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NCT ID: NCT06358651 Recruiting - Clinical trials for Social Anxiety Disorder

Fasedienol Nasal Spray for the Acute Treatment of Anxiety in Adults With Social Anxiety Disorder (PALISADE-3)

PALISADE-3
Start date: March 28, 2024
Phase: Phase 3
Study type: Interventional

This U.S. Phase 3 clinical trial is designed to evaluate the efficacy, safety, and tolerability of the acute intranasal (i.n.) administration of Fasedienol Nasal Spray (fasedienol) (3.2 µg) to relieve symptoms of acute anxiety in adult subjects ages 18 through 65 with Social Anxiety Disorder induced by a public speaking challenge (PSC) in a clinical setting. In addition, safety and tolerability of i.n. administration of 3.2 µg of fasedienol, as-needed, up to 6 times per day for up to 12 months, will be assessed in those subjects who complete PALISADE-3 and choose to enter the distinct open-label extension phase of the study.

NCT ID: NCT06358638 Recruiting - Sickle Cell Disease Clinical Trials

Sickle Cell Disease Transplant Using a Nonmyeloablative Approach for Patients With Anti-donor Red Cell AntibodY

SUN-RAY
Start date: April 3, 2024
Phase: Phase 2
Study type: Interventional

This multicenter prospective study seeks to determine if daratumumab given, prior to HLA-identical sibling donor transplantation using alemtuzumab, low dose total-body irradiation, and sirolimus, can prevent pure red blood cell aplasia with an acceptable safety profile in patients with anti-donor red blood cell antibodies, achieving an event-free survival similar to transplanted patients without such antibodies.

NCT ID: NCT06358560 Recruiting - Stress Clinical Trials

Applied Clinical Neuroscience and Its Effect on Self-reported Stress and Other Physiological Markers

Start date: March 4, 2024
Phase:
Study type: Observational

The purpose of this study is to see if an applied clinical neuroscience (ACN) approach to the symptom of 'stress' has a measurable effect on an individual's self-reported stress level. Physiological markers will be measured and analyzed to potentially allow for greater insight and aid in setting up any future research on this topic. This is an independent research study.

NCT ID: NCT06358274 Recruiting - Thru-hiking Clinical Trials

Nutritional and Metabolic Dynamics of Thru-Hiking: A Longitudinal Study on the Colorado Trail

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

Thru-hiking the Colorado Trail presents distinct challenges owing to its diverse landscapes and high altitudes. The study aims to delve into the physiological and nutritional facets of extended wilderness trekking among thru-hikers. Activities encompass participant recruitment from the Colorado Trail Foundation community, baseline and post-trail assessments including blood lipid panel analysis and anthropometric measurements, data collection during the trail period involving recording daily mileage, exertion levels, and dietary intake, rigorous statistical analysis to explore correlations among various parameters, and adherence to ethical considerations including obtaining formal approval and ensuring informed consent procedures are followed to safeguard participants' rights and privacy. Through this endeavor, the study seeks to offer insights into the metabolic responses and cardiovascular implications associated with thru-hiking, shedding light on the interplay between diet, lifestyle factors, and metabolic health in challenging environments. The specific aims include examining the metabolic responses and cardiovascular implications associated with thru-hiking, exploring correlations between dietary intake and blood lipid profiles, and elucidating the interplay between lifestyle factors and metabolic health in demanding environments. This study is not limited to program evaluation, quality assurance, or improvement activities within a specific department or setting but rather seeks to contribute to scientific knowledge and inform evidence-based recommendations for individuals engaging in thru-hiking or similar high-intensity activities.

NCT ID: NCT06357832 Recruiting - Clinical trials for Major Depressive Disorder

New Investigational Stimulation Protocol for Treatment of Major Depression Disorder (MDD)

Start date: April 29, 2024
Phase: N/A
Study type: Interventional

The BrainsWay Deep Transcranial Magnetic Stimulation (Depp TMS) device is intended for the treatment of depressive episodes in patients suffering from Major Depressive Disorder (MDD). The device technology is based on the application of deep brain TMS by means of repetitive pulse trains at a determined frequency. The purpose of the current study is to evaluate the safety and effectiveness of a new investigational stimulation protocol delivered with the BrainsWay Deep TMS device, for the treatment of MDD, demonstrating that it is non-inferior to the current standard-of-care stimulation protocol, in a randomized, controlled study.

NCT ID: NCT06357702 Recruiting - Clinical trials for Temporomandibular Disorder

K23- Physical Self Regulation vs Placebo

Start date: April 4, 2024
Phase: N/A
Study type: Interventional

This study will use a between-person design. Participants will be treatment-seeking patients with chronic masticatory muscle pain. Participants who are eligible for the study and consent to participate will be randomly assigned to receive a brief behavioral intervention for chronic orofacial pain called Physical Self-Regulation or a control intervention. Interventions will be administered via telehealth in both arms. Both interventions will consist of 2 50-minute sessions scheduled approximately two weeks apart. Participants will be contacted two weeks and three months after completing the interventions to provide additional follow-up data. Investigators hypothesize that both PSR-TH and the control intervention will demonstrate strong feasibility (i.e., recruitment of at least 1 participant per week, >75% retention, >95% interventionist fidelity, and adequate acceptability, credibility, and burden). Investigators also hypothesize that specific biopsychosocial variables will moderate PSR-TH-related changes in outcomes, and that PSR-TH-related changes in perceived control over pain, self-efficacy, coping, parafunctional habits, and relaxation will mediate treatment effects.

NCT ID: NCT06357533 Recruiting - Clinical trials for Non-Small Cell Lung Cancer

Phase III, Open-label, Study of First-line Dato-DXd in Combination With Rilvegostomig for Advanced Non-squamous NSCLC With High PD-L1 Expression (TC ≥ 50%) and Without Actionable Genomic Alterations

TROPION-Lung10
Start date: April 11, 2024
Phase: Phase 3
Study type: Interventional

The purpose of this study is to evaluate efficacy and safety of Dato-DXd in combination with rilvegostomig or rilvegostomig monotherapy compared with pembrolizumab monotherapy as a first line therapy in participants with locally advanced or metastatic non-squamous NSCLC with high PD-L1 expression (TC ≥ 50%) and without actionable genomic alterations.

NCT ID: NCT06357520 Recruiting - Clinical trials for Healthy Participants

A Study to Investigate the Pharmacokinetics of Baxdrostat When Given Alone and in Combination With Itraconazole in Healthy Participants

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

The main purpose of this study is to assess the effect of itraconazole on the pharmacokinetic (PK) of baxdrostat.

NCT ID: NCT06357247 Recruiting - Stroke Clinical Trials

The Effect of SRS on Hemiplegia in Stroke Survivors

Start date: March 4, 2024
Phase: N/A
Study type: Interventional

Strokes are one of the leading causes of long term disability and death in the United States. A stroke occurs when the blood supply to the brain is blocked, damaging parts of the brain. Many stroke survivors have difficulty completing dexterous hand movements and manipulating objects due brain damage in the sensorimotor cortex. Damage to these areas can cause decreased motor movements and tactile sensation on the affected side. Research shows that tactile sensation is necessary for maintaining grip, grading grip forces and decreasing object slippage. Therefore, it is important to address tactile sensation with motor performance during stroke rehabilitation to improve performance outcomes among stroke survivors.

NCT ID: NCT06357182 Recruiting - Clinical trials for Acute Myeloid Leukemia

Iadademstat in Combination With Azacitidine and Venetoclax in Treating Newly Diagnosed Acute Myeloid Leukemia

Start date: June 30, 2024
Phase: Phase 1
Study type: Interventional

This phase I trial tests the safety, side effects, and best dose of iadademstat when given together with azacitidine and venetoclax in treating patients with newly diagnosed acute myeloid leukemia (AML). Iadademstat inhibits the LSD1 protein and may lead to inhibition of cell growth in LSD1-overexpressing cancer cells. Chemotherapy drugs, such as azacitidine, work in different ways to stop the growth of cancer cells, either by killing the cells, by stopping them from dividing, or by stopping them from spreading. Venetoclax is in a class of medications called B-cell lymphoma-2 (Bcl-2) inhibitors. It may stop the growth of cancer cells by blocking Bcl-2, a protein needed for cancer cell survival. Giving iadademstat with azacitidine and venetoclax may be safe, tolerable and/or effective in treating patients with newly diagnosed AML who cannot undergo intensive chemotherapy.