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Showing 1-20 of 418 trials
NCT07570628
This observational study aims to evaluate the real-life use of a digital tool (Fragiclic) by general practitioners (GPs) and nurses to screen and assess frailty in adults aged 65 and over. Frailty is a syndrome that increases the risk of loss of autonomy, falls, hospitalizations, or death. The tool includes simple screening questionnaires (such as SEGAm) and a comprehensive assessment (CGA - Comprehensive Geriatric Assessment) to better manage patients' health. The main question it aims to answer is: * What proportion of patients aged 65 and over will benefit from frailty screening or assessment using Fragiclic over 12 months? A secondary question is \- Does the use of Fragiclic reduce the risk of unplanned hospitalizations or death in these patients? For the secondary question, researchers will compare patients who received screening or assessment (with or without a Personalized Care Plan (PCP)) to those who did not, to determine if Fragiclic improves their health outcomes. Participants will not have additional tasks: Their GP or nurse will use Fragiclic during routine consultations. Some patients may be asked to provide information about their health or quality of life (via their healthcare provider). All data will be collected anonymously and securely
NCT07460336
This single-center, randomized, open-label, controlled study aims to evaluate the effect of cofrogliptin on pancreatic β-cell function in adults with latent autoimmune diabetes in adults (LADA). Following a screening period of up to 6 weeks, 84 eligible participants will be randomized in a 1:1 ratio via a sealed-envelope method, stratified by baseline GADA titer (≥0.3 vs \<0.3). Participants will be assigned to one of two treatment arms: (1) metformin (with or without insulin) plus vitamin D3, or (2) metformin (with or without insulin) plus vitamin D3 and cofrogliptin. Cofrogliptin will be administered orally at a dose of 10 mg once every 2 weeks, and vitamin D3 at 2000 IU once daily, for a total treatment duration of 52 weeks. Study visits are planned at baseline and at Weeks 12, 26, 38, and 52, during which mixed-meal tolerance tests (MMTT) and other protocol-specified assessments will be conducted.
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)
NCT05860088
The goal of this controlled-feeding cross-over diet intervention is to compare a beef diet to a vegetarian diet on muscle fatigue in older adults. The aims are: AIM 1: To test the hypothesis that muscle fatigue is attenuated in older adults consuming beef compared to older adults consuming a plant-based diet. AIM2: To test the hypothesis that daily beef consumption improves biochemical indicators related to muscle fatigue. Participants will be randomized to consume either a beef-based diet or vegetarian diet under controlled-feeding conditions for 8 weeks. After a 2-week washout period, participants will cross-over to consume either the beef diet or vegetarian diet for 8 weeks. Body composition and functional muscle outcomes will be measured during each 8-week feeding period. Blood samples will also be collected.
NCT06116838
The goal of this study is to understand how transcutaneous spinal cord stimulation (tSCS) waveform, modulation frequency, and stimulation location impact lower extremity muscle activation and participant comfort in adults without neurologic conditions.
NCT07036458
To Evaluate the Mass Balance Recovery, Metabolite Profile and Metabolite Identification in Healthy Male Subjects
NCT07544173
The goal of this clinical trial is to learn whether intravenous magnesium sulphate can reduce emergence agitation as effectively as intravenous dexmedetomidine in adult patients undergoing otorhinolaryngology surgery under general anesthesia. The main questions it aims to answer are: \- Is intravenous magnesium sulphate non-inferior to intravenous - dexmedetomidine in reducing the proportion of emergence agitation (defined as Richmond Agitation-Sedation Scale \[RASS\] ≥2)? Are there differences between the two drugs in terms of hemodynamic stability, severity, onset and duration of emergence agitation, and recovery profile? Researchers will compare continuous intravenous magnesium sulphate infusion (20 mg/kg/hour) with continuous intravenous dexmedetomidine infusion (0.5 µg/kg/hour) to see if magnesium sulphate provides similar protection against emergence agitation with fewer hemodynamic side effects. Participants will: * Be randomized to receive either magnesium sulphate or dexmedetomidine infusion from induction of anesthesia until the end of surgery. * Undergo standardized general anesthesia with sevoflurane, fentanyl, and rocuronium. * Be assessed for emergence agitation using the Richmond Agitation-Sedation Scale (RASS) after discontinuation of anesthetic agents. * Have intraoperative heart rate, mean arterial pressure, anesthetic consumption, and vasoactive drug use recorded. * Be evaluated postoperatively for pain, opioid requirement, and extubation time.
NCT07542561
The goal of this clinical trial is to learn whether an artificial intelligence-assisted internet-based mindfulness intervention for emotional distress (iMIED) can prevent or reduce anxiety and depressive symptoms in adults with subclinical emotional distress. The main questions it aims to answer are: Can iMIED reduce anxiety symptoms, as measured by the Generalized Anxiety Disorder-7 (GAD-7)? Can iMIED reduce depressive symptoms, as measured by the Patient Health Questionnaire-9 (PHQ-9)? Researchers will compare participants receiving iMIED plus access to usual mental health resources with participants receiving usual mental health resources alone to see whether iMIED leads to greater improvement in emotional distress over time. Participants will: complete online screening and baseline assessments; be randomly assigned to either the iMIED intervention group or the control group; if assigned to the intervention group, complete a 49-day AI-assisted online mindfulness self-help program using a WeChat mini-program and AI support tool; complete follow-up online questionnaires during the intervention and at 3, 6, 12, 18, and 24 months after the intervention; report information on mental health symptoms, quality of life, healthcare use, sleep, stress, resilience, and life satisfaction.
NCT07327541
This study aims to evaluate the cognitive function, physical function, and pain levels of community-dwelling older adults to determine the impact of cognitive ability on physical function and pain. It also seeks to establish foundational data for strategies to prevent dementia and sarcopenia. Therefore, the purpose of this study is to measure the cognitive function (overall cognition, executive function, memory, attention, etc.), physical function (muscle mass, muscle strength, gait and balance ability), and pain of community-dwelling older adults, and to analyze the correlations between these factors.
NCT06581874
In the absence of easy access to second-line ambulatory care, the number of 'inappropriate' psychiatric emergency visits is increasing, with emergency departments becoming the gateway to mental health care. This is the context in which the 'med@psy' system was set up in the Toulon-Provence-Mediterranean metropolitan area by a private psychiatrist. It facilitates access to psychiatric second referral for General Practitioners (GPs) by pooling the 48-hour supply of psychiatric consultations in real time. It is assumed that this system will facilitate access to outpatient psychiatric care and help to optimize the organisation of patient care and follow-up. The aim of this study is to evaluate the med@psy system in the care pathway for patients with psychiatric disorders. This study main objective is to compare the proportion of patients with a psychiatric disorder who will receive outpatient follow-up 1 month after a visit to a psychiatric emergency department without hospitalization (Group 1) versus 1 month after a consultation with a psychiatrist within 48 hours via the med@psy system (Group 2).
NCT07520318
Oculgen has begun a study of an investigational drug called OCUL101 as a possible treatment for neovascular AMD. An investigational drug is one that has not been approved by regulatory agencies, such as the Food and Drug Administration (FDA) in the United States (US), the European Medicines Agency (EMA) in the European Union (EU), or others. A comparator drug, Eylea® (aflibercept), will also be used in this study. Aflibercept is approved by regulatory agencies to treat neovascular AMD. VEGF-A (vascular endothelial growth factor A) is a protein released by the body in response to certain conditions that encourages the eye to form new blood vessels that are weak and leaky. This can lead to leakage of fluid and swelling in the macula; the part of the eye that helps you see clearly. C5 (component 5) is a part of the immune system released when there is ongoing damage to the eye such as when you have neovascular AMD. When it becomes too active in the eye, it can cause inflammation and further damage, leading to thinning of the back of the eye, a condition called geographic atrophy (GA). OCUL101 works by blocking both VEGF-A and C5. The main purpose of this study is to see how safe and tolerable OCUL101 is and how well OCUL101 works in participants when compared with aflibercept. From here on, OCUL101 and aflibercept will be referred to as the "study drug." This study is divided into 2 periods: a screening period and a study treatment period. During each study period, you will have 1 or more visits with your study doctor at the center. The screening visit will last about 3 hours, and all other visits will last about 3 to 6 hours. This study has 2 Parts. Part A uses the 10.4 mg dose of OCUL101 and Part B uses 2 doses of OCUL101 (6.5 mg and 10.4 mg) to compare with 2 mg of aflibercept. Before any study-related tests and procedures can be done, you will be asked to read and sign this informed consent form, and then the study will begin with a screening visit. The purpose of the screening visit is to decide whether or not you meet the requirements to take part in this study. If you do not meet the requirements, the study doctor will explain why and will discuss other treatment options with you. If the study doctor decides that you meet all of the requirements to be in this study, you will be assigned to either Part A or randomly assigned (like drawing straws) to one of the groups in Part B. You will then receive one of the following study treatment plans: * Part A, 10.4 mg of OCUL101 * Part B, Group 1, 6.5 mg of OCUL101 + as needed study treatments of 10.4 mg OCUL101 * Part B, Group 2, 10.4 mg of OCUL101 * Part B, Group 3, 10.4 mg of OCUL101 * Part B, Group 4, 2 mg of aflibercept You will receive 3 injections between Day 1 and Week 8, after which you may or may not receive additional injections every 8 weeks until Week 36. After you receive the set number of injections for your Part/group, you may receive additional injections during the study if the study doctor thinks it will help you. You will have an 80% (4 in 5) chance of receiving OCUL101 and a 20% (1 in 5) chance of receiving aflibercept. This is a double-masked study, which means you and some of the people involved in the study will not be told if you are receiving OCUL101 or aflibercept. However, this information will be given to the study doctor if it becomes necessary for your safety. The eye receiving the study drug is called "the study eye". If the other eye, called the "fellow eye", needs treatment with anti-VEGF therapy, you can discuss this with your study doctor. This treatment may be provided during your study visit, if appropriate. Description of the procedures and assessments * Medical history: Includes questions about any diseases, chronic or ongoing conditions, surgeries, cancer history, reproductive status, and smoking history. Any information about current or previous medicines will also be recorded. * Demographics: Information to be collected includes age, sex, and race/ethnicity. * Physical examination: Physical examination of the chest, abdomen, head and neck, and musculoskeletal system will be done as per your study doctor's preferred methods. * Eye examinations: Throughout the study you will have several eye tests. Both the front and back of your eye will be examined and some of these eye exams may occur in both eyes. Eye drops may be used to make your pupils (center part of your eye) look larger (dilated) and easier to look through. * BCVA: You will sit in front of an eye chart to read the letters and test the sharpness and accuracy of your vision. * Contrast sensitivity: You will sit in front of an eye chart read the letters where the letters are lighter and darker shades. * Color Vision Testing: Your vision will be tested to see how well you see color by having you look at color vision charts. * Assessment of metamorphopsia: Metamorphopsia is when you see lines as wavy or bent instead of straight.
NCT07522125
This study was aimed to examine the effects of participation in a 12-week multicomponent exercise program on frailty, cognitive function, and sleep quality among older adults. The primary research questions of this study are as follows: 1. Is a multicomponent exercise program effective in reducing frailty levels in older adults? 2. Is a multicomponent exercise program effective in improving cognitive functions (memory, attention, and executive functions) in older adults? 3. Is a multicomponent exercise program effective in improving sleep quality in older adults? The study hypothesizes that participation in a multicomponent exercise program will lead to a reduction in frailty levels, improvement in cognitive functions, and enhancement of sleep quality among older adults. Researchers were compared the multicomponent exercise program to a control group (no intervention) to see if the multicomponent exercise program works on frailty, cognitive function, and sleep quality among older adults. Intervention group participants were: \- attended the multicomponent exercise program, 12-week period, with sessions held twice weekly, each lasting 45-60 minutes, in groups of 6-8 participants at a municipally affiliated healthy living center under nurse supervision.
NCT07274592
The aim is to examine the effect of a psychoeducation program based on the Psychosocial Development Theory applied to older adults on self-critical rumination, self-esteem, and psychological well-being, as well as the relationship between these concepts. The constant and repetitive thinking of older adults about their past mistakes and failures is defined as self-critical rumination, which can have negative effects on mental health, lead to a decline in quality of life, and cause older adults to experience an unhappy process. For this study, a psychoeducation program based on Erikson's psychosocial stages of development was prepared. The program aims to differentiate rumination levels among older adults, provide suggestions on how to reduce these ruminative thoughts, and teach techniques for dealing with repetitive thoughts, thereby equipping individuals with methods to cope with ruminative thinking. It is expected that elderly individuals who acquire this coping method will experience changes in their psychological well-being and self-esteem. This study's examination of the effects of the psychoeducational program on psychological well-being provides a critical contribution to improving the quality of life of elderly individuals.
NCT07038317
The goal of this study is to examine if e-cigarette education messages delivered using a source and presentation tailored to one's vaping status influences young adults' vaping behaviors. The main questions it aims to answer are: 1. Does receiving e-cigarette education messages presented using a source (expert or peer) and sidedness (one or two-sided) optimized for the current vaper group influence vaping cessation among young adults who vape daily? 2. Does receiving e-cigarette education messages presented using a source (expert or peer) and sidedness (one or two-sided) optimized for the non-vaper group influence vaping initiation among young adults who are susceptible to vaping? Participants will be randomly assigned to either the treatment (receiving messages tailored to one's vaping status) or the control (receiving non-tobacco messages) condition and receive SMS three times per week over the course of 6 months. They will complete self-report assessment and show salivary cotinine results for nicotine testing at 4 timepoints.
NCT07508449
The study project aims to implement therapeutic patient education for migraine, promoting improvement in outpatient clinical practice by providing counseling moments specifically dedicated to known health risk factors (sedentary lifestyle, physical inactivity, unhealthy eating habits), thanks to the integration of the skills of Neurology Specialists and those of CURIAMo.
NCT07507279
Because hand and cognitive functions decline in the elderly, intervention programs addressing these problems are necessary. In recent years, creating rehabilitation programs using technology has gained popularity. The aim of this study is to examine the effects of technology-based rehabilitation using LMC (Light Mood Enhancer) and dual upper extremity tasks on joint position sense, grip strength, functionality, and executive functions in elderly individuals; and to compare these effects with those of an exercise program performed solely with an LMC device and a control group consisting of a hand rehabilitation program performed with a physiotherapist. The research is a randomized controlled trial and will consist of 3 groups. After randomization, individuals' joint position sense, gross and fine grip strength, functionality, and executive functions will be evaluated. Evaluations will be performed twice, at the beginning and end of the 8-week program.
NCT07504952
The goal of this clinical trial is to find out whether taking probiotics can improve thinking ability and gut (digestive) symptoms in healthy adults. The study will also explore whether probiotics affect mental health, alcohol cravings, and drinking and eating behaviours. The main questions it aims to answer are: * Do probiotics improve everyday thinking, attention, and memory? * Do probiotics reduce digestion issues or discomfort? * Do probiotics modulate alcohol cravings? * Do probiotics improve mood, stress, and anxiety levels? * Do probiotics influence drinking behaviour? * Do probiotics influence eating behaviour? Researchers will compare a probiotic supplement to a placebo (a look-alike product with no active ingredients) to see whether probiotics have real effects. Participants will be randomly assigned to one of these groups, and neither the participants nor the researchers will know who is receiving which treatment during the study. Participants will: * Take either a probiotic supplement or a placebo every day for 8 weeks * Complete online questionnaires about their mood, thinking, eating and drinking behaviours, and digestive health at the start and end of the study * Provide basic lifestyle and demographic information This study aims to better understand whether probiotics could be a simple and low-cost way to support cognitive function, digestive health and other wellbeing outcomes in generally healthy adults.
NCT06133530
Human milk oligosaccharides (HMOs) are the third-most abundant component in mothers' milk and are an important prebiotic factor for the development of the gut microbiota of infants, promoting the growth of certain beneficial bacterial strains and providing protection against many bacterial and viral infections. HMOs induce immunomodulatory activity by affecting immune cell populations and functions. In a simulator of the adult human intestinal microbial ecosystem, fermentation of HMOs led to an increase of bifidobacteria in parallel with an increase in short-chain fatty acids as well as a reduction in inflammation markers, supporting the potential of HMOs to provide health benefits also in adults. Long-term stay in microgravity induces many physiological responses, including diminished immune function and impaired glucose tolerance which may lead to rather severe consequences. Similarly, hypoxia conditions as in the Concordia station, affects the immune system and may lead to impaired glucose tolerance and insulin resistance. The hypothesis is that HMOs as a prebiotic supplement will mitigate changes in immune function, glucose tolerance, lipid homeostasis, and neurotransmitter production. It is expected that HMO supplementation will * Modulate gut microbiota composition and function * Improve inflammation status * Improve immune function * Improve glucose tolerance * Improve nutritional status * Prevent changes in neurotransmitters associated with anxiety and depression. During the stay in Antarctica an HMO blend will be supplemented to the verum group of volunteers. The control group will receive a placebo. Experiment days with blood drawing, an oral glucose tolerance test, saliva sampling, and feces samples are planned once before, about every second month in Concordia, and once after return.
NCT06925880
Double-blind randomized placebo-controlled clinical trial with two parallel arms. The main objective is to evaluate the efficacy and safety of creatine supplementation in older adults who have been operated on for total knee arthroplasty and undergoing a usual rehabilitation program. The intervention will consist of daily creatine monohydrate supplementation for 12 weeks. The intervention will start after surgery with a loading dose of 20g/day for 1 week and then continue with a maintenance dose of 5g/day for 11 weeks. Main outcome mesures included muscle mass, muscle strenght, sarcopenia, frailty, functional capacity and physical performance and will be assessed at baseline, 3 and 6 months follow-up.
NCT04479943
The MOVIN (Mobilizing Older adult patients Via a systems-based Intervention) randomized controlled trial is designed to evaluate the impact of the MOVIN intervention on improving the functional ability of older adult hospital patients and reducing their healthcare utilization post-hospitalization. MOVIN is a program to increase patient ambulation while hospitalized. The study's hypothesis is that MOVIN will improve functional outcomes for hospitalized older adult patients by producing a change in nursing practice and culture of ambulation on inpatient units. MOVIN is a unit-based intervention. Therefore all patients on this unit are exposed to the intervention once it is implemented regardless of whether or not they participate in the trial. The study will enroll 360-420 total hospitalized participants 65 years and older for the duration of their stay. It will also enroll any nurses 18 years and older who worked on the units during the study and are willing to fill out surveys.