There are about 173942 clinical studies being (or have been) conducted in United States. The country of the clinical trial is determined by the location of where the clinical research is being studied. Most studies are often held in multiple locations & countries.
The purpose of this prospective pilot study is to gather preliminary evidence evaluating spinal cord stimulation (SCS) as a potential therapy for the treatment of rigidity and painful spasms in patients with stiff person syndrome (SPS), a rare autoimmune neurological condition. The hypothesis is that SCS-mediated clinical improvement occurs through multi-modal mechanisms of action targeting several components of neuronal inhibitory signaling pathways in the spinal cord.
This study experimentally investigates 1) whether ultra processed food (UPF) intake contributes to depression by increasing low mood and poor sleep due to blood glucose fluctuations (which then increases the desire to consume more UPFs) and 2) to investigate the effectiveness of a 2-week meal-kit intervention that provides convenient and tasty minimally processed foods (MPF) to reduce depression. The following aims and hypotheses are tested: Aim 1: To investigate whether UPF intake and low mood contribute to each other in a cyclical fashion through the mechanisms of blood glucose fluctuations and disrupted sleep in individuals with moderate-to-severe depression. H1: It is hypothesized that UPF intake and high blood glucose will be associated with low mood in individuals with depression. Aim 2: To establish an industry partnership to investigate whether commercially available meal kit delivery reduces symptoms of depression in individuals with moderate-to-severe depression relative to a nutrition education control condition. H2: Meal kit delivery will lead to reductions in depression symptoms and daily reductions in low mood relative to the control condition (nutrition guidance only).
A combination of generally regarded as safe (GRAS) compounds named GLY-LOW, which included: alpha lipoic acid, pyridoxamine, nicotinamide, piperine and thiamine, were examined in pre-clinical experiments. GLY-LOW supplementation reduced caloric intake and increased insulin sensitivity in mice. In female mice, GLY-LOW supplementation reversed aging-related declines in female hormones. Studies in humans are needed to examine the feasibility, utility and efficacy of GLY-LOW supplementation in post-menopausal women with obesity toward improving aging-related impairments. The effect of GLY-LOW supplementation on these obesity and biological age-related impairments in post-menopausal adult female humans with obesity is unknown. We aim to translate the findings of GLY-LOW supplementation in animals to a cohort of healthy, postmenopausal females at birth with obesity by conducting a one-group, no-placebo comparer, pre post intervention clinical trial. Additionally, we propose to examine the specific effect of supplementation by GLY-LOW on biological aging via retina scan. The objectives of the proposed pilot study are: I. Conduct a 6-month pilot study to examine the feasibility, utility and efficacy of GLY-LOW supplementation in a total of 40 postmenopausal female born adults > 55 years with obesity (> 30 BMI) Ia. Examine alterations in self-reported caloric intake and the following health and biological aging, parameters prior to and after 6 months of GLY-LOW supplementation: 1. Self-reported Caloric Intake 2. Metabolic disease risk 3. Cardiovascular disease risk 4. Metabolic assessments 5. Hormones 6. Physical Function and Fitness 7. Muscular strength 8. Cognitive Function and Depression assessments 9. Systemic inflammation 10. Biological aging 11. Safety parameters (also every 2 months during the intervention; ECG at baseline and 2 months only) 12, Compliance measures (pill counts and interviews every 2 months during the intervention)
The study is designed to understand the safety, tolerability, pharmacokinetics, immunogenicity, and preliminary antitumor activity of MGC026 in participants with relapsed or refractory, unresectable, locally advanced or metastatic solid tumors The study has a dose escalation portion and a cohort expansion portion of the study. Participants will receive MGC026 by intravenous (IV) infusion. The dose of MGC026 will be assigned at the time of enrollment. Participants may receive up to 35 treatments if there are no severe side effects and as long as the cancer does not get worse. Participants will be monitored for side effects, and progression of cancer, have blood samples collected for routing laboratory work, and blood samples collected for research purposes.
The purpose of this study is to investigate the ability of an experimental dentifrice containing 1150 parts per million (ppm) fluoride to remineralize acid-softened dental enamel and help prevent further demineralization compared to a 0 ppm fluoride placebo dentifrice and a marketed, fluoride-containing dentifrice (Reference Dentifrice).
The goal of this clinical trial is to evaluate the SMILE app, a Digital Health Platform (DHP), that will deliver a mindfulness intervention, designed to mitigate COVID-19 related stress. Additionally, the SMILE app will remotely collect self-reported psychological and physiological metrics of mental health and autonomic regulation. Study participants are adults who self-identify as African American, Black and/or Latino, and who have clinically significant levels of anxiety. The study aims are: - Aim 1: Establish the effectiveness and durability of an 8-week Mindfulness DHP intervention. The investigators will focus on two constructs important to mental health and hypothesize that: A) Anxiety, self-report stress and quality-of-life measures will significantly improve when comparing: A.1) Pre-to-post intervention, and; A.2) Control vs. intervention groups over 8 weeks and at 1-month follow-up. B) Arousal, autonomic indices of HRV (reflecting parasympathetic activation) will significantly improve, when comparing: B.1) Pre-to-post intervention, and; B.2) Control vs. intervention groups over 8 weeks and at 1-month follow-up. - Aim 2: Establish the sustainability of two Mindfulness DHP interventions utilizing retention, usage (frequency), and participant satisfaction. - Aim 3: Examine associations between COVID-19 related stress, mental health outcomes, and HRV. Examine the extent to which COVID-19 related stress and mental health symptoms are linked to HRV at baseline and how that relationship changes over time. Participants will be assigned to 1 of 3 arms of the study: MTIA intervention, MAPP intervention, or wait-list control. All participants will be mailed a device with the SMILE app installed, and the equipment for recording cardiac data in the home. All participants will complete the baseline psychometrics measures and physiological stress test using the instructions provided on the SMILE app. Those assigned to the MTIA or MAPP intervention groups will then participate in their assigned intervention over the subsequent 8 weeks. During these 8 weeks, psychometric and physiological data will be completed biweekly for all participants. 3 months following the initial baseline, all participants will complete a final psychometric/physiological evaluation.
There is well documented evidence that ingesting dietary carbohydrate in large amounts tends to increase postprandial glucose. In healthy populations, this is not necessarily a problem, but continuous exposure to high levels of glucose-hyperglycemia-is a defining characteristic and risk factor for type 2 diabetes mellitus. Consuming a carbohydrate-rich food as the final food in a meal sequence has been shown to significantly reduce postprandial glucose excursions in both diabetes patients and in healthy controls. The exact mechanisms behind this phenomenon are not well understood, but one proposed course is simply that the vegetable and protein already being digested slows the rate of glucose rise. Despite the findings, little-to-no research has examined how manipulating the order of foods in a meal impacts subsequent exercise responses. In this experimental crossover study, each participant will undergo two acute feeding conditions (carbohydrate-rich foods first vs. last in a meal), which will be followed by exercise 60 minutes later. We will observe the effects of meal order on postprandial glucose, substrate/fuel utilization, and subjective perceptions at rest and during 30 minutes of exercise.
The preclinical curriculum related to firearm violence and safety counseling at the UCLA David Geffen School of Medicine (DGSOM) has been expanded for the Class of 2027, informed by the results and conclusions of an initial study of firearm safety counseling by medical students (ClinicalTrials.gov ID: NCT05242627), which was conducted by the present study team. The 1-hour firearm safety counseling training session used in that study will be taught again to first-year medical students in the Class of 2027, but training will be augmented with additional instruction; the Class will receive additional comprehensive instruction on suicide risk assessment and will participate in small group breakout sessions, to facilitate the opportunity for students to discuss issues related to firearm violence as a public health issue and to practice firearm safety counseling with standardized patient actors (SPs). Assessment of access to firearms and firearm safety counseling will be added as a standard component of the Social History that students are taught to obtain from patients during clinical examinations. The goal of the expanded training is to increase the prevalence of medical student counseling when they are conducting a history and physical examination in a simulated patient encounter with an SP 6 months after the initial training session, when compared to results from the initial study. The scenario provided to the SP will be identical to that used in the initial study and is a situation in which firearm safety counseling is warranted. Students will participate in a survey to ascertain their knowledge of firearm violence and their attitudes about physician counseling about firearm safety, prior to formal instruction. Informed consent will be obtained from students to use their responses in educational research. Following the didactic and small group sessions, students will be asked to complete a post-training survey that is similar to the original survey, as a means of assessing knowledge gained and any change in attitudes about physician counseling. The simulated patient encounter will occur approximately 6 months later, after which students will complete another survey to determine retention of knowledge and their experience during the simulated patient encounter. Students will not be told before the encounter that they will be evaluated regarding firearm safety counseling. The SP will identify which students did and did not raise the issue of firearm safety. Videos recorded of each students' sessions (routinely obtained for grading purposes) will be viewed by investigators for those students who provide informed consent, to determine the quality of counseling, if it was conducted. Results from this follow-up study will be compared to the results of the initial study as a historical control, to determine whether augmentation of firearm safety counseling training above a 1-hour didactic session increases firearm safety counseling by medical students in a clinical setting and whether it improves retention of knowledge about firearm violence.
The goal of this clinical trial is to test the feasibility of a web app about colorectal cancer screening in patients with an upcoming primary care appointment. The main questions it aims to answer are: - Among patients who use the web app, what proportion will request a colorectal cancer screening test via the program? - How many patients will respond to a text message intervention to use the web app? Participants will receive a text message informing them of the value of colorectal cancer screening, and inviting them to click a hyperlink to learn more. The hyperlink will take participants to the web app. The web app: 1) asks questions and use algorithms to determine if routine colorectal cancer screening is needed, and 2) if screening is indicated, shows a brief educational video about colorectal cancer screening and allows participants to request a screening test via the program. Researchers will compare four different versions of the text message invitation to see if some messages result in higher program completion rates than others.
The goal of this clinical trial is to test the ability of HT-6184 to decrease inflammation and pain in patients after third molar removal. The main question it aims to answer are: - Does HT-6184 decrease inflammation in patients after third molar removal? - Does HT-6184 decrease pain in patients after third molar removal? Participants will be asked to do the following during the clinical trial: - Take a single oral dose of HT-6184 or placebo - Allow a oral surgeon remove their third molar teeth - Blood draws on 5 occurrences - Rate their pain intensity - Attend two follow-up appointments on day 1 and day 2 after third molar removal - Participate in one follow-up phone call 5-7 days after third molar removal