Alabama Paid Clinical Trials

The purpose of this clinical trial to characterize changes in bone mineral density during continuous treatment with relugolix combination tablet for up to 48 months (4 years) and 1 year of post-treatment follow-up in premenopausal women with heavy menstrual bleeding associated with uterine leiomyomas (fibroids) or with moderate-to-severe pain associated with endometriosis. Read Less

Knee osteoarthritis (OA) is the most prevalent form of arthritis, a significant cause of disability in the U.S. With an aging population and the rise in obesity rates, the prevalence of knee OA is expected to climb, significantly reducing quality of life (QOL) for those suffering from this debilitating condition. Current national efforts to reduce analgesic utilization highlight the critical need for safe, effective, and accessible alternatives for pain relief. Low-carbohydrate diets (LCDs) reduce inflammation and pain independent of weight loss, indicating that diet interventions offer a non-pharmacological complementary treatment. However, differences exist in metabolism that are rarely addressed in diet intervention studies. Thus, it is important to assess the potential of different diets in a broad population of chronic pain sufferers to determine the potential of diets to reduce knee OA pain. We have shown that a LCD was associated with reduced evoked knee OA pain, daily pain and oxidative stress when compared to either a USDA diet or a diet-as-usual control. Both experimental diets reduced weight to a similar degree, arguing that diet quality was likely the key factor in pain reduction, as opposed to weight loss. However, previous studies comparing diets have utilized diet prescriptions with less control for adherence to the diets. To overcome this obstacle, and in line with our recent work, we will provide all snacks and meals during the diet intervention to increase adherence and retention in the study, allowing for better control over diet interventions and consistency of foods within each study group. We will recruit adults with knee OA (N=200) to complete our two-phase protocol. Phase 1 will involve a 1-week diet run-up that will allow for quantification of pain measures, psychosocial variables (socioeconomic status, nutritional knowledge, proximity to grocery stores, food insecurity), and diet quality to provide a baseline for comparison. Phase 2 will be a 6-week randomized diet intervention (LCD or USDA diet) in which both groups will be provided with all meals at the direction of study personnel and input from participants. Evoked pain tasks, measures of pain disability, severity, catastrophizing, and interference will be assessed every 3 weeks in addition to QOL measures, mood, and depression. Physiological variables will be assessed through blood draws (inflammatory profile) and dual-energy X-ray absorptiometry scans (DXA; body composition, visceral fat) at the end of Phases 1 and 2. This will be the first study to examine the efficacy of these diets to reduce knee OA pain with an emphasis on interactions with biopsychosocial variables. Changes in all pain measures following Phase 2 will be assessed with respect to published measures of clinically-meaningful differences in pain and disability, as well as for statistical significance. The central hypothesis is that the LCD will improve pain and QOL in participants with knee OA more than the USDA diet, but that both will be beneficial. Specific Aim 1: To investigate the efficacy of the diets to reduce pain and improve QOL. Hypothesis 1: The LCD group will show significantly greater reductions in: a) self-reported pain (\>1.7 in pain intensity) and, b) evoked pain (\>30%) when compared to the USDA diet. Hypothesis 2: The LCD group will show greater improvements in: a) QOL, b) mood, and c) self-reported improvement (\>50% participants reporting "much improved" or "very much improved"). Hypothesis 3 (secondary): Both diets will result in improved pain disability, severity, catastrophizing and pain related fear; the LCD will outperform the USDA diet. Specific Aim 2: To explore individual differences in diet and baseline measures. Hypothesis 1: Baseline diet quality will be negatively associated with baseline pain sensitivity Hypothesis 2: Those reporting greater a) food insecurity and/ or b) proximity to grocery stores will report poorer-quality diets. Specific Aim 3: To determine whether physiological variables contribute to diet effects or lack thereof. Hypothesis 1: Baseline physiological measures (inflammatory profile) will predict: a) pain sensitivity, and b) reductions in pain. Hypothesis 2: Change in physiological measures (inflammatory profile, adiposity, leptin) will be related to: a) change in pain measures, b) change in QOL, c) self-reported improvement and, d) mood. Read Less

Subjects who completed either OBERON or TITANIA will be offered the opportunity to consent for this Multicentre, Double-blind, Randomised, Placebo controlled, Parallel Group, Phase 3, extension study to evaluate the safety and efficacy of Tozorakimab in adult participants with symptomatic COPD. Read Less

The purpose of the study is to compare Mezigdomide (CC-92480/BMS-986348) with carfilzomib and dexamethasone (MeziKD) against carfilzomib and dexamethasone (Kd) in the treatment of RRMM: SUCCESSOR-2. Read Less

The purpose of this study is to evaluate the safety and efficacy of glofitamab, as monotherapy and in combination with a standard chemoimmunotherapy regimen: rituximab, ifosfamide, carboplatin, and etoposide (R-ICE) in pediatric and young adult participants with relapsed and refractory (R/R) mature B-cell non-Hodgkin lymphoma (B-NHL). Read Less

This is a multicenter randomized, double-blind, placebo-controlled Phase 2 study designed to evaluate the efficacy, safety, and tolerability of two doses of CT1812 compared to placebo in participants diagnosed with early Alzheimer's disease. Read Less

The purpose of this study is to compare the efficacy and safety of a real time video telehealth pulmonary rehabilitation intervention with standard of care in patients hospitalized for an exacerbation of chronic obstructive pulmonary disease (COPD) to determine the impact on hospital readmissions and respiratory morbidity, and to investigate the cost-effectiveness of the intervention. Read Less

The aim of this study is to provide darolutamide treatment to patients who participated in a previous study with darolutamide supported by Bayer and the treating doctor considers that the continuation of the treatment with darolutamide to be beneficial. Patients will be carried over from the previous studies and continue in this study with darolutamide treatment on the same dosage. They will also return to the study centers for doctor's visits as often as they did in the previous study. Read Less

The participants of this study would have relapsed/refractory follicular lymphoma. Follicular lymphoma is a type of blood cancer. It is referred to as 'relapsed' when the disease has come back after a period of improvement after that follows a treatment regimen and 'refractory' when treatment no longer works. Stage 1 of this trial will study the safety and the level that adverse effects of each of the study drug combinations can be tolerated (known as tolerability). It is also designed to establish a recommended study drug dosage for stage 2 and 3. Stage 1 of the study is completed. Stages 2 and 3 will evaluate and compare how long participants live without their disease getting worse when receiving the study drug in combination with other drug treatment versus the placebo (dummy drug) in combination with other drug treatment. Read Less

The purpose of the study is to evaluate the pharmacokinetic (PK) of certolizumab pegol (CZP) in study participants aged 6 to 17 years with moderate to severe chronic plaque psoriasis (PSO) in order to support extrapolation of efficacy. Read Less

This non-randomized, rollover extension study will provide post-trial access to pelacarsen (TQJ230) to participants who have successfully completed either of the double-blind parent studies (CTQJ230A12303 or CTQJ230A12304). Read Less

Generalized anxiety disorder (GAD) is usually treated with antidepressant therapy (ADT); however, sometimes ADTs alone are not enough to adequately treat GAD. The purpose of this study is to assess how safe and effective ABBV-932 is when added to the antidepressant therapies in adult participants with GAD who have had an inadequate response ADTs. ABBV-932 is an investigational drug being developed for the adjunctive treatment of GAD. Participants will be randomly assigned to receive ABBV-932 or Placebo in addition to their currently prescribed ADTs. There is 1 in 3 chance of participants assigned to Placebo. Approximately 315 adult participants with GAD and inadequate response to ADTs will be enrolled in approximately 50 sites in the United States and Puerto Rico. Participants will receive oral capsules of ABBV-932 or matching placebo in addition to their prescribed ADT for 6 weeks and then will be followed for an additional 4 week follow-up period. There may be higher treatment burden for participants in this trial compared to their standard of care. Participants will attend regular visits during the study at a hospital or clinic. The effect of the treatment will be checked by medical assessments, blood tests, checking for side effects and completing questionnaires. Read Less