see if the program can improve positive parenting behaviors, reduce caregiver stress, and help get young children ready for school. In the preliminary phase of this clinical trial, investigators are aiming to answer these questions: 1. Are caregivers of childhood cancer survivors willing to participate in the PLAY program and complete assessments before and after the program? 2. Do caregivers of childhood cancer survivors rate the PLAY program as easy to use? 3. Are caregivers of childhood cancer survivors satisfied with the PLAY program? 4. How can the PLAY program be improved in the future? When the child is transitioning to maintenance phase therapies or off cancer treatment, caregivers will be invited to participate and complete surveys when they begin the study as well as a videotaped interaction task with their child. Children will complete brief developmental testing at the beginning of the program. Caregivers will then complete the PLAY Program, which will involve completing 7 weekly or bi-weekly online modules and meeting with a trained coach by videoconference for up to 8 one-hour sessions over three months. Sessions will focus on helping their child get ready for school and help their family adjust and cope with stress. Caregivers will repeat the surveys and videotaped interaction task again three months later, after the PLAY program is completed. They will also be invited to participate in an interview to learn about their experience in the program. Read Less

This phase IIA trial compares the effect of acolbifene versus low dose tamoxifen in preventing breast cancer in premenopausal women at high risk for developing breast cancer. The usual approach for patients at increased risk for breast cancer is to undergo yearly breast magnetic resonance imaging or ultrasound in addition to yearly mammogram. Premenopausal women at very high lifetime risk for breast cancer (greater than 50%) can consider preventive removal (mastectomy) of both breasts. Premenopausal women age 35 or older with a prior diagnosis of atypical hyperplasia, lobular carcinoma in situ, or an estimated 10-year risk of greater than or equal to 3% or estimated 10-year risk of greater than or equal to 2-5 times that of the average woman (depending on age) may be advised to consider five years of standard dose tamoxifen. Standard dose tamoxifen is four times the dose used in this study. Estrogen can cause the development and growth of breast cancer cells. Acolbifene and tamoxifen blocks the use of estrogen by breast cells. This study may help researchers measure the effects of acolbifene and low dose tamoxifen on markers of breast cancer risk in mammogram imaging, breast tissue, and in blood samples. Read Less

Long-term, multicenter, multinational, observational, registry of patients with AQP4+ NMOSD that is designed to collect data on clinical outcomes and safety in patients prescribed Alexion C5 inhibitor therapies (C5IT). The registry will also collect data on patient reported outcomes (PROs), quality of life (QoL), and targeted AQP4+ NMOSD therapies used to provide evidence on the real-world impact of ALXN-C5IT on patients with AQP4+ NMOSD. Read Less

US, multicenter, cohort, open label observational study with primary data collection. Ancillary protocol-specified procedures to address the study objectives (eg, assessment of ADA) may be considered outside the standard of care for acid sphingomyelinase deficiency (ASMD), but the study methodology remains non-interventional, as the additional collection of data from participants will not dictate treatment. The total overall study duration will be 5 years. The follow-up period will be a minimum of 1 year to a maximum of 3 years. The enrollment period will be up to 4 years, to allow a minimum of 1 year of follow-up for the last participant enrolled. Read Less

Study BH-30236-01 is a first-in-human (FIH), Phase 1/1b, open-label, dose escalation and expansion study in participants with relapsed/refractory acute myelogenous leukemia (R/R AML) or higher-risk myelodysplastic syndrome (HR-MDS). Phase 1 (Dose Escalation) will evaluate the safety, tolerability, pharmacokinetics (PK), pharmacodynamics (PD), and preliminary efficacy of BH-30236 administered orally. Approximately 50 participants may be enrolled in Phase 1 of the study. Phase 1b (Dose Expansion) will follow Phase 1 to further understand the relationships among dose, exposure, toxicity, tolerability, and clinical activity. Up to 24 participants may be enrolled in Phase 1b of the study. The dose expansion part (Phase 1b) will be followed to understand the relationships among dose, exposure, toxicity, tolerability and clinical activity. Up to 24 participants may be enrolled in Phase 1b of the study. Read Less

This phase III trial studies magnetic resonance imaging (MRI) surveillance and prophylactic cranial irradiation (PCI) to see how well they work compared to MRI surveillance alone in treating patients with small cell lung cancer. MRI scans are used to monitor the possible spread of the cancer with an MRI machine over time. PCI is radiation therapy that is delivered to the brain in hopes of preventing spread of cancer into the brain. The use of brain MRI alone may reduce side effects of receiving PCI and prolong patients' lifespan. Monitoring with MRI scans alone (delaying radiation until the actual spread of the cancer) may be at least as good as the combination of PCI with MRI scans. Read Less

Medtronic is sponsoring and funding the AFFIX study, a prospective, post-market, multicenter, nonrandomized, single-arm, interventional clinical study. The purpose of this study is to evaluate the performance and safety of the MaxTack™ Motorized Fixation Device when used for fixation of prosthetic material to soft tissue in minimally invasive ventral hernia repair procedures. Read Less