Nashville, TN Paid Clinical Trials

This study will assess the safety and effectiveness of the SAPIEN 3/SAPIEN 3 Ultra transcatheter heart valve (THV) in patients with a failing aortic bioprosthetic valve. Read Less

The purpose of the study is to evaluate the efficacy of lacosamide (LCM) versus an Active Comparator chosen based on standard of care (StOC) in severe and nonsevere seizure burden (defined as total minutes of electroencephalographic neonatal seizures (ENS) per hour) in neonates with seizures that are not adequately controlled with previous anti-epileptic drug (AED) treatment. Read Less

Randomized, blinded, placebo-controlled, Phase 2 study of INBRX-109 in unresectable or metastatic conventional chondrosarcoma patients. Read Less

The SOAP registry is a prospective, multicenter, electronic registry. The goal is to investigate the indications, mode of airway management, predisposing factors, and obstetric and anesthetic outcomes of pregnant patients who receive general anesthesia for cesarean delivery. Read Less

A Phase 1/2 dose escalation study of BCL-2 Inhibitor ZN-d5 and the Wee1 Inhibitor ZN-c3 in Subjects with Acute Myeloid Leukemia (AML). Read Less

This is an open-label, multisite Phase I dose escalation, safety, pharmacokinetics (PK) and pharmacodynamics (PD) trial of BNT152+153 in various solid tumor indications. The clinical trial will enroll patients with various solid tumors that are metastatic or unresectable for whom there is no available standard therapy likely to confer clinical benefit, or patients who are not candidates for such available therapy. The trial consists of Part 1 and Part 2 with adaptive design elements: Part 1 consists of Groups A and B. Group A is a BNT153 monotherapy dose escalation in patients with advanced solid malignancies until the maximal tolerated dose (MTD) is defined. If MTD is not reached, maximum administered dose (MAD) may be used for further development (or another dose as determined by the safety review committee [SRC]). Group B is a BNT152 monotherapy dose escalation in patients with advanced solid malignancies until the MTD or optimal biological dose (OBD; the lowest safe dose associated with optimal biological activity) is defined, whichever occurs earlier. Group A will be activated first while the time point for Group B activation is at sponsor's decision. Part 2 will start after the MTD or MAD or another dose as determined by the SRC have been established for BNT153 and MTD or OBD for BNT152 in Part 1. Part 2 (Part 2A, 2B and 2C) is a dose escalation of BNT152+153 in patients with advanced solid malignancies until the recommended Phase II dose (RP2D) is defined. Part 2 may implement a biomarker cohort if a clinical benefit is observed at one or more doses of BNT152+153 that show a clear PD effect in the peripheral blood. The Biomarker Cohort will recruit patients at selected sites. Read Less

The goal of this two-group randomized trial is to determine the feasibility and acceptability of a remotely-delivered health coaching intervention offered in conjunction with usual care for patients with an acute exacerbation of chronic low back pain who present to the emergency department (ED). The main questions this feasibility trial aims to answer are: Is our health coaching intervention and randomized trial methodology feasible to conduct? Is our health coaching intervention acceptable to participants and ED providers? Participants will be randomized to one of two groups (usual ED care plus health coaching or usual ED care plus education) and complete outcome assessments at 3 and 6 months after ED discharge. Participants and ED providers will also complete an interview. Read Less

KB707-01 is a Phase 1, open-label, multicenter, dose escalation and expansion study to evaluate the safety and tolerability of KB707 in adults with locally advanced or metastatic solid tumors who have progressed on standard of care therapy, cannot tolerate standard of care therapy, refused standard of care therapy, or for whom there is no standard of care therapy. In this study, patients will receive KB707 via direct intratumoral (IT) injection into solid tumors to assess the safety and tolerability as well preliminary efficacy of KB707 monotherapy treatment. Read Less

The aim of this study is to assess the safety and tolerability of BMS-986360 as monotherapy and in combination with chemotherapy or nivolumab in participants with advanced solid tumors. Read Less

A migraine is a moderate to severe headache on one side of the head. A migraine attack is a headache that may be accompanied by throbbing, nausea, vomiting, sensitivity to light and sound, or other symptoms. A number of treatments are available for adults with migraine but there are limited approved treatments available for pediatric participants. The main goal of the study is to evaluate the safety and efficacy (how well treatment works) of a low-dose and high-dose of atogepant in pediatric participants between the ages of 6 and 17. Atogepant is a medicine currently approved to treat adults with episodic migraine (0 to 14 migraine days per month) and is being studied in pediatric participants between the ages of 6 and 17 with a history of episodic migraine. This is a Phase 3, randomized, double-blind study of atogepant in participants with a history of episodic migraine with an open-label pharmacokinetic substudy. Eligible participants will be randomized into 6 different groups. Participants between the ages of 12 and 17 will be randomized to receive placebo, low-dose atogepant, or high-dose atogepant for 12 weeks. Participants between the ages of 6 and 11 will also be randomized to receive placebo, low-dose atogepant, or high-dose atogepant for 12 weeks. The specific atogepant doses to be used in participants between the ages of 6 and 11 will be determined after the PK substudy is complete. Around 450 participants will be enrolled in approximately 100 sites. Placebo, low-dose atogepant, and high-dose atogepant are given as a tablet to take by mouth once a day. At the end of Week 12, participants will either undergo a follow-up visit 4 weeks after last study treatment or join an extension study where they can continue to receive atogepant for another 52 weeks. There may be a bigger responsibility for participants in this study. Participants will attend regular visits during the study at a hospital or clinic. The effects of treatment will be checked by medical assessments, blood tests, checking for side effects, and completing questionnaires. Read Less

This study evaluates the efficacy and safety of Autologous Muscle Derived Cells for Urinary Sphincter Repair (AMDC-USR; generic name: iltamiocel) compared to a placebo in the reduction of stress incontinence episode frequency in adult female patients with post-surgical persistent or recurrent stress urinary incontinence (SUI). Half of the participants will receive AMDC-USR (injections with cells) and the other half will receive placebo. Read Less

The investigators will test the hypothesis that reducing insulin doses using a low carbohydrate diet (LCD) will be associated with with improved insulin sensitivity (Aim 1) and blood vessel health (Aim 2). Read Less