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NCT ID: NCT05536375 Recruiting - Healthy Clinical Trials

A Pilot Feasibility Study of Detection of IL-11 and Other Cytokines in the Exhaled Breath Condensate (EBC) and Blood of Healthy Volunteers

Start date: September 20, 2022
Phase: N/A
Study type: Interventional

IL-11 is a receptor previously proven to be highly expressed in human lungs with idiopathic lung fibrosis, and in animal model, IL-11 receptor neutralizing antibody has been shown to prevent the process of fibrosis in bleomycin-induced lung fibrosis in rats. Separately, investigators know the expression of IL-11 can be detected in human by measuring its expression in the exhaled breath condensate (EBC) and serum. With the sera obtained, investigators will examine a whole range of other interleukins which had been implicated in mammalian lung fibrosis. Investigators aim to measure IL-11 in a pilot of human volunteers (healthy). This is important to subsequently see if IL-11 expression is increased in patients with a range of fibrotic diseases, with the potential to be used as diagnostic tool as well and to select patients who may benefit from IL-11 neutralizing antibody to delay/ cure their lung fibrosis including patients with idiopathic pulmonary fibrosis (IPF), drug/ radiation induced fibrosis and possibly even lung fibrosis as a chronic sequelae of COVID infection. IL-11 also has been shown to be highly relevant in cardiac patients- including chronic heart failure patients. Having reference ranges for IL-11 in the blood and EBC of healthy human volunteers will also be useful in future drug trials for IL-11 antibodies for future cardiac studies.

NCT ID: NCT05533372 Recruiting - Healthy Clinical Trials

MAD Study of IA-14069

Start date: October 10, 2022
Phase: Phase 1
Study type: Interventional

The purpose of this study is to assess the safety, tolerability, pharmacokinetics, and pharmacodynamics of multiple ascending oral doses of IA-14069 in healthy subjects and in patients with RA on stable dosese of MTX, with preliminary assessment of efficacy in RA patients.

NCT ID: NCT05532501 Recruiting - Healthy Clinical Trials

The Effects of Intranasal and Oral Administration of Oxytocin on Responses to Emotional Scenes

Start date: September 20, 2022
Phase: N/A
Study type: Interventional

The study will investigate whether oxytocin administered either intranasally or orally (lingual) (24 international units, IU) can differentially modulate men's neural and behavioral responses to emotional scenes using an implicit emotional paradigm.

NCT ID: NCT05528848 Recruiting - Healthy Clinical Trials

Multi-System Analysis of Opioid Receptor Binding

Start date: September 20, 2022
Phase: Phase 1
Study type: Interventional

This study will enroll up to 60 adults (including 30 females and 30 males) in three cohorts of up to 20 subjects each. In all three groups, [11C]carfentanil whole-body PET imaging will be used to examine the central nervous system (CNS) and broader systemic opioid binding in an initial scan session. In the two groups not receiving standard of care medication assisted treatment (MAT) for opioid use disorder (OUD) the effects on [11C]carfentanil binding potential of the blockade of opioid binding by the non-selective opioid antagonist naloxone administered parenterally in a second scan session will also be examined. If two scans are completed they can be done on the same day or on different days.

NCT ID: NCT05525845 Recruiting - Healthy Clinical Trials

Studying the Hedonic and Homeostatic Regulation of Food Intake Using Functional MRI

Start date: September 8, 2022
Phase: N/A
Study type: Interventional

The purpose of this study is to investigate how gut hormones and brain areas respond differently to gastric distention, tasteless calories, or palatable food and how this alters appetite.

NCT ID: NCT05523401 Recruiting - Healthy Clinical Trials

Acute Effects of 2C-B Compared With MDMA and Psilocybin in Healthy Subjects

2C-B
Start date: August 16, 2023
Phase: Phase 1
Study type: Interventional

4-bromo-2,5-dimethoxyphenethylamine (2C-B) is a psychoactive substance with reportedly similar acute effects to both the prototypical empathogen 3,4-methylenedioxymethamphetamine (MDMA, Ecstasy) and the classic psychedelic substance psilocybin (contained in "magic, hallucinogenic mushrooms"). Pharmacologically, MDMA mainly releases serotonin (5-HT) via the serotonin transporter (SERT) and psilocybin mainly acts as direct agonist at 5-HT2A receptors. 2C-B interacts with both the 5-HT2A receptor and SERT which is in line with its reported mixed effects profile. However, scientific studies are lacking. There is an increased interest in psychiatric research on the therapeutic properties of MDMA and psilocybin and also on mixed empathogenic-psychedelic substances.

NCT ID: NCT05521269 Recruiting - Healthy Clinical Trials

Dose Study of ANX1502 in Healthy Volunteers

Start date: June 27, 2022
Phase: Phase 1
Study type: Interventional

This study will evaluate the safety, tolerability, pharmacokinetics (PK), and pharmacodynamics (PD) of ANX1502 (prodrug) and ANX1439 (active drug) in healthy participants.

NCT ID: NCT05517928 Recruiting - Healthy Clinical Trials

A Study to Evaluate the Impact of Lactobacillus Rhamnosus GG on Proton Pump Inhibitor-Induced Gut Dysbiosis

Start date: March 3, 2023
Phase: N/A
Study type: Interventional

The purpose of this study is to investigate the impact of the probiotic Lactobacillus rhamnosus (LGG) on proton pump inhibitor (PPI)-induced changes to the microbes that live in the gastrointestinal tract and are passed out in the stool. PPI medicines reduce stomach acid and are commonly used to treat acid reflux disease.

NCT ID: NCT05516680 Recruiting - Healthy Clinical Trials

Effects and Central Mechanism of Electroacupuncture and MRI-navigated rTMS for PSD

Start date: October 22, 2022
Phase: N/A
Study type: Interventional

Introduction: Post-stroke depression (PSD) is the most common mental complication after stroke and has a serious impact on functional outcomes and quality of life. Antidepressants are the first-line treatment for PSD, but many reported side effects remain. Clinical research and practice guidelines have shown that electro-acupuncture and rTMS have a positive effect on PSD. This trial aims to study the efficacy and safety of electro-acupuncture and a modern MRI-navigated rTMS for PSD and to explore its fMRI-based central mechanism on depression. It is hypothesized that electro-acupuncture and MRI-navigated rTMS treatment improves depressive symptoms, neuro-patho-physiological behaviors, quality of life and central response in PSD. Methods: In this randomized, controlled, assessors-blinded trial, sixty-four patients with PSD will be randomly allocated into the experiment group (n=32) or control group(n=32) . The experiment group will receive electro-acupuncture and MRI-navigated rTMS, and the control group will receive MRI-navigated rTMS treatment, in 12-20 sessions over 4 weeks. In addition, ten healthy people for fMRI scanning will be recruited as a healthy control group without any intervention. The primary outcome is the change from baseline in the Hamilton Depression Scale-24 items (HAMD-24) scores at week 4. The primary analysis of central mechanism mainly involves cortical morphology, local spontaneous brain activity, and default mode network (DMN) functional connectivity based on fMRI at 0-wk and 4-wk. Secondary outcomes include the neuro-patho-physiological and quality of life changes in cortical excitability with motor evoked potential test(MEP), National Institutes of Health Stroke Scale(NIHSS), EuroQol Five Dimensions Questionnaire(EQ-5D) Scale, Modified Barthel Index(MBI) Scale and Short Form-Health Scale of Traditional Chinese Medicine(SF-HSTCM). Additional indicators include the Acceptability Questionnaire and Health Economics Evaluation (cost-effectiveness analysis) to assess acceptability and economic practicality of the treatment in study. Outcomes are assessed at baseline and post intervention. Discussion: Electro-acupuncture and MRI-navigated rTMS therapy could become an alternative treatment for PSD, and it is expected that this trial will provide reliable clinical evidence and potential effect mechanism for the future use of electro-acupuncture and MRI-navigated rTMS for PSD.

NCT ID: NCT05506007 Recruiting - Healthy Clinical Trials

A Clinical Trial to Compare the Safety, Tolerability, and PK Properties of DA-5216 and DA-5216-R and to Evaluate the Food Effect on DA-5216.

Start date: August 29, 2022
Phase: Phase 1
Study type: Interventional

This is a randomized, open-label, single dose, 2-part, cross-over clinical trial to compare the safety, tolerability, and pharmacokinetic properties of DA-5216 and DA-5216-R and to evaluate the food effect on DA-5216 in healthy adult subjects