Birmingham, AL Paid Clinical Trials

The purpose of this study is to find out what combination of components, if any, offers the best support for keeping weight off after someone loses weight. Long term weight loss maintenance is a challenge for many people who lose weight. There are many strategies, or components, people may use to avoid regain, but investigators do not know if there is a best, or optimal, combination of such components that can be done without adding a lot of cost or other burdens for people. * The primary goal of this clinical trial is to identify the optimal package that maximizes weight loss maintenance. * The study also wants to understand the reasons why these components may work and if certain components help specific sub-groups of people. Participants will engage in a 16-week Phase 1 Weight Loss Program. Participants who lose 5% or more of their weight during that program will continue to Phase 2 Extended Care and be randomly assigned to 0, 1, 2, 3, or all of four methods of weight loss maintenance. They will use their assigned package for 12 months. Researchers will compare 16 different possible combinations of components and learn which of the 16 packages offers the best support for keeping weight off. The four components participants could be assigned to in Phase 2 are: 1. Reduced Food Variety: Limiting the variety of foods participants eat by having them choose a few high-calorie, low nutrient foods to eat regularly 2. Home-based Resistance Training: Engaging in exercises that build strength from the comfort of the participant's own home 3. Buddy Training and Support: Having a friend or "buddy" get trained to support the participant 4. Acceptance and Commitment (ACT) Workshops: Having participants learn skills to handle tough thoughts and feelings about weight control in a healthy way Participants will have their weight measured and complete surveys 4 times if they complete both Phase 1 and Phase 2. During Phase 1, participants will attend weekly group sessions and be in touch with a study staff member investigators call a Wellness Coach. During Phase 2, participants will stay in touch with their Wellness Coach, use their assigned package, and answer questions about their experience periodically. Read Less

The purpose of this study is to compare the efficacy and safety of BEM/RZR to SOF/VEL in adults with chronic HCV. Read Less

This study will test the safety of a drug called PF-08046054/SGN-PDL1V alone and with pembrolizumab in participants with solid tumors. It will also study the side effects of this drug. A side effect is anything a drug does to your body besides treating your disease. Participants will have solid tumor cancer that has spread through the body (metastatic) or cannot be removed with surgery (unresectable). This study will have five parts. Parts A and B of the study will find out how much PF-08046054/SGN- PDL1V should be given to participants. Part C will use the dose found in Parts A and B to find out how safe PF-08046054/SGN-PDL1V is and if it works to treat solid tumor cancers. In Part D and E, participants will be given PF-08046054/SGN-PDL1V with pembrolizumab to find out how safe this combination is and if it works to treat solid tumor cancers. Read Less

The purpose of this study is to evaluate the efficacy of digoxin in treating relapsed non-SHH, non-WNT medulloblastoma in pediatric and young adult patients. Read Less

The purpose of this study is to find out whether a medicine called spesolimab helps people with pyoderma gangrenosum (PG). The main aim is to see whether spesolimab leads to closure of PG ulcers. This study is open to adults with ulcerative PG with at least 1 ulcer that measures between 5 cm\^2 to 80 cm\^2 in size. This study has 2 parts. In Part 1, participants are put into groups randomly, which means by chance. 1 group gets spesolimab and the other group gets placebo. Placebo injections look like spesolimab injections, but do not contain any medicine. Every participant has a 2 in 3 chance of getting spesolimab. For the first 8 weeks, participants also take corticosteroid medicine by mouth. In Part 2, participants are put into groups again. Participants without open ulcers have an equal chance of getting spesolimab or placebo. Participants with open skin ulcers will get spesolimab. In both parts, participants receive spesolimab or placebo as an infusion into a vein every 4 weeks. Participants are in the study for about 1.5 years. During this time, they visit the study site 20 times. At study visits, doctors check the participant's skin for signs of PG. The doctors also regularly check participants' health and take note of any unwanted effects. The results of the groups are compared to see whether the treatment works. Read Less

The goal of this clinical trial is to learn if ARD-101 works to treat hyperphagia-related behavior in patients with Prader-Willi syndrome (PWS). It will also teach us about the safety of ARD-101. The main questions it aims to answer are: * Does ARD-101 improve the total score of the HQCT-9 (hyperphagia questionnaire for clinical trials, 9 questions)? * What medical problems do participants have when taking ARD-101? Researchers will compare ARD-101 to a placebo (a look-alike substance that contains no drug) to see if ARD-101 works to treat hyperphagia in PWS subjects. Eligible participants will: * Take ARD-101 or a placebo every day for 12 weeks. * Visit the clinic or have a tele-visit once every 2 to 4 weeks during dosing and then have a tele-visit 4 weeks after stopping the ARD-101 or placebo. * Patients/Caregivers will keep a daily diary. Read Less

The Infrascanner model 2500 is a handheld, noninvasive device that is FDA-cleared to detect traumatic intracranial hematomas. FDA clearance K200203 was issued in 2020, K211617 added pediatric age group to the IFU in 2022, and K241389 approved higher laser power use to address dark skinned patients in 2024. This non randomized observational study aims to evaluate the utility of this device by evaluating its ability to provide decision support information to optimize care for patients with suspected traumatic intracranial hematomas. It is important to note that the intended use of the device is in accordance with its FDA approved indication. The intent is to generate actionable knowledge that along with standard clinical signs, facilitates the early detection of intracranial hemorrhage (ICH) in patients with suspected traumatic brain injury (TBI) in a combat setting. The ultimate goal is to modify and optimize international protocols for inexpensive, bedside, portable, and noninvasive detection of traumatic ICH in conflict zones across the globe. This multicenter, prospective, observational, implementation science study will evaluate the field utility of the Infrascanner Model 2500 in an active combat setting using a pragmatic, sequential research design consisting of two phases-baseline phase and device phase. Using the current Ukrainian medical care system, patients with suspected TBIs will be monitored, and their outcomes will be tracked using standard-of-care practices (baseline phase). After the baseline data collection period is complete, an amendment to the protocol will be submitted to initiate the device phase. After training and upon approval, the Infrascanner device will be deployed to the facilities described above to provide health care providers with additional decision support, and the impact of its use will be compared to the baseline data. The outcome of interest is the time from admission at each enrollment study location to a definitive CT scan diagnosis of ICH. The investigators hypothesize that the use of the device will provide decision support to health care providers, decrease the time to traumatic ICH detection, thus enabling more expedient care. This prospective study will include all patients with suspected combat-related head trauma identified by clinical signs of TBI, such as decreased GCS score, abnormal pupil exam, and/or asymmetrical motor exam, on admission to the clinical enrollment site (mobile hospital or regional clinical hospital) regardless of the presence of pharmacologic sedation. At the Vinnytsia hospital (Role 4), combat polytrauma preoperative patients will also be screened. Exclusion criteria include evidence of extensive scalp injury, including lacerations, avulsions, or abrasions that prevent proper placement of the Infrascanner device on a subject's head or prevent placement of the device in the specified locations. During the baseline phase (Figure 1), 100 patients will be enrolled at stabilization points and the mobile/first-line hospital, 100 will be enrolled at the second-line hospital, and 100 will be enrolled at the third-line hospital. Thus, from a total of 300 subjects, baseline data on the time from admission at each enrollment study location to a definitive CT scan diagnosis of ICH and treatment and early outcomes will be collected. Once the baseline phase is complete and the amendment for the device phase is approved, it will be initiated. During this device phase, the Infrascanner will be deployed to stabilization points and the three levels of care (mobile hospitals and regional clinical hospitals). Data collection will continue until 100 patients are enrolled in the device phase for the three levels of care. All data collection at the baseline and device phases will occur at the same locations, and the data elements will be identical, except for Infrascanner data collected during the device phase. By comparing data from the baseline and device phase, the investigators will assess the utility of the device to provide decision support information to providers and potentially reduce time to definitive diagnosis by CT scan and thus treatment, as well as the association between Infrascanner use and early patient outcomes. Read Less

The objective of this study is to determine if early high volume intravenous fluid administration (hyperhydration) may be effective in mitigating or preventing complications of shiga toxin-producing E. coli (STEC) infection in children and adolescents when compared with traditional approaches (conservative fluid management). Read Less

Study CTQJ230A12303 is a randomized, double-blind placebo-controlled, Phase IIIb study to evaluate the efficacy, safety and tolerability of pelacarsen (TQJ230) 80 mg s.c. QM compared with placebo s.c. QM in US Black/African American and Hispanic participants with established ASCVD and elevated levels of Lp(a) who are treated for cardiovascular (CV) risk factors according to local practice/guidelines for the reduction of cardiovascular risk. Read Less

Approximately 240 eligible adult participants (≥18 years old) who meet Diagnostic and Statistical Manual of Mental Disorders (DSM-5-TR) criteria for Major Depressive Disorder (MDD) will be enrolled. Participants will be randomly assigned to receive a single oral dose of Psilocybin 25 mg, Psilocybin 5 mg, or inactive placebo. The purpose of this study is to evaluate the efficacy, safety, and tolerability of Psilocybin 25 mg versus placebo in adults with MDD, as assessed by the difference between groups in change in depressive symptoms from Baseline to Day 43 post-dose, and to characterize the durability of initial treatment effect and subsequent response to optional Psilocybin 25 mg re-administration(s) during the 1-year Follow-up Period. Read Less

Vorasidenib in combination with pembrolizumab in participants with recurrent or progressive isocitrate dehydrogenase-1 (IDH-1) mutant Glioma. Read Less

This study will investigate the safety, tolerability, pharmacokinetics, and preliminary efficacy of ONO-4685 in patients with relapsed or refractory T cell Lymphoma Read Less