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NCT04924088
The legal team in medical-legal partnerships works with healthcare providers to improve their clients' lives. It is unknown whether this approach is better than providing usual legal services, with no special emphasis on non-legal matters and no particular collaboration with healthcare providers. The investigators propose to randomly assign 300 Veterans with housing-related legal problems to either legal help from a medical-legal partnership or help from lawyers in the community. The investigators will follow the randomized Veterans in this study for one year to determine if there is a difference between the two groups of Veterans in their housing situations and their mental health. The investigators will also interview Veterans in both groups about their experience of the legal services they have received.
NCT07588984
This research program includes two coordinated prospective studies (FLOURISH and THRIVE) evaluating the real-world effectiveness of Noom's digital health programs on weight, cardiometabolic biomarkers, physiological health indicators, and program engagement. FLOURISH is a 6-arm prospective cohort study comparing an Education-only control, Noom Weight, standard-dose compounded semaglutide, microdose compounded semaglutide, standard-dose tirzepatide (Noom Plus), and microdose tirzepatide (Noom Plus Microdose). THRIVE is a nested 2-arm prospective study comparing a Proactive Health program to a Noom Free Tier control. Participants complete monthly surveys, remote biomarker collection (Tasso device), connected-scale weigh-ins, and in-app biometric assessments (FaceScan, BodyScan). Microdose and Free Tier arms also use wearable fitness trackers. Primary outcomes are changes in cardiometabolic biomarkers, weight, body composition, and GLP-1 side effect profile. Total N = 2,310; 24-month duration.
NCT07502534
This study is a multicenter, randomized, double-masked, parallel-group, reference-drug-controlled clinical trial of IBI3027 in healthy male volunteers. Healthy volunteers will be randomly assigned in a 1:1 ratio to receive either IBI3027 or DUPIXENT?. The dosage for both groups is 300 mg. The entire study includes a 28-day screening period and a 56-day observation period (including 3 days of hospitalization). Randomization is stratified by body weight at baseline (D1) ≤ 70 kg vs. \> 70 kg.
NCT07419633
In this study, participants will be assigned to receive HMB, 2-HOBA, a combination of both, or a comparison supplement for a set period of time. During the study, participants will attend scheduled visits where researchers will assess muscle strength, physical function, and overall health. Blood samples may be collected to measure markers related to metabolism, inflammation, and oxidative stress. Study staff will also monitor safety and any side effects throughout the study.
NCT07587073
This pragmatic, cluster-randomized trial will evaluate whether a comprehensive CalAIM-aligned care model consisting of Enhanced Care Management, selected Community Supports, Transitional Care Services, and residential care coordination improves population health outcomes among high-risk Medi-Cal managed care members in California compared with usual CalAIM service delivery. The intervention is intended to improve continuity of care after discharge, reduce potentially avoidable utilization, increase successful linkage to outpatient and social supports, and improve community tenure and patient-reported outcomes.
NCT02629692
Phase 1/2 study to determine safety, tolerability, pharmacokinetics, and anti-leukemic activity of Vodobatinib (K0706) in treatment-refractory/intolerant CML
NCT05545306
Background: Diet-induced thermogenesis (DIT) is the amount of energy one s body uses to eat food, absorb the nutrients from the food, and process those nutrients. Researchers would like to understand more about how changing the balances of protein, fat, carbohydrates, and total calories in the diet can affect DIT. Objective: To learn how different diets can change a person s DIT. Eligibility: Healthy people aged 18 to 60 years who have not intentionally lost weight in the past 6 months. Design: Participants will stay in a clinic for about 35 days. They will eat only the food provided. They will receive 8 different diets during the study, including 7 test diets. Participants will undergo multiple tests. They will be screened with blood and urine tests and a test of their heart function. During the first few days: Their waist, thigh, and neck circumference will be measured. They will have a DXA scan: They will lie on a padded table for about 20 minutes while an instrument measures the amount of fat in their body. They will be tested for diabetes. They will answer questionnaires about topics including eating behavior, hunger, and stress. Throughout the study: Their weight will be measured daily. Blood tests will be repeated. They will stay in a metabolic chamber a total of 9 times. They will remain in a closed room for 24 hours while researchers monitor the room temperature and levels of oxygen and carbon dioxide. Participants will collect all their urine for each 24-hour period. ...
NCT07269301
The purpose of this study is to understand the effects of decreased liver function on the study medicine (PF-07328948). People with decreased liver function may process the study medicine differently from healthy people. Study is seeking participants who: * Are between 18 and 75 years of age. * Have a BMI (body mass index) of 17.5 to 40 kg/m2, inclusive, and a total body weight of more than or equal to 45 kilograms or 99 pounds. Participants will take the study medicine as a tablet once at the study clinic and then will stay onsite for about 6 days. During this time, the study team will check for the participant's treatment experience and take some blood samples to test the level of PF-07328948. This will help understand if certain level of decreased liver function could affect the study medicine being processed in the body.
NCT07578103
The consumption of an adequate quantity of protein in the diet is essential to maintain a healthy body composition and functioning. It is also well established that all proteins are not equal regarding their ability to promote health benefits. Recently, we have innovated in that matter by showing that under the context of high intake of dietary fat, the dairy protein casein was more effective than a mix of proteins representative of a western diet to prevent body weight gain and insulin resistance. This was explained in part by modifications of the gut microbiota. This finding represents the main conceptual basis of the present research program that is aimed to determine the impact of dairy protein from yogurt compared to a plant-based equivalent on body composition indicators including muscle mass and bone mineral density, in relation to the profile of the gut microbiota, the production of newly discovered protein-derived metabolites, and markers of metabolic health. This program will include a human and an animal component requiring the testing of these variables before and after a standardized intervention. The human component will be a clinical study consisting of a 12-week diet-based weight loss intervention in postmenopausal overweight women being randomly assigned to one of the three following groups: yogurt, plant-based yogurt, or kept on diet without supplements. The animal experimentation will permit to causally determine the implication of the gut microbiota in the protein effects following transfer of the human bacteria to germ free mice and validate the benefits seen in humans. It is anticipated that these two complementary investigative approaches will allow a thorough documentation of the impact of fermented dairy protein on body composition and functioning, a better understanding of the underlying mechanisms, and the identification of new biomarkers to better appreciate related health benefits.
NCT05211713
The aim of the project is firstly, to develop an app-based mental health intervention for adolescents. Secondly, to evaluate the effect of this app. The overarching goal is to offer a low-threshold intervention, called Opp, that is easily accessible and free to use for all adolescents in Norway.
NCT07576855
The goal of this study is to learn whether a telephone-based program that helps people share life memories can reduce loneliness and improve mental well-being, life satisfaction, and social support in older adults and their caregivers living in rural areas. This study has two parts. In the first part, researchers will gather feedback from a small group of older adults and informal caregivers to see if the updated telephone reminiscence program works well and is easy to use. In the second part, researchers will test the telephone reminiscence program in a clinical trial study to see whether the updated telephone reminiscence program reduces loneliness and improves social support, life satisfaction, and mental well-being in older adults and their caregivers. The researchers will also examine how the program impacts how often and for what reason you reminisce. The main questions this study aims to answer are: * Does the telephone reminiscence program improve social support, life satisfaction, and mental well-being and reduce loneliness in rural older adults and their caregivers? How does the telephone reminiscence impact how often and for what reason participants reminisce? * How often and how long do participants use the program? * How satisfied are older adults and informal caregivers with the program? In this study researchers will compare participants who begin the telephone reminiscence program right away with participants who start the program after a 12-week waiting period to see whether starting the program earlier leads to better outcomes. Participants will: * Take part in telephone calls 3 times a week that invite older adults to talk about their life experiences. * Answer brief survey questions about social support, loneliness, and mental well-being, and life satisfaction over time. * Include both older adults and their informal caregivers, who may also participate by recording questions in their own voice.
NCT01148381
The influence of genes on addictive and neuropsychiatric disorders is complex, especially given that multiple genes likely influence certain behaviors that are correlated with addiction. Researchers are interested in looking at the genetic information of individuals who are enrolled on National Institute for Drug Abuse studies to investigate specific genetic variants that may be related to substance abuse. Researchers will study the effects of genes on several aspects of thinking such as attention, memory, decision making, problem solving, learning, and emotional feelings, and investigate the ways in which genetic information affects addictive behaviors and substance abuse. In addition, researchers will study how genes may explain differences in imaging data in substance users. Objectives: \- To collect genetic information for research on genetic aspects of addiction and substance abuse. Eligibility: * Adults age 18 or older * (1) healthy, non-drug-using nonsmokers, * (2) healthy smokers, * (3) healthy individuals dependent on other commonly abused drugs, and * (4) individuals with other psychiatric disorders. * Participants must be enrolled in another National Institute on Drug Abuse, Intramural Research Program imaging protocol. Design: * This study involves one to two visits to National Institute on Drug Abuse, Intramural Research Program that may be separate from the participant's current research protocol study visits or on the same day as those visits. * Participants will provide a blood sample and complete questionnaires about mood, memory, and learning. * Participants may also be asked to do a few tasks, such as playing computer games involving coin tosses and money management, or responding to questions on a computer screen.
NCT04849923
Background: Muscular strength training interventions have long been a cornerstone in the prevention, non-surgical management and rehabilitation of the entire spectrum of musculoskeletal injuries and diseases. The key goal of strength training, especially during rehabilitation, is to regain healthy musculoskeletal function. Yet, there remains a fundamental lack of understanding with regards to the relationship between subject-specific musculoskeletal biomechanics (i.e. multi-body dynamics function) and different types of strength training interventions because of limitations in assessing these parameters outside the research setting. Thus, clinicians, physiotherapists and coaches continue making training recommendations based on subjective and generalised guidelines, with ineffective or possibly harmful consequences for individual patients and athletes. Goal: This project aims to advance strength training guidelines and monitoring of training safety and efficiency by means of subject-specific anatomically-based modelling, biomechanical analysis of musculoskeletal function and mobile monitoring of training volume and muscular fatigue in the athletic and recreational setting. Method: For validation purposes, the investigators will conduct an 8-week intervention study in healthy volunteers with strength training of the key muscle-tendon groups associated with knee joint stability and relate the changes in musculoskeletal and biomechanical parameters to the training-specific parameters and muscular fatigue from mobile monitoring through correlation analysis. Relevance: In Switzerland, more than 1.3 Mio people are members of a fitness center. Strength training is not only a cornerstone in the maintenance of fitness and rehabilitation from musculoskeletal injuries and diseases as the most frequently reported health issues.
NCT07568574
Objectives: The primary objective is to assess the safety and tolerability of medical drugs with the potential to enhance performance (PES) in professional athletes over a 5.5 year period, encompassing a 25-week PES Exposure period and 5 year long term follow-up of period comprehensive health and safety monitoring. The secondary objective is to evaluate the impact of PES on athletic performance through validated sport specific and clinical assessments. Methods: This prospective hybrid design study will enrol 60 adult participants, divided into two groups. The first group will receive performance-enhancing substances (PES) directly through the study, administered as Investigational Medicinal Products (IMPs) under comprehensive medical supervision for up to 25 weeks. The second group will include natural athletes and those already using PES prescribed by their own doctors. All substances used in this study are medically approved by national regulatory agencies (e.g., FDA, MHRA, EMA, EDE, etc.), and market authorised. Participants undergo enrollment and baseline health and performance assessments, prior to a 25 weeks of PES exposure. During the period of PES exposure, participants undergo periodic monitoring of comprehensive physiological biomarkers alongside subjective assessments. Following the PES exposure phase, participants will complete repeat baseline health and performance assessments, followed by a titration phase and, where indicated, post-cycle therapy (PCT) to support the restoration of physiological function toward baseline. The study will conclude with a five-year longitudinal follow-up period to monitor long-term health outcomes. During this phase, participants will undergo annual assessments, including cardiac electrocardiography (ECG), echocardiography, magnetic resonance imaging (MRI), blood and urine biomarkers, routine vital signs, and quality-of-life measures. Additional imaging will include brain functional MRI (fMRI) and vital organ ultrasound at years 1, 3, and 5, with cardiac CT performed as clinically indicated. Athlete safety biomarker assessments, clinical evaluations, and adverse event reporting, will be continuously evaluated by study doctors and with additional safety oversight from a Data Safety Monitoring Board, Independent Medical Commission (a multidisciplinary panel of medical experts), and a Medical Monitor.
NCT05441306
This is a randomized pilot study to test the acceptance and use of PerHL among formerly incarcerated individuals
NCT05612672
Geographic Information Systems (GIS) and spatial analysis have become important tools in public health informatics but have rarely been applied to the hospital setting. In this study we apply these tools to address the challenge of Hospital Acquired Infections (HAIs) by building, implementing, and evaluating a new computer application which incorporates mapping and geographic data to assist hospital epidemiologists in identifying HAI clusters and assessing transmission risk. We expect that incorporation of geographic information into the workflow of hospital epidemiologists will have a profound effect on our understanding of disease transmission and HAI risk factors in the hospital setting, radically altering the workflow and speed of response of infection preventionists and improving their ability to prevent HAIs.
NCT07554365
AN01 is a selective small-molecule dual inhibitor of phosphodiesterase 3 and 4 (PDE3/4). As a potential new therapy for COPD, AN01 is expected to serve either as a monotherapy for COPD or as adjunctive therapy to current inhaled standard treatments, potentially generating synergistic complementary effects in patients requiring additional therapeutic options. The primary objective of this study is to evaluate the safety, tolerability, and pharmacokinetics of multiple doses of AN01 in healthy participants.
NCT07122011
This experimental study explores the neurophysiological mechanisms associated with pain modulation following a single session of low-intensity resistance exercise combined with BFR in healthy young adults. The study evaluates changes in sensory thresholds before and after the intervention using validated quantitative sensory testing (QST) methods. These include pressure pain thresholds, conditioned pain modulation, thermal thresholds, and temporal summation. The findings may contribute to a better understanding of the role of the nervous system in exercise-induced hypoalgesia, particularly in response to BFR protocols, with implications for future research in pain and rehabilitation.
NCT07386730
This study is being conducted to understand changes in brain activity following administration of two different drugs (Psilocybin and Dextromethorphan) in older adults with low well-being. The main questions it aims to answer are, does psilocybin: 1. Acutely increase complexity of EEG activity in older adults with low well-being, as modulated by the presence of biomarkers of Alzheimer's disease (AD) pathology. 2. Longitudinally decrease plasma markers of neuroinflammation, as modulated by the presence of biomarkers of AD pathology. 3. Explore longitudinal changes in autonomic physiology via wearable recording devices as well as longitudinal structural and functional brain changes measured in the MRI Participants will be in the study for up to 3 months, which will include 3 to 4 in person visits and 3 to 4 remote visits. Most visits will be between 1 to 3 hours, but the dosing visit will last a minimum of 8 hours and could be as long as 12 hours. During the dosing visit, all participants will receive a single dose of the study drugs and dosages listed below. Researchers will compare participants who receive the following drug options: * A low-to-moderate dose of Psilocybin (5-10 mg) * A moderate-to-high dose of Psilocybin (25-30 mg) * A low-to-moderate dose of Dextromethorphan (30-60 mg) * A moderate-to-high dose of Dextromethorphan (80-90 mg)
NCT07565766
The goal of this clinical trial is to evaluate the effect of a mouthrinse containing an active ingredient benzydamine hydrochloride in the absence of daily oral hygiene. The study includes periodontally healthy female subjects and experimental phase will last for three days. Plaque accumulation is the primary evaluated outcome, measured by a particular periodontal index called Plaque Control Record (PCR). Gingival inflammation (bleeding) is the secondary evaluated outcome, measured by a particular periodontal index called Bleeding on Probing (BoP). Researchers will compare benzyadamine hydrochloride mouthrinse to a placebo (a look-alike substance that contains no active ingredient) mouthwash to see whether benzydamine hydrochloride use results in greater plaque accumulation.