Birmingham, AL Paid Clinical Trials

This will be a 6-month randomized clinical trial with two arms: moderately carbohydrate-restricted diet and a fat-restricted control diet. This 6-month study will have 2 phases: a 12-week controlled feeding phase and a 12-week "free living" phase. During the controlled feeding phase, all food will be provided to the families of the participants for the entirety of the 12 weeks. Participants (n=80) will have been diagnosed with NAFLD based on the presence of current evidence of active disease, which will be determined by the ongoing presence of hepatic steatosis estimated by diffusely echogenic liver via ultrasound suggestive of fatty liver and a serum alanine aminotransferase (ALT) level of 45 U/L or greater. All participants will be children and adolescents age 10-17 yrs.; will have an HbA1c \<7.0; and will be overweight or obese (BMI \>85th percentile). It is anticipated that most participants will be sedentary. The investigators will inquire as to routine physical activity at screening. All participants will be asked to maintain their usual level of physical activity throughout the study. Physical activity will be monitored via a smart watch provided to each participant at the beginning of the study, and participants will be queried weekly by the study dietitian regarding changes in physical activity. Participants who use oral contraceptives will be asked to maintain consistent use of these preparations throughout the study. Hormone use will be examined as a potential covariate in statistical analyses. Read Less

The purpose of the study is to observe the outcomes of patients with acute myeloid leukemia who do not receive an immediate second round of chemotherapy after undergoing a standard mid-induction bone marrow biopsy. Read Less

The aim of this study is to evaluate the therapeutic benefits of a 10-week online coach-guided EEWP on psychosocial health among adults with SCI. Read Less

GDX012 is a novel cell therapy developed for the treatment of certain types of cancer, including Acute Myeloid Leukemia (AML). The main aims of the study are to learn how safe GDX012 is, how treatment with GDX012 is tolerated and to determine the best dose of GDX012. 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

The purpose of this initiative is to improve care and outcomes for infants with HLHS by expanding the NPC-QIC national registry to gather clinical care process, outcome, and developmental data on infants with HLHS between diagnosis and 12 months of age, by improving the use of standards into everyday practice across pediatric cardiology centers, and by engaging parents as partners in the process. Read Less

The CHAP2 study is designed to provide preliminary data for a larger multicenter study to assess whether treatment of stage 1 hypertension (HTN) in pregnancy improves maternal and or neonatal outcomes. The primary objective of this pilot study is to determine if anti-HTN treatment to BP\<130/80mmHg in pregnant patients with stage 1 HTN is associated with a difference in birthweight percentile at delivery. Patients with stage 1 hypertension in pregnancy will be randomized to BP goals of \<130/80mmHg or usual care to treatment only if BPs ≥140/90mmHg. For this pilot, the investigator will randomize a total of 74 eligible participants, 37 to active treatment to BP\<130/80mmHg and 37 to usual care. Read Less

Living with spinal cord injury (SCI) can have a significant negative impact on an individual's mental health and restrict participation in personally valued activities and roles. Acceptance and commitment therapy (ACT) is an evidence-based approach that can lessen symptoms of mental health disorders (e.g., depressive symptoms) and improve quality of life through mindfulness and acceptance processes and behavior change processes for valued living. Evidence for ACT for individuals living with SCI, however, is limited to a very few studies that involved in-person group-based ACT and did not focus on depressed individuals with SCI. The primary goal of this study is to evaluate the effects of an 8-week videoconferencing ACT program on improving mental health outcomes in depressed individuals living with SCI. The primary hypotheses are that the ACT group will show improvements in depressive symptoms at posttest and 2-month follow-up compared to the wait-list control group. Investigators will invite 120 individuals living with SCI and reporting depressive symptoms and randomly assign them to either the ACT group or the wait-list control group. The ACT group will receive eight weekly individual ACT sessions guided by a coach through videoconferencing with a booster session at 1-month follow-up. The wait-list control group will continue his or her own care as usual during the study period and have the option to receive eight individual ACT sessions after study participation ends. Data will be collected at pretest, posttest, and 2-month follow-up and compared between the ACT group and the control group over time. About 40% of individuals living with SCI report depressive symptoms and other mental health symptoms, and mental health disorders following SCI are associated with negative long-term outcomes. Managing uncomfortable or painful thoughts and emotions arising from functional limitations and accepting changed lives while moving forward for valued living through ACT skill practice will help individuals with SCI alleviate symptoms of mental health conditions, promote engagement in personally valued activities, and improve quality of life. Read Less

Constraint-Induced Movement Therapy or CI Therapy is a form of treatment that systematically employs the application of selected behavioral techniques delivered in intensive treatment over consecutive day with the following strategies utilized: behavioral strategies are implemented to improve the use of the more- affected limb in life situation called a Transfer Package (TP), motor training using a technique called shaping to make progress in successive approximations, repetitive, task oriented training, and strategies to encourage or constrain participants to use the more-affected extremity including restraint of the less-affected arm in the upper extremity (UE) protocol. Numerous studies examining the application of CI therapy with UE rehabilitation after stroke have demonstrated strong evidence for improving the amount of use and the quality of the more-affected UE functional use in the participant's daily life situation. CI Therapy studies with adults, to date, have explored intensive treatment for participants with a range from mild-to-severe motor impairment following stroke with noted motor deficits and limited use of the more-affected arm and hand in everyday activities. Each CI Therapy protocol was designed for the level of impairment demonstrated by participants recruited for the study. However, often following stroke, patients not only have motor deficits but somatosensory impairments as well. The somatosensory issues have not, as yet, been systematically measured and trained in CI Therapy protocols with adults and represent an understudied area of stroke recovery. We hypothesize that participants with mild-to-severe motor impairment and UE functional use deficits can benefit from CI therapy protocols that include somatosensory measurement and training components substituted for portions of motor training without loss in outcome measure gains. Further, we hypothesize that adults can improve somatosensory outcomes as a result of a combined CI therapy plus somatosensory component protocol. Read Less

Constraint-Induced Therapy (CI Therapy) is a behavioral approach to neurorehabilitation and consists of multi-components that have been applied in a systematic method to improve the use of the limb or function addressed in the intensive treatment. CI Therapy for the more-affected upper extremity (UE) post-stroke is administered in daily treatment sessions over consecutive weekdays. Sessions include motor training with repeated, timed trials using a technique called shaping, a set of behavioral strategies known as the Transfer Package (TP) to improve the use of the more-affected hand in the life situation, and strategies to remind participants to use the more-affected UE including restraint. Robust improvements in the amount and qualify of use have been realized with stroke participants from mild-to-severe UE impairment. Read Less

This study is to allow continued use of ribociclib (LEE011) as single agent or in combination with other investigational treatments in patients benefitting from treatment in an eligible Novartis-sponsored ribociclib (LEE011) study that has reached its primary objective(s) or has been halted for other reasons. Read Less

The purpose of this study is to investigate the brain activity associated with cognitive tasks (thinking, reasoning, remembering) in order to understand how the brain works during certain tasks and to improve treatment for diseases like dementia and attention deficit disorders. Cognitive (thinking) impairment may include poor memory function, poor attention span, or psychiatric disorders (ex: ADD, depression). The investigators are interested in the brain activity related to these issues, and want to investigate changes in brain activity while we record activity from specific areas of the brain. These recordings are in addition to clinical (routine or standard of care) recordings being performed to monitor for seizures and do not impact the clinical care. Read Less