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NCT ID: NCT06400004 Not yet recruiting - Heart Diseases Clinical Trials

Lumason® Infusion vs. Bolus Administrations

Start date: April 30, 2024
Phase: Phase 3
Study type: Interventional

A phase III study designed as a randomized, within-patient comparison of continuous infusion of diluted Lumason® versus the bolus administration of undiluted Lumason® for degree of LVO and assessment of LV EBD (co-primary endpoints).

NCT ID: NCT06399861 Not yet recruiting - Clinical trials for Extremely Premature Infant

Humidity in Incubators for Tiny Infants

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

The objective of the study is to assess 2 different initial incubator humidification protocols for infants <25 weeks' gestation admitted to the neonatal intensive care unit (NICU). The hypothesis is that a higher starting humidity decreases dehydration and results in no difference in survival or morbidity. Higher (90%) and lower (70%) starting humidity will be compared.

NCT ID: NCT06399692 Not yet recruiting - Clinical trials for Coronary Artery Disease

REvascularization CHoices Among Under-Represented Groups Evaluation: The RECHARGE Trial - Women

RECHARGE:W
Start date: May 1, 2024
Phase: Phase 3
Study type: Interventional

This is a research study in women to compare the outcomes of two procedures that restore blood flow to the arteries of the heart. In one procedure the blockages are ballooned and then stented with a small wire mesh tube through a small incision in the wrist or the groin. The other procedure is an open-heart operation in which healthy blood vessels from inside the chest, leg, and/or forearm are used to "bypass" the blockages (like a detour). Outcomes will be measured by comparing survival and improvement in quality-of-life.

NCT ID: NCT06399679 Not yet recruiting - Clinical trials for Anticholinergic Toxicity

Rivastigmine to Prevent Recurrence of Antimuscarinic Delirium

RIVA-AP
Start date: June 2024
Phase: Phase 2
Study type: Interventional

Antimuscarinic delirium (AMD) is a common and dangerous toxicology condition caused by poisoning by medications and other chemicals that block muscarinic receptors. Physostigmine is effective in reversing AMD but has a short duration of action, and patient commonly experience recurrence of AMD after initial control with physostigmine. Recent case reports and small observational studies suggest that rivastigmine, which has a longer duration of action than physostigmine, might be useful in the treatment of AMD. In order to investigate the effectiveness of rivastigmine in preventing recurrence of AMD after initial control with physostigmine, the investigators propose a randomized, placebo-controlled clinical trial of rivastigmine for AMD. The investigators hypothesize that patients treated with rivastigmine after initial control of AMD with physostigmine will experience less recurrence of antimuscarinic delirium than those treated with placebo.

NCT ID: NCT06399653 Not yet recruiting - Clinical trials for Alcohol Use Disorder

Non-invasive Vagal Nerve Stimulation as Novel Treatment to Improve Functional Outcomes in Veterans With Alcohol Use Disorder

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

Alcohol use disorder (AUD) is a major health concern amongst Veterans as it causes functional impairments and decreased quality of life. Current AUD treatments show limited effectiveness in reducing withdrawal-related psychological and physical distress, which drives the urge to drink to relieve these symptoms. The investigators propose the vagus nerve, which is the primary nerve of the "rest and digest" branch of the autonomic nervous system via its bidirectional connections between the brain and the body, as a novel treatment target for AUD. The goal of this study is to assess treatment efficacy and mechanism of action. Noninvasive neuromodulation technologies offer the possibility for innovative, low risk treatments to support the rehabilitation and community reintegration of Veterans with AUD.

NCT ID: NCT06399640 Not yet recruiting - Clinical trials for Acute Myeloid Leukemia

Eltanexor and Venetoclax in Relapsed or Refractory Myelodysplastic Syndrome and Acute Myeloid Leukemia

Start date: July 31, 2024
Phase: Phase 1
Study type: Interventional

This phase I trial tests the safety, side effects, and best dose of eltanexor in combination with venetoclax for the treatment of patients with myelodysplastic syndrome (MDS) or acute myeloid leukemia (AML) that has come back after a period of improvement (relapsed) or that has not responded to previous treatment (refractory). Eltanexor works by trapping "tumor suppressing proteins" within the cell, thus causing the cancer cells to die or stop growing. 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 eltanexor together with venetoclax may be safe, tolerable and/or effective in treating patients with relapsed or refractory MDS or AML.

NCT ID: NCT06399276 Not yet recruiting - Breast Cancer Clinical Trials

4:3 Intermittent Fasting Intervention in Adults With Breast Cancer and Overweight or Obesity

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

This is a 3 month single arm pilot and feasibility study designed to examine the impact of an intermittent fasting lifestyle weight loss intervention on pre-specified clinical milestones (change in body weight, adherence to the fasting program, and moderate-to vigorous physical activity, MVPA) in adults with overweight and obesity and breast cancer after they have completed their cancer treatment. The investigators will also evaluate feasibility of recruitment and retention of study participants, safety of the intervention, and obtain feedback from participants to improve the program. Participants will receive a 3 month lifestyle weight loss program focusing on a 4:3 intermittent fasting paradigm (3 modified fast days per week) and support to increase physical activity to 150 minutes per week. Outcome measures will be assessed at the end of the 3 month intervention (primary endpoint) and after a 3 month weight maintenance follow up phase.

NCT ID: NCT06399263 Not yet recruiting - Anorexia Nervosa Clinical Trials

Study of Psilocybin for Anorexia in Young Adults

SPANYA
Start date: June 2024
Phase: Phase 2
Study type: Interventional

This is a single site trial of psilocybin therapy for the treatment of refractory Anorexia Nervosa in young adults. The psilocybin therapy will include three preparatory sessions, psilocybin dosing session one (20mg), two integration sessions, psilocybin dosing session two (30mg), and four final integration sessions. Eating disorder symptoms will be measured pre and post treatment. Two family members of each young adult participant will be enrolled in the study. One of which will be required to attend a portion of two preparatory sessions and a portion of two integration sessions and receive psychoeducation about supporting the young adult participant through preparation and integration for psilocybin therapy. Investigators hypothesize that psilocybin will increase cognitive flexibility and that this increase will predict long-term changes in cognitive rigidity, habitual eating, and exercise behaviors in patients with Anorexia Nervosa.

NCT ID: NCT06398847 Not yet recruiting - Neuropathic Pain Clinical Trials

Virtual Reality (VR) Self-Hypnosis Software

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

This single-site study of self-hypnosis software using an off-the-shelf virtual reality (VR) device (OculusGoâ„¢) to determine the software's safety, usability, and preliminary efficacy in pain relief for HIV-associated chronic pain patients. This is funded under the i Prism Funding through Mount Sinai Innovations.

NCT ID: NCT06398730 Not yet recruiting - Healthy Volunteers Clinical Trials

A Phase 1, Dose-Escalation, Positron Emission Tomography Study to Assess the Safety, Pharmacokinetics, Dosimetry and Biodistribution of GEH200521 (18F) Injection Co-Administered With GEH200520 Injection in Healthy Volunteers

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

This is a Phase 1, single-center, open-label, single-arm, dose-escalation positron emission tomography study to assess the safety and tolerability, immunogenicity, Pharmacokinetics, dosimetry, and biodistribution after GEH200521 (18F) Injection is co-administered with GEH200520 Injection in healthy volunteers. The estimated study duration for each subject is approximately 28 days. The primary study objective is to evaluate the safety and tolerability of the IMPs, the selected mass doses of GEH200520 Injection co-administered with a fixed dose of GEH200521 (18F) Injection.