Alabama Paid Clinical Trials

Although there is evidence in the literature that gammaglobulin replacement therapy can lead to a reduction in the prevalence of pulmonary infection and improved lung function, there is no published study to guide immunologists regarding the use of spirometry in titrating IG therapy to assist in the management of immunodeficiency patients with regards to gammaglobulin replacement therapy. The investigators propose to study the use of spirometry to identify patients that could potentially benefit from an increase in IGRT. The investigators will identify 22 common variable immune deficiency (CVID) study subjects on stable IGRT replacement therapy equivalent to 0.40 to 0.60 gm/kg per 4 weeks who have evidence of mild to moderate obstruction as assessed by an FEF25-75% between 50% and 80% of predicted. Patients who are on Hizentra will be preferentially recruited. Of these 22, 11 will be identified at random and treated for 6 months at their current dose (control population). The remaining 11 study subjects (treatment group) will have their level of IGRT increased by the equivalent of 0.05 gm/kg in dose per 4 weeks, adjusted for bioavailability as per manufacturer's instructions. On average, rounded up to the nearest gram, this will typically increase their dose of Hizentra by 2 gm per week. Read Less

This study offers 5 fractions of radiation treatment through partial breast irradiation in patients with early stage breast cancer after having a lumpectomy. Read Less

This is a Phase 2, multi-site, two-period, open label randomized crossover (Period 1 and 2) study. Participants are randomized 1:1 to one of two 8-week on-demand product sequences - TFV douche then oral F/TDF or oral F/TDF then TFV douche - with a 2 to 4-week washout period in between. Domains of safety, acceptability, adherence, and PK/PD (sub-study only) are assessed for each product. Read Less

The goal of this study is to evaluate whether a psychological intervention (BMT-CARE) is effective at improving the quality of life in caregivers and patients treated with hematopoietic cell transplant compared to usual care, and to identify critical facilitators and barriers for BMT-CARE implementation and adoption. Read Less

A phase 1b/2 study of XTMAB-16 in patients with pulmonary sarcoidosis Read Less

The Investigators have recently published on differences in pain sensitivity measures between cis and trans individuals in the local area. The investigators observed the anticipated differences in pain sensitivity between CM and CW (CW \> CM), but found that the TW were phenotypically similar to CW in all measures. However, the investigators did not assess hormone level, nor did the investigators recruit TM participants. Here, with the assistance of two local community group stakeholders the investigators will recruit the following groups: CM, CW, TM+T (currently taking exogenous testosterone), TW+E (exogenous estradiol), TM, and TW (n=20/group). The investigators will use quantitative sensory testing to assess sensitivity to cold, pressure, and heat via standardized protocols. Blood samples will be taken for assessment of stress and reproductive hormone levels, immune cell populations and stimulated cytokine release. Finally, questionnaires will measure pain state, quality of life (QOL), voice QOL, body image, appearance, self-reported health, masculinity/femininity, community connectedness, gender role, sleep, depression, social support, adverse childhood experiences and stigma. Read Less

Knee osteoarthritis (OA) is the most prevalent form of arthritis and race is a risk factor for poor outcomes. Non-Hispanic Black individuals (NHB) report greater disability and pain severity compared to Non-Hispanic Whites (NHW). These differences are reinforced through social and biological mechanisms, ultimately resulting in disparities in pain experience and associated quality of life. National efforts to reduce analgesic utilization highlight the critical need for safe, effective, and accessible alternatives for pain relief for underserved/at-risk populations. Low-carbohydrate diets (LCDs) reduce inflammation and pain independent of weight loss, indicating that diet interventions offer a non-pharmacological alternative. However, racial differences exist in metabolism that are rarely addressed in diet intervention studies. Therefore, a LCD may have greater pain-reducing effects in NHBs and provide an alternative treatment for pain. This will be the first study to examine the efficacy of these diets to reduce knee OA pain with an emphasis on race and interactions with biopsychosocial variables. Aim 1: To investigate the efficacy of the LCD to reduce pain and improve QOL. Hypothesis 1: The LCD group will show significantly greater reductions in: self-reported pain and evoked pain when compared to the USDA diet. Hypothesis 2: The LCD group will show greater improvements in: QOL, mood, and self-reported improvement. Hypothesis 3: Both diets will result in improved pain disability, severity, catastrophizing and pain-related fear; the LCD will outperform the USDA diet. Objective 2: To explore racial differences in diet effects and baseline measures. Hypothesis 1: NHBs will show greater improvements in pain, QOL, and mood. Hypothesis 2: NHBs will report greater food insecurity and less proximity to grocery stores. Hypothesis 3: Diet quality will be negatively associated with baseline pain sensitivity. Objective 3: To determine whether physiological variables contribute to diet effects or lack thereof. Hypothesis 1: Baseline physiological measures will predict: pain sensitivity and reductions in pain. NHBs will show greater inflammation at baseline than NHWs. Hypothesis 2: Change in physiological measures will be related to: change in pain, change in QOL, self-reported improvement and mood. NHWs will show greater reductions in inflammation and adiposity than NHBs. Read Less

This study will monitor device performance and outcomes in subjects undergoing implantation of the Edwards SAPIEN 3 Transcatheter Pulmonary Valve System with Alterra Adaptive Prestent in the post-approval setting Read Less

The purpose of this study is to find out whether the study drug, LY3537982, is safe and effective in cancer patients who have a specific genetic mutation (KRAS G12C). Patients must have already received or were not able to tolerate the standard of care, except for specific groups who have not had cancer treatment. The study will last up to approximately 4 years. Read Less

The purpose of this study is to assess the safety and tolerability of two 5-day infusion cycles of IV gallium in adult patients with CF who are infected with NTM. Funding Source - FDA Office of Orphan Products Development (OOPD) Read Less

One in three American adults have prediabetes, and up to 70% of adults with prediabetes eventually develop type 2 diabetes. With the high cost of treating diabetes, cost-effective approaches are needed to reduce the incidence of diabetes. One new strategy may be to change when people eat. Studies in rodents suggest that a form of intermittent fasting that limits eating to a short time period each day and involves fasting for the rest of the day (time-restricted eating; TRE) improves blood sugar control and cardiovascular health. Preliminary studies suggest that TRE also improves blood sugar, weight loss, and cardiovascular health in humans. This study will be the first full-scale, controlled feeding trial to determine whether TRE can improve 24-hour blood sugar control, 24-hour blood pressure, and cardiovascular disease risk factors even when food intake is matched to the control group. This clinical trial will also determine whether the benefits of TRE depend on the time of day that people eat. Participants will be assigned to one of three groups: (1) 'Early TRE' (eat between \~8 am-3 pm), (2) 'Mid-day TRE' (eat between \~1 pm - 8 pm), or (3) Control Schedule (\~8 am - 8 pm) for 8 weeks. All food will be provided and matched between groups. Read Less

The study proposes to complete the development of and then establish the safety, efficacy, and clinical risk/benefit of a novel hospital incubator pad with stochastic vibrotactile stimulation (SVS) that will provide a complementary treatment and the first improvement in the clinical management of apnea of prematurity (AOP) in over 20 years. Currently, the only approved therapy for AOP is Caffeine Citrate. The SVS mattress pad can prove to be an effective, non-invasive adjunct to Caffeine Citrate for preterm infants with potential to shorten the need for respiratory support as well as overall shortened length of stay. Read Less