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Healthy Volunteers clinical trials

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NCT ID: NCT06374706 Not yet recruiting - Stroke Clinical Trials

Effects of End-Effector Type Rehabilitation Robots-Morning Walk on Symmetrical Walking Patterns in Individuals With Hemiparesis

Start date: May 1, 2024
Phase: N/A
Study type: Interventional

In this study, our objective is to explore and evaluate interventions to improve the process of recovery following a stroke. The main focus is on enhancing symmetrical walking patterns in adults who have experienced neurological deficits due to a stroke. The primary tool will be an end-effector type rehabilitation robot, the Morning Walk®. This robot has been specifically designed to assist in enhancing symmetrical walking patterns for individuals recovering from a stroke Morning Walk® has received approval from the FDA, meaning it meets stringent safety and efficacy standards.

NCT ID: NCT06369454 Not yet recruiting - Healthy Volunteers Clinical Trials

A Study to Learn About How Different Forms of the Study Medicine Called Ritlecitinib Pass the Intestines of Healthy Male Adults When Taken With or Without Food

Start date: May 1, 2024
Phase: Phase 1
Study type: Interventional

The purpose of this study is to learn about how different forms of the study medicine called ritlecitinib pass the intestines of healthy male adults when taken with or without food. This study is seeking healthy participants who have: - Aged 18 years or older; - male who are healthy as determined by medical assessment; - BMI of 16-32 kg/m2, and a total body weight >45 kg (99 lb). All participants in this study will receive a ritlecitinib oral dose in two different forms (solution without food, capsule with or without food). The study will take up to 3 months, including the screening period and follow-up phone call. Participants will have to stay at the study clinic for at least 11 days. There will be 3 periods in total, and a washout period of at least 3 days between dosings in Period 1 and Period 2, and at least 7 days between dosings in Period 2 and Period 3 for this study. On day 1 of each period, participants will take one form of Riltecitinib without food for the first two periods and with food for the last period. Participants will have blood samples taken both before and after taking ritlecitinib. A follow-up phone call will be made at 28 to 35 days after the last study period.

NCT ID: NCT06363630 Not yet recruiting - Healthy Volunteers Clinical Trials

A Study to Evaluate the Effect of Cytochrome P450 (CYP) 3A Inhibitor (Itraconazole) and Inducer (Rifampin) on the Drug Levels of Golcadomide (BMS-986369) in Healthy Participants

Start date: April 16, 2024
Phase: Phase 1
Study type: Interventional

The purpose of this study is to evaluate the drug-drug interaction (DDI) potential of coadministration of itraconazole or rifampin on the single dose drug levels of golcadomide.

NCT ID: NCT06361381 Not yet recruiting - Healthy Volunteers Clinical Trials

The Combined Effect of TENS and TaVNS on Pressure and Heat Pain Thresholds in Pain-Free Subjects

Start date: April 2024
Phase: N/A
Study type: Interventional

Transcutaneous electrical nerve stimulation (TENS) is a non-invasive modality that utilizes electrical currents to modulate pain in populations with acute and chronic pain. TENS has been demonstrated to produce hypoalgesic effects in postoperative pain, fibromyalgia, knee osteoarthritis, and healthy subjects. Transcutaneous auricular vagus nerve stimulation (TaVNS) is a non-invasive modality that modulates the vagus nerve by stimulating its auricular branches. The effects of the combination of TENS and TaVNS on producing an analgesic response have not been studied. Considering that TENS and TaVNS both stimulate similar analgesic pathways but through different means of activation, the investigators can hypothesize that a combination of both methods can produce a more pronounced analgesic response. Therefore, the objective of this study is to assess the hypoalgesic effect of a combination of TENS and TaVNS in pain-free subjects. The study will be a simple crossover design conducted at the University of Hartford. Subjects will be recruited from the University of Hartford population via oral communication, digital flyers, and posters on campus. Thirty participants will undergo two sessions in a crossover manner with one week in between. During one session, the participants will receive TENS with active TaVNS and the other session will be a placebo procedure (TENS with placebo TaVNS). The order of these sessions will be randomized. Importantly, the pressure pain threshold (PPT) and heat pain threshold (HPT) assessors will be blinded to the treatment category. For active TaVNS, a frequency of 25 Hz will be applied with a pulse duration of 200 µs. For placebo TaVNS, the intensity will be increased to a sensory level and then decreased to 0 mA. High frequency TENS of 100Hz will be applied in both sessions, with a pulse duration of 200 µsec, asymmetrical biphasic square waveform, and intensity of maximal tolerance without pain. TENS and TaVNS will be turned on for 30 minutes after a baseline measurement of outcomes. TENS and TaVNS will then be turned off, but the electrodes will remain on until completion of post-treatment assessment. Pressure pain threshold, heat pain threshold, blood pressure, oxygen saturation and heart rate will be tested 4 times: Once pre-intervention, once during intervention, once immediately after the intervention and once 15 minutes post-intervention.

NCT ID: NCT06360211 Not yet recruiting - Healthy Volunteers Clinical Trials

A Study to Learn About How BAY2927088 Affects the Level of Midazolam in the Blood When Both Drugs Are Taken Together in Healthy Participants

Start date: April 17, 2024
Phase: Phase 1
Study type: Interventional

Researchers are looking for a better way to treat people who have advanced non-small cell lung cancer (NSCLC) with specific genetic changes called Epidermal growth factor receptor (EGFR) and Human epidermal growth factor receptor 2 (HER2) mutations. Advanced NSCLC refers to a type of lung cancer that has spread from the lungs to nearby tissues or other body parts. People with advanced NSCLC may have changes in certain proteins like EGFR and HER2 that cause uncontrolled cell growth and increased spread of cancer. In this study, participants will be healthy and will not benefit from taking the study treatment, BAY2927088. However, the study will provide information about how to test BAY2927088 in future studies on people with advanced NSCLC with EGFR or HER2 mutations. BAY2927088 is under development for the treatment of advanced NSCLC with EGFR or HER2 mutations. It is expected to work against these changed proteins, which might slow down the spread of cancer. Researchers think that BAY2927088 might affect an enzyme (called CYP3A4) that breaks down drugs in the body. This might make the effects of some drugs weaker or stronger. Midazolam is a drug that is broken down by CYP3A4. By studying the level of midazolam in the blood, researchers can understand how BAY2927088 might influence this enzyme's activity. The main purpose of this study is to find out how BAY2927088, taken as a single dose and as multiple doses, affects the level of another drug, called midazolam, in the blood of healthy participants. To achieve this goal, researchers will measure the following for midazolam when participants take it with or without BAY2927088: - Area under the curve (AUC): a measure of the total amount of midazolam in participants' blood over time - Maximum observed concentration (Cmax): the highest amount of midazolam in participants' blood The study will have 3 treatment periods: Period 1 (Day 1 to Day 2): On Day 1, participants will take midazolam Period 2 (Day 3 to Day 4): On Day 3, participants will take midazolam with BAY2927088 Period 3 (Day 5 to Day 15): On Days 5 to 13, participants will take BAY2927088 On Day 14, participants will take midazolam with BAY292708 Participants will be part of the study for about 8 weeks with at least 3 visits to the study clinic. Participants will visit the study clinic: - More than/at least once, within 2 to 28 days before the treatment starts - Once on the day before the treatment starts and will stay in the clinic until Day 15 of the treatment - Once, within 7 to 10 days after they finish treatment for a health checkup During the study, the doctors and their study team will: - do physical examinations - collect blood samples from the participants to measure the blood levels of midazolam and of BAY2927088 - check participants' health by performing tests such as blood and urine tests, and checking heart health using an electrocardiogram (ECG) - ask the participants questions about how they are feeling and what adverse events they are having An adverse event is any medical problem that a participant has during a study. Doctors keep track of all adverse events, irrespective if they think it is related or not to the study treatment.

NCT ID: NCT06359626 Not yet recruiting - Healthy Volunteers Clinical Trials

Bioequivalence Study Between YHP2205 and YHR2401 in Healthy Volunteers

Start date: July 9, 2024
Phase: Phase 1
Study type: Interventional

A randomized, open-label, single-dose, 2-sequence, 2-period, crossover clinical trial to investigate the bioequivalence between YHP2205 and YHR2401 in healthy volunteers

NCT ID: NCT06356194 Not yet recruiting - Clinical trials for Healthy Volunteer Study

Drug-drug Interaction Study of Biktarvy and Bemnifosbuvir/Ruzasvir

Start date: April 15, 2024
Phase: Phase 1
Study type: Interventional

Drug-drug interaction study of Biktarvy and Bemnifosbuvir/Ruzasvir

NCT ID: NCT06355648 Not yet recruiting - Healthy Volunteers Clinical Trials

Advanced Clinical Practitioners in the ED

Start date: May 3, 2024
Phase:
Study type: Observational

No patient data is involved in the study. This study is designed to understand better how Emergency Care Advanced Clinical Practitioners (EC-ACPs) work in emergency departments (EDs). The main research question is: 1) What is the EC-ACP's perception of assimilation into emergency care teams, what tensions are created due to the role, and what system adaptations are required to facilitate integration? With secondary aims : 1. What are the common organisational factors that affect the implementation of the EC-ACP workforce, and what recommendations can be made to improve Trust-wide implementation? 2. How are EC-ACPs deployed in two contrasting emergency departments, what differences can be identified in their Work-As-Done (WAD), and how does this compare to the Work-As-Imagined (WAI) of the role? Participants will all be staff members who work in the hospital. Patient data is not being collected or processed. This is a mixed-method study using two approaches to collect data: 1. Observation of the EC-ACPs at work - noting how they interact with colleagues and how they are deployed in the ED. 2. Interviews with various staff who work with the EC-ACPs clinically or in various managerial or director roles. Background In the UK, a health care role has been developed called Advanced Clinical Practitioners (ACPs). ACPs work in various clinical settings, but this study focuses on those in Emergency Care. While non-medical practitioners have worked in Emergency Departments (EDs) for over 20 years, the ACP role is relatively new. Most ACPs in ED are from a nursing or paramedical background, but they can also be from other allied health professions like physiotherapy. After the base qualification, ACPs undertake a three-year master's degree with clinical portfolios. Once qualified, the goal is to create clinicians who work alongside doctors, seeing, treating, and discharging patients. Unlike previous practitioner roles, EC-ACPs treat the whole spectrum of ED patients, from minor injuries and illnesses to the sickest patients needing the highest level of care. These roles were heavily supported by local and political desires to create blended workforces to meet increasing patient demands. The problem with implementing ACP roles is that initially, little consultation was held with stakeholders in EDs. This has resulted in various trade-offs. For example, trainee doctors often feel displaced by trainee ACPs seeking to learn the same or similar skills. Previous research on advanced roles in ED has focused on direct clinical comparisons between doctors and practitioners. Researchers have investigated which professional (doctors vs. nurse practitioners) triages patients quickest or who is more accurate at interpreting X-rays. There are several problems with these approaches. The first is that they can create a professional rivalry. The second problem is that these approaches oversimplify what is a more complex system of care.

NCT ID: NCT06352528 Not yet recruiting - Healthy Volunteers Clinical Trials

A Study to Assess the Drug Levels of Repotrectinib in Healthy Participants and Participants With Moderate and Severe Hepatic Impairment

Start date: April 26, 2024
Phase: Phase 1
Study type: Interventional

The purpose of this study is to assess the drug levels of a single oral dose of repotrectinib in participants with moderate and severe HI, and in healthy matched control participants with normal hepatic function.

NCT ID: NCT06350851 Not yet recruiting - Healthy Volunteers Clinical Trials

Development of a New Rapid Diagnostic Test to Support Onchocerciasis Elimination

Obi1
Start date: April 2024
Phase: N/A
Study type: Interventional

Onchocerciasis, also known as river blindness, is one of the disease targeted for elimination by the World Health Organization (WHO) in the group of Neglected Tropical Diseases. Existing diagnostic tools for onchocerciasis have limitations that make mapping, epidemiological assessments and verification of elimination of onchocerciasis difficult. It is in this context that WHO, in its 2021-2030 roadmap for onchocerciasis, has identified the development of new diagnostic tests, or the improvement of existing diagnostic tests, as a critical condition for achieving the goal of eliminating onchocerciasis transmission. To this end, a series of cross-sectional studies will be carried out in Cameroun over a one year period to collect and characterize biological samples for the development and evaluation of a new rapid diagnostic test for onchocerciasis. The study will target individuals aged 18 and over, mono-infected with one of the filarial species Onchocerca volvulus, Loa loa or Mansonella perstans; and non-infected. At the end of this study, data on the endemicity of onchocerciasis, loiasis and mansonellosis in the selected communities will be updated. More importantly, a new rapid diagnostic test will be developed, which can then be used to monitor the activities of onchocerciasis control programs.