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NCT00090662
Increased numbers of white blood cells called eosinophils can cause disease. To investigate this disease, researchers need blood, urine, sputum, stool, cerebrospinal fluid, skin and/or bone marrow samples to compare to samples from patients with this problem. Some of the samples will be used for genetic testing or future research. This study will last for about 10 years and will include a maximum of 50 paid volunteers ages 18 to 65. ...
NCT06290258
This study aims to evaluate the efficacy of fecal microbiota transplantation on the gastrointestinal symptoms, autistic symptoms and emotional behavior symptoms of patients with autism spectrum disorder, and investigate the relations between the brain-gut axis, cytokines and autism spectrum disorder. Fecal microbiota transplantation have the potentials to improve intestinal microbiota composition, regulate immunity, and then improve gastrointestinal symptoms, autistic symptoms, emotional behavior symptoms and sleep of children with autism spectrum disorder. Early intervention at school-age may even benefit development, improve cognition and prognosis.
NCT06873724
This is a Phase 1, randomized, double-blind, placebo-controlled, single dose, first in human safety, tolerability, and pharmacokinetic study of SPY003-207 in healthy participants.
NCT06402461
The goal of this randomized controlled study is to examine whether allocation based on preference to one of two brief mindfulness meditation practices (mindfulness of the breath or mindfulness of sounds) influences the potentially beneficial effects of these practices, and influences participants' intention to engage in further mindfulness practice. To the end, members of the general public will be randomly assigned to one of three groups: (1) a group in which they choose which of the two mindfulness practices they do; (2) a group in which they are randomly allocated to do one of the mindfulness practices; and (3) a control group that listens to an audiobook extract. The level of mindfulness of each group will be compared, along with some other outcomes.
NCT07486115
The main objectives of this trial are to investigate safety, tolerability and pharmacokinetics (PK) of BI 3814916 in healthy male and female trial participants.
NCT06716502
Acute respiratory failure is a medical emergency rapidly leading to death, if not timely treated. Prompt Continuous Positive Airway Pressure (CPAP) improves patient outcomes. However, pre-hospital CPAP is currently limited to healthcare providers due to the absence of easy-to-use and immediate devices specifically designed for the non-medical population. The efficacy and usability of a new portable CPAP device will be assessed. This device is specifically designed for potential use in out-of-hospital scenarios involving acute respiratory failure. The evaluation will focus not only on the performance of the device but also on its easiness of use.
NCT00453505
Objectives Noninvasive stimulation of the central and peripheral nervous system, including transcranial magnetic stimulation (TMS), transcranial direct and alternating current stimulation (tDCS and tACS, respectively) and cutaneous/peripheral nerve stimulation (C/PNS) alone or paired with TMS (paired associative stimulation, PAS), has been increasingly used in the investigation of cortical plasticity and as a possible adjuvant strategy in neurorehabilitation. It has been shown that TMS, tDCS, tACS and C/PNS can modulate motor function in healthy volunteers, as well as in patients with neurological disorders such as stroke. One fundamental problem is that the optimal parameters of stimulation to modulate motor function by all of these techniques are not known. The purpose of this protocol is to explore within safe guidelines, the effects of different stimulation parameters on motor cortical function, on oscillatory brain dynamics measured with magnetoencephalography (MEG) and electroencephalography (EEG), on eye movements, and on fMRI activation. In addition, this protocol will be used to train new fellows coming to NINDS Human Cortical Physiology Section (HCPS) in the use of TMS, tDCS, tACS and C/PNS techniques. We expect that information emerging from these studies will allow us to 1) optimize experimental protocols or stimulation parameters to collect pilot data in healthy volunteer for future patient-oriented hypothesis-driven protocols,2)to collect pilot data for power analysis for future patient-oriented hypothesis driven protocols, and 3) to train new fellows in the use of these different methods. Study Population Up to 1500 healthy volunteers, age 18 and older. Design Healthy volunteers will receive one or more of the following types of stimulation alone or in combination: (1) single- and paired-pulse TMS with inter-stimulus intervals of greater than 1s and up to 20s and intensities of up to 100% of stimulator output; (2) 1 Hz TMS for up to 30mins and up to 115% of resting motor threshold (RMT) intensity; (3) tDCS applied at an intensity of up to 4 mA for a duration of up to 60mins, as long the total charge does not exceed 7.2 C; (4) tACS applied at a peak-to-peak intensity of up to 4 mA for a duration of up to 60 minutes, minutes, as long the total charge does not exceed 7.2 C; (5) C/PNS applied alone with intensities below 130% of the peripherally-elicited-motor-threshold for up to 2 hours, or intensities up to 300% of sensory threshold when C/PNS is paired with TMS. All of these parameters of stimulation and procedures have safely been used as previously reported in the literature. Sham stimulations will be delivered for each modality as scientifically needed. Some substudies may involve recording of behavior or brain activity only (such as behavioral testing, MRI, and MEG) if brain stimulation targets are unknown. This information can help design future brain stimulation protocols. Each subject may participate in up to 20 sessions. A single session may last no longer than 8 hours to allow for initial testing paradigm followed by retests or performing other components of the same substudy later in the day. Appropriate rest breaks and meal breaks will occur during long sessions. Subjects participate in one experimental session per day under this protocol. The 20 experimental sessions will be scheduled over a twenty-year period. CTDB is used to track the number of sessions per subject so it does not exceed 20 sessions. The AIs are responsible for entering the subjects/sessions into CTDB. We will test the effects of these different forms of stimulation on motor cortical excitability, cognitive and motor behavioral tasks, and brain state measures derived from neuroimaging data (i.e. - MRI, fMRI, MEG and EEG). Stimulation may be applied before, after, or during physiological (i.e. motor evoked potentials, M-wave, F-wave, or H-Reflexes), neuroimaging or behavioral measures. Under this protocol, we conduct: Exploratory Sub-studies: These substudies are exploratory in nature and are conducted in order to develop information to generate better informed future hypotheses and/or power analyses. We have set an upper limit of 40 subjects per sub-study. Hypothesis-Testing Sub-studies: Hypothesis-testing sub-studies are studies with specific hypotheses to be tested. These sub-studies undergo statistical and PIRC review after 6 subjects per group (e.g., after 12 subjects, 6 per arm, if two groups are studied), before additional subjects can be recruited. Together, the P.I. and PIRC will decide whether to continue the sub-study with more subjects without an amendment or whether an amendment or protocol would be necessary. A memo requesting a review of hypothesis-testing sub-studies for possible additional enrollment (beyond 6) will be sent to PIRC and the statistical reviewer. This protocol is ...
NCT07310264
This is a first-in-human (FIH) study of orally administered VT-5006 (also known as AX-5006) in healthy adult volunteers (HVs) and adult participants with Parkinson's disease (PD). The goal of this clinical trial is to learn if VT-5006 is safe and tolerable in healthy volunteers and in participants with PD. It has three Parts (A, B, and C). Part A: Healthy volunteers aged 18-54 will attend a screening visit, take a single dose of VT-5006 or matching placebo after an overnight fast, stay in the clinic for three nights, and complete a follow-up visit. One group of participants in Part A will be asked to return to the clinic after approximately two weeks, take a single dose of VT-5006 or matching placebo after consuming a high-fat meal and stay in the clinic for another three nights. Part B: Healthy volunteers aged 18-54 will attend a screening visit, take one dose of VT-5006 or matching placebo each day for seven days after fasting overnight, stay in the clinic for 10 nights, and complete a follow up visit. Part C: Participants with PD aged 40-80 will attend a screening visit, take one dose of VT-5006 (high dose), VT-5006 (low dose), or matching placebo each day for 28 days, complete two overnight stays in the clinic, attend three clinic visits, one phone call and a follow up visit.
NCT06690294
Background: Many people in the United States are overweight or obese. This natural history study will look into how life events during childhood can impact eating behaviors and weight gain as adults. Objective: To explore how childhood experiences affect adult eating behaviors. Eligibility: Healthy people aged 18 to 60 years. Design: Participants will have 3 clinic visits. They will be screened with blood tests. They will answer questions about their alcohol and tobacco use. At the next visit, participants will undergo these activities: Parts of their body (such as waist, neck, and thighs) will be measured with a tape. They will have an imaging scan to find out how much body fat they have. They will start wearing a device like a wristwatch that measures their physical activity. They will wear this device for up to 10 days. They will wear a device on their upper arm or belly that measures blood glucose (sugar) levels. Participants will wear this for 7-10 days. They will answer questions about their education, childhood, and routines. They will receive a kit to collect a stool sample at home. At the last visit, participants will have these tests: Participants will relax and breathe normally while wearing a clear, plastic canopy that fits over their entire head. Blood samples will be taken before and after participants drink a sugary drink. Participants will be offered a large selection of foods for lunch. They will eat as much as they want. Then they will answer questions about how they feel about food and themselves.
NCT07165015
The purpose of this study is to assess the amount of LY3537031 that reaches the bloodstream and the time it takes for the body to get rid of it when given to participants with renal (kidney) impairment and to healthy participants.
NCT07483606
The aim of this study is to conduct a Turkish validity and reliability study of the "Prevention of Toxic Chemicals in the Environment for Children Tool," developed to examine the knowledge and attitudes of parents and prospective parents regarding the effects of toxic chemicals in the environment on children's development.
NCT07481708
The goal of this study is to learn what happens to enlicitide (MK-0616) in a healthy person's body over time (pharmacokinetic or PK study). Researchers also want to learn about the safety of enlicitide and if people tolerate it.
NCT07470866
The purpose of this clinical trial is to compare the amount of tafamidis in the blood of healthy adult participants after taking two different forms of tafamidis by mouth under fed conditions.
NCT03561545
During weightlessness, the cardiovascular system is subject to rapid changes which has been demonstrated in studies of short term (Space Shuttle) and long term missions to Skylab, MIR, and the International Space Station (Nicogossian et al., 1989; Blomquist, 1994; Platts et al., 2014). There is also evidence for changes in the blood vessel structure, the metabolism and the responses to vasodilator and constrictor substances that might have long-term health consequences resembling the effects of aging on the cardiovascular system (Hughson and Shoemaker, 2004). Cardiovascular adaptations cause an increased incidence of postflight orthostatic intolerance (fainting), decreased cardiac output and reduced exercise capacity. Besides these postflight effects, weightlessness could also have harmful consequences during the flight. For example, it has been shown that cardiac arrhythmia may occur during space missions, even in healthy individuals (Convertino, 2009). To understand the cardiovascular reactions of the human body to changing conditions of gravity is thus an important aim of space science. While non-invasive imaging of microcirculation is a very promising tool to evaluate cardiovascular condition, knowledge on the involvement of the microcirculation in cardiovascular alterations induced by weightlessness is very limited and further research in this field seems promising. Before using a non-invasive technique for imaging the microcirculation during space flights, it has to be evaluated on earth. Different proven simulation models exist for investigating the effects of weightlessness on the human body under terrestrial conditions: head down bed rest, dry and wet immersion, and parabolic flights. Among these models, only parabolic flight recreates a real state of weightlessness (see the participant document of information for a description of parabolic flights). Cardiovascular studies have often been performed during parabolic flights. Within the limitations inherent to the method (short duration of weightlessness - about 21 s - following and followed by hypergravity 20 s periods at 1.8g), some remarkable results have been published over the years. The aim of our research approach is to test feasibility of the in vivo evaluation of the microcirculation in parabolic flight in order to be able to better describe cardiovascular response mechanisms under these conditions. In this context, we expect alterations in the microcirculatory flow during the weightlessness period of parabolic flight. Our approach might help develop a diagnostic tool to more easily identify weightlessness-induced cardiovascular diseases and improve strategies for adapting astronauts to weightlessness prior to the space mission.
NCT07310901
This study will assess the safety of the investigational drug CRB-913 and how it is processed in the body. The study has two parts: Part 1 will measure drug levels in healthy adults after taking CRB-913 tablets, and Part 2 will compare three doses of CRB-913 with placebo to evaluate safety, effects on body weight, and drug levels in the blood. Part 2 is blinded, meaning participants, study doctors, and the sponsor will not know which treatment is given. Participants in Part 2 will take study treatment for 12 weeks and will be followed for 28 days after treatment ends.
NCT06342713
This study is the first-in-human (FIH) study of BGB-45035. The study will evaluate the safety, tolerability, pharmacokinetics, and pharmacodynamics of BGB-45035 with both a single dose and multiple doses administered at different dose levels in healthy participants, followed by a Part E to evaluate the safety and tolerability of BGB-45035 in adults with autoimmune dermatological diseases like atopic dermatitis (AD) and prurigo nodularis (PN). An additional biomarker cohort will be evaluated in Part F. Study details include: * The study duration will be up to 24 months. * The treatment duration will be up to 14 days for Parts A-D, up to 12 weeks for Part E, and up to 3 weeks for Part F. * Safety follow-up 30 days after last dose of study drug.
NCT07060404
In Papua New Guinea, administration of primaquine (PQ) or tafenoquine (TQ) to breastfeeding mothers is contraindicated during the first six months postpartum, when infants are recommended to be exclusively breastfed, because of a lack of comprehensive pharmacokinetic data on PQ/TQ neonatal and infant exposure via breast milk. The therapeutic restriction of PQ/TQ use in lactating women during the first six months postpartum effectively translates into \~10% of females being excluded from radical cure in endemic areas at any time. This is because many at risk women live in remote areas, are frequently lost to follow-up, or may have conceived again before they reattend. As a result, radical cure is rarely achieved and women are exposed to recurrent infections and cumulative risk of anaemia. Relapses may occur for years, placing subsequent pregnancies at risk and perpetuating intergenerational failure of fetal growth. They also contribute to malaria transmission, thus household and community exposure to vivax malaria. The goal of the present study is to determine how much PQ/TQ is transferred to a suckling baby, if a mother receives a treatment course of PQ/TQ at time of delivery. We also want to confirm that this treatment is safe and has no major side effects for babies in Papua New Guinea. The study Interventions areas follows: Group 1 - Participants receive PNG standard of care; PQ given 6-months postpartum; Group 2 - Participants receive a 14-day treatment regimen of PQ, at the standard dose prescribed in PNG for vivax radical cure (0.5 mg/kg/day for 14 days); Group 3 - Participants receive an accelerated high-dose 7-day treatment regimen of PQ, as per current WHO recommendations (1.0 mg/kg/day for 7 days); Group 4 - Participants receive a single dose of 300mg tafenoquine. All participants will be monitored for a total duration of 6 months, with the safety, tolerability, pharmacokinetics and preliminary relapse efficacy of PQ/TQ evaluated at standardised time points over this period (Day 0, 1, 3, 6, 8, 15, 20, 28, and Month 2, 3, 4, 5 and 6). At each of these time points, participants will be asked to describe any symptoms they may be experiencing, participate in a medical examination, and provide a blood and breast milk sample for drug analysis and safety (biochemistry and haematology testing). The investigators will also collect a small blood sample (heel prick) from the infant to measure drug concentrations and safety testing.
NCT06223555
Background: Researchers use mixed meal tolerance tests (MMTTs) to look at how people s bodies respond to eating a meal. However, researchers do not agree on how to decide the number of calories to give in each meal. Some use fixed meals, which are the same size for everyone, and some use adjusted meals, based on the size of the person s body. Researchers want to know which MMTT is best to use for future research. Objective: To learn how fixed vs adjusted meals affect blood glucose levels in healthy people. Eligibility: Healthy people aged 18 years or older. Design: Participants will have 3 or 4 clinic visits of up to 8 hours in 8 weeks. Participants will have baseline tests: Their height, weight, and waist size will be measured. They will have an oral glucose tolerance test: A needle attached to a tube (IV) will be inserted into a vein in the arm. They will have a sugary drink. Blood samples will be taken from the tube at intervals up to 3 hours after the drink. They will have a body scan. Participants will have 2 MMTT visits. One will include a fixed meal and one will include an adjusted meal. They will have tests at both visits: Resting metabolic rate: A clear hood will be placed over the participant s head while they rest for 20 minutes. This will measure the oxygen they breathe in and out. MMTT. Participants will have 5 minutes to drink a liquid meal. Blood samples will be taken at intervals for the next 4 hours....
NCT07476469
This study investigates if anhedonia and anxiety symptoms are associated with alterations in reinforcement learning, effort trade-offs for wins vs. punishments, and foraging behavior under threat. Moreover, it will investigate whether these processes can be influenced by a metabolic load and/or transcutaneous vagus nerve stimulation (tVNS). The project consists of (a) an online reinforcement learning study, used to characterize learning, reward sensitivity, and meta-cognition, and (b) a laboratory study in which participants first undergo fMRI while completing an effort-based decision-making task. Second, participants will complete two sessions in VR with randomized active or sham tVNS during a foraging task before and after a caloric load with concurrent physiological recordings.
NCT07394595
In comparing the two types of cycling exercises, the perceptual responses, such as perceived exertion and fatigue, as well as subjective feelings of energy, are crucial metrics. Lower limb cycling is traditionally associated with higher levels of exertion due to the larger muscle groups involved. However, when EMS is applied, both upper and lower limb cycling might exhibit altered perceptions of effort and energy levels, with EMS potentially equalizing the exertional differences. This research is significant for designing exercise programs that optimize energy expenditure and enhance performance, particularly in rehabilitative settings or for individuals looking to diversify their physical training regimens.