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Showing 1-13 of 13 trials
NCT07572838
The ALTER-EGO study is a monocentric, observational clinical investigation designed to evaluate the safety, usability, and feasibility of the humanoid robotic platform Alter-Ego as an assistive device in hospital and simulated home-care settings. The system is intended to support healthcare and rehabilitation professionals in the management of patients with Amyotrophic Lateral Sclerosis (ALS). Alter-Ego is an anthropomorphic, wheeled, self-balancing social robot equipped with compliant robotic arms and SoftHand synergistic grippers. It operates in teleoperated, semi-autonomous, or fully autonomous modes and integrates advanced navigation, mapping, object manipulation, and natural language processing capabilities. The robot is not classified as a medical device under EU Regulation 2017/745, as it does not perform diagnostic or therapeutic functions, but provides logistical, communicative, and organizational support. The study is conducted at ICS Maugeri IRCCS (Milan Camaldoli). Participants include healthcare professionals (physicians, nurses, physiotherapists, occupational therapists, speech therapists, and healthcare assistants) and up to 40 hospitalized ALS patients. Patients are not direct operators of the robot but provide experiential feedback. A total of 40 experiments are organized into four clusters: Cluster 1 - Telemedicine (Teleoperated or Semi-Autonomous Mode) Within a simulated home-care environment, Alter-Ego supports remote clinical and rehabilitation activities through four specific tasks: Simulated Remote Medical Visit (First Home Transition): A physician conducts a tele-visit via the robot, asking health-related questions, performing visual neurological assessments using cameras and microphones, requesting specific motor tasks, and reviewing vital parameters from home monitoring devices. This task addresses the need for expert supervision during early discharge phases. Assistive Device Training: A physiotherapist and nurse remotely verify and guide the correct use of assistive devices such as non-invasive ventilation systems, PEG, or patient lifters, providing practical instructions to patients and caregivers. Home Environment Assessment: An occupational therapist uses the robot in semi-autonomous mode to map the domestic environment and, in tele-guided mode, visually inspect spaces to identify architectural barriers and optimize assistive device placement. Telerehabilitation: Physiotherapists and speech therapists use the robot's audio-video interface and display to conduct remote rehabilitation sessions and functional evaluations, providing visual and verbal feedback. Cluster 2 - Delivery Services (Autonomous Mode) The robot autonomously transports small items within the hospital ward, including medical records, blood collection kits, rehabilitation tools, and small food or beverage packages. Cluster 3 - Guidance and Welcome Assistance (Autonomous Mode) Alter-Ego presents ward service information to newly admitted patients and provides personalized daily reminders regarding scheduled rehabilitation activities. Cluster 4 - Monitoring (Autonomous Mode) The robot administers the Visual Analog Scale (VAS) for pain assessment and includes an exploratory function for detecting vocal distress keywords (e.g., "pain," "help," "thirst") using AI-based speech recognition, alerting staff when necessary. Primary endpoints include usability and feasibility (System Usability Scale - SUS; Questionnaire for User Interaction Satisfaction - QUIS; NASA Raw Task Load Index - NASA-RTLX) and safety assessment through systematic recording of adverse events. Secondary outcomes include healthcare professionals' satisfaction with autonomous robot performance, patient satisfaction (Likert scales), and psychosocial impact on professionals (selected PIADS items). The ALTER-EGO study aims to determine whether an anthropomorphic robotic platform can safely and effectively support multidisciplinary ALS care, improve workflow efficiency, and enhance patient-centered assistance in both hospital and transitional home-care settings.
NCT07270614
This study aims to find out whether an 8-week sports injury prevention program can improve lower-body performance-such as power, agility, and balance-among female college athletes in Saudi Arabia. Sports participation has increased among women in Saudi Arabia, but many injury-prevention programs were originally designed for male athletes and may not meet the specific needs of females. This study will help determine whether a tailored program can reduce injury risks and improve athletic performance. Female athletes aged 18-35 years who have been training and competing for at least one year can participate. Athletes with recent injuries, pregnancy, or chronic medical conditions that could affect performance will not be included. Participants will complete tests before and after the program, including jumping, balance, and agility assessments. The prevention program includes warm-up exercises, stretching, strengthening, jumping drills, balance work, and agility training. By comparing results before and after the program, the study will show whether this type of training can help female athletes stay safer and perform better.
NCT07344636
Zone 2 training, a low-intensity endurance exercise performed at approximately 66-80% of VO₂max or near the first ventilatory threshold, has gained popularity for improving aerobic capacity, fat metabolism, and mitochondrial efficiency. It preserves glycogen stores and delays fatigue, making it an essential training method for both athletes and recreational exercisers. Nicotinamide adenine dinucleotide (NAD) is a vital metabolite that regulates cellular energy metabolism and redox homeostasis. It participates in oxidative reactions within the tricarboxylic acid cycle and electron transport chain, sustaining ATP synthesis and mitochondrial efficiency. Exercise influences multiple pathways of NAD metabolism, altering the NAD⁺/NADH ratio and thereby affecting energy production and fatigue resistance. Studies have shown that both aerobic exercise and NAD precursor supplementation (e.g., nicotinamide riboside \[NR\]) can elevate body NAD levels and enhance mitochondrial function, though findings remain inconsistent due to variations in dosage and participants' characteristics. This study aims to investigate how acute NR supplementation interacts with Zone 2 cycling training in adults. Specifically, it examines the temporal and dose-dependent effects of NR supplementation on metabolic flexibility and exercise performance. The results may clarify the potential synergistic benefits of combining NAD supplementation with low-intensity endurance training to improve aerobic adaptability.
NCT07447141
This is a Phase Ia, single-center, randomized, double-blind, placebo-controlled, single ascending dose (SAD) study. The primary purpose of this study is to evaluate the safety, tolerability, and pharmacokinetics (PK) of DBM-1152A Inhalation Solution in healthy Chinese adult subjects.
NCT07416643
Abnormal postprandial blood glucose (PPG) is considered as a strong predictor for developing metabolic diseases worldwide. Nowadays, little understanding is available on how a carbohydrate-rich food matrix and the starch structures within interact with the gastrointestinal tract to help in controlling PPG. In this investigation, the use Acacia gum enriched flour will be used to explore the effect of adding the gum as food supplement on PPG in healthy humans.
NCT07413536
The goal of this Phase Ia clinical trial is to evaluate the safety, tolerability, and pharmacokinetics of EB070 injection following single ascending subcutaneous doses in healthy adult volunteers. The main questions it aims to answer are: Is EB070 injection safe and well tolerated at increasing single subcutaneous dose levels in healthy subjects? What are the pharmacokinetic characteristics of EB070 after single-dose administration? This is a single-center, randomized, double-blind, placebo-controlled, single ascending-dose (SAD) study. A total of 36 healthy volunteers will be enrolled and assigned to one of five dose cohorts (21 mg, 75 mg, 225 mg, 450 mg, or 600 mg). Subjects in each cohort will be randomized in a 3:1 ratio to receive a single subcutaneous injection of EB070 or placebo. A sentinel dosing strategy will be applied. In the 21 mg cohort, one subject will initially receive EB070. In the remaining cohorts, two sentinel subjects (one receiving EB070 and one receiving placebo) will be dosed first. Dose escalation and enrollment of the remaining subjects will proceed after evaluation of safety and tolerability within 48 hours after dosing. Participants will: Undergo screening assessments prior to dosing Receive a single subcutaneous injection of EB070 or placebo Stay in the Phase I unit for approximately 3 days for safety monitoring and pharmacokinetic and anti-drug antibody (ADA) sample collection Return for scheduled outpatient visits for PK, ADA, and safety assessments through Day 113 Safety will be assessed throughout the study by monitoring adverse events, vital signs, physical examinations, 12-lead ECGs, and laboratory tests. Pharmacokinetic parameters and anti-drug antibodies (ADA) will be evaluated as secondary outcomes.
NCT07336836
The goal of this 5 day interventional study was to investigate the effects on multiple biological molecules (multi-omics) of Bryleos's commercially available oral LathMized™ Nicotinamide adenine dinucleotide (LNAD+) supplement in healthy adults aged 45-75 years. The main question to be answered was whether LNAD+ supplementation is associated with change in biological markers relevant to subjects' health. Also, the study determined whether this oral NAD+ formulation raised NAD+ levels including inside blood cells, after the 5 day treatment period, measured on post-treatment Day 1 (Day 6). Thus, the study compared NAD+ levels and impact on biological markers in the LNAD+ arm versus control placebo arm. Safety in this population was assessed using clinical laboratory tests, daily self-reporting of symptoms, and data from a wearable device.
NCT07225478
The goal of this clinical study is to evaluate how well a new in-office whitening system works to whiten teeth compared to some other commercially available in-office whitening systems.
NCT07260331
This study aims to investigate the effects of musical stimulation intensity on postural control in athletes using a virtual reality-based (VR) static posturography system. Athletes from various sports disciplines will be exposed to low-, medium-, and high-intensity music during balance assessments. The study will analyze changes in postural stability parameters under different auditory stimulation levels to understand the interaction between auditory processing, proprioception, and motor control in athletes.
NCT07243613
This study examined how the body and mood respond to intense physical effort in elite male and female rowers. Athletes completed a maximal rowing test after one week of hard training. Researchers collected blood samples before and after exercise to measure stress hormones and brain-related chemicals. They also used a short questionnaire to assess how the athletes felt emotionally before the test. The goal of the study is to better understand how physical and mental fatigue develop in well-trained athletes, and whether men and women respond differently.
NCT07101341
This study aims to compare the acute effects at the cardiovascular (heart rate, blood pressure) and physiological (lactate) levels, as well as the perception of effort and fatigue, of four exercise modalities, one based on the traditional aerobic training methodology, another based on high-intensity interval training (HIIT), another consisting of aerobic exercise performed in conjunction with an immersive virtual reality (VR) application, and a last one consisting of exercise with HIIT-type parameters but also performed in conjunction with an immersive VR application. All participants will complete one session of each of the four exercise modalities, analyzing the variables studied in each for subsequent analysis and comparison.
NCT07178288
This study at Hashemite University looks at how people with and without tennis elbow (AKA lateral elbow tendinopathy) feel pressure pain and how their bodies briefly "turn down" pain after a cold stimulus. Participants complete brief questionnaires (basic demographics without names, a tennis-elbow symptom form, and a physical-activity form) and then have their pressure-pain threshold (PPT) tested with a handheld device that slowly increases pressure on standard spots near the elbow and wrist; they say when it first becomes painful. To test the body's built-in anti-pain system (conditioned pain modulation, CPM), one hand is placed in ice water (the cold-pressor task) and PPT is measured again at set times (before, during, and after the cold stimulus) to see how much pain sensitivity changes and how long that change lasts. Both PPT reliability and CPM after effect are measured in this study. The study findings may help improve future assessment and treatment of musculoskeletal pain conditions.
NCT07199270
he goal this clinical trail is to evaluate the safety、Pharmacokinetic and immunogenicity of GR2303 injection。 Subjects will be enrolled in different groups in sequential order, and within each group will be randomly assigned to receive either GR2303 injection or placebo administration, with each Subjects will be enrolled in only one of these groups